TRUSCULPT

K133739 · Cutera, Inc. · PBX · Sep 5, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K133739
• Device Name: TRUSCULPT
• Applicant: Cutera, Inc.
• Product Code: PBX · General, Plastic Surgery
• Decision Date: Sep 5, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The truSculpt is intended to generate heat within body tissues for the treatment of selected medical conditions, such as the relief of minor aches and pain, muscle spasms, and an increase in local circulation. It is also intended to provide temporary reduction in the appearance of cellulite.

Device Story

truSculpt system comprises a console, RF handpieces, and a truGlide massage roller. Handpieces deliver RF energy (bipolar/monopolar) to subcutaneous tissue to induce moderate temperature rise; system monitors epidermal temperature for active control. Separate mechanical roller provides massage. Operated by clinicians in a clinical setting. Console controls all system functions; treatment activation via fingerswitch. RF energy elevates tissue temperature to treat pain, muscle spasms, and improve local circulation; massage component reduces cellulite appearance. Benefits include non-invasive symptom relief and aesthetic improvement.

Clinical Evidence

No clinical data.

Technological Characteristics

RF energy delivery (300kHz – 50 MHz, 300 W max); Bipolar/Monopolar modes. Patient contact materials: Polyethylene (3M Tegaderm) and 316 Stainless Steel. Features active temperature sensing and control. System includes console, RF handpieces, and mechanical massage roller. Complies with IEC 60601-1-2 for electromagnetic compatibility.

Indications for Use

Indicated for patients requiring topical heating to elevate tissue temperature for relief of pain, muscle spasms, and increased local circulation, and for temporary reduction in the appearance of cellulite.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• Cutera truSculpt RF Device (K122389)

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

September 5, 2014

Cutera Incorporated Dr. Bradley Renton Vice President of Regulatory and Medical Affairs 3240 Bayshore Boulevard Brisbane, California 94005

Re: K133739

Trade/Device Name: truSculpt Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: PBX Dated: June 6, 2014 Received: June 9, 2014

Dear Dr. Renton:

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.

for

Sincerely yours,

# David Krause -S

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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## Section 4 Indications for Use

510(k) Number (if known): K133739

Device Name: _ truSculpt

#### Indications for Use:

The truSculpt RF energy is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.

The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite.

Prescription Use xx (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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# Section 5 510(K) Summary

This 510(K) Summary of safety and effectiveness for the truSculpt RF device is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.

| Applicant: | Cutera, Inc. |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 3240 Bayshore Blvd., Brisbane, CA 94005 |
| Contact Person: | Bradley Renton |
| Telephone: | 415-657-5568 – phone |
| Fax: | 415-715-3568 - fax |
| Email: | [e-mail] |
| Preparation Date: | June 6, 2014 |
| Device Trade Name: | truSculpt |
| Common Name: | Massager, Vacuum, Radio Frequency Induced Heat |
| Classification Name: | Electrosurgical cutting and coagulation device and<br>accessories, PBX, 21 CFR 878-4400 |
| Legally Marketed Predicate<br>Device: | Cutera truSculpt RF Device (K122389) |
| Device Description: | The truSculpt device consists of a console, one or more RF<br>handpieces that connect to the console with an umbilical<br>cable, and a truGlide massage roller. All system functions<br>are controlled through the console. The handpieces deliver<br>RF energy to generate a heating profile that produces a<br>moderate temperature rise in the subcutaneous tissue, while<br>monitoring epidermal temperature. In addition, there is a<br>separate mechanical roller that can be used as a massager. |
| Intended Use: | The truSculpt is intended to generate heat within body<br>tissues for the treatment of selected medical conditions,<br>such as the relief of minor aches and pain, muscle spasms,<br>and an increase in local circulation. It is also intended to<br>provide temporary reduction in the appearance of cellulite. |
| Specific Indications: | The truSculpt RF energy is intended to provide topical<br>heating for the purpose of elevating tissue temperature for<br>the treatment of selected medical conditions such as relief o<br>pain, muscle spasms, and increase in local circulation.<br>The truSculpt massage device is intended to provide a<br>temporary reduction in the appearance of cellulite. |

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## Attachment 5 510(K) Summary

### Requirements for Safety

IEC 60601-1-2 Medical Electrical Equipment – Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility

truSculpt Software Verification and Validation Testing Report (V0005 rN)

Results of Clinical Study: None

Summary of Technological See table below Characteristics:

Conclusion:

Cutera believes that the requested changes are substantially equivalent to the predicate device and do not raise any new issues of safety or effectiveness.

| Feature/Parameter | Current | Cutera truSculpt RF Device (K122389) |
|---------------------------------------|---------------------------------------|-----------------------------------------------|
| Infrared light | No | Yes (optional); up to 20 W max, 700 – 2000 nm |
| Massage | Yes – as a separate handpiece | Yes – as a separate handpiece |
| Vacuum (suction) | No | Yes |
| Temperature sensing | Yes | Yes |
| Temperature sensing<br>active control | Yes | Yes |
| Treatment activation | Fingerswitch | Footswitch |
| Area treated | 16 – 40 cm² | 16 – 40 cm² |
| Electrode shape | Square or Rectangle | Square |
| RF frequency | 300kHz – 50 MHz | 300kHz – 50 MHz |
| RF type | Bipolar / Monopolar | Bipolar / Monopolar |
| Max RF power | 300 W | 300 W |
| Duty cycle | 0 – 100% | 0 – 100% |
| Patient contact<br>material | Polyethylene (3M Tegaderm) and 316 SS | Polyethylene (3M Tegaderm) and 316 SS |