[Federal Register Volume 79, Number 95 (Friday, May 16, 2014)]
[Rules and Regulations]
[Pages 28404-28407]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-11174]


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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.

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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