[Federal Register Volume 83, Number 203 (Friday, October 19, 2018)]
[Rules and Regulations]
[Pages 52964-52966]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22840]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 868

[Docket No. FDA-2018-N-3684]


Medical Devices; Anesthesiology Devices; Classification of the 
Positive Airway Pressure Delivery System

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 positive airway pressure delivery system 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 positive airway pressure delivery system'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 October 19, 2018. The classification was 
applicable on June 5, 2018.

FOR FURTHER INFORMATION CONTACT: Deepika Arora Lakhani, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 2543, Silver Spring, MD 20993-0002, 
301-796-4042, [email protected].

SUPPLEMENTARY INFORMATION: 

[[Page 52965]]

I. Background

    Upon request, FDA has classified the positive airway pressure 
delivery system 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 (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 to a predicate device that does not require 
premarket approval (see 21 U.S.C. 360c(i)). 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 21 CFR part 807 (21 U.S.C. 360(k) and 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 (21 U.S.C. 360c(f)(2)). 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 (21 U.S.C. 360c(a)(1)). Although the device 
was automatically 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 PMA 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 December 14, 2017, FRESCA Medical submitted a request for De 
Novo classification of the CURVE TM Positive Airway Pressure 
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 June 5, 2018, 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 868.5273. We have named 
the generic type of device positive airway pressure delivery system, 
and it is identified as a prescription noninvasive ventilatory device 
that delivers expiratory positive airway pressure for patients 
suffering from obstructive sleep apnea. The system also provides 
positive airway pressure during incipient apnea. The system may include 
a dedicated flow generator and a patient interface.
    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--Positive Airway Pressure Delivery System Risks and Mitigation
                                Measures
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            Identified risks                   Mitigation measures
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Adverse tissue reaction................  Biocompatibility evaluation,
                                          and Labeling.
Electromagnetic interference with other  Electromagnetic compatibility
 devices.                                 testing, and Labeling.
Infection..............................  Reprocessing validation, and
                                          Labeling.
Device software failure leading to       Software verification,
 ineffective treatment.                   validation, and hazard
                                          analysis.
Device hardware failure/malfunction      Non-clinical performance
 leading to high airway pressure,         testing, and Labeling.
 carbon dioxide rebreathing or
 ineffective treatment.
Electrical shock injury or thermal       Electrical safety, thermal
 injury.                                  safety, and mechanical
                                          testing; Software
                                          verification, validation, and
                                          hazard analysis; and Labeling.
Use error leading to ineffective         Labeling.
 therapy or patient injury.
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[[Page 52966]]

    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. In order 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, positive airway pressure delivery 
systems 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 and 21 CFR 801.5, as long as 
the conditions of 21 CFR 801.109 are met (referring to 21 U.S.C. 
352(f)(1)).

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.

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 and guidance. 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 21 CFR part 814, subparts A through E, regarding 
premarket approval, have been approved under OMB control number 0910-
0231; the collection of information in 21 CFR part 820, regarding 
quality system regulation, have been approved under OMB control number 
0910-0073; 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 
part 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, part 868 is 
amended as follows:

PART 868--ANESTHESIOLOGY DEVICES

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

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


0
2. Add Sec.  868.5273 to subpart F to read as follows:


Sec.  868.5273  Positive airway pressure delivery system.

    (a) Identification. A positive airway pressure delivery system is a 
prescription noninvasive ventilatory device that delivers expiratory 
positive airway pressure for patients suffering from obstructive sleep 
apnea. The system also provides positive airway pressure during 
incipient apnea. The system may include a dedicated flow generator and 
a patient interface.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use, 
including the following:
    (i) Waveform testing must simulate breathing conditions and 
evaluate pressure and airflow response over a range and combination of 
high and low breath rates and tidal volumes.
    (ii) Use life testing must demonstrate adequate device performance 
over the labeled use life of the device.
    (iii) Device integrity testing must demonstrate that the device can 
withstand typical forces expected during use.
    (iv) Carbon dioxide rebreathing testing must be performed.
    (v) System flow rate, maximum expiratory pressure, inhalation 
pressure, and intra-mask static pressure testing must be performed.
    (vi) Air bolus testing must demonstrate that the device can 
withstand worst-case scenario air pressures.
    (vii) Maximum limited pressure testing of the flow generator in 
single fault condition must be performed.
    (viii) Maximum output temperature testing of delivered gas, if 
humidified, must be performed.
    (3) Performance data must validate reprocessing instructions for 
any reusable components of the device.
    (4) Performance data must demonstrate the electrical, thermal, and 
mechanical safety and the electromagnetic compatibility of the device.
    (5) Software verification, validation, and hazard analysis must be 
performed.
    (6) Labeling must include the following:
    (i) Therapy pressure range;
    (ii) Use life and replacement schedule for all components;
    (iii) Cleaning instructions; and
    (iv) Instructions for assembly and connection of device components.

    Dated: October 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22840 Filed 10-18-18; 8:45 am]
 BILLING CODE 4164-01-P