Medical Devices; General and Plastic Surgery Devices; Classification of the Powered Surgical Instrument for Improvement in the Appearance of Cellulite
Federal Register, Volume 79 Issue 106 (Tuesday, June 3, 2014)
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
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:
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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
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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.
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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.
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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.
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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.
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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.
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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
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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.
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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
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