Rule2022-02357
Medical Devices; General and Plastic Surgery Devices; Classification of the Carbon Dioxide Gas Controlled Tissue Expander
Primary source
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Published
February 4, 2022
Effective
February 4, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is classifying the carbon dioxide gas controlled tissue expander 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 carbon dioxide gas controlled tissue expander'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 87 Issue 24 (Friday, February 4, 2022)</title>
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[Federal Register Volume 87, Number 24 (Friday, February 4, 2022)]
[Rules and Regulations]
[Pages 6419-6422]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-02357]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 878
[Docket No. FDA-2021-N-0948]
Medical Devices; General and Plastic Surgery Devices;
Classification of the Carbon Dioxide Gas Controlled Tissue Expander
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 carbon dioxide gas
[[Page 6420]]
controlled tissue expander 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 carbon dioxide
gas controlled tissue expander'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 February 4, 2022. The classification was
applicable on December 21, 2016.
FOR FURTHER INFORMATION CONTACT: Tajanay Ki, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4553, Silver Spring, MD 20993-0002, 301-796-6441,
<a href="/cdn-cgi/l/email-protection#edb98c878c838c94c3a684ad8b898cc385859ec38a829b"><span class="__cf_email__" data-cfemail="7e2a1f141f101f075035173e181a1f5016160d50191108">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the carbon dioxide gas controlled
tissue expander 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 (see 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.
We believe this De Novo classification will enhance patients'
access to beneficial innovation. 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
section 513 c(f)(2)(B)(i) of the FD&C Act). As a result, other device
sponsors do not have to submit a De Novo request or premarket approval
application to market a substantially equivalent device (see section
513(i) of the FD&C Act, 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 8, 2015, FDA received AirXpanders' request for De Novo
classification of the AeroForm[supreg] Tissue Expander 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 section 513(a)(1)(B) of the FD&C Act). 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 21, 2016, 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
878.3510.\1\ We have named the generic type of device carbon dioxide
gas-controlled tissue expander, and it is identified as a prescription
device intended for temporary subcutaneous or submuscular implantation
to stretch the skin for surgical applications, specifically to develop
surgical flaps and additional tissue coverage. The device is made of an
inflatable elastomer shell and is filled with carbon dioxide gas. The
device utilizes a remote controller to administer doses of carbon
dioxide gas from an implanted canister inside the device.
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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.
[[Page 6421]]
Table 1--Carbon Dioxide Gas Controlled Tissue Expander Risks and
Mitigation Measures
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Identified risks Mitigation measures
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Pain................................... Labeling; and
<bullet> From overexpansion with Software verification,
carbon dioxide. validation and hazard
analysis.
Tissue damage.......................... In-vivo performance testing;
Labeling; and
<bullet> From overexpansion with Software verification,
carbon dioxide. validation and hazard
analysis.
Prolonged treatment time............... In-vivo performance testing;
<bullet> Due to under expansion Non-clinical performance
because of carbon dioxide testing; Labeling; and
permeation.
<bullet> Due to overexpansion with Software verification,
carbon dioxide. validation and hazard
analysis.
Re-operation........................... In-vivo performance testing and
Non-clinical performance
testing.
<bullet> Due to no expansion
because of device failure
<bullet> Due to overexpansion with
carbon dioxide
Under expansion, overexpansion, or no Electromagnetic compatibility,
expansion. electrical safety, and
wireless compatibility
testing; Labeling;
<bullet> Due to interference with Software verification,
other devices. validation and hazard
analysis;
<bullet> Due to user error......... Human factors testing; and
Patient training.
Adverse tissue reaction................ Biocompatibility evaluation.
Infection.............................. Sterilization validation and
Shelf life testing.
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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) of the FD&C Act.
At the time of classification, carbon dioxide gas controlled tissue
expanders 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. 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 878
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
878 is amended as follows:
PART 878--GENERAL AND PLASTIC SURGERY DEVICES
0
1. The authority citation for part 878 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 878.3510 to subpart D to read as follows:
Sec. 878.3510 Carbon dioxide gas controlled tissue expander.
(a) Identification. A carbon dioxide gas controlled tissue expander
is a prescription device intended for temporary subcutaneous or
submuscular implantation to stretch the skin for surgical applications,
specifically to develop surgical flaps and additional tissue coverage.
The device is made of an inflatable elastomer shell and is filled with
carbon dioxide gas. The device utilizes a remote controller to
administer doses of carbon dioxide gas from an implanted canister
inside the device.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) In-vivo performance testing must be conducted to obtain the
adverse event profile associated with use, and demonstrate that the
device performs as intended under anticipated conditions of use.
(2) The patient-contacting components of the device must be
demonstrated to be biocompatible.
(3) Performance data must demonstrate the sterility of patient-
contacting components of the device.
(4) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use. The
following performance characteristics must be tested:
(i) Cycle testing of expander showing that there are no leaks or
tears after repeated cycling;
(ii) Mechanical assessment of implanted carbon dioxide
(CO<INF>2</INF>) canister including high impact testing;
(iii) Leak testing of expander showing that device does not leak
CO<INF>2</INF>;
(iv) Assessment of gas permeability during expansion and after full
expansion; and
(v) Mechanical assessment of expander (tensile set, breaking force,
shell joint test, and fused or adhered joint testing).
(5) Performance data must be provided to demonstrate the
electromagnetic compatibility, electrical safety, and wireless
compatibility of the device.
[[Page 6422]]
(6) Software verification, validation, and hazard analysis must be
performed.
(7) Performance data must support shelf life by demonstrating
continued sterility of the device or the sterile components, package
integrity, and device functionality over the identified shelf life.
(8) Human factors testing and analysis must validate that the
device design and labeling are sufficient for the end user.
(9) Physician labeling must include:
(i) The operating parameters, name, and model number of the
indicated external dosage controller;
(ii) Information on how the device operates and the typical course
of treatment;
(iii) Information on the population for which the device has been
demonstrated to be effective;
(iv) A detailed summary of the device technical parameters; and
(v) Provisions for choosing an appropriate size implant that would
be exchanged for the tissue expander.
(10) Patient labeling must include:
(i) Warnings, precautions, and contraindications, and adverse
events/complications;
(ii) Information on how the device operates and the typical course
of treatment;
(iii) The probable risks and benefits associated with the use of
the device;
(iv) Post-operative care instructions; and
(v) Alternative treatments.
(11) Patient training must include instructions for device use,
when it may be necessary to contact a physician, and cautionary
measures to take when the device is implanted.
Dated: January 26, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-02357 Filed 2-3-22; 8:45 am]
BILLING CODE 4164-01-P
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