Rule2021-26201
Medical Devices; Anesthesiology Devices; Classification of the Isocapnic Ventilation Device
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 2, 2021
Effective
December 2, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 229 (Thursday, December 2, 2021)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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,
<a href="/cdn-cgi/l/email-protection#095d666d6d274a667c7b7d676c70496f6d682761617a276e667f"><span class="__cf_email__" data-cfemail="e9bd868d8dc7aa869c9b9d878c90a98f8d88c781819ac78e869f">[email protected]</span></a>.
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 O<INF>2</INF> 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
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