[Federal Register Volume 79, Number 95 (Friday, May 16, 2014)]
[Rules and Regulations]
[Pages 28404-28407]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-11174]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 880
[Docket No. FDA-2014-N-0438]
Medical Devices; General Hospital and Personal Use Devices;
Classification of the Intravascular Administration Set, Automated Air
Removal System
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is classifying the
intravascular administration set, automated air removal system 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 intravascular administration set, automated
air removal system's 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 June 16, 2014. The classification was
effective on March 4, 2014.
FOR FURTHER INFORMATION CONTACT: Alan Stevens, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave. Bldg. 66, Rm. 2561, Silver Spring, MD 20993-0002, 301-796-6294.
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), 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
[[Page 28405]]
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) 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), 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) 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). 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.
In accordance with section 513(f)(1) of the FD&C Act, FDA issued an
order on October 23, 2008, classifying the AirPurge System into class
III, because it was not substantially equivalent to a device that was
introduced or delivered for introduction into interstate commerce for
commercial distribution before May 28, 1976, or a device which was
subsequently reclassified into class I or class II. On October 29,
2008, Anesthesia Safety Products, LLC submitted a request requesting
classification of the AirPurge System 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 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 March 4, 2014, FDA issued an order to the requestor
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 880.5445.
Following the effective date of this final classification order,
any firm submitting a premarket notification (510(k)) for an
intravascular administration set, automated air removal system will
need to comply with the special controls named in this final order. The
device is assigned the generic name intravascular administration set,
automated air removal system, and it is identified as a prescription
device used to detect and automatically remove air from an
intravascular administration set with minimal to no interruption in the
flow of the intravascular fluid. The device may include an air
identification mechanism, software, an air removal mechanism, tubing,
apparatus to collect removed air, and safety control mechanisms to
address hazardous situations.
FDA has identified the following risks to health associated
specifically with this type of device, as well as the mitigation
measures required to mitigate these risks.
Table 1--Identified Risks and Mitigation Measures
----------------------------------------------------------------------------------------------------------------
Identified risk Mitigation measures
----------------------------------------------------------------------------------------------------------------
Embolus......................... Hazard Argument.
Software.
Electromagnetic Compatibility.
Human Factors.
Labeling.
Nonclinical Performance Testing.
Infusion Delivery Error......... Hazard Argument.
Software.
Electromagnetic Compatibility.
Human Factors.
Labeling.
Nonclinical Performance Testing.
Electric Shock.................. Hazard Argument.
Electrical Safety.
Electromagnetic Compatibility.
Adverse Tissue Reaction......... Hazard Argument.
Biocompatibility.
Infection....................... Sterilization.
Shelf Life.
----------------------------------------------------------------------------------------------------------------
FDA believes that the following special controls, in combination
with the general controls, address these risks to health and provide
reasonable assurance of the safety and effectiveness:
1. Provide an argument demonstrating that all reasonably
foreseeable hazards have been adequately addressed with respect to the
persons for whose use the device is represented or intended and
[[Page 28406]]
the conditions of use for the device, which includes the following:
Description of the device indications for use, design, and
technology, use environments, and users in sufficient detail to
determine that the device complies with all special controls.
Demonstrate that controls are implemented to address
device system hazards and their causes.
Include a justification supporting the acceptability
criteria for each hazard control.
A traceability analysis demonstrating that all credible
hazards have at least one corresponding control and that all controls
have been verified and validated in the final device design.
2. Appropriate software verification, validation, and hazard
analysis must be performed.
3. The device parts that directly or indirectly contact the patient
must be demonstrated to be biocompatible.
4. Performance data must demonstrate the sterility of fluid path
contacting components and the shelf life of these components.
5. The device must be designed and tested for electrical safety and
electromagnetic compatibility (EMC).
6. Nonclinical performance testing data must demonstrate that the
device performs as intended under anticipated conditions of use. The
following performance characteristics must be tested:
Device system and component reliability testing must be
conducted.
Fluid ingress protection testing must be conducted.
Testing of safety controls must be performed to
demonstrate adequate mitigation of hazardous situations, including
sensor failure, flow control failure, improper device position, device
malfunction, infusion delivery error, and release of air to the
patient.
7. A human factors validation study must demonstrate that use
hazards are adequately addressed.
8. The labeling must include the following:
The device's air identification and removal response time.
The device's minimum air volume identification
sensitivity.
The minimum and maximum flow rates at which the device is
capable of reliably detecting and removing air.
Quantification of any fluid loss during device air removal
operations as a function of flow rate.
Intravascular administration set, automated air removal systems are
prescription devices restricted to patient use only upon the
authorization of a practitioner licensed by law to administer or use
the device (21 CFR 880.5445(a); 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 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 intravascular administration set,
automated air removal system 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 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. K080644: De Novo Request per 513(f)(2) pursuant to the Agency's
not substantially equivalent (NSE) determination, dated October 23,
2008, from Anesthesia Safety Products, LLC, dated October 29, 2008.
List of Subjects in 21 CFR Part 880
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
880 is amended as follows:
PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES
0
1. The authority citation for 21 CFR part 880 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
2. Add Sec. 880.5445 to subpart F to read as follows:
Sec. 880.5445 Intravascular Administration Set, Automated Air Removal
System.
(a) Identification. An intravascular administration set, automated
air removal system, is a prescription device used to detect and
automatically remove air from an intravascular administration set with
minimal to no interruption in the flow of the intravascular fluid. The
device may include an air identification mechanism, software, an air
removal mechanism, tubing, apparatus to collect removed air, and safety
control mechanisms to address hazardous situations.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Provide an argument demonstrating that all reasonably
foreseeable hazards have been adequately addressed with respect to the
persons for whose use the device is represented or intended and the
conditions of use for the device, which includes the following:
(i) Description of the device indications for use, design, and
technology, use environments, and users in sufficient detail to
determine that the device complies with all special controls.
(ii) Demonstrate that controls are implemented to address device
system hazards and their causes.
(iii) Include a justification supporting the acceptability criteria
for each hazard control.
(iv) A traceability analysis demonstrating that all credible
hazards have at least one corresponding control and that all controls
have been verified and validated in the final device design.
[[Page 28407]]
(2) Appropriate software verification, validation, and hazard
analysis must be performed.
(3) The device parts that directly or indirectly contact the
patient must be demonstrated to be biocompatible.
(4) Performance data must demonstrate the sterility of fluid path
contacting components and the shelf life of these components.
(5) The device must be designed and tested for electrical safety
and electromagnetic compatibility (EMC).
(6) Nonclinical performance testing data must demonstrate that the
device performs as intended under anticipated conditions of use. The
following performance characteristics must be tested:
(i) Device system and component reliability testing must be
conducted.
(ii) Fluid ingress protection testing must be conducted.
(iii) Testing of safety controls must be performed to demonstrate
adequate mitigation of hazardous situations, including sensor failure,
flow control failure, improper device position, device malfunction,
infusion delivery error, and release of air to the patient.
(7) A human factors validation study must demonstrate that use
hazards are adequately addressed.
(8) The labeling must include the following:
(i) The device's air identification and removal response time.
(ii) The device's minimum air volume identification sensitivity.
(iii) The minimum and maximum flow rates at which the device is
capable of reliably detecting and removing air.
(iv) Quantification of any fluid loss during device air removal
operations as a function of flow rate.
Dated: May 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-11174 Filed 5-15-14; 8:45 am]
BILLING CODE 4160-01-P