This 510(k) premarket notification for the ThermaCool TC System primarily concerns a modification to an existing device, specifically a reformulated Coupling Fluid. The submission explicitly states that "There are no applicable FDA mandated performance standards for electrosurgical cutting and coagulation device and accessories."

Therefore, the provided document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

This document focuses on establishing substantial equivalence to previously cleared devices (K013639 and K021402) for the modified system (specifically the new coupling fluid), rather than demonstrating a new performance for the entire ThermaCool TC System. Substantial equivalence for this type of modification often relies on comparing material properties and safety, rather than extensive clinical performance studies with specific statistical metrics.

Here's why the prompt's requested information is not available in the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The document does not define specific performance metrics or acceptance criteria for the device or its new coupling fluid.
2. Sample size used for the test set and the data provenance: Not present. There is no mention of a test set, sample size, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. Ground truth is not discussed as there is no performance study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not present.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not present. This is not an AI-assisted device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not present. This is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not present.
8. The sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

The key takeaway is that this 510(k) is for a minor modification (coupling fluid reformulation) to an already cleared device, and thus, the submission primarily addresses the substantial equivalence of this modification, not a comprehensive performance study of the entire system as if it were a novel device.

Summary

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030142

510(k) Premarket Notification

Summary of Safety and Effectiveness Information

ThermaCool TC SYSTEM JANUARY 14, 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:

Name: Thermage 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.

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ProCode: 79GEI

Equivalent Device(s):

The modified ThermaCool TC System accessory claims substantial equivalence to the ThermaCool 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 reformulated Coupling Fluid.

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 510.782.2287 fax

Submission Correspondent:

Pamela M. Buckman, R.N., M.S. Thermage 4058 Point Eden Way Hayward, CA 94545-3721 510.782.2286 telephone 510.782.2287 fax

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K030142 2/2

Manufacturing Facility:

At the present time, this ThermaCool TC System accessory is contract manufactured according to Thermage specifications.

Performance Standards:

: 上一篇:

There are no applicable FDA mandated performance standards for electrosurgical cutting and coagulation device and accessories. However, voluntary standards such as in-house Standard Operating 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 U.S. Department of Health & Human Services. The logo features a stylized image of an eagle's head with three profiles within the head. The text "DEPARTMENT FOR HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle's head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 3 2003

Thermage, Inc. Pamela M. Buckman, R.N., M.S. 4058 Point Eden Way Hayward, California 94545-3721

Re: K030142

Trade/Device Name: ThermaCool TC System Regulation Number: 878:4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: January 14, 2003 Received: January 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. 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. Pamela M. Buckman

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). Other general information on your responsibilities under the Act may be obtained 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,

Miriam 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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510(k) NUMBER: Ko 3014L

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.

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

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

minua

MONITOR K030142

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.