THERMAGE THERMACOOL SYSTEM

K040135 · Thermage, Inc. · GEI · Jun 21, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040135
• Device Name: THERMAGE THERMACOOL SYSTEM
• Applicant: Thermage, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jun 21, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Thermage ThermaCool System is indicated for use in Dermatologic and General Surgical procedures for electro coagulation and hemostasis; noninvasive treatment of periorbital wrinkles and mytids and non-invasive treatment of facial wrinkles and rhytids.

Device Story

Thermage ThermaCool System is an electrosurgical unit used in dermatologic and general surgical procedures. System components include an RF generator, cooling module, cryogen canister, handpiece assembly with treatment tip, and accessories (cables, tubing, footswitch, coupling fluid, return pad, skin marking paper). The device delivers radiofrequency (RF) energy to tissue to achieve electrocoagulation and hemostasis; it also treats facial and periorbital wrinkles non-invasively. The system is operated by clinicians in a clinical setting. The cooling module and cryogen are used to protect the skin surface during RF delivery. The healthcare provider uses the handpiece to apply energy to the target area; the resulting thermal effect is intended to improve the appearance of wrinkles and rhytids. The device is substantially equivalent to the previously cleared ThermaCool TC system.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, principle of operation, and materials compared to the predicate device.

Technological Characteristics

Electrosurgical unit (21 CFR 878.4400). Components: RF generator, cooling module, cryogen canister, handpiece, treatment tip. Sterilization: Ethylene oxide (EO) per EN 550; EO residuals conform to ISO 10993-7. Biocompatibility: ISO 10993-1 (limited exposure).

Indications for Use

Indicated for dermatologic and general surgical procedures requiring electrocoagulation and hemostasis, and for the non-invasive treatment of periorbital and facial wrinkles and rhytids in adult patients.

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

• ThermaCool TC (K021402)

Submission Summary (Full Text)

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| JUN 2 1 2004 | K040135 1/3 |
|--------------|-------------|
|--------------|-------------|

### 13.0 510(k) Safety Summary

#### A. Name of Device

| Trade Name: | Thermage ThermaCool System |
|----------------------|--------------------------------------------------------------------------------------|
| Common Name: | Electrosurgical Unit and Accessories |
| Classification Name: | Device, Electrosurgical Cutting and Coagulation and<br>Accessories (21 CFR 878.4400) |
| Contact Person: | Pamela M. Buckman, RN, MS<br>Vice President, Regulatory/Clinical Affairs |

#### B. Predicate Device

ThermaCool System

| 510 (k) Number | Name of Device | Decision Date |
|----------------|----------------|------------------|
| K021402 | ThermaCool TC | November 5, 2002 |

### C. Device Description

The Thermage ThermaCool System consists of the following components:

- RF Generator .
- Cooling Module ●
- Cryogen Canister .
- Handpiece Assembly (consisting of Handpiece and Treatment Tip) .
- Accessory cables and tubing .
- Optional footswitch component .
- Accessories: coupling fluid, return pad and skin marking paper .

The Handpiece Assembly and Cooling Module connect to the RF Generator.

#### D. Indicated Use

The Thermage ThermaCool System is indicated for use in Dermatologic and General Surgical procedures for electro coagulation and hemostasis; noninvasive treatment of periorbital wrinkles and mytids and non-invasive treatment of facial wrinkles and rhytids.

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040131 2/3

There is a sterilization contract in compliance with 21 CFR 801.150 between Thermage and IBA Griffith. This contract defines the responsibilities of both parties. Sterilization validation will be performed in accordance with EN 550, utilizing the half-cycle method of sterilization validation to verify a sterility assurance level of 10 .

### EO Residuals

Acceptable EO residual levels will be in conformance with the requirements of consensus standard ISO 10993-7: Biological Evaluation of Medical Devices Part 7 Ethylene Oxide Sterilization Residuals. The Thermage Treatment Tip is a "limited exposure" device in accordance with ISO 10993-1:1992, subclause 5.2 (limited exposure; devices whose single or multiple use or contact is likely to be up to 24 hours). Allowable limits for limited exposure devices are: 20 mg EO and 12 mg ECH (average daily dose).

Verification that EO and ECH residuals are below allowable limits shall be confirmed as part of the EO cycle and product aeration validation. Manufactured product shall also be routinely monitored for EO and ECH residuals (minimum quarterly).

### Skin Marking Paper

### Sterilization

The Thermage Skin Marking Paper will be sterilized using 100% ethylene oxide at IBA Griffith in Salt Lake City, Utah. The address is 5725 West Harold Gatty Road, Salt Lake City, Utah 84116. The establishment registration number is 1721676.

There is a sterilization contract in compliance with 21 CFR 801.150 between Thermage and IBA Griffith. This contract defines the responsibilities of both parties. Sterilization validation will be performed in accordance with EN 550, utilizing the half-cycle method of sterilization validation to verify a sterility assurance level of 10 . O

## EO Residuals

Acceptable EO residual levels will be in conformance with the requirements of consensus standard ISO 10993-7: Biological Evaluation of Medical Devices Part 7 Ethylene Oxide Sterilization Residuals. The Thermage Skin Marking Paper is a "limited exposure" device in accordance with ISO 10993-1:1992, subclause 5.2 (limited exposure: devices whose single or multiple use or contact is likely to be up to 24 hours). Allowable limits for limited exposure devices are: 20 mg EO and 12 mg ECH (average daily dose).

Verification that EO and ECH residuals are below allowable limits shall be confirmed as part of the EO cycle and product aeration validation. Manufactured product shall also be routinely monitored for EO and ECH residuals (minimum quarterly).

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### Technical characteristics نا

The technological characteristics and clinical use data of the ThermaCool System for the expanded indication are substantially equivalent to the previously cleared ThermaCool TC System.

#### ப் Summary

By virtue of design, principle of operation, materials and intended use, the Thermage ThermaCool System is substantially equivalent to devices currently cleared for marketing in the United States.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services. 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.

JUN 2 1 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Pamela M. Buckman, RN, MS Vice President, Regulatory/Clinical Affairs Thermage 4058 Point Eden Way Hayward, California 94545-3721

Re: K040135

Trade/Device Name: Thermage ThermaCool System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: April 30, 2004 Received: May 3, 2004

Dear Ms. Buckman:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your bector. 9 rQxy press.
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 for use stated in the encrosule) to regally manent date of the Medical Device Ameridae, or to commerce prior to May 20, 1776, the enational with the provisions of the Federal Food. Drug. devices that have been recalismed in assess approval of a premarket approval application (PMA). and Cosment Act (Act) market the device, subject to the general con.rols provisions of the Act. The You may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the Fist labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (secure) nits existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations iPA ma may be subject to such additional controller issues of the 21, Parts 800 to 898. In addition, FDA may be found in the Ood of Peachar Succerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issualites over device complies with other requirements of the Act that FDA has made a delemination administered by other Federal agencies. You must or any Federal statures and regulations daministered of registration and listing (21 letting (21 let comply with an the Act 3 requirements) 110, good manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); and 1f applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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# Page 2 - Ms. Pamela M. Buckman, RN, MS

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin marketing of substantial equivalence of your device to a legally premarket notification. The PDA miding of substantal equice 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 if you desire specific advice for your do not on one and the regulation entitled, the regulation entitled, comaci the Office of Compunation at (301) of the Part 807.97). You may obtain "Misbranding by relerence to premantel notilities. In the Act from the Division of Small other general information on your responsions at its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at the consumer attrak Manufacturers, International and Consenter Passes http://www.fda.gov/cdrh/dsmamain.html

Sincerely yours,

Miriam C. Provost

fal Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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(IF Not Known NUMBER 510(k) KNOWN):

Thermage ThermaCool System

K040135

INDICATIONS FOR USE:

DEVICE NAME:

The Thermage ThermaCool System is indicated for use in:

- · Dermatologic and general surgical procedures for electro coagulation and hemostasis,
- · Non-invasive treatment of periorbital wrinkles and rhytids
- Non-invasive treatment of facial wrinkles and rhytids

| Prescription Use | X |
|----------------------|---|
| OR | |
| Over-The-Counter-Use | |

(Per 21 CFR 801.109)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number: K040135

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