The provided document is a 510(k) premarket notification for the ThermaCool TC System. It describes a modification to an existing device, specifically a modified "Skin Marking Paper." This document focuses on establishing substantial equivalence to previously cleared devices (K013639 and K021402), rather than presenting a new study with acceptance criteria and device performance evaluation in the format requested.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not available in this document.

The document states:

"There are no applicable FDA mandated performance standards for electrosurgical cutting and coagulation device and accessories."
It refers to "in-house Standard Operating Procedures and QSR based vendor qualification procedures" for manufacturing, but these do not constitute device performance acceptance criteria or a study proving those criteria are met for the device itself in terms of clinical or technical effectiveness.
The FDA letter confirms that a substantial equivalence determination was made based on the indications for use provided.

Summary

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/2 AUG - 1 2003

K032088

510(k) Premarket Notification

Summary of Safety and Effectiveness Information

ThermaCool TC SYSTEM July 3, 2003

ThermaCool TC System Device Name:

Common Name(s): RF Unit, coagulator

Classification Name: Electrosurgical cutting and coagulation device and accessories

Establishment Name & Registration Number:

Thermage Name: Number: 2954746

Classification:

Title 21, Code of Federal Regulations,

$ 878.4400 Electrosurgical cutting and coagulation device and accessories. (a) 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. (b) Classification. Class II.

ProCode: 79GEI

Equivalent Device(s):

The modified ThermaCool TC System claims substantial equivalence to the ThermacCool TC System K013639 and K021402.

Description of the Device:

The device as described in the above referenced Premarket Notifications has been modified to include a modified Skin Marking Paper.

Applicant / Sponsor Name / Address:

Thermage 4058 Point Eden Way Hayward, CA 94545-3721 510.782.2286 telephone 510.782.2287 fax

Contact Person:

Pamela M. Buckman, R.N., M.S. Thermage 4058 Point Eden Way Hayward, CA 94545-3721 510.782.2286 telephone 510.723.3348 fax

Submission Correspondent:

Pamela M. Buckman, R.N., M.S. Thermage 4058 Point Eden Way Hayward, CA 94545-3721 510.782.2286 telephone 510. 723.3348 fax

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032088 1/2

Manufacturing Facility:

At the present time, this ThermaCool TC System accessory is manufactured by Thermage Inc. in accordance with defined Thermage specifications

Performance Standards:

There are no applicable FDA mandated performance standards for electrosurgical cutting and coagulation device and accessories. However, voluntary standards such as in-house Standard Operaing Procedures and QSR based vendor qualification procedures are in place and utilized in the production of the device.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized abstract design resembling a bird or human figure with flowing lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 1 2003

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

Re: K032088

Trade/Device Name: ThermaCool TC System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: July 3, 2003 Received: July 15, 2003

Dear Ms. Buckman:

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.

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 (OS) 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. Pamela Buckman, R.N., M.S.

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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Muriam C. Provost

for 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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Page 1 of 1

510(k) NUMBER: Ko32088

DEVICE NAME: ThermaCool TC System

INDICATIONS FOR USE:

The ThermaCool TC System is indicated for use in

Non-invasive treatment of periorbital rhytids and wrinkles ●
· Dermatologic and general surgical procedures for electrocoagulation and hemostasis.

Muriam C. Provost

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

K032088 510(k) Number_

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use (Optional format 1-2-96)

ThermaCool510.doc

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
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.(b)
Classification. Class II.