[Federal Register Volume 79, Number 115 (Monday, June 16, 2014)]
[Rules and Regulations]
[Pages 34222-34224]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-13905]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 878
[Docket No. FDA-2014-N-0655]
Medical Devices; General and Plastic Surgery Devices;
Classification of the Nonabsorbable Expandable Hemostatic Sponge for
Temporary Internal Use
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order.
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SUMMARY: The Food and Drug Administration (FDA) is classifying the
nonabsorbable expandable hemostatic sponge for temporary internal use
into class II (special controls). The special controls that will apply
to the device are identified in this order and will be part of the
codified language for the nonabsorbable expandable hemostatic sponge
for temporary internal use classification. The Agency is classifying
the device into class II (special controls) in order to provide a
reasonable assurance of safety and effectiveness of the device.
DATES: This order is effective July 16, 2014. The classification was
applicable April 3, 2014.
FOR FURTHER INFORMATION CONTACT: Kelley Burridge, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. G425, Silver Spring, MD 20993-0002, 301-
796-7630.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless and until the
device is classified or reclassified into class I or II, or FDA issues
an order finding the device to be substantially equivalent, in
accordance with section 513(i) of the FD&C Act, to a predicate device
that does not require premarket approval. The Agency determines whether
new devices are substantially equivalent to predicate devices by means
of premarket notification procedures in section 510(k) of the FD&C Act
(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
Section 513(f)(2) of the FD&C Act, as amended by section 607 of the
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144, July 9, 2012), provides two procedures by which a person may
request FDA to classify a device under the criteria set forth in
section 513(a)(1). Under the first procedure, the person submits a
premarket notification under section 510(k) of the FD&C Act for a
device that has not previously been classified and, within 30 days of
receiving an order classifying the device into class III under section
513(f)(1) of the FD&C Act, the person requests a classification under
section 513(f)(2). Under the second procedure, rather than first
submitting a premarket notification under section 510(k) of the FD&C
Act and then a request for classification under the first procedure,
the person determines that there is no legally marketed device upon
which to base a determination of substantial equivalence and requests a
classification under section 513(f)(2) of the FD&C Act. If the person
submits a request to classify the device under this second procedure,
FDA may decline to undertake the classification request if FDA
identifies a legally marketed device that could provide a reasonable
basis for review of substantial equivalence with the device or if FDA
determines that the device submitted is not of ``low-moderate risk'' or
that general controls would be inadequate to control the risks and
special controls to mitigate the risks cannot be developed.
In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA will
classify the device by written order within 120 days. This
classification will be the initial classification of the device.
On January 30, 2013, RevMedx, Inc., submitted a request for
classification of XSTAT under section 513(f)(2) of the FD&C Act. The
manufacturer recommended that the device be classified into class II
(Ref. 1).
In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request in order to classify the device under the criteria for
classification set forth in section 513(a)(1) of the FD&C Act. FDA
classifies devices into class II if general controls by themselves are
insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls to provide reasonable assurance of the safety and
effectiveness of the device for its intended use. After review of the
information submitted in the de novo request, FDA determined that the
device can be classified into class II with the establishment of
special controls. FDA believes these special controls, in addition to
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
Therefore, on April 3, 2014, FDA issued an order to the requestor
classifying the device into class II. FDA is codifying the
classification of the device by adding Sec. 878.4452.
Following the effective date of this final classification
administrative order, any firm submitting a premarket notification
(510(k)) for a nonabsorbable expandable hemostatic sponge for temporary
internal use will need to comply with the special controls named in the
final administrative order.
The device is assigned the generic name nonabsorbable expandable
hemostatic sponge for temporary internal use, and it is identified as a
prescription device intended to be placed temporarily into junctional,
non-compressible wounds, which are not amenable to tourniquet use, to
control bleeding until surgical care is acquired. The sponges expand
upon contact with blood to fill the wound cavity and provide a physical
barrier and pressure that facilitates formation of a clot. The device
consists of sterile nonabsorbable radiopaque compressed sponges and
[[Page 34223]]
may include an applicator to facilitate delivery into a wound.
FDA has identified the following risks to health associated with
this type of device and the measures required to mitigate these risks
in table 1:
Table 1--Nonabsorbable Expandable Hemostatic Sponge for Temporary
Internal Use Risks and Mitigation Measures
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Identified risk Mitigation measure
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Failure to Stop Bleeding or Recurrence of Non-Clinical Performance
Bleeding. Data.
In Vivo Performance Data.
Stability Assessment.
Labeling.
Obstruction of Vital Organs.............. Human Factors Testing.
Labeling.
Embolization............................. In Vivo Performance Data.
Collateral Tissue Damage (e.g., In Vivo Performance Data.
paralysis, nerve damage, tissue
necrosis).
Labeling.
Adverse Tissue and Allergic Reactions.... Material Characterization.
Biocompatibility.
In Vivo Performance Data.
Labeling.
Infection (e.g., cellulitis, Toxic Shock Sterility Testing.
Syndrome, sepsis).
Stability Assessment.
Reoperation Due to Material Retained in Non-Clinical Performance
Body. Data.
In Vivo Performance Data.
Human Factors Testing.
Labeling.
Sponge Deployment Failure................ Non-Clinical Performance
Data.
In Vivo Performance Data.
Stability Assessment.
Human Factors Testing.
Labeling.
Improper Application Technique or Use Human Factors Testing.
Error.
Labeling.
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FDA believes that the following special controls, in addition to
the general controls, address these risks to health and provide
reasonable assurance of safety and effectiveness:
1. Performance data must demonstrate the biocompatibility of
patient-contacting components.
2. Performance data must demonstrate the sterility of patient-
contacting components including endotoxin and pyrogenicity assessments.
3. Performance data must support device stability by demonstrating
continued sterility of the patient-contacting components of the device,
package integrity, and device functionality over the requested shelf
life.
4. Assessment of material characteristics must be sufficient to
support safety under anticipated conditions of use. Assessments must
include the following:
Material specifications;
immunogenicity; and
viral inactivation for animal-derived materials.
5. Non-clinical performance data must demonstrate that the device
performs as intended under anticipated conditions of use. The following
performance characteristics must be tested:
Absorption capacity;
extent of swelling;
mechanical properties;
expansion force/pressure;
radiopacity; and
deployment/applicator functionality.
6. In vivo performance data must demonstrate safe and effective use
by verifying that the device performs as intended under anticipated
conditions of use. Appropriate analysis/testing must demonstrate that
the product: Controls bleeding, does not promote adverse local or
systemic effects, and can be completely removed from the wound. The
following performance characteristics must be tested:
Deployment;
control of bleeding;
radiopacity;
retrieval; and
assessment of local and systemic effects.
7. Human factors testing and analysis must validate that the device
design and labeling are sufficient for appropriate use by emergency
responders deploying the device as well as surgeons retrieving the
device from wounds.
8. Labeling must include:
Specific instructions for deployment by emergency
responders and retrieval by surgeons;
warnings, cautions, and limitations needed for safe use of
the device;
information on how the device operates and the typical
course of treatment;
a detailed summary of the in vivo and human factors
testing pertinent to use of the device;
appropriate imaging information to ensure complete
retrieval of device; and
an expiration date/shelf life.
Nonabsorbable expandable hemostatic sponges for temporary internal
use are prescription devices restricted to patient use only upon the
authorization of a practitioner licensed by law to administer or use
the device. (Sec. 878.4452; see section 520(e) of the FD&C Act (21
U.S.C. 360j(e)) and 21 CFR 801.109 (Prescription devices).)
Prescription-use restrictions are a type of general controls as defined
in section 513(a)(1)(A)(i) of the FD&C Act.
Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act if FDA determines that premarket notification is
not necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this type of device, FDA has
determined that premarket notification is necessary to provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, this device type is not exempt from premarket
[[Page 34224]]
notification requirements. Persons who intend to market this type of
device must submit to FDA a premarket notification, prior to marketing
the device, which contains information about the nonabsorbable
expandable hemostatic sponge for temporary internal use they intend to
market.
II. Environmental Impact
The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
III. Paperwork Reduction Act of 1995
This final administrative order establishes special controls that
refer to previously approved collections of information found in other
FDA regulations. These collections of information are subject to review
by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of
information in part 807, subpart E, regarding premarket notification
submissions have been approved under OMB control number 0910-0120, and
the collections of information in 21 CFR part 801, regarding labeling
have been approved under OMB control number 0910-0485.
IV. Reference
The following reference has been placed on display in the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and is available electronically at http://www.regulations.gov.
1. K130218: De novo request per 513(f)(2) of the Federal Food,
Drug, and Cosmetic Act from RevMedx, Inc., dated January 28, 2013.
List of Subjects in 21 CFR Part 878
Medical devices, General and plastic surgery devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
878 is amended as follows:
PART 878--GENERAL AND PLASTIC SURGERY DEVICES
0
1. The authority citation for 21 CFR part 878 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 878.4452 to subpart E to read as follows:
Sec. 878.4452 Nonabsorbable expandable hemostatic sponge for
temporary internal use.
(a) Identification. A nonabsorbable expandable hemostatic sponge
for temporary internal use is a prescription device intended to be
placed temporarily into junctional, non-compressible wounds, which are
not amenable to tourniquet use, to control bleeding until surgical care
is acquired. The sponges expand upon contact with blood to fill the
wound cavity and provide a physical barrier and pressure that
facilitates formation of a clot. The device consists of sterile,
nonabsorbable radiopaque compressed sponges and may include an
applicator to facilitate delivery into a wound.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Performance data must demonstrate the biocompatibility of
patient-contacting components.
(2) Performance data must demonstrate the sterility of patient-
contacting components including endotoxin and pyrogenicity assessments.
(3) Performance data must support device stability by demonstrating
continued sterility of the patient-contacting components of the device,
package integrity, and device functionality over the requested shelf
life.
(4) Assessment of material characteristics must be sufficient to
support safety under anticipated conditions of use. Assessments must
include the following:
(i) Material specifications.
(ii) Immunogenicity.
(iii) Viral inactivation for animal-derived materials.
(5) Non-clinical performance data must demonstrate that the device
performs as intended under anticipated conditions of use. The following
performance characteristics must be tested:
(i) Absorption capacity.
(ii) Extent of swelling.
(iii) Mechanical properties.
(iv) Expansion force/pressure.
(v) Radiopacity.
(vi) Deployment/applicator functionality.
(6) In vivo performance data must demonstrate safe and effective
use by verifying that the device performs as intended under anticipated
conditions of use. Appropriate analysis/testing must demonstrate that
the product: Controls bleeding, does not promote adverse local or
systemic effects, and can be completely removed from the wound. The
following performance characteristics must be tested:
(i) Deployment.
(ii) Control of bleeding.
(iii) Radiopacity.
(iv) Retrieval.
(v) Assessment of local and systemic effects.
(7) Human factors testing and analysis must validate that the
device design and labeling are sufficient for appropriate use by
emergency responders deploying the device as well as surgeons
retrieving the device from wounds.
(8) Labeling must include:
(i) Specific instructions for deployment by emergency responders
and retrieval by surgeons.
(ii) Warnings, cautions, and limitations needed for safe use of the
device.
(iii) Information on how the device operates and the typical course
of treatment.
(iv) A detailed summary of the in vivo and human factors testing
pertinent to use of the device.
(v) Appropriate imaging information to ensure complete retrieval of
device.
(vi) An expiration date/shelf life.
Dated: June 10, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13905 Filed 6-13-14; 8:45 am]
BILLING CODE 4164-01-P