[Federal Register Volume 82, Number 246 (Tuesday, December 26, 2017)]
[Rules and Regulations]
[Pages 60865-60867]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27784]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 868

[Docket No. FDA-2017-N-6568]


Medical Devices; Anesthesiology Devices; Classification of the 
External Negative Pressure Airway Aid

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the external negative pressure airway aid into class II (special 
controls). The special controls that apply to the device type are 
identified in this order and will be part of the codified language for 
the external negative pressure airway aid's classification. We are 
taking this action because we have determined that classifying the 
device into class II (special controls) will provide a reasonable 
assurance of safety and effectiveness of the device. We believe this 
action will also enhance patients' access to beneficial innovative 
devices, in part by reducing regulatory burdens.

DATES: This order is effective December 26, 2017. The classification 
was applicable on December 23, 2015.

FOR FURTHER INFORMATION CONTACT: Todd Courtney, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2530, Silver Spring, MD 20993-0002, 301-796-6371, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Upon request, FDA has classified the external negative pressure 
airway aid as class II (special controls), which we have determined 
will provide a reasonable assurance of safety and effectiveness. In 
addition, we believe this action will enhance patients' access to 
beneficial innovation, in part by reducing regulatory burdens by 
placing the device into a lower device class than the automatic class 
III assignment.
    The automatic assignment of class III occurs by operation of law 
and without any action by FDA, regardless of the level of risk posed by 
the new device. Any device that was not in commercial distribution 
before May 28, 1976, is automatically classified as, and remains 
within, class III and requires premarket approval unless and until FDA 
takes an action to classify or reclassify the device

[[Page 60866]]

(see 21 U.S.C. 360c(f)(1)). We refer to these devices as 
``postamendments devices'' because they were not in commercial 
distribution prior to the date of enactment of the Medical Device 
Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic 
Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to 
classify or reclassify a device into class I or II. We may issue an 
order finding a new device to be substantially equivalent under section 
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that 
does not require premarket approval. We determine whether a new device 
is substantially equivalent to a predicate by means of the procedures 
for premarket notification under section 510(k) of the FD&C Act and 
part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
    FDA may also classify a device through ``De Novo'' classification, 
a common name for the process authorized under section 513(f)(2) of the 
FD&C Act. Section 207 of the Food and Drug Administration Modernization 
Act of 1997 established the first procedure for De Novo classification 
(Pub. L. 105-115). Section 607 of the Food and Drug Administration 
Safety and Innovation Act modified the De Novo application process by 
adding a second procedure (Pub. L. 112-144). A device sponsor may 
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device 
that has not previously been classified. After receiving an order from 
FDA classifying the device into class III under section 513(f)(1) of 
the FD&C Act, the person then requests a classification under section 
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k) 
and then a request for classification, if the person determines that 
there is no legally marketed device upon which to base a determination 
of substantial equivalence, that person requests a classification under 
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA shall 
classify the device by written order within 120 days. The 
classification will be according to the criteria under section 
513(a)(1) of the FD&C Act. Although the device was automatically placed 
within class III, the De Novo classification is considered to be the 
initial classification of the device.
    We believe this De Novo classification will enhance patients' 
access to beneficial innovation, in part by reducing regulatory 
burdens. When FDA classifies a device into class I or II via the De 
Novo process, the device can serve as a predicate for future devices of 
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a 
result, other device sponsors do not have to submit a De Novo request 
or premarket approval application in order to market a substantially 
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial 
equivalence''). Instead, sponsors can use the less-burdensome 510(k) 
process, when necessary, to market their device.

II. De Novo Classification

    On August 18, 2014, Sommetrics submitted a request for De Novo 
classification of the cNEP Airway Management System. 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.
    We classify 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 that, in combination with the general controls, provide 
reasonable assurance of the safety and effectiveness of the device for 
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the 
information submitted in the request, we determined that the device can 
be classified into class II with the establishment of special controls. 
FDA has determined that these special controls, in addition to the 
general controls, will provide reasonable assurance of the safety and 
effectiveness of the device.
    Therefore, on December 23, 2015, FDA issued an order to the 
requester classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 868.5105. We have named 
the generic type of device external negative pressure airway aid, and 
it is identified as a prescription device that applies negative 
pressure to a patient's neck to aid in providing a patent airway during 
procedures requiring anesthesia.
    FDA has identified the following risks to health associated 
specifically with this type of device and the measures required to 
mitigate these risks in table 1.

   Table 1--External Negative Pressure Airway Aid Risks and Mitigation
                                Measures
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              Identified risks                   Mitigation measures
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Impaired blood flow........................  Clinical performance
                                              testing.
Failure of device or negative pressure       Non-clinical performance
 mechanism.                                   testing.
Adverse tissue reaction....................  Biocompatibility.
Dislodging of plaque, leading to possible    Labeling.
 stroke.
Inadequate collar fit......................  Labeling.
Use error..................................  Labeling.
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    FDA has determined that special controls, in combination with the 
general controls, address these risks to health and provide reasonable 
assurance of safety and effectiveness. For a device to fall within this 
classification, and thus avoid automatic classification in class III, 
it would have to comply with the special controls named in this final 
order. The necessary special controls appear in the regulation codified 
by this order. This device is subject to premarket notification 
requirements under section 510(k) of the FD&C Act.
    At the time of classification, external negative pressure airway 
aids are for prescription use only. Prescription devices are exempt 
from the requirement for adequate directions for use for the layperson 
under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 
CFR 801.5, as long as the conditions of 21 CFR 801.109 are met.

III. Analysis of 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.

[[Page 60867]]

IV. 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 
the guidance document ``De Novo Classification Process (Evaluation of 
Automatic Class III Designation)'' have been approved under OMB control 
number 0910-0844; the collections of information in part 814, subparts 
A through E, regarding premarket approval, have been approved under OMB 
control number 0910-0231; 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.

List of Subjects in 21 CFR Part 868

    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 
868 is amended as follows:

PART 868--ANESTHESIOLOGY DEVICES

0
1. The authority citation for part 868 is revised to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
2. Add Sec.  868.5105 to subpart F to read as follows:


Sec.  868.5105   External negative pressure airway aid.

    (a) Identification. An external negative pressure airway aid is a 
prescription device that applies negative pressure to a patient's neck 
to aid in providing a patent airway during procedures requiring 
anesthesia.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must document any adverse events 
observed during clinical use, including impaired blood flow, and 
demonstrate that the device performs as intended under anticipated 
conditions.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated patient positions, does 
not fail during use, and does not lose negative pressure capability. 
The following testing should be performed:
    (i) Ability of the device to maintain a seal during various patient 
positions;
    (ii) Device leakage testing to demonstrate the device maintains 
vacuum;
    (iii) Drop testing to ensure the device does not incur functional 
damage after dropping the device; and
    (iv) Functional testing after high and low storage temperature.
    (3) All patient contacting components must be demonstrated to be 
biocompatible.
    (4) Labeling must include:
    (i) A summary of clinical testing results, including any adverse 
events and evidence that effectiveness has been achieved.
    (ii) Technical specifications of the device, including collar 
sizes, maximum duration of use, operating temperature, and storage 
temperature range.
    (iii) Technical specifications of the vacuum source, including 
maximum vacuum level and operational vacuum level.
    (iv) Instructions for use that includes how to place the device, 
determination of size, verification of suction, reference to training 
materials, and information on troubleshooting the device if it does not 
attach properly.
    (v) A warning to screen patients for carotid artery disease due to 
the probable risk of the device to dislodge arterial plaques in the 
carotid artery.
    (vi) A warning to exclude patients with anatomical abnormalities.
    (vii) A warning not to use the device during medical procedures 
involving medications that contain propofol.

    Dated: December 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27784 Filed 12-22-17; 8:45 am]
 BILLING CODE 4164-01-P