[Federal Register Volume 79, Number 106 (Tuesday, June 3, 2014)]
[Rules and Regulations]
[Pages 31859-31861]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-12814]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 878
[Docket No. FDA-2014-N-0576]
Medical Devices; General and Plastic Surgery Devices;
Classification of the Powered Surgical Instrument for Improvement in
the Appearance of Cellulite
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order.
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SUMMARY: The Food and Drug Administration (FDA) is classifying the
powered surgical instrument for improvement in the appearance of
cellulite into class II (special controls). The Agency is classifying
the device into class II (special controls) in order to provide a
reasonable assurance of safety and effectiveness of the device.
DATES: This order is effective July 3, 2014. The classification was
applicable on July 12, 2013.
FOR FURTHER INFORMATION CONTACT: Jitendra Virani, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. G459, Silver Spring, MD 20993-0002, 301-
796-6398.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless and until the
device is classified or reclassified into class I or II, or FDA issues
an order finding the device to be substantially equivalent, in
accordance with section 513(i) of the FD&C Act, to a predicate device
that does not require premarket approval. The Agency determines whether
new devices are substantially equivalent to predicate devices by means
of premarket notification procedures in section 510(k) of the FD&C Act
(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
Section 513(f)(2) of the FD&C Act, as amended by section 607 of the
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144, July 9, 2012, 126 Stat. 1054), provides two procedures by which a
person may request FDA to classify a device under the criteria set
forth in section 513(a)(1) (a de novo request). Under the first
procedure, the person submits a premarket notification under section
510(k) of the FD&C Act for a device that has not previously been
classified and, within 30 days of receiving an order classifying the
device into class III under section 513(f)(1) of the FD&C Act, the
person requests a classification under section 513(f)(2). Under the
second procedure, rather than first submitting a premarket notification
under section 510(k) and then a request for classification under the
first procedure, the person determines that there is no legally
marketed device upon which to base a determination of substantial
equivalence and requests a classification under section 513(f)(2) of
the FD&C Act. If the person submits a request to classify the device
under this second procedure, FDA may decline to undertake the
classification request if FDA identifies a legally marketed device that
could provide a reasonable basis for review of substantial equivalence
with the device or if FDA determines that the device submitted is not
of ``low-moderate risk'' or that general controls would be inadequate
to control the risks and special controls to mitigate the risks cannot
be developed.
In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA will
classify the device by written order within 120 days. This
classification will be the initial classification of the device. In
accordance with section 513(f)(1) of the FD&C Act, FDA issued an order
on March 14, 2011, classifying the Cabochon System into class III,
because it was not substantially equivalent to a device that was
introduced or delivered for introduction into interstate commerce for
commercial distribution before May 28, 1976, or a device which was
subsequently reclassified into class I or class II. On October 29,
2011, Cabochon Aesthetics, Inc., submitted a request for classification
of the Cabochon System under section 513(f)(2) of the FD&C Act. The
manufacturer recommended that the device be classified into class II
(Ref. 1).
In accordance with section 513(f)(2) of the FD&C Act, 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. FDA
classifies devices into class II if general controls by themselves are
insufficient to provide reasonable
[[Page 31860]]
assurance of safety and effectiveness, but there is sufficient
information to establish special controls to provide reasonable
assurance of the safety and effectiveness of the device for its
intended use. After review of the information submitted in the de novo
request, FDA determined that the device can be classified into class II
with the establishment of special controls. FDA believes these special
controls, in addition to general controls, will provide reasonable
assurance of the safety and effectiveness of the device.
Therefore, on July 12, 2013, FDA issued an order to the requestor
classifying the device into class II. FDA is codifying the
classification of the device by adding Sec. 878.4790.
Following the effective date of this final classification
administrative order, any firm submitting a premarket notification
(510(k)) for a powered surgical instrument for improvement in the
appearance of cellulite will need to comply with the special controls
named in the final administrative order.
The device is assigned the generic name powered surgical instrument
for improvement in the appearance of cellulite, and it is identified as
a prescription device that is used for the controlled release of
subcutaneous tissue for improvement in the appearance of cellulite. The
device consists of a cutting tool powered by a motor and a means for
instrument guidance to control the areas of subcutaneous tissue cutting
underneath the cellulite depressions or dimples.
FDA has identified the following risks to health associated with
this type of device and the measures required to mitigate these risks:
Table 1--Powered Surgical Instrument for Improvement in the Appearance
of Cellulite Risks and Mitigation Measures
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Identified risks Mitigation measures
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Mechanical Injury (excessive treatment Non-clinical Testing.
or treatment of non-intended areas). In Vivo Evaluation.
Infection.............................. Sterility Assurance Testing.
Shelf-life Testing.
Electrical Shock....................... Electrical Safety Testing.
Electromagnetic Interference........... Electromagnetic Compatibility
(EMC) Testing.
Adverse Tissue Reaction................ Biocompatibility Testing.
Use Error.............................. In Vivo Evaluation.
Labeling.
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FDA believes that the following special controls, in addition to
the general controls, address these risks to health and provide
reasonable assurance of safety and effectiveness:
(1) Non-clinical testing must be performed to demonstrate that the
device meets all design specifications and performance requirements,
and to demonstrate durability and mechanical integrity of the device.
(2) In vivo evaluation of the device must demonstrate device
performance, including the safety of the release methodology and blood
loss at the treatment sites.
(3) All elements of the device that may contact the patient must be
demonstrated to be biocompatible.
(4) Electrical safety and electromagnetic compatibility of the
device must be demonstrated.
(5) The labeling must include a summary of in vivo evaluation data
and all the device specific warnings, precautions, and/or
contraindications.
(6) Sterility and shelf-life testing for the device must
demonstrate the sterility of patient contacting components and the
shelf life of these components.
Powered surgical instruments for improvement in the appearance of
cellulite are prescription devices restricted to patient use only upon
the authorization of a practitioner licensed by law to administer or
use the device. (Proposed Sec. 878.4790(a) (21 CFR 878.4790(a)); see
section 520(e) of the FD&C Act (21 U.S.C. 360j(e)) and Sec. 801.109
(21 CFR 801.109) (Prescription devices.).) Prescription use
restrictions are a type of general controls as defined in section
513(a)(1)(A)(i) of the FD&C Act.
Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act if FDA determines that premarket notification is
not necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this type of device, FDA has
determined that premarket notification is necessary to provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, this device type is not exempt from premarket notification
requirements. Persons who intend to market this type of device must
submit to FDA a premarket notification prior to marketing the device,
which contains information about the powered surgical instrument for
improvement in the appearance of cellulite they intend to market.
II. 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.
III. Paperwork Reduction Act of 1995
This final administrative 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 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.
IV. Reference
The following reference has been placed on display in the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and is available electronically at http://www.regulations.gov.
1. K101231: De Novo Request per 513(f)(2) pursuant to the
Agency's NSE Determination, dated March 14, 2011, from Cabochon
Aesthetics, Inc., dated October 29, 2011.
[[Page 31861]]
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 21 CFR part 878 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 878.4790 to subpart E to read as follows:
Sec. 878.4790 Powered surgical instrument for improvement in the
appearance of cellulite.
(a) Identification. A powered surgical instrument for improvement
in the appearance of cellulite is a prescription device that is used
for the controlled release of subcutaneous tissue for improvement in
the appearance of cellulite. The device consists of a cutting tool
powered by a motor and a means for instrument guidance to control the
areas of subcutaneous tissue cutting underneath the cellulite
depressions or dimples.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Non-clinical testing must be performed to demonstrate that the
device meets all design specifications and performance requirements,
and to demonstrate durability and mechanical integrity of the device.
(2) In vivo evaluation of the device must demonstrate device
performance, including the safety of the release methodology and blood
loss at the treatment sites.
(3) All elements of the device that may contact the patient must be
demonstrated to be biocompatible.
(4) Electrical safety and electromagnetic compatibility of the
device must be demonstrated.
(5) The labeling must include a summary of in vivo evaluation data
and all the device specific warnings, precautions, and/or
contraindications.
(6) Sterility and shelf-life testing for the device must
demonstrate the sterility of patient contacting components and the
shelf life of these components.
Dated: May 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12814 Filed 6-2-14; 8:45 am]
BILLING CODE 4160-01-P