ULTRASHAPE SYSTEM

K141708 · Syneron Medical, Ltd. · OHV · Oct 6, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K141708
• Device Name: ULTRASHAPE SYSTEM
• Applicant: Syneron Medical, Ltd.
• Product Code: OHV · General, Plastic Surgery
• Decision Date: Oct 6, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4590
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The UltraShape 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 Story

UltraShape System uses focused ultrasound energy to disrupt subcutaneous adipose tissue (SAT) for non-invasive aesthetic body contouring. System comprises a control unit and two ultrasonic transducers; transducers convert electrical signals into mechanical (acoustical) energy via piezoelectric ceramic elements. Device targets SAT while sparing neighboring tissues like blood vessels, nerves, and muscle. Real-time optical and acoustic feedback is provided via a tracking and guidance system. Operated by clinicians in a clinic setting. Output is focused ultrasound energy; healthcare providers use the system to achieve abdominal circumference reduction. Benefits include non-invasive fat reduction with minimal discomfort and high patient satisfaction.

Clinical Evidence

Clinical evaluation included two prospective, single-arm studies (n=102) and one additional safety study (n=21). Subjects (mean age 44, majority female) received three treatments at two-week intervals with follow-up at 2, 4, 8, and 12 weeks. Primary endpoint was abdominal circumference reduction. Results showed average midline reduction of -2.37 cm at 12 weeks with minimal weight change (<1%). Safety profile was positive; adverse events were mild to moderate, resolving within hours or days. No serious device-related adverse events reported.

Technological Characteristics

System includes console with computer and two ultrasonic transducers. Transducers utilize piezoelectric effect with ceramic elements. Features real-time optical/acoustic tracking and guidance. Biocompatibility per ISO 10993. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2. Focused ultrasound energy delivery.

Indications for Use

Indicated for non-invasive reduction in abdominal circumference in patients seeking aesthetic body contouring.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Syneron Contour I V3.1 (K133238)

Submission Summary (Full Text)

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

October 6, 2014

Syneron Medical Ltd. c/o Ms. Janice Hogan Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, PA 19103

Re: K141708

Trade/Device Name: Syneron 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: September 12, 2014 Received: September 12, 2014

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 (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, Binita S. Ashar -S 2014.10.06 08:36:38 -04'00' 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

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement on last page |
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| Indications for Use |
|---------------------|
|---------------------|

| 510(k) Number (if known) | K141708 |
|------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | UltraShape System |
| Indications for Use (Describe) | The UltraShape 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. |
| Type of Use ( <i>Select one or both, as applicable</i> ) | |
| <div> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)<br/>Subpart C) </div> | Over-The-Counter Use (21 CFR 801 |

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### 510(k) SUMMARY

### Syneron Medical Ltd.'s UltraShape 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 Ruthie Amir, MD, Global Vice President of Clinical and Regulatory Affairs Phone: [phone] Facsimile: 972-73-244-2202

Contact Person: Janice Hogan Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, PA 19103 Phone: [phone] Facsimile: 267 675 4601

Date Prepared: October 2, 2014

#### Name of Device

Syneron UltraShape System

#### Common or Usual Name

Focused Ultrasound Stimulator System for Aesthetic Use

## Classification

Focused Ultrasound Stimulator System for Aesthetic Use

21 CFR 878.4590, Class II, product code OHV

#### Predicate Devices

Syneron Contour I V3.1 (K133238)

#### Intended Use / Indications for Use

The UltraShape 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 System is comprised of multiple components, including the control unit and two ultrasonic transducers. The UltraShape System selectively targets subcutaneous

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adipose tissue via focused ultrasound for the purpose of non-invasive aesthetic body contouring. The transducer is an electro-mechanical device that converts 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 purpose of this submission is to increase acoustic intensity and to add an additional smaller ultrasound transducer.

## Technological Characteristics

The UltraShape System is 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 quidance system. The transducers functionality is based on the piezoelectric effect implemented with the ceramic element.

## Performance Data

The following nonclinical performance testing was 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, cytotoxicity testing 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, at a focal depth highly similar to that of the predicate device.
- 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.
- . 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 demonstrated the electrical safety of the device.
- 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.

In addition, clinical evaluation of the device in the intended population was performed in two, separate, prospective, single arm studies. The studies evaluated the safety and

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effectiveness of the UltraShape in 102 enrolled subjects. The majority of the subjects were female with mean age of 44 years. After baseline screening, patients underwent three treatments each at two weeks apart, with follow-up visits at 2, 4, 8 and 12 weeks after the The abdominal circumference reduction, weight, satisfaction and safety last treatment. results were assessed for the study subjects throughout the study visits. The results demonstrated that at final follow-up, subjects achieved an average of -2.37 cm circumference reduction at the midline. Similar treatment results were observed at the measurement points 2 cm above and 2 cm below the midline. It should also be noted that very little weight change was observed in the study subjects overall, with an average weight change measuring less than 1% at 12 weeks (or longer term follow up) for all subjects. Midline circumference reduction results in the weight stable subjects (-2.18 cm) were very similar to the results observed in the overall population. Therefore, the subject device demonstrated substantially equivalent performance over time compared to the predicate in the overall study population and in the weight stable subgroup. Additional sensitivity analyses, including last observation carried forward (LOCF) and worst case analyses, continue to demonstrate the robust treatment effect of the UltraShape in abdominal circumference reduction. The safety profile of the UltraShape device was maintained through long term follow up: the only events in the studies were mild to moderate in severity and resolved within a few hours or days. In addition, the majority of subjects in the UltraShape studies reported overall satisfaction with treatment. An additional prospective clinical study assessed the device safety profile in 21 patients. 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, multiple clinical studies with the UltraShape device demonstrated successful circumference reduction and a positive safety profile, with no device related serious adverse events. Thus, the clinical studies support substantial equivalence to the predicate.

# Substantial Equivalence

The UltraShape has the same indications for use, similar technological characteristics and the same principles of operation as its predicate device. The technological differences between the UltraShape and the Contour I V3.1 mainly consist of differences in acoustic intensity and the addition of a smaller transducer. Nonclinical and clinical studies of the UltraShape have demonstrated the safety and effectiveness profile of the UltraShape 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 Special Controls Guidance Document. Testing demonstrated that the device performs as intended. The UltraShape device is substantially equivalent to its predicate device (K133238).