[Federal Register Volume 79, Number 106 (Tuesday, June 3, 2014)]
[Rules and Regulations]
[Pages 31859-31861]
From the Federal Register Online via the Government Printing 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.
------------------------------------------------------------------------

    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