[Federal Register Volume 86, Number 229 (Thursday, December 2, 2021)]
[Rules and Regulations]
[Pages 68396-68397]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26201]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 868

[Docket No. FDA-2021-N-0622]


Medical Devices; Anesthesiology Devices; Classification of the 
Isocapnic Ventilation Device

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the isocapnic ventilation device 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 isocapnic 
ventilation device'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.

DATES: This order is effective December 2, 2021. The classification was 
applicable on March 14, 2019.

FOR FURTHER INFORMATION CONTACT: Todd Courtney, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1216, Silver Spring, MD 20993-0002, 301-796-6371, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the isocapnic ventilation device 
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, 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 (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 device by means of the 
procedures for premarket notification under section 510(k) of the FD&C 
Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
    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 is required 
to 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.
    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, 2017, Thornhill Research, Inc. submitted a request 
for De Novo classification of the ClearMate. 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

[[Page 68397]]

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 March 14, 2019, FDA issued an order to the requester 
classifying the device into class II. In this final order, FDA is 
codifying the classification of the device by adding 21 CFR 
868.5480.\1\ We have named the generic type of device isocapnic 
ventilation device, and it is identified as a prescription device used 
to administer a blend of carbon dioxide and oxygen gases to a patient 
to induce hyperventilation. This device may be labeled for use with 
breathing circuits made of reservoir bags (21 CFR 868.5320), oxygen 
cannulas (21 CFR 868.5340), masks (21 CFR 868.5550), valves (21 CFR 
868.5870), resuscitation bags (21 CFR 868.5915), and/or tubing (21 CFR 
868.5925).
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    \1\ FDA notes that the ``ACTION'' caption for this final order 
is styled as ``Final amendment; final order,'' rather than ``Final 
order.'' Beginning in December 2019, this editorial change was made 
to indicate that the document ``amends'' the Code of Federal 
Regulations. The change was made in accordance with the Office of 
Federal Register's (OFR) interpretations of the Federal Register Act 
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and 
parts 21 and 22), and the Document Drafting Handbook.
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    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--Isocapnic Ventilation Device Risks and Mitigation Measures
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            Identified risks                   Mitigation measures
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Hypocapnia (lacking CO2)...............  Nonclinical performance
                                          testing, and Labeling.
Hypercapnia (excess CO2)...............  Nonclinical performance
                                          testing, and Labeling.
Hypoxemia (lacking O2).................  Nonclinical performance
                                          testing, and Labeling.
High airway pressure (e.g., barotrauma)  Nonclinical performance
                                          testing, and Labeling.
Adverse tissue reaction................  Biocompatibility evaluation.
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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. 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).
    At the time of classification, isocapnic ventilation devices 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.

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. 3501-3521). 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 collections of information in part 807, subpart E, regarding 
premarket notification submissions, have been approved under OMB 
control number 0910-0120; the collections of information in 21 CFR part 
820, regarding quality system regulation, have been approved under OMB 
control number 0910-0073; 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 continues to read as follows:

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

0
2. Add Sec.  868.5480 to subpart F to read as follows:


Sec.  868.5480   Isocapnic ventilation device.

    (a) Identification. An isocapnic ventilation device is a 
prescription device used to administer a blend of carbon dioxide and 
oxygen gases to a patient to induce hyperventilation. This device may 
be labeled for use with breathing circuits made of reservoir bags 
(Sec.  868.5320), oxygen cannulas (Sec.  868.5340), masks (Sec.  
868.5550), valves (Sec.  868.5870), resuscitation bags (Sec.  
868.5915), and/or tubing (Sec.  868.5925).
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Nonclinical performance testing data must demonstrate that the 
device performs as intended under anticipated conditions of use, 
including the following performance characteristics:
    (i) Gas concentration accuracy testing for the range of intended 
concentrations;
    (ii) Airway pressure delivery accuracy testing;
    (iii) Supplemental O2 flowrate accuracy testing;
    (iv) Alarm testing; and
    (v) Use life testing.
    (2) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (3) Labeling must include the following:
    (i) Instructions for use;
    (ii) A precaution that monitoring of capnography is necessary 
during treatment with non-spontaneously breathing patients; and
    (iii) Use life specification.

    Dated: November 29, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26201 Filed 12-1-21; 8:45 am]
BILLING CODE 4164-01-P