TIVAMED COOLED RF SYSTEM, MODEL 78001

K082962 · Tivamed, Inc. · GEI · Dec 4, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K082962
• Device Name: TIVAMED COOLED RF SYSTEM, MODEL 78001
• Applicant: Tivamed, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 4, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TivaMed Cooled RF System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.

Device Story

TivaMed Cooled RF System utilizes radiofrequency (RF) energy to selectively heat tissue volumes beneath the surface; cryogen is delivered to the interior of the treatment tip to cool and protect surface tissue during operation. Device is intended for use in general surgical procedures for electrocoagulation and hemostasis. System operation involves RF energy delivery for thermal effects; cooling mechanism prevents surface damage. Device is used by clinicians in surgical settings.

Clinical Evidence

Bench testing only. Device underwent biocompatibility, electrical, and mechanical testing in accordance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-2, AAMI/ANSI/ISO 11135-1:2007, and ISO 10993-1 standards.

Technological Characteristics

Electrosurgical unit using RF energy for tissue heating and cryogen for surface cooling. Complies with IEC 60601-1 (General Safety), IEC 60601-1-2 (EMC), IEC 60601-1-4 (Programmable Electrical Medical Systems), and IEC 60601-2-2 (High Frequency Surgical Equipment). Sterilization via ethylene oxide per AAMI/ANSI/ISO 11135-1:2007.

Indications for Use

Indicated for use in general surgical procedures requiring electrocoagulation and hemostasis. No specific patient population, age, or gender restrictions are defined.

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

• Thermage ThermaCool™ System (K000944)
• Thermage ThermaCool™ System (K013639)

Submission Summary (Full Text)

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DEC 0 4 2008

# KO82962

Page 1 of 2

| Section 5 – 510(k) Summary | |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | TivaMed, Inc.<br>450 Sheridan Ave.<br>Palo, Alto, CA 94306<br>Office: 650-321-3332<br>Fax: [phone] |
| Contact Person: | Shelley Trimm<br>RA & QS Consultant, Alquest, Inc.<br>4410 El Camino Real, Ste 204<br>Los Altos, Ca 94022<br>Ph: 707.508.5527<br>FAX: [phone]<br>Email: [e-mail] |
| Date Prepared: | October 2, 2008 |
| Trade Name: | TivaMed Cooled RF System<br>(Electrosurgical Unit and Accessories – Common Name) |
| Classification: | Class II<br>21 CFR 878.4400: Device, Electrosurgical, Cutting and<br>Coagulation and Accessories |
| Product Code: | GEI |
| Predicate Device(s): | The subject device is equivalent to the following devices:<br>Thermage ThermaCool™ System, K000944 (cleared<br>7/19/2000); and<br>Thermage ThermaCool™ System K013639 (cleared<br>1/29/2002). |
| Device Description: | TivaMed Cooled RF System uses radiofrequency (RF)<br>energy to selectively heat a given volume of tissue<br>beneath the surface, while cryogen is delivered to the<br>inside of the treatment tip to cool and protect the surface<br>tissue. |
| Intended Use: | The TivaMed Cooled RF System is indicated for use in<br>general surgical procedures for electrocoagulation and<br>hemostasis |

TivaMed, Inc.

CONFIDENTIAL PreMarket Notification for the TivaMed RF Cooled System

TivaMed, Inc.

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K082962

Page 2 of 2

| Functional and<br>Safety Testing: | To verify the device design met its functional and<br>performance requirements, representative samples of the<br>device underwent biocompatibility, electrical, and<br>mechanical testing in accordance with IEC 60601-1,<br>Medical Electrical Equipment - General Requirements for<br>Safety; IEC 60601-1-2, IEC 60601-1-4, Medical Electrical<br>Equipment - General Requirements for Safety -<br>Programmable Electrical Medical Systems; IEC 60601-2-<br>2 Medical Electrical Equipment - Particular Requirements<br>for the Safety of High Frequency Surgical Equipment;<br>AAMI/ANSI/ISO 11135-1:2007 Sterilization of health<br>care products - Ethylene oxide - Part 1: Requirements for<br>development, validation and routine control of a<br>sterilization process for medical devices; ISO 10993-1,<br>Biological Evaluation of Medical Devices - Part 1:<br>Evaluation and Testing; Federal Register, Volume 43, No.<br>122, 1978; FDA "ETO, ECH, and EG Proposed<br>Maximum Residue Limits and Maximum Limits of<br>Exposure". |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | TivaMed, Inc., considers the TivaMed Cooled RF System<br>to be equivalent to the predicate device listed above. This<br>conclusion is based upon the devices' similarities in<br>principles of operation, technology, materials, and<br>indications for use. |

TivaMed, Inc.

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CONFIDENTIAL PreMarket Notification for the TivaMed RF Cooled System

TivaMed, Inc.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### DEC. 0 4 2008

TivaMed. Inc. % Ms. Shelley Trimm Alquest. Inc. 4410 El Camino Real. Suite 204 Los Altos, California 94022

Re: K082962

Trade/Device Name: TivaMed Cooled RF System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: October 2, 2008 Received: October 3, 2008

Dear Ms. Trimm:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Ms. Shelley Trimm

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Mullerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K082962

# Section 4 - Indications for Use Statement

Device Name: TivaMed Cooled RF System

The TivaMed Cooled RF System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Nest R. Odell forman

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number

TivaMed, Inc.

CONFIDENTIAL

PreMarket Notification for the TivaMed RF Cooled System

TivaMed, Inc.

CONFIDENTIAL