THOMAS MEDICAL ELECTRODES

K022593 · Thomas Medical, Inc. · HGI · Nov 1, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K022593
• Device Name: THOMAS MEDICAL ELECTRODES
• Applicant: Thomas Medical, Inc.
• Product Code: HGI · Obstetrics/Gynecology
• Decision Date: Nov 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4120
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

Thomas Medical Electrodes are surgical accessories used for electrosurgical procedures. The device functions by delivering electrical energy to soft tissue to perform cutting and coagulation. It is intended for use by clinicians in a medical setting for gynecological and dermatological applications, specifically targeting the uterine cervix and various skin lesions. The device acts as an interface between an electrosurgical generator and the patient's tissue, allowing the physician to precisely excise or coagulate tissue during surgical interventions. This facilitates the removal of lesions and management of tissue conditions, providing a therapeutic benefit through controlled electrosurgical destruction or excision.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrosurgical electrode accessory for use with electrosurgical generators. Designed for soft tissue cutting and coagulation. Form factor consists of conductive tips for tissue contact. Operates via electrical energy transfer. No software or complex electronic components described.

Indications for Use

Indicated for soft tissue cutting and coagulation of the uterine cervix, including treatment of intraepithelial neoplasia, condylomata acuminata, and various lesions such as polyps, molluscum contagiosum, nevi, seborrheic keratosis, and achricordon.

Regulatory Classification

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## 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. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div style="display:inline-block;"> ✓ </div> |
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| (Per CFR 801.109) | |

OR

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

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