UltraShape System

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 17, 2016 Syneron Medical Ltd. % Ms. Janice Hogan Hogan Lovells Us Llp 1835 Market Street 29th Floor Philadelphia, Pennsylvania 19103 Re: K162163 Trade/Device Name: Ultrashape System Regulation Number: 21 CFR 878.4590 Regulation Name: Focused Ultrasound Stimulator System for Aesthetic Use Regulatory Class: Class II Product Code: OHV Dated: October 21, 2016 Received: October 21, 2016 Dear Ms. Hogan: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, Jennifer R. Stevenson -A For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use 510(k) Number (if known) K162163 Device Name UltraShape System Indications for Use (Describe) The UltraShape System delivers focused ultrasound energy that can disrupt subcutaneous adipose tissue (SAT) for lipolysis (breakdown of fat) to provide a non-invasive a desired aesthetic effect. It is intended for non-invasive reduction in abdominal circumference and fat reduction in the flanks and thighs. | Type of Use (Select one or both, as applicable) | |---------------------------------------------------------------------------------------------------------| | <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | | <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | # PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### 510(k) SUMMARY ## Syneron Medical Ltd.'s UltraShape System # Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared Ruthie Amir, MD, Global Vice President of Clinical, Regulatory and Education Syneron Medical Ltd. P.O.B. 550 Industrial Zone, Tavor Building Yokneam Illit, 20692 Israel Phone: 972-73-244-2200 Facsimile: 972-73-244-2202 Contact Person: Janice Hogan Hogan Lovells U.S. LLP 1835 Market Street, 29th Floor Philadelphia, PA 19103 Phone: 267 675 4600 Facsimile: 267 675 4601 Date Prepared: November 17, 2016 ## Name of Device Syneron UltraShape System #### Common or Usual Name Focused Ultrasound Stimulator System for Aesthetic Use ## Classification 21 C.F.R. § 878.4590, Class II, product code OHV #### Predicate/Reference Devices Predicate: Syneron UltraShape System (K141708) #### Intended Use / Indications for Use The UltraShape System delivers focused ultrasound energy that can disrupt subcutaneous adipose tissue (SAT) for lipolysis (breakdown of fat) to provide a non-invasive approach to achieve a desired aesthetic effect. It is intended for non-invasive reduction in abdominal circumference and fat reduction in the flanks and thighs. #### Device Description The UltraShape System is comprised of multiple components, including the control unit and two ultrasonic transducers. The UltraShape System selectively targets subcutaneous adipose tissue via focused ultrasound for the purpose of non-invasive aesthetic body {4}------------------------------------------------ contouring. The transducers are electro-mechanical devices that convert an electrical signal into mechanical (acoustical) energy. The operating parameters of the UltraShape System achieve selective disruption of adipose tissue without damaging neighboring tissues such as blood vessels, nerves, or muscle. The UltraShape System has two treatment modes available, the Single Focus Deep Mode and the Super Mode. # Technological Characteristics The UltraShape System has similar technological characteristics compared to its predicate. Both devices are comprised of the system console, including the computer, and two ultrasonic transducers. The transducers deliver the focused ultrasound energy beam to the targeted treatment area, and real-time optical and acoustic feedback (optional) on the treatment is provided via the tracking and guidance system. With both the UltraShape and its predicate, the transducers' functionality is based on the piezoelectric effect implemented with the ceramic element. The transducers' membranes of the subject UltraShape are composed of the same material as previously cleared for the U-Sculpt transducer of the predicate. In addition, the subject UltraShape System has the same treatment parameters as the previously cleared UltraShape device, including the same frequency, burst duration, node duration, and user interface. The power intensity levels were previously cleared for the UltraShape, and the focal distribution of the energy beams delivered to the treatment area is consistent between the device and its predicate, including the focal depth, diameter, and length. Therefore, the subject UltraShape System has very similar technological characteristics as its predicate. # Performance Data Nonclinical Performance Testing. The following nonclinical performance testing was previously conducted to support the substantial equivalence of the UltraShape System to the predicate device, consistent with FDA's Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use (2011). In all instances, the UltraShape System functioned as intended. - Biocompatibility testing in accordance with ISO 10993 for skin irritation, sensitization, and cytotoxicity supported the biocompatibility of the patient-contacting components of the device. - . Beam profile testing demonstrated that the acoustic energy is delivered and concentrated in the desired target location. - Acoustic power testing demonstrated that the acoustic power of the transducers is highly predictable with low variability. - In vitro acoustic and thermal measurements demonstrated the safety of non-targeted tissues both proximal and distal to the targeted region. {5}------------------------------------------------ - Software verification and validation was performed, and demonstrated that the ● software performs as intended. - . Electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2) and electromagnetic immunity testing was conducted and results were passing. - . In vivo testing in an animal model was performed which demonstrated the treatment effects of the UltraShape, and supported its safety and efficacy profile for the intended use. Clinical Data: In addition, clinical evaluation of the UltraShape device for non-invasive lipolysis of the thighs was performed in a prospective, single-arm, self-controlled study. A total of 47 subjects (all female) across a range of ages, ethnicities, and skin types were enrolled at 3 U.S. sites. The mean age was 46 years and the majority of the subjects were Caucasian. The mean weight at baseline was 70±10 kg (range 51-103 kg). Each subject received 3 biweekly treatments on one randomized thigh, while the other thigh remained untreated throughout the study to serve as a control. Subject follow up was conducted at 4 weeks, 8 weeks, and 16 weeks after the last treatment. The study met its primary effectiveness endpoint, where blinded reviewers who were shown randomized pairs of thigh photographs correctly identified both pre- versus post-treatment and treated versus untreated thighs in 81% of cases. Further, even in the Intent-to-Treat population, with worst case imputation where all missing data were treated as failures, 64% of the subjects were successes. UltraShape treated thighs showed statistically significantly greater circumference reduction compared to the control thighs at each follow-up visit. Fat thickness reduction results following UltraShape treatment were statistically significantly greater compared to controls as measured by ultrasound. Investigators were satisfied with results following UltraShape treatment for 77% of the subjects at 4 week follow up, 81% of the subjects at 8 week follow up, and 68% of the subjects at 16 week follow up. At 4, 8 and 16 weeks following end of treatments. 62%, 61% and 68% of the subjects were satisfied or very satisfied. Finally, treatment with the UltraShape System in the thigh area demonstrated a strong positive safety profile, with no adverse events reported after 128 treatment sessions and only mild anticipated treatment responses (e.g., erythema) that resolved without intervention. This is consistent with the results observed for prior UltraShape clearances, including the predicate device. The study design and results are further summarized in the table below. | Study Design | Prospective, single-arm, self-controlled, multicenter clinical study | |--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sample size | 47 subjects at 3 sites were enrolled in the study | | Principal<br>Eligibility<br>Criteria | • Fat thickness of at least 1.5 cm in the treated area as measured by<br>calibrated caliper.<br>• BMI interval: 22 ≤ BMI ≤ 30 (normal to overweight, but not obese).<br>• General good health confirmed by medical history and skin examination<br>of the treated area. | | Follow up<br>intervals | 3 treatment visits and follow up visits at 4 weeks, 8 weeks, and 16 weeks. | | Endpoints | Primary: Circumference and fat reduction in thighs was based on visual<br>assessment of randomized photographs of before (baseline) versus after (16<br>weeks following last treatment), as well as treated versus untreated thighs by 2<br>blinded reviewers. The primary endpoint was achieved when at least 80% of<br>treated versus control thighs and pre- versus post-treatment photographs were<br>correctly identified. | | | Secondary:<br>- Circumference reduction on treated thigh compared to control thigh.<br>- Fat thickness reduction on the treated thigh compared to the control<br>thigh, measured by ultrasound.<br>- Fat thickness reduction on the treated thigh compared to the control<br>thigh, measured by caliper.<br>- Investigator satisfaction assessment.<br>- Subject satisfaction self-assessment.<br>- Subjects' comfort level assessed immediately after each treatment. | | Effectiveness<br>Results | Primary: Met endpoint; blinded reviewers identified correctly (by agreement<br>between the blinded reviewers) both the pre-/post-treatment photographs as<br>well as the treated/un-treated thighs in 81% (30 of 37) subjects. | | | Secondary:<br>- UltraShape treated thighs showed statistically significantly greater<br>circumference reduction compared to the control thighs at each follow-<br>up visit.<br>- Fat thickness reduction results following UltraShape treatment were<br>statistically significantly greater compared to controls as measured by<br>ultrasound.<br>- Fat thickness reduction results following UltraShape treatment were<br>greater compared to controls as measured by caliper, although the<br>difference was not statistically significant at all visits.<br>- Investigators were satisfied with results following UltraShape treatment<br>for 77% of the subjects at 4 week follow up, 81% of the subjects at 8<br>week follow up, and 68% of the subjects at 16 week follow up.<br>- At 4, 8 and 16 weeks following end of treatments, 62%, 61% and 68% of<br>the subjects were satisfied or very satisfied.<br>- Subjects reported no to minimal pain on average for each of the three<br>treatments. | | Safety<br>Results | No adverse events were reported after 128 treatment sessions were conducted.<br>The only immediate responses recorded were mild and resolved completely<br>within days without any intervention. | {6}------------------------------------------------ Therefore, clinical evaluation of the subject UltraShape device demonstrated its favorable performance and safety profile for lipolysis of the thighs. Results thus further support substantial equivalence of the device as compared to the predicate. # Substantial Equivalence The UltraShape has the same intended use and very similar indications for use, technological characteristics, and principles of operation as its predicate device. The technological differences between the UltraShape and its predicate mainly consist of minor improvements to the device to facilitate use. Nonclinical and clinical studies of the {7}------------------------------------------------ UltraShape have demonstrated the device's safety and effectiveness profile in the intended population. Thus, the UltraShape is substantially equivalent to the predicate device. # Conclusion Syneron's UltraShape System is a Focused Ultrasound Stimulator System for Aesthetic Use Class II device that has been evaluated in nonclinical testing in accordance with FDA's corresponding Special Controls Guidance Document. Testing demonstrated that the device performs as intended. The UltraShape device is substantially equivalent to its predicate device (K141708).