[Title 21 CFR 876]
[Code of Federal Regulations (annual edition) - April 1, 1999 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION,]
[Subchapter H - MEDICAL DEVICES]
[Part 876 - GASTROENTEROLOGY-UROLOGY DEVICES]
[From the U.S. Government Printing Office]
21FOOD AND DRUGS81999-04-011999-04-01falseGASTROENTEROLOGY-UROLOGY DEVICES876PART 876FOOD AND DRUGSFOOD AND DRUG ADMINISTRATION,MEDICAL DEVICES
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES--Table of Contents
Subpart A--General Provisions
Sec.
876.1 Scope.
876.3 Effective dates of requirement for premarket approval.
876.9 Limitations of exemptions from section 510(k) of the Federal
Food, Drug, and Cosmetic Act (the act).
Subpart B--Diagnostic Devices
876.1075 Gastroenterology-urology biopsy instrument.
876.1400 Stomach pH electrode.
876.1500 Endoscope and accessories.
876.1620 Urodynamics measurement system.
876.1725 Gastrointestinal motility monitoring system.
876.1800 Urine flow or volume measuring system.
Subpart C--Monitoring Devices
876.2040 Enuresis alarm.
Subpart D--Prosthetic Devices
876.3350 Penile inflatable implant.
876.3630 Penile rigidity implant.
876.3750 Testicular prosthesis.
Subpart E--Surgical Devices
876.4020 Fiberoptic light ureteral catheter.
876.4270 Colostomy rod.
876.4300 Endoscopic electrosurgical unit and accessories.
876.4370 Gastroenterology-urology evacuator.
876.4400 Hemorrhoidal ligator.
876.4480 Electrohydraulic lithotriptor.
876.4500 Mechanical lithotriptor.
876.4530 Gastroenterology-urology fiberoptic retractor.
876.4560 Ribdam.
876.4590 Interlocking urethral sound.
876.4620 Ureteral stent.
876.4650 Water jet renal stone dislodger system.
876.4680 Ureteral stone dislodger.
876.4730 Manual gastroenterology-urology surgical instrument and
accessories.
876.4770 Urethrotome.
876.4890 Urological table and accessories.
Subpart F--Therapeutic Devices
876.5010 Biliary catheter and accessories.
876.5030 Continent ileostomy catheter.
876.5090 Suprapubic urological catheter and accessories.
876.5130 Urological catheter and accessories.
876.5160 Urological clamp for males.
876.5210 Enema kit.
876.5220 Colonic irrigation system.
876.5250 Urine collector and accessories.
876.5270 Implanted electrical urinary continence device.
876.5280 Implanted mechanical/hydraulic urinary continence device.
876.5320 Nonimplanted electrical continence device.
876.5365 Esophageal dilator.
876.5450 Rectal dilator.
876.5470 Ureteral dilator.
876.5520 Urethral dilator.
876.5540 Blood access device and accessories.
[[Page 340]]
876.5600 Sorbent regenerated dialysate delivery system for
hemodialysis.
876.5630 Peritoneal dialysis system and accessories.
876.5665 Water purification system for hemodialysis.
876.5820 Hemodialysis system and accessories.
876.5830 Hemodialyzer with disposable insert (Kiil type).
876.5860 High permeability hemodialysis system.
876.5870 Sorbent hemoperfusion system.
876.5880 Isolated kidney perfusion and transport system and
accessories.
876.5895 Ostomy irrigator.
876.5900 Ostomy pouch and accessories.
876.5920 Protective garment for incontinence.
876.5955 Peritoneo-venous shunt.
876.5970 Hernia support.
876.5980 Gastrointestinal tube and accessories.
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
Source: 48 FR 53023, Nov. 23, 1983, unless otherwise noted.
Subpart A--General Provisions
Sec. 876.1 Scope.
(a) This part sets forth the classification of gastroenterology-
urology devices intended for human use that are in commercial
distribution.
(b) The identification of a device in a regulation in this part is
not a precise description of every device that is, or will be, subject
to the regulation. A manufacturer who submits a premarket notification
submission for a device under part 807 may not show merely that the
device is accurately described by the section title and identification
provisions of a regulation in this part, but shall state why the device
is substantially equivalent to other devices, as required by
Sec. 807.87.
(c) To avoid duplicative listings, a gastroenterology-urology device
that has two or more types of uses (e.g., used both as a diagnostic
device and as a therapeutic device) is listed only in one subpart.
(d) References in this part to regulatory sections of the Code of
Federal Regulations are to chapter I of title 21, unless otherwise
noted.
[52 FR 17737, May 11, 1987; 52 FR 22577, June 12, 1987]
Sec. 876.3 Effective dates of requirement for premarket approval.
A device included in this part that is classified into class III
(premarket approval) shall not be commercially distributed after the
date shown in the regulation classifying the device unless the
manufacturer has an approval under section 515 of the act (unless an
exemption has been granted under section 520(g)(2) of the act). An
approval under section 515 of the act consists of FDA's issuance of an
order approving an application for premarket approval (PMA) for the
device or declaring completed a product development protocol (PDP) for
the device.
(a) Before FDA requires that a device commercially distributed
before the enactment date of the amendments, or a device that has been
found substantially equivalent to such a device, has an approval under
section 515 of the act FDA must promulgate a regulation under section
515(b) of the act requiring such approval, except as provided in
paragraph (b) of this section. Such a regulation under section 515(b) of
the act shall not be effective during the grace period ending on the
90th day after its promulgation or on the last day of the 30th full
calendar month after the regulation that classifies the device into
class III is effective, whichever is later. See section 501(f)2)(B) of
the act. Accordingly, unless an effective date of the requirement for
premarket approval is shown in the regulation for a device classified
into class III in this part, the device may be commerically distributed
without FDA's issuance of an order approving a PMA or declaring
completed a PDP for the device. If FDA promulgates a regulation under
section 515(b) of the act requiring premarket approval for a device,
section 501(f)(1)(A) of the act applies to the device.
(b) Any new, not substantially equivalent, device introduced into
commercial distribution on or after May 28, 1976, including a device
formerly marketed that has been substantially altered, is classified by
statute (section 513(f) of the act) into class III without any grace
period and FDA must have issued an order approving a PMA or declaring
completed a PDP for the device
[[Page 341]]
before the device is commercially distributed unless it is reclassified.
If FDA knows that a device being commercially distributed may be a
``new'' device as defined in this section because of any new intended
use or other reasons, FDA may codify the statutory classification of the
device into class III for such new use. Accordingly, the regulation for
such a class III device states that as of the enactment date of the
amendments, May 28, 1976, the device must have an approval under section
515 of the act before commercial distribution.
[52 FR 17737, May 11, 1987]
Sec. 876.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
(a) The Food and Drug Administration (FDA's) decision to grant an
exemption from the requirement of premarket notification (section 510(k)
of the act) for a generic type of class I device is based upon the
existing and reasonably foreseeable characteristics of commercially
distributed devices within that generic type. Because FDA cannot
anticipate every change in intended use or characteristic that could
significantly affect a device's safety or effectiveness, manufacturers
of any commercially distributed class I device for which FDA has granted
an exemption from the requirement of premarket notification must still
submit a premarket notification to FDA before introducing or delivering
for introduction into interstate commerce for commercial distribution
the device when:
(1) The device is intended for a use different from its intended use
before May 28, 1976, or the device is intended for a use different from
the intended use of a preamendments device to which it had been
determined to be substantially equivalent; e.g., the device is intended
for a different medical purpose, or the device is intended for lay use
where the former intended use was by health care professionals only; or
(2) The modified device operates using a different fundamental
scientific technology than that in use in the device before May 28,
1976; e.g., a surgical instrument cuts tissue with a laser beam rather
than with a sharpened metal blade, or an in vitro diagnostic device
detects or identifies infectious agents by using a deoxyribonucleic acid
(DNA) probe or nucleic acid hybridization technology rather than culture
or immunoassay technology.
(b) The exemption from the requirement of premarket notification for
a generic type of class II device applies only to those class II devices
that have existing or reasonably foreseeable characteristics of
commercially distributed devices within that generic type, or, in the
case of in vitro diagnostic devices, for which a misdiagnosis, as a
result of using the device, would not be associated with high morbidity
or mortality. A class II device for which FDA has granted an exemption
from the requirement of premarket notification must still submit a
premarket notification when:
(1) The device is intended for a use different from the intended use
of a legally marketed device in that generic type of device; e.g., the
device is intended for a different medical purpose, or the device is
intended for lay use where the former intended use was by health care
professionals only; or
(2) The modified device operates using a different fundamental
scientific technology than a legally marketed device in that generic
type of device; e.g., a surgical instrument cuts tissue with a laser
beam rather than with a sharpened metal blade, or an in vitro diagnostic
device detects or identifies infectious agents by using deoxyribonucleic
acid (DNA) probe or nucleic acid hybridization technology rather than
culture or immunoassay technology; or
(3) The device is an in vitro device that is intended:
(i) For use in the diagnosis, monitoring, or screening of neoplastic
diseases with the exception of immunohistochemical devices;
(ii) For use in screening or diagnosis of familial and acquired
genetic disorders, including inborn errors of metabolism;
(iii) For measuring an analyte that serves as a surrogate marker for
screening, diagnosis, or monitoring life-threatening diseases such as
acquired immune deficiency syndrome
[[Page 342]]
(AIDS), chronic or active hepatitis, tuberculosis, or myocardial
infarction or to monitor therapy;
(iv) For assessing the risk of cardiovascular diseases;
(v) For use in diabetes management;
(vi) For identifying or inferring the identity of a microorganism
directly from clinical material;
(vii) For detection of antibodies to microorganism other than
immunoglobulin G (IgG) and IgG assays when the results are not
qualitative, or are used to determine immunity, or the assay is intended
for use in matrices other than serum or plasma;
(viii) For noninvasive testing; and
(ix) For near patient testing (point of care).
[54 FR 25049, June 12, 1989, as amended at 63 FR 59227, Nov. 3, 1998]
Subpart B--Diagnostic Devices
Sec. 876.1075 Gastroenterology-urology biopsy instrument.
(a) Identification. A gastroenterology-urology biopsy instrument is
a device used to remove, by cutting or aspiration, a specimen of tissue
for microscopic examination. This generic type of device includes the
biopsy punch, gastrointestinal mechanical biopsy instrument, suction
biopsy instrument, gastro-urology biopsy needle and needle set, and
nonelectric biopsy forceps. This section does not apply to biopsy
instruments that have specialized uses in other medical specialty areas
and that are covered by classification regulations in other parts of the
device classification regulations.
(b) Classification. (1) Class II (performance standards).
(2) Class I for the biopsy forceps cover and the non-electric biopsy
forceps. The devices subject to this paragraph (b)(2) are exempt from
the premarket notification procedures in subpart E of part 807 of this
chapter.
[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996]
Sec. 876.1400 Stomach pH electrode.
(a) Identification. A stomach pH electrode is a device used to
measure intragastric and intraesophageal pH (hydrogen ion
concentration). The pH electrode is at the end of a flexible lead which
may be inserted into the esophagus or stomach through the patient's
mouth. The device may include an integral gastrointestinal tube.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996]
Sec. 876.1500 Endoscope and accessories.
(a) Identification. An endoscope and accessories is a device used to
provide access, illumination, and allow observation or manipulation of
body cavities, hollow organs, and canals. The device consists of various
rigid or flexible instruments that are inserted into body spaces and may
include an optical system for conveying an image to the user's eye and
their accessories may assist in gaining access or increase the
versatility and augment the capabilities of the devices. Examples of
devices that are within this generic type of device include cleaning
accessories for endoscopes, photographic accessories for endoscopes,
nonpowered anoscopes, binolcular attachments for endoscopes, pocket
battery boxes, flexible or rigid choledochoscopes, colonoscopes,
diagnostic cystoscopes, cystourethroscopes, enteroscopes,
esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic
illuminators for endoscopes, incandescent endoscope lamps, biliary
pancreatoscopes, proctoscopes, resectoscopes, nephroscopes,
sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers,
cytology brushes for endoscopes, and lubricating jelly for transurethral
surgical instruments. This section does not apply to endoscopes that
have specialized uses in other medical specialty areas and that are
covered by classification regulations in other parts of the device
classification regulations.
(b) Classification. (1) Class II (performance standards).
(2) Class I for the photographic accessories for endoscope,
miscellaneous bulb adapter for endoscope, binocular
[[Page 343]]
attachment for endoscope, eyepiece attachment for prescription lens,
teaching attachment, inflation bulb, measuring device for panendoscope,
photographic equipment for physiologic function monitor, special lens
instrument for endoscope, smoke removal tube, rechargeable battery box,
pocket battery box, bite block for endoscope, and cleaning brush for
endoscope. The devices subject to this paragraph (b)(2) are exempt from
the premarket notification procedures in subpart E of part 807 of this
chapter.
[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996]
Sec. 876.1620 Urodynamics measurement system.
(a) Identification. A urodynamics measurement system is a device
used to measure volume and pressure in the urinary bladder when it is
filled through a catheter with carbon dioxide or water. The device
controls the supply of carbon dioxide or water and may also record the
electrical activity of the muscles associated with urination. The device
system may include transducers, electronic signal conditioning and
display equipment, a catheter withdrawal device to enable a urethral
pressure profile to be obtained, and special catheters for urethral
profilometry and electrodes for electromyography. This generic type of
device includes the cystometric gas (carbon dioxide) device, the
cystometric hydrualic device, and the electrical recording cystometer,
but excludes any device that uses air to fill the bladder.
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 876.9.
[48 FR 53023, Nov. 23, 1983, as amended at 63 FR 59228, Nov. 3, 1998]
Sec. 876.1725 Gastrointestinal motility monitoring system.
(a) Identification. A gastrointestinal motility monitoring system is
a device used to measure peristalic activity or pressure in the stomach
or esophagus by means of a probe with transducers that is introduced
through the mouth into the gastrointestinal tract. The device may
include signal conditioning, amplifying, and recording equipment. This
generic type of device includes the esophageal motility monitor and
tube, the gastrointestinal motility (electrical) system, and certain
accessories, such as a pressure transducer, amplifier, and external
recorder.
(b) Classification. Class II (performance standards).
Sec. 876.1800 Urine flow or volume measuring system.
(a) Identification. A urine flow or volume measuring system is a
device that measures directly or indirectly the volume or flow of urine
from a patient, either during the course of normal urination or while
the patient is catheterized. The device may include a drip chamber to
reduce the risk of retrograde bacterial contamination of the bladder and
a transducer and electrical signal conditioning and display equipment.
This generic type of device includes the electrical urinometer,
mechanical urinometer, nonelectric urinometer, disposable nonelectric
urine flow rate measuring device, and uroflowmeter.
(b) Classification. (1) Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 876.9.
[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 63
FR 59228, Nov. 3, 1998]
Subpart C--Monitoring Devices
Sec. 876.2040 Enuresis alarm.
(a) Identification. An enuresis alarm is a device intended for use
in treatment of bedwetting. Through an electrical trigger mechanism, the
device sounds an alarm when a small quantity of urine is detected on a
sensing pad. This generic type of device includes conditioned response
enuresis alarms.
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 876.9.
[48 FR 53023, Nov. 23, 1983, as amended at 63 FR 59228, Nov. 3, 1998]
[[Page 344]]
Subpart D--Prosthetic Devices
Sec. 876.3350 Penile inflatable implant.
(a) Identification. A penile inflatable implant is a device that
consists of two inflatable cylinders implanted in the penis, connected
to a reservoir filled with radiopaque fluid implanted in the abdomen,
and a subcutaneous manual pump implanted in the scrotum. When the
cylinders are inflated, they provide rigidity to the penis. This device
is used in the treatment of erectile impotence.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See Sec. 876.3.
[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987]
Sec. 876.3630 Penile rigidity implant.
(a) Identification. A penile rigidity implant is a device that
consists of a single semi-rigid rod or a pair of semi-rigid rods
implanted in the penis to provide rigidity. It is used in the treatment
of erectile impotence.
(b) Classification. Class III (permarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See Sec. 876.3.
[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987]
Sec. 876.3750 Testicular prosthesis.
(a) Identification. A testicular prosthesis is an implanted device
that consists of a solid or gel-filled silicone rubber prosthesis that
is implanted surgically to resemble a testicle.
(b) Classification. Class III (premarket approval).
(c) Date premarket approval application (PMA) or notice of product
development protocol (PDP) is required. A PMA or notice of completion of
a PDP is required to be filed with the Food and Drug Administration on
or before July 5, 1995, for any testicular prosthesis that was in
commercial distribution before May 28, 1976, or that has on or before
July 5, 1995, been found to be substantially equivalent to a testicular
prosthesis that was in commercial distribution before May 28, 1976. Any
other testicular prosthesis shall have an approved PMA or a declared
completed PDP in effect before being placed in commercial distribution.
[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 60
FR 17216, Apr. 5, 1995]
Subpart E--Surgical Devices
Sec. 876.4020 Fiberoptic light ureteral catheter.
(a) Identification. A fiberoptic light ureteral catheter is a device
that consists of a fiberoptic bundle that emits light throughout its
length and is shaped so that it can be inserted into the ureter to
enable the path of the ureter to be seen during lower abdominal or
pelvic surgery.
(b) Classification. Class II (performance standards).
Sec. 876.4270 Colostomy rod.
(a) Identification. A colostomy rod is a device used during the loop
colostomy procedure. A loop of colon is surgically brought out through
the abdominal wall and the stiff colostomy rod is placed through the
loop temporarily to keep the colon from slipping back through the
surgical opening.
(b) Classification. Class II (performance standards).
Sec. 876.4300 Endoscopic electrosurgical unit and accessories.
(a) Identification. An endoscopic electrosurgical unit and
accessories is a device used to perform electrosurgical procedures
through an endoscope. This generic type of device includes the
electrosurgical generator, patient plate, electric biopsy forceps,
electrode, flexible snare, electrosurgical alarm system, electrosurgical
power supply unit, electrical clamp, self-opening rigid snare, flexible
suction coagulator electrode, patient return wristlet, contact jelly,
adaptor to the cord for transurethral surgical instruments, the electric
cord for transurethral surgical instruments, and the transurethral
desiccator.
(b) Classification. Class II (performance standards).
[[Page 345]]
Sec. 876.4370 Gastroenterology-urology evacuator.
(a) Identification. A gastroenterology-urology evacuator is a device
used to remove debris and fluids during gastroenterological and
urological procedures by drainage, aspiration, or irrigation. This
generic type of device includes the fluid evacuator system, manually
powered bladder evacuator, and the AC-powered vacuum pump.
(b) Classification. (1) Class II (special controls) for the
gastroenterology-urology evacuator when other than manually powered. The
device is exempt from the premarket notification procedures in subpart E
of part 807 of this chapter subject to Sec. 876.9.
(2) Class I for the gastroenterology-urology evacuator when manually
powered. The device subject to this paragraph (b)(2) is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
[48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25049, June 12, 1989;
63 FR 59228, Nov. 3, 1998]
Sec. 876.4400 Hemorrhoidal ligator.
(a) Identification. A hemorrhoidal ligator is a device used to cut
off the blood flow to hemorrhoidal tissue by means of a ligature or band
placed around the hemorrhoid.
(b) Classification. Class II (performance standards).
Sec. 876.4480 Electrohydraulic lithotriptor.
(a) Identification. An electrohydraulic lithotriptor is an AC-
powered device used to fragment urinary bladder stones. It consists of a
high voltage source connected by a cable to a bipolar electrode that is
introduced into the urinary bladder through a cystoscope. The electrode
is held against the stone in a water-filled bladder and repeated
electrical discharges between the two poles of the electrode cause
electrohydraulic shock waves which disintegrate the stone.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See Sec. 876.3.
[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987]
Sec. 876.4500 Mechanical lithotriptor.
(a) Identification. A mechanical lithotriptor is a device with steel
jaws that is inserted into the urinary bladder through the urethra to
grasp and crush bladder stones.
(b) Classification. Class II (performance standards).
Sec. 876.4530 Gastroenterology-urology fiberoptic retractor.
(a) Identification. A gastroenterology-urology fiberoptic retractor
is a device that consists of a mechanical retractor with a fiberoptic
light system that is used to illuminate deep surgical sites.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25049, June 12, 1989]
Sec. 876.4560 Ribdam.
(a) Identification. A ribdam is a device that consists of a broad
strip of latex with supporting ribs used to drain surgical wounds where
copious urine drainage is expected.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25049, June 12, 1989]
Sec. 876.4590 Interlocking urethral sound.
(a) Identification. An interlocking urethral sound is a device that
consists of two metal sounds (elongated instruments for exploring or
sounding body cavities) with interlocking ends, such as with male and
female threads or a rounded point and mating socket, used in the repair
of a ruptured urethra. The device may include a protective cap to fit
over the metal threads.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996]
[[Page 346]]
Sec. 876.4620 Ureteral stent.
(a) Identification. A ureteral stent is a tube-like implanted device
that is inserted into the ureter to provide ureteral rigidity and allow
the passage of urine. The device may have finger-like protrusions or
hooked ends to keep the tube in place. It is used in the treatment of
ureteral injuries and ureteral obstruction.
(b) Classification. Class II (performance standards).
Sec. 876.4650 Water jet renal stone dislodger system.
(a) Identification. A water jet renal stone dislodger system is a
device used to dislodge stones from renal calyces (recesses of the
pelvis of the kidney) by means of a pressurized stream of water through
a conduit. The device is used in the surgical removal of kidney stones.
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 876.9.
[48 FR 53023, Nov. 23, 1983, as amended at 63 FR 59228, Nov. 3, 1998]
Sec. 876.4680 Ureteral stone dislodger.
(a) Identification. A ureteral stone dislodger is a device that
consists of a bougie or a catheter with an expandable wire basket near
the tip, a special flexible tip, or other special construction. It is
inserted through a cystoscope and used to entrap and remove stones from
the ureter. This generic type of device includes the metal basket and
the flexible ureteral stone dislodger.
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 876.9.
[48 FR 53023, Nov. 23, 1983, as amended at 63 FR 59228, Nov. 3, 1998]
Sec. 876.4730 Manual gastroenterology-urology surgical instrument and accessories.
(a) Identification. A manual gastroenterology-urology surgical
instrument and accessories is a device designed to be used for
gastroenterological and urological surgical procedures. The device may
be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-
urology surgical instruments include the biopsy forceps cover, biopsy
tray without biopsy instruments, line clamp, nonpowered rectal probe,
nonelectrical clamp, colostomy spur-crushers, locking device for
intestinal clamp, needle holder, gastro-urology hook, gastro-urology
probe and director, nonself-retaining retractor, laparotomy rings,
nonelectrical snare, rectal specula, bladder neck spreader, self-
retaining retractor, and scoop.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25049, June 12, 1989]
Sec. 876.4770 Urethrotome.
(a) Identification. A urethrotome is a device that is inserted into
the urethra and used to cut urethral strictures and enlarge the urethra.
It is a metal instrument equipped with a dorsal-fin cutting blade which
can be elevated from its sheath. Some urethrotomes incorporate an
optical channel for visual control.
(b) Classification. Class II (performance standards).
Sec. 876.4890 Urological table and accessories.
(a) Identification. A urological table and accessories is a device
that consists of a table, stirrups, and belts used to support a patient
in a suitable position for endoscopic procedures of the lower urinary
tract. The table can be adjusted into position manually or electrically.
(b) Classification. (1) Class II (special controls) for the
electrically powered urological table and accessories. The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 876.9.
(2) Class I for the manually powered table and accessories, and for
stirrups for electrically powered table. The device subject to this
paragraph (b)(2) is
[[Page 347]]
exempt from the premarket notification procedures in subpart E of part
807 of this chapter.
[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 63
FR 59228, Nov. 3, 1998]
Subpart F--Therapeutic Devices
Sec. 876.5010 Biliary catheter and accessories.
(a) Identification. A biliary catheter and accessories is a tubular
flexible device used for temporary or prolonged drainage of the biliary
tract, for splinting of the bile duct during healing, or for preventing
stricture of the bile duct. This generic type of device may include a
bile collecting bag that is attached to the biliary catheter by a
connector and fastened to the patient with a strap.
(b) Classification. Class II (performance standards).
Sec. 876.5030 Continent ileostomy catheter.
(a) Identification. A continent ileostomy catheter is a flexible
tubular device used as a form during surgery for continent ileostomy and
it provides drainage after surgery. Additionally, the device may be
inserted periodically by the patient for routine care to empty the ileal
pouch. This generic type of device includes the rectal catheter for
continent ileostomy.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25050, June 12, 1989]
Sec. 876.5090 Suprapubic urological catheter and accessories.
(a) Identification. A suprapubic urological catheter and accessories
is a flexible tubular device that is inserted through the abdominal wall
into the urinary bladder with the aid of a trocar and cannula. The
device is used to pass fluids to and from the urinary tract. This
generic type of device includes the suprapubic catheter and tube,
Malecot catheter, catheter punch instrument, suprapubic drainage tube,
and the suprapubic cannula and trocar.
(b) Classification. (1) Class II (performance standards).
(2) Class I for the catheter punch instrument, nondisposable cannula
and trocar, and gastro-urological trocar. The devices subject to this
paragraph (b)(2) are exempt from the premarket notification procedures
in subpart E of part 807 of this chapter.
[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996]
Sec. 876.5130 Urological catheter and accessories.
(a) Identification. A urological catheter and accessories is a
flexible tubular device that is inserted through the urethra and used to
pass fluids to or from the urinary tract. This generic type of device
includes radiopaque urological catheters, ureteral catheters, urethral
catheters, coude catheters, balloon retention type catheters, straight
catheters, upper urinary tract catheters, double lumen female
urethrographic catheters, disposable ureteral catheters, male
urethrographic catheters, and urological catheter accessories including
ureteral catheter stylets, ureteral catheter adapters, ureteral catheter
holders, ureteral catheter stylets, ureteral catheterization trays, and
the gastro-urological irrigation tray (for urological use).
(b) Classification. (1) Class II (performance standards).
(2) Class I for the ureteral stylet (guidewire), stylet for gastro-
urological catheter, ureteral catheter adapter, ureteral catheter
connector, and ureteral catheter holder. The devices subject to this
paragraph (b)(2) are exempt from the premarket notification procedures
in subpart E of part 807 of this chapter.
[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996]
Sec. 876.5160 Urological clamp for males.
(a) Identification. A urological clamp for males is a device used to
close the urethra of a male to control urinary incontinence or to hold
anesthetic or radiography contrast media in the urethra temporarily. It
is an external clamp.
[[Page 348]]
(b) Classification. Class I (general controls).
Sec. 876.5210 Enema kit.
(a) Identification. An enema kit is a device intended to instill
water or other fluids into the colon through a nozzle inserted into the
rectum to promote evacuation of the contents of the lower colon. The
device consists of a container for fluid connected to the nozzle either
directly or via tubing. This device does not include the colonic
irrigation system (Sec. 876.5220).
(b) Classification. Class I (general controls). The device is exempt
from the current good manufacturing practice regulations in part 820,
with the exception of Sec. 820.180, with respect to general requirements
concerning records, and Sec. 820.198, with respect to complaint files.
Sec. 876.5220 Colonic irrigation system.
(a) Identification. A colonic irrigation system is a device intended
to instill water into the colon through a nozzle inserted into the
rectum to cleanse (evacuate) the contents of the lower colon. The system
is designed to allow evacuation of the contents of the colon during the
administration of the colonic irrigation. The device consists of a
container for fluid connected to the nozzle via tubing and includes a
system which enables the pressure, temperature, or flow of water through
the nozzle to be controlled. The device may include a console-type
toilet and necessary fittings to allow the device to be connected to
water and sewer pipes. The device may use electrical power to heat the
water. The device does not include the enema kit (Sec. 876.5210).
(b) Classification. (1) Class II (performance standards) when the
device is intended for colon cleansing when medically indicated, such as
before radiological or endoscopic examinations.
(2) Class III (premarket approval) when the device is intended for
other uses, including colon cleansing routinely for general well being.
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before December 26, 1996 for any colonic
irrigation system described in paragraph (b)(2) of this section that was
in commercial distribution before May 28, 1976, or that has, on or
before December 26, 1996 been found to be substantially equivalent to a
colonic irrigation system described in paragraph (b)(2) of this section
that was in commercial distribution before May 28, 1976. Any other
colonic irrigation system shall have an approved PMA in effect before
being placed in commercial distribution.
[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 61
FR 50707, Sept. 27, 1996]
Sec. 876.5250 Urine collector and accessories.
(a) Identification. A urine collector and accessories is a device
intended to collect urine. The device and accessories consist of tubing,
a suitable receptacle, connectors, mechanical supports, and may include
a means to prevent the backflow of urine or ascent of infection. The two
kinds of urine collectors are:
(1) A urine collector and accessories intended to be connected to an
indwelling catheter, which includes the urinary drainage collection kit
and the closed urine drainage system and drainage bag; and
(2) A urine collector and accessories not intended to be connected
to an indwelling catheter, which includes the corrugated rubber sheath,
pediatric urine collector, leg bag for external use, urosheath type
incontinence device, and the paste-on device for incontinence.
(b) Classification. (1) Class II (special controls) for a urine
collector and accessories intended to be connected to an indwelling
catheter. The device is exempt from the premarket notification
procedures in subpart E of part 807 of this chapter subject to
Sec. 876.9.
(2) Class I (general controls) for a urine collector and accessories
not intended to be connected to an indwelling catheter. If the device is
not labeled or otherwise represented as sterile, it is exempt from the
current good manufacturing practice regulations in part 820, with the
exception of Sec. 820.180, with respect to general requirements
[[Page 349]]
concerning records, and Sec. 820.198, with respect to complaint files.
[48 FR 53023, Nov. 23, 1983, as amended at 63 FR 59228, Nov. 3, 1998]
Sec. 876.5270 Implanted electrical urinary continence device.
(a) Identification. An implanted electrical urinary device is a
device intended for treatment of urinary incontinence that consists of a
receiver implanted in the abdomen with electrodes for pulsed-stimulation
that are implanted either in the bladder wall or in the pelvic floor,
and a battery-powered transmitter outside the body.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before December 26, 1996 for any implanted
electrical urinary continence device that was in commercial distribution
before May 28, 1976, or that has, on or before December 26, 1996 been
found to be substantially equivalent to an implanted electrical urinary
continence device that was in commercial distribution before May 28,
1976. Any other implanted electrical urinary continence device shall
have an approved PMA or a declared completed PDP in effect before being
placed in commercial distribution.
[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 61
FR 50707, Sept. 27, 1996]
Sec. 876.5280 Implanted mechanical/hydraulic urinary continence device.
(a) Identification. An implanted mechanical/hydraulic urinary
continence device is a device used to treat urinary incontinence by the
application of continuous or intermittent pressure to occlude the
urethra. The totally implanted device may consist of a static pressure
pad, or a system with a container of radiopaque fluid in the abdomen and
a manual pump and valve under the skin surface that is connected by
tubing to an adjustable pressure pad or to a cuff around the urethra.
The fluid is pumped as needed from the container to inflate the pad or
cuff to pass on the urethra.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See Sec. 876.3.
[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987]
Sec. 876.5320 Nonimplanted electrical continence device.
(a) Identification. A nonimplanted electrical continence device is a
device that consists of a pair of electrodes on a plug or a pessary that
are connected by an electrical cable to a battery-powered pulse source.
The plug or pessary is inserted into the rectum or into the vagina and
used to stimulate the muscles of the pelvic floor to maintain urinary or
fecal continence. When necessary, the plug or pessary may be removed by
the user. This device excludes an AC-powered nonimplanted electrical
continence device and the powered vaginal muscle stimulator for
therapeutic use (Sec. 884.5940).
(b) Classification. Class II (performance standards).
Sec. 876.5365 Esophageal dilator.
(a) Identification. An esophageal dilator is a device that consists
of a cylindrical instrument that may be hollow and weighted with mercury
or a metal olive-shaped weight that slides on a guide, such as a string
or wire and is used to dilate a stricture of the esophagus. This generic
type of device includes esophageal or gastrointestinal bougies and the
esophageal dilator (metal olive).
(b) Classification. Class II (performance standards).
Sec. 876.5450 Rectal dilator.
(a) Identification. A rectal dilator is a device designed to dilate
the anal sphincter and canal when the size of the anal opening may
interfere with its function or the passage of an examining instrument.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996]
[[Page 350]]
Sec. 876.5470 Ureteral dilator.
(a) Identification. A ureteral dilator is a device that consists of
a specially shaped catheter or bougie and is used to dilate the ureter
at the place where a stone has become lodged or to dilate a ureteral
stricture.
(b) Classification. Class II (performance standards).
Sec. 876.5520 Urethral dilator.
(a) Identification. A urethral dilator is a device that consists of
a slender hollow or solid instrument made of metal, plastic, or other
suitable material in a cylindrical form and in a range of sizes and
flexibilities. The device may include a mechanism to expand the portion
of the device in the urethra and indicate the degree of expansion on a
dial. It is used to dilate the urethra. This generic type of device
includes the mechanical urethral dilator, urological bougies, metal or
plastic urethral sound, urethrometer, filiform, and filiform follower.
(b) Classification. (1) Class II (performance standards).
(2) Class I for the urethrometer, urological bougie, filiform and
filiform follower, and metal or plastic urethral sound. The devices
subject to this paragraph (b)(2) are exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996]
Sec. 876.5540 Blood access device and accessories.
(a) Identification. A blood access device and accessories is a
device intended to provide access to a patient's blood for hemodialysis
or other chronic uses. When used in hemodialysis, it is part of an
artificial kidney system for the treatment of patients with renal
failure or toxemic conditions and provides access to a patient's blood
for hemodialysis. The device includes implanted blood access devices,
nonimplanted blood access devices, and accessories for both the
implanted and nonimplanted blood access devices.
(1) The implanted blood access device consists of various flexible
or rigid tubes, which are surgically implanted in appropriate blood
vessels, may come through the skin, and are intended to remain in the
body for 30 days or more. This generic type of device includes various
shunts and connectors specifically designed to provide access to blood,
such as the arteriovenous (A-V) shunt cannula and vessel tip.
(2) The nonimplanted blood access device consists of various
flexible or rigid tubes, such as catheters, cannulae or hollow needles,
which are inserted into appropriate blood vessels or a vascular graft
prosthesis (Secs. 870.3450 and 870.3460), and are intended to remain in
the body for less than 30 days. This generic type of device includes
fistula needles, the single needle dialysis set (coaxial flow needle),
and the single needle dialysis set (alternating flow needle).
(3) Accessories common to either type include the shunt adaptor,
cannula clamp, shunt connector, shunt stabilizer, vessel dilator,
disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring,
joint ring, fistula adaptor, and declotting tray (including contents).
(b) Classification. (1) Class III (premarket approval) for the
implanted blood access device.
(2) Class II (performance standards) for the nonimplanted blood
access device.
(3) Class II (performance standards) for accessories for both the
implanted and the nonimplanted blood access devices not listed in
paragraph (b)(4) of this section.
(4) Class I for the cannula clamp, disconnect forceps, crimp plier,
tube plier, crimp ring, and joint ring, accessories for both the
implanted and nonimplanted blood access device. The devices subject to
this paragraph (b)(4) are exempt from the premarket notification
procedures in subpart E of part 807 of this chapter.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval for the device described in paragraph (b)(1). See Sec. 876.3.
[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 61
FR 1122, Jan. 16, 1996]
[[Page 351]]
Sec. 876.5600 Sorbent regenerated dialysate delivery system for hemodialysis.
(a) Identification. A sorbent regenerated dialysate delivery system
for hemodialysis is a device that is part of an artificial kidney system
for the treatment of patients with renal failure or toxemic conditions,
and that consists of a sorbent cartridge and the means to circulate
dialysate through this cartridge and the dialysate compartment of the
dialyzer. The device is used with the extracorporeal blood system and
the dialyzer of the hemodialysis system and accessories (Sec. 876.5820).
The device includes the means to maintain the temperature, conductivity,
electrolyte balance, flow rate and pressure of the dialysate, and alarms
to indicate abnormal dialysate conditions. The sorbent cartridge may
include absorbent, ion exchange and catalytic materials.
(b) Classification. Class II (performance standards).
Sec. 876.5630 Peritoneal dialysis system and accessories.
(a) Identification. (1) A peritoneal dialysis system and accessories
is a device that is used as an artificial kidney system for the
treatment of patients with renal failure or toxemic conditions, and that
consists of a peritoneal access device, an administration set for
peritoneal dialysis, a source of dialysate, and, in some cases, a water
purification mechanism. After the dialysate is instilled into the
patient's peritoneal cavity, it is allowed to dwell there so that
undesirable substances from the patient's blood pass through the lining
membrane of the peritoneal cavity into this dialysate. These substances
are then removed when the dialysate is drained from the patient. The
peritoneal dialysis system may regulate and monitor the dialysate
temperature, volume, and delivery rate together with the time course of
each cycle of filling, dwell time, and draining of the peritoneal cavity
or manual controls may be used. This generic device includes the
semiautomatic and the automatic peritoneal delivery system.
(2) The peritoneal access device is a flexible tube that is
implanted through the abdominal wall into the peritoneal cavity and that
may have attached cuffs to provide anchoring and a skin seal. The device
is either a single use peritioneal catheter, intended to remain in the
peritoneal cavity for less than 30 days, or a long term peritoneal
catheter. Accessories include stylets and trocars to aid in the
insertion of the catheter and an obturator to maintain the patency of
the surgical fistula in the abdominal wall between treatments.
(3) The disposable administration set for peritoneal dialysis
consists of tubing, an optional reservoir bag, and appropriate
connectors. It may include a peritoneal dialysate filter to trap and
remove contaminating particles.
(4) The source of dialysate may be sterile prepackaged dialysate
(for semiautomatic peritoneal dialysate delivery systems or ``cycler
systems'') or dialysate prepared from dialysate concentrate and sterile
purified water (for automatic peritoneal dialysate delivery systems or
``reverse osmosis'' systems). Prepackaged dialysate intended for use
with either of the peritoneal dialysate delivery systems is regulated by
FDA as a drug.
(b) Classification. Class II (performance standards).
Sec. 876.5665 Water purification system for hemodialysis.
(a) Identification. A water purification system for hemodialysis is
a device that is intended for use with a hemodialysis system and that is
intended to remove organic and inorganic substances and microbial
contaminants from water used to dilute dialysate concentrate to form
dialysate. This generic type of device may include a water softener,
sediment filter, carbon filter, and water distillation system.
(b) Classification. Class II (performance standards).
Sec. 876.5820 Hemodialysis system and accessories.
(a) Identification. A hemodialysis system and accessories is a
device that is used as an artificial kidney system for the treatment of
patients with renal failure or toxemic conditions and that consists of
an extracorporeal blood system, a conventional dialyzer, a
[[Page 352]]
dialysate delivery system, and accessories. Blood from a patient flows
through the tubing of the extracorporeal blood system and accessories to
the blood compartment of the dialyzer, then returns through further
tubing of the extracorporeal blood system to the patient. The dialyzer
has two compartments that are separated by a semipermeable membrane.
While the blood is in the blood compartment, undesirable substances in
the blood pass through the semipermeable membrane into the dialysate in
the dialysate compartment. The dialysate delivery system controls and
monitors the dialysate circulating through the dialysate compartment of
the dialyzer.
(1) The extracorporeal blood system and accessories consists of
tubing, pumps, pressure monitors, air foam or bubble detectors, and
alarms to keep blood moving safely from the blood access device and
accessories for hemodialysis (Sec. 876.5540) to the blood compartment of
the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes
between the blood and the dialysate through the semipermeable membrane.
The semipermeable membrane of the conventional dialyzer has a
sufficiently low permeability to water that an ultrafiltration
controller is not required to prevent excessive loss of water from the
patient's blood. This conventional dialyzer does not include
hemodialyzers with the disposable inserts (Kiil type) (Sec. 876.5830) or
dialyzers of high permeability (Sec. 876.5860).
(3) The dialysate delivery system consists of mechanisms that
monitor and control the temperature, conductivity, flow rate, and
pressure of the dialysate and circulates dialysate through the dialysate
compartment of the dialyzer. The dialysate delivery system includes the
dialysate concentrate for hemodialysis (liquid or powder) and alarms to
indicate abnormal dialysate conditions. This dialysate delivery system
does not include the sorbent regenerated dialysate delivery system for
hemodialysis (Sec. 876.5600), the dialysate delivery system of the
peritoneal dialysis system and accessories (Sec. 876.5630), or the
controlled dialysate delivery system of the high permeability
hemodialysis system Sec. 876.5860).
(4) Remote accessories to the hemodialysis system include the
unpowered dialysis chair without a scale, the powered dialysis chair
without a scale, the dialyzer holder set, dialysis tie gun and ties, and
hemodialysis start/stop tray.
(b) Classification. (1) Class II (performance standards) for
hemodialysis systems and all accessories directly associated with the
extracorporeal blood system and the dialysate delivery system.
(2) Class I for other accessories of the hemodialysis system remote
from the extracorporeal blood system and the dialysate delivery system,
such as the unpowered dialysis chair, hemodialysis start/stop tray,
dialyzer holder set, and dialysis tie gun and ties. The devices subject
to this paragraph (b)(2) are exempt from the premarket notification
procedures in subpart E of part 807 of this chapter.
[48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25050, June 12, 1989]
Sec. 876.5830 Hemodialyzer with disposable insert (Kiil type).
(a) Identification. A hemodialyzer with disposable inserts (Kiil
type) is a device that is used as a part of an artificial kidney system
for the treatment of patients with renal failure or toxemic conditions
and that includes disposable inserts consisting of layers of
semipermeable membranes which are sandwiched between support plates. The
device is used with the extracorporeal blood system and the dialysate
delivery system of the hemodialysis system and accessories
(Sec. 876.5820).
(b) Classification. Class II (performance standards).
[48 FR 53023, Nov. 23, 1983, as amended at 53 FR 11253, Apr. 6, 1988]
Sec. 876.5860 High permeability hemodialysis system.
(a) Identification. A high permeability hemodialysis system is a
device that is used as an artificial kidney system for the treatment of
patients with renal failure or toxemic conditions, and that has a
dialyzer with a semipermeable membrane that is more permeable to
[[Page 353]]
water than the semipermeable membrane of the conventional dialyzer. The
device system consists of an extracorporeal blood system, a high
permeability dialyzer, and a controlled dialysate delivery system that
incorporates an ultrafiltration controller to prevent excessive loss of
water from the patient's blood. This highly permeable, semipermeable
membrane may also permit greater loss of higher molecular weight
substances from the blood, compared with the conventional dialyzer of
the hemodialysis system and accessories (Sec. 876.5820). The
extracorporeal blood system is the same generic type of extracorporeal
blood system that is used in the hemodialysis system and accessories
(Sec. 876.5820). The controlled dialysate delivery system also is
similar to the conventional disalysate delivery system of the
hemodialysis system and accessories (Sec. 876.5820), with the addition
of an ultrafiltration controller to regulate the rate of the removal of
water from the patient's blood and ensure that the pressure on the
dialysate side of the membrane is always lower than on the blood side.
This generic type of device includes the sealed dialysate delivery
system.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See Sec. 876.3.
[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987]
Sec. 876.5870 Sorbent hemoperfusion system.
(a) Identification. A sorbent hemoperfusion system is a device that
consists of an extracorporeal blood system similar to that identified in
the hemodialysis system and accessories (Sec. 876.5820) and a container
filled with adsorbent material that removes a wide range of substances,
both toxic and normal, from blood flowing through it. The adsorbent
materials are usually activated-carbon or resins which may be coated or
immobilized to prevent fine particles entering the patient's blood. The
generic type of device may include lines and filters specifically
designed to connect the device to the extracorporeal blood system. The
device is used in the treatment of poisoning, drug overdose, hepatic
coma, or metabolic disturbances.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See Sec. 876.3.
[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987]
Sec. 876.5880 Isolated kidney perfusion and transport system and accessories.
(a) Identification. An isolated kidney perfusion and transport
system and accesssories is a device that is used to support a donated or
a cadaver kidney and to maintain the organ in a near-normal physiologic
state until it is transplanted into a recipient patient. This generic
type of device may include tubing, catheters, connectors, an ice storage
or freezing container with or without bag or preservatives, pulsatile or
nonpulsatile hypothermic isolated organ perfusion apparatus with or
without oxygenator, and disposable perfusion set.
(b) Classification. Class II (performance standards).
Sec. 876.5895 Ostomy irrigator.
(a) Identification. An ostomy irrigator is a device that consists of
a container for fluid, tubing with a cone-shaped tip or a soft and
flexible catheter with a retention shield and that is used to wash out
the colon through a colostomy, a surgically created opening of the colon
on the surface of the body.
(b) Classification. Class II (performance standards).
Sec. 876.5900 Ostomy pouch and accessories.
(a) Identification. An ostomy pouch and accessories is a device that
consists of a bag that is attached to the patient's skin by an adhesive
material and that is intended for use as a receptacle for collection of
fecal material or urine following an ileostomy, colostomy, or
ureterostomy (a surgically created opening of the small intestine, large
intestine, or the ureter on the surface of the body). This generic type
[[Page 354]]
of device and its accessories includes the ostomy pouch, ostomy
adhesive, the disposable colostomy appliance, ostomy collector,
colostomy pouch, urinary ileostomy bag, urine collecting ureterostomy
bag, ostomy drainage bag with adhesive, stomal bag, ostomy protector,
and the ostomy size selector, but excludes ostomy pouches which
incorporate arsenic-containing compounds.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25050, June 12, 1989]
Sec. 876.5920 Protective garment for incontinence.
(a) Identification. A protective garment for incontinence is a
device that consists of absorbent padding and a fluid barrier and that
is intended to protect an incontinent patient's garment from the
patient's excreta. This generic type of device does not include diapers
for infants.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter. The
device is also exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, regarding general requirements concerning records, and
Sec. 820.198, regarding complaint files.
[48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25050, June 12, 1989]
Sec. 876.5955 Peritoneo-venous shunt.
(a) Identification. A peritoneo-venous shunt is an implanted device
that consists of a catheter and a pressure activated one-way valve. The
catheter is implanted with one end in the peritoneal cavity and the
other in a large vein. This device enables ascitic fluid in the
peritoneal cavity to flow into the venous system for the treatment of
intractable ascites.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See Sec. 876.3.
[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987]
Sec. 876.5970 Hernia support.
(a) Identification. A hernia support is a device, usually made of
elastic, canvas, leather, or metal, that is intended to be placed over a
hernial opening (a weakness in the abdominal wall) to prevent protrusion
of the abdominal contents. This generic type of device includes the
umbilical truss.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter. The
device is exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, regarding general requirements concerning records, and
Sec. 820.198, regarding complaint files.
[48 FR 53023, Nov. 23, 1983, as amended at 59 FR 63010, Dec. 7, 1994]
Sec. 876.5980 Gastrointestinal tube and accessories.
(a) Identification. A gastrointestinal tube and accessories is a
device that consists of flexible or semi-rigid tubing used for
instilling fluids into, withdrawing fluids from, splinting, or
suppressing bleeding of the alimentary tract. This device may
incorporate an integral inflatable balloon for retention or hemostasis.
This generic type of device includes the hemostatic bag, irrigation and
aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile
infant gavage set, gastrointestinal string and tubes to locate internal
bleeding, double lumen tube for intestinal decompression or intubation,
feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube,
single lumen tube with mercury weight balloon for intestinal intubation
or decompression, and gastro-urological irrigation tray (for
gastrological use).
(b) Classification. (1) Class II (performance standards).
(2) Class I (general controls) for the dissolvable nasogastric feed
tube guide for the nasogastric tube.
[49 FR 573, Jan. 5, 1984]
[[Page 355]]