The UltraShape Power System delivers focused ultrasound energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect. It is intended for non-invasive reduction in abdominal circumference.

Device Description

The UltraShape Power System is comprised of multiple components, including the control unit and two ultrasonic transducers. The UltraShape Power System selectively targets subcutaneous adipose tissue via focused ultrasound for the purpose of non-invasive aesthetic body contouring. The transducers are electro-mechanical devices that convert an electrical signal into mechanical (acoustical) energy. The operating parameters of the UltraShape Power System achieve selective disruption of adipose tissue without damaging neighboring tissues such as blood vessels, nerves, or muscle.

The primary purpose of this submission is to add an increased acoustic intensity level to the device. Additional minor changes since the prior clearances were also included as part of this submission.

AI/ML Overview

The UltraShape Power System is a medical device designed for non-invasive reduction of abdominal circumference by disrupting subcutaneous adipose tissue (SAT) using focused ultrasound energy.

1. Acceptance Criteria and Reported Device Performance:

The primary efficacy endpoint for the UltraShape Power System was the reduction in abdominal circumference and fat thickness. While specific acceptance criteria for "statistically significant" were not explicitly detailed in terms of a numerical threshold, the study's results demonstrated strong positive outcomes.

Acceptance Criteria	Reported Device Performance
Statistically significant reduction in abdominal circumference	Achieved: 2.55 cm reduction at 12 weeks post-treatment (statistically significant). Consistent reduction at midline, 2 cm above, and 2 cm below midline.
Statistically significant reduction in fat thickness	Achieved: 3.63 mm reduction at 12 weeks post-treatment (mean change adjusted for baseline: 3.77 ± 1.11 mm), which was statistically significant.
Positive safety profile (no adverse events/minimal discomfort)	Achieved: No adverse events reported in the main 43-subject study. An additional 21-patient study reported only one minor event from which the patient fully recovered. Subjects reported minimal discomfort and high comfort levels (100% or 96%).
High patient satisfaction/willingness to recommend	Achieved: By 2 weeks, approximately two-thirds of subjects were satisfied and 81% would recommend the procedure. While satisfaction slightly decreased over time, overall results were positive.
Device functions as intended	Achieved: Nonclinical performance testing (beam profile, acoustic power, thermal evaluation, software V&V, electrical safety, EMC, biocompatibility, in vivo animal testing) demonstrated the device functioned as intended.

2. Sample Sizes and Data Provenance:

Test Set (Clinical Evaluation):
- Main Study: 43 enrolled subjects.
- Additional Safety Study: 21 patients.
- Data Provenance: Not explicitly stated, but the submission is from Syneron Medical Ltd. (Israel), and the study likely took place in a clinical setting related to their operations. It can be inferred to be prospective as it describes recruitment, treatment, and follow-up over specified time periods.
- Demographics (Main Study): Mean age 48 years, 95% female, all Caucasian.
Training Set: Not applicable for this type of device and study. The studies described are clinical trials for safety and effectiveness, not for training a machine learning algorithm.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable in the context of this device. The "ground truth" for efficacy was objective measurements (abdominal circumference, fat thickness) and patient-reported outcomes (satisfaction, comfort). These do not require expert consensus in the same way an imaging diagnostic device might.

4. Adjudication Method:

Not applicable. The study utilized objective physical measurements and patient self-assessment questionnaires, not the adjudication of expert interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This was a standalone clinical evaluation of a physical device for aesthetic purposes, not a diagnostic imaging device requiring expert interpretation.

6. Standalone Performance (Algorithm Only):

Yes, in a sense. The described clinical studies (43 subjects, 21 patients) evaluate the device only without human-in-the-loop performance influencing the primary efficacy outcomes. The device is operated by a healthcare professional, but the effectiveness measurements (circumference, fat thickness reduction) are direct outcomes of the device's action on the body, not a human interpretation of an algorithm's output.

7. Type of Ground Truth Used:

Efficacy:
- Objective Measurements: Abdominal circumference reduction (measured physically).
- Objective Measurements: Fat thickness reduction (presumably measured by imaging, though the method isn't specified, it's an objective physical change).
Safety: Observational data for adverse events and patient-reported comfort/discomfort.
Patient Satisfaction: Self-reported patient satisfaction and willingness to recommend.

8. Sample Size for the Training Set:

Not applicable. This is not a device driven by a machine learning algorithm that requires a training set in the conventional sense.

9. How the Ground Truth for the Training Set was Established:

Not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized depiction of a human figure, represented by three overlapping profiles, with a wing-like shape extending from the head. The profiles are facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 8, 2016

Syneron Medical Ltd % Ms. Janice Hogan Regulatory Counsel Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103

Re: K160896

Trade/Device Name: Ultrashape Power System Regulation Number: 21 CFR 878.4590 Regulation Name: Focused Ultrasound Stimulator System for Aesthetic Use Regulatory Class: Class II Product Code: OHV Dated: June 6, 2016 Received: June 6, 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 yours,

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}------------------------------------------------

Indications for Use

510(k) Number (if known) K160896

Device Name UltraShape Power System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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 Drug 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 Power System

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

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

Company Contact Person: Ruthie Amir, MD, Global Vice President of Clinical, Regulatory and Education

Submission Contact Person: Janice Hogan, Hogan Lovells US LLP

Date Prepared: July 7, 2016

Name of Device

Syneron UltraShape Power System

Common or Usual Name

Focused Ultrasound Stimulator System for Aesthetic Use

Classification

21 CFR 878.4590, Class II, product code OHV

Predicate Devices

Syneron Medical Ltd.'s UltraShape (K141708) Syneron Medical Ltd.'s Contour I V3.1 (K133238)

Intended Use / Indications for Use

Device Description

{4}------------------------------------------------

UltraShape Power System achieve selective disruption of adipose tissue without damaging neighboring tissues such as blood vessels, nerves, or muscle.

Technological Characteristics

The UltraShape Power System has very similar technological characteristics compared to its predicates. The device continues to be a focused ultrasound device intended for the same indications as the predicates. The proposed and predicate devices are all prescription use only devices and all require the same number of treatments per treatment session. The targeted anatomic area for the UltraShape Power System is identical to the predicate devices. Each of the device systems is comprised of the system control unit, including the computer, and ultrasonic transducer(s). The transducer is the patient-contacting component for both the proposed and predicates devices. The transducers for the UltraShape Power System and the predicates are electromechanical devices that convert the electrical signal into mechanical (acoustic) energy using the same piezoelectric ceramic acoustics core. The UltraShape Power System and the predicates all have a real-time video tracking and guidance system that guides the operator through treatment, and captures and processes the treatment information. The screen size for the real-time display is the same for the proposed and predicate devices. The UltraShape Power System and its predicates all include the same temperature sensors as a safety feature.

In addition, the UltraShape Power System has the same frequency, burst duration, node duration, and user interface as the predicates. The UltraShape Power and its predicates deliver ultrasound energy to the treatment area in a similar manner with similar focal distribution. The primary difference between the UltraShape Power and its predicates is the additional option for treatment at an increased acoustic intensity using the small transducer; the subject UltraShape small transducer includes acoustic intensity level of 660 W/cm', compared to the predicate small transducer's acoustic intensity level of 550 W/cm².

Further, the UltraShape Power System also includes minor modifications to the pulser and power distribution unit compared to the predicates. The Pulser component of the device was modified to be smaller with a new design, and this change did not require any changes in the treatment parameters. An additional treatment mode option was also added. Minor improvements were also made to the UltraShape Power System compared to the predicates, including improved accuracy for output power and temperature measurement and an improved video camera (HD digital instead of analog). None of these changes significantly impact device performance or raise new types of safety and effectiveness questions.

The technological differences between the UltraShape Power and its predicates have been evaluated in clinical testing, and results demonstrated that the device performs in a substantially equivalent manner with no adverse events. Therefore, the changes do not raise any new types of safety or effectiveness questions.

{5}------------------------------------------------

Performance Data

The following nonclinical performance testing was conducted to support the substantial equivalence of the UltraShape Power 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 Power System functioned as intended.

Beam profile testing demonstrated that the acoustic energy is delivered and concentrated in the desired target location, at a focal depth similar to that of the predicate devices.
. Acoustic power testing demonstrated that the acoustic power of the transducers met specifications, is well defined, and presents low variability.
. In vitro thermal evaluation was conducted and results were passing, demonstrating the absence of thermal coagulation or lesion in tissue.
. Software verification and validation was performed, and demonstrated that the software performs as intended.
. Electrical safety (IEC 60601-1, IEC 60601-2-37) and electromagnetic compatibility (IEC 60601-1-2) testing was conducted and results were passing.
. Biocompatibility of the patient-contacting components of the device was established.
In vivo testing in an animal model was performed to evaluate the device treatment mode, and results supported the device safety and efficacy profile for the intended use.

In addition, clinical evaluation of the device in the intended population was performed in a prospective single arm study. The study evaluated the safety and effectiveness of the UltraShape Power in 43 enrolled subjects. Eligible subjects received treatments with continued follow up to 12 weeks after treatment. Mean age was 48 years and most of the subjects were females (95%). All subjects were Caucasian. The study primary efficacy endpoint was achieved with statistically significant reduction in abdominal circumference, progressing from 2 weeks following the first treatment to 12 weeks post treatment (2.55 cm reduction). The circumference reduction was consistent at all measurements (midline, 2 cm above midline and 2 cm below midline). Responder analysis results also demonstrated that the majority of subjects achieved circumference reduction with device treatment. The study data also demonstrated statistically significant fat thickness reduction compared to baseline, reaching 3.63 mm reduction at 12 weeks post treatment (mean change adjusted for baseline 3.77±1.11 mm). Subjects were asked to rate their overall satisfaction with treatment on a 5point scale (-2=very disappointed to +2=very satisfied). By 2 weeks after treatment, approximately two-thirds of subjects were satisfied (somewhat satisfied or very satisfied), which continued at 4 weeks follow up; subsequent results reflected slightly lower satisfaction with increasing time from treatment. At 2 week follow-up, 81% of subjects stated that they would recommend the procedure to a friend or family, again with slightly decreasing rates with increasing time from treatment. Approximately half of the subjects were satisfied with the time required for the treatment results at 2 weeks, slightly decreasing over subsequent

{6}------------------------------------------------

follow-up visits, and approximately one-third of subjects felt slimmer after treatment (30%), with similar results at subsequent follow-up visits. Regarding the comfort of the treatment, 100% of subjects felt it was comfortable at all time points, with the exception of a single subject at 8 and 10 weeks (96% of subjects felt comfortable). Overall, subjects reported that they experienced improvement following treatment with the UltraShape Power. Treatment with the UltraShape Power demonstrated a positive safety profile, with no adverse events.

Additional safety data from a prospective clinical study of 21 patients treated with added treatment mode) further confirm the safety profile of the device. Subjects underwent 3 treatment sessions each 2 weeks apart: follow-up visits occurred at 2, 4, 8 and 12 weeks after the last treatment visit. The study results further supported the safety profile of device treatment with only one minor event from which the patient completely recovered without the need for any intervention. Subjects reported minimal discomfort and overall satisfaction with the treatments.

Therefore, performance data demonstrated the safety and effectiveness profile of the UltraShape Power for its intended use.

Substantial Equivalence

The UltraShape Power has the same indications for use and similar technological characteristics and principles of operation as its predicate devices. The technological differences between the UltraShape Power and previously cleared UltraShape devices, including the increased acoustic intensity, additional treatment mode, and software/hardware changes, do not raise new types of safety or effectiveness questions. Nonclinical and clinical studies have been conducted to evaluate the UltraShape Power, and results confirm that the device performs as intended and in a similar manner compared to the predicates. Thus, the UltraShape Power is substantially equivalent to the predicate devices.

Conclusion

Syneron's UltraShape Power 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 Special Controls Guidance Document. Testing demonstrated that the device performs as intended. The UltraShape Power device is substantially equivalent to its predicate devices (K141708, K133238).

Regulation Number and Section

§ 878.4590 Focused ultrasound stimulator system for aesthetic use.

(a)
Identification. A Focused Ultrasound Stimulator System for Aesthetic Use is a device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.