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Written comments and suggestions may be submitted at any time for Agency consideration to Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. Alternatively, electronic comments may be submitted to http://www.regulations.gov . All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. Comments may not be acted upon by the Agency until the document is next revised or updated.
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This guidance document was developed as a special control guidance to support the classification of the contact cooling system for aesthetic use into class II (special controls). The device is intended to apply cooling to the body to achieve temporary changes in physical appearance. This guidance document is issued in conjunction with a Federal Register notice announcing the classification of the contact cooling system for aesthetic use.
Following the effective date of the final rule, manufacturers of devices within this generic type of device will need to address the issues covered in the special control guidance. However, the manufacturer need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness.
FDA believes that special controls, when combined with the general controls, will be sufficient to provide reasonable assurance of the safety and effectiveness of the contact cooling system for aesthetic use. Therefore, a manufacturer who intends to market a device of this generic type must (1) conform to the general controls of the Federal Food, Drug & Cosmetic Act (the FD&C Act), including the premarket notification requirements described in 21 CFR 807 Subpart E, (2) address the specific risks to health associated with the contact cooling system for aesthetic use, including those identified in this guidance, and (3) obtain a substantial equivalence determination from FDA prior to marketing the device.
This special control guidance document identifies the classification regulation and product code for the contact cooling system for aesthetic use (refer to Section 3. Scope). Other sections of this guidance document list the risks to health FDA has identified and describe measures that, if followed by manufacturers and combined with the general controls, will generally address the risks associated with these contact cooling systems and lead to a timely 510(k) review. This document supplements other FDA documents regarding the specific content requirements of a premarket notification submission. You should also refer to 21 CFR 807.87, the guidance, Format for Traditional and Abbreviated 510(k)s 1 and the section of CDRH’s Device Advice, How to Prepare a 510(k) Submission. 2
The scope of this document is limited to the following class II device (product code OOK) described below.
We recommend you identify your device using regulation and product code described in Section 3. Scope and include the following:
In the table below, FDA has identified the risks to health generally associated with the use of the contact cooling system for aesthetic use addressed in this document. The measures recommended to mitigate these identified risks are given in this guidance document, as also shown in the table below. You should also conduct a risk analysis before submitting your premarket notification to identify any other risks specific to your device. We recommend the premarket notification describe the risk analysis method and include the results. If you elect to use an alternative approach to address a particular risk identified in this guidance document, or you have identified risks additional to those in the guidance, you should provide sufficient detail to support the approach you have used to address that risk.
We recommend that preclinical testing be performed to demonstrate that the contact cooling system for aesthetic use meets all design specification and performance requirements. The testing should confirm that interface temperature shall have a steady state accuracy within ± 0.5oC of the target value, that feedback and control of the cooling mechanism is active during treatment, and that there is a mechanism incorporated into the device to ensure the device does not exceed a safe cooling limit. Testing should demonstrate the accuracy of the method for targeting the region of interest and, if applicable, for monitoring the progress or result of treatment. If a vacuum system is included in the device design, a mechanism should be incorporated to ensure that the device does not exceed a safe vacuum limit.
Testing should be performed to assess the probability of system failure, the means by which system failure can be mitigated, and the means by which system failure is apparent to the user. The overall system should be tested to ensure proper performance to design specifications and to assess the failure modes and probabilities. Bench testing may also be used to assess the likelihood that the conditions of use may affect system performance.
We recommend that you submit the information for software-controlled devices described in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. 3 The kind of information we recommend you submit is determined by the “level of concern,” which is related to risks associated with software failure. The level of concern for a device may be minor, moderate, or major. FDA believes that the software used to operate the device presents a “moderate level of concern” as described in the Software Guidance because a failure or latent design flaw could directly result in minor injury to the patient or operator.
In addition, we recommend that the development of the control software follow IEC 60601-1-4: Medical electrical equipment – Part 1-4; “General Requirements for Safety; Collateral Standard: Programmable electrical medical devices” or equivalent methods.
We recommend that you evaluate the functionality and safety of the contact cooling system for aesthetic use under simulated use conditions using in vivo or ex vivo models as appropriate. Studies should characterize dose dependent tissue effects and permit an assessment of the probability of an inadvertent deposition of energy into distal and/or surrounding non-target tissue. In addition to mitigating the risks of an unintentional dose being delivered to non-target tissue, evidence should be provided that demonstrates that the desired tissue effects are limited to well-defined target areas with clearly evident boundaries. Testing protocols should also simulate actual use conditions and demonstrate the system’s functional ability. Tissue histology demonstrating evidence of targeted cell death while ensuring normal cellular appearance of surrounding tissue could be a critical component of this testing.
The conduct of preclinical animal studies should follow modern practices of humane care and use (please refer to Appendix A), including thorough veterinary medical record-keeping at all stages of the study, appropriate training of personnel, and adequate controls for the minimization of infections, pain and distress, and other experimental confounders. Standard operating procedures consistent with refinements, reductions, and where appropriate validated models exist, replacement, should also be implemented. 4 FDA also requires that animal studies to support marketing and research applications are conducted in compliance with Good Laboratory Practice for Nonclinical Laboratory Studies (21 CFR Part 58).
FDA may recommend that you collect clinical data for a contact cooling system for aesthetic use with any of the following:
FDA will consider alternatives to clinical testing when the proposed alternatives are supported by an adequate scientific rationale.
If a clinical study is needed, we recommend that you evaluate the safety and effectiveness of the particular contact cooling system for aesthetic use demonstrating its ability to achieve the desired aesthetic results in a significant portion of the target population when used for the proposed indications for use and under the proposed conditions of use, including adequate direction for use and warnings against unsafe use that appear in the labeling. We suggest that you use any clinical studies that are conducted to confirm the safety of the device that was established through bench and animal testing.
If a clinical study is needed to demonstrate substantial equivalence, i.e., conducted prior to obtaining a 510(k) clearance of the device, the study must be conducted under the Investigational Device Exemptions (IDE) regulation, 21 CFR Part 812. We believe that the system addressed by this guidance document is a significant risk device as defined in 21 CFR 812.3(m). 5 In addition to the requirement of having an FDA-approved IDE, sponsors of such trials must comply with the regulations governing institutional review boards (21 CFR Part 56) and informed consent (21 CFR Part 50).
We recommend that you evaluate the biocompatibility of the device as described in the International Organization for Standardization (ISO) standard ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing for intermittent external contact with intact external body surfaces. If identical materials and identical material processing are used in a predicate device with the same type and duration of patient contact, you may identify the predicate device in lieu of performing biocompatibility testing.
We recommend that you demonstrate the EMC of the device by performing EMC testing as described in the following FDA-recognized standard or equivalent method.
We recommend that you demonstrate the electrical and mechanical safety of the device by performing electrical and mechanical safety testing as described in the following FDA-recognized standard or equivalent method.
The premarket notification must include labeling in sufficient detail to satisfy the requirements of 21 CFR 807.87(e). The following suggestions are aimed at assisting you in preparing the labeling that satisfies the requirements of 21 CFR Part 801. 6
We recommend that you provide a user manual with the device. The user manual should include descriptions of:
As a prescription device, under 21 CFR 801.109, the device is exempt from having adequate directions for lay use. Labeling must include, however, adequate information for practitioner use of the device, including indications, effects, routes, methods, frequency and duration of administration and any relevant hazards, contraindications, side effects and precautions. (21 CFR 801.109(d)).
We recommend the indications for use statement include that the device is intended as a non-invasive dermatological aesthetic treatment and name the area or areas of use. We recommend that the indications for use be included in the user manual.
We recommend that you advise users not to use the device in areas of open wounds or lesions, active implantables (e.g., pacemakers or defibrillators), or metallic implants, or on individuals who have cryoglobulinemia or paroxysmal cold hemoglobinuria or any other disease conditions that could be exacerbated by topical cooling.
We recommend that storage conditions be included in the user manual.
Should describe serious adverse reactions and potential safety hazards, limitations in use imposed by them, and steps that should be taken if they occur.
Should include an appropriate warning if there is reasonable evidence of an association of a serious hazard with the use of the device. A causal relationship need not have been proved.
Should include an appropriate warning that there is a potential hazard for individuals who may have underlying cold sensitive health conditions or reduced skin sensitivity due to other medical conditions.
We believe a warning is appropriate when the device is commonly used for a disease or condition for which there is a lack of valid scientific evidence of effectiveness for that disease or condition and such usage is associated with a serious risk or hazard.
Should include information regarding any special care to be exercised by the practitioner and/or patient for the safe and effective use of the device, for example:
As stated in Section 9, the conduct of preclinical animal studies should follow modern practices of humane care and use. All animal studies should be designed based on the modern practices described in the following references.
4 ANSI/AAMI/ISO 10993-2:2006: Biological evaluation of medical devices – Part 2: Animal welfare requirements
5 For additional information regarding clinical trial requirements, see Information Sheet Guidances Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors, available at: http://www.fda.gov/ScienceResearch/SpecialTopics/ RunningClinicalTrials/GuidancesInformationSheetsandNotices/default.htm
6 Although final labeling is not required for 510(k) clearance, final labeling must comply with the requirements of 21 CFR Part 801 before a medical device is introduced into interstate commerce. In addition, final labeling for prescription medical devices must comply with 21 CFR 801.109. Labeling recommendations in this guidance are consistent with the requirements of Part 801.