THOMAS MEDICAL ELECTRODES

• K Number: K022593
• Device Name: THOMAS MEDICAL ELECTRODES
• Manufacturer: THOMAS MEDICAL, INC.
• Date Cleared: 2002-11-01 ( 88 days)
• Product Code: HGI
• Regulation Number: 884.4120
• Type: Traditional
• Panel: Obstetrics/Gynecology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

To be used for soft tissue cutting of the uterine cervix and coagulation, intraepithelial neoplasia, condylomata acuminata, and miscellaneous lesions; polyps, molluscum contagiosum, nevi, seborrheic keratosis, achricordon, etc.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA regarding the Thomas Medical Electrodes. It is a regulatory document and does not contain the kind of information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth information, etc.) because these types of studies are not typically required for a 510(k) clearance, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device.

Therefore, I cannot provide the requested information based on the given text. The prompt asks for details about a study that proves the device meets acceptance criteria, but this document only states that the device is substantially equivalent to a predicate device and can proceed to market.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is a common symbol associated with healthcare and medicine. The text "Department of Health" is arranged around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2002

Re: K022593

Mr. Thomas J. Zinnanti President and CEO Thomas Medical, Inc. 4100-C Nine McFarland Drive ALPHARETTA GA 30004

Trade/Device Name: Thomas Medical Electrodes Regulation Number: 21 CFR 884.4120 Regulation Name: Gynecologic electrocautery and accessories

Regulatory Class: II Product Code: 85 HGI Dated: July 30, 2002 Received: August 5, 2002

Dear Mr. Zinnanti:

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 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 Par: 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 Aet); 21 CFR 1000-1050,

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This letter will allow you to begin marketing your device as described in your 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 one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	[phone]
876.2xxx, 3xxx, 4xxx, 5xxx	[phone]
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	[phone]
892.2xxx, 3xxx, 4xxx, 5xxx	[phone]
Other	[phone]

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html.

Sincerely yours.

Nancy C. Snogdon

Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section #4

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Indications for Use

510(k) Number:	K022593 (to be assigned)
Device Name:	Thomas Medical Electrodes
Intended Use:	To be used for soft tissue cutting of the uterine cervix and coagulation, intraepithelial neoplasia, condylomata acuminata, and miscellaneous lesions; polyps, molluscum contagiosum, nevi, seborrheic keratosis, achricordon, etc.

:

:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓
(Per CFR 801.109)

OR

Over-the-counter use	____________________
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(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number

Page 5 of、バ

Page 5 of 17

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Regulation Number and Section

§ 884.4120 Gynecologic electrocautery and accessories.

(a)
Identification. A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables.(b)
Classification. Class II (performance standards).