THERMOGARD & THERMOGARD PLUS ABC

K972628 · Conmedcorp · GEI · Aug 27, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K972628
• Device Name: THERMOGARD & THERMOGARD PLUS ABC
• Applicant: Conmedcorp
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Aug 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

dispersive electrode used for the dispersion and return to the electrosurgical generator of therapeutic (RF) energy introduced to the patient at the active electrode during electrosurgical procedures.

Device Story

ConMed ThermoGard and ThermoGard Plus ABC are dispersive electrodes (grounding pads) used during electrosurgical procedures. Device functions as return path for therapeutic RF energy from patient back to electrosurgical generator. Used in clinical settings (e.g., OR) by surgeons or surgical staff. Device ensures safe current dispersion to prevent thermal injury at site of contact. Benefits patient by completing electrical circuit necessary for monopolar electrosurgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dispersive electrode for RF energy return. Passive device. No software, electronics, or energy source. Materials and dimensions not specified in provided text.

Indications for Use

Indicated for patients undergoing electrosurgical procedures requiring the dispersion and return of therapeutic RF energy to an electrosurgical generator.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ira D. Duesler, Jr. Quality Engineer ConMed® Corporation . 310 Broad Street Utica, New York 13501

AUG 27 1997

Re: K972628

Trade Name: ConMed ThermoGard™ & ThermoGard™ Plus ABC Dispersive Electrodes Regulatory Class: II Product Code: GEI Dated: July 11, 1997 Received: July 14, 1997

Dear Mr. Duesler:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality Svstem Kegulation (QS) for Medica! Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or

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Page 2 - Mr. Ira D. Duesler, Jr.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market. . . . . . . . . . . .

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

focollaz

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

Enclosure

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510(k) Number (if known):

ConMed ThermoGard" & ThermoGard" Plus abc Device Name: ___ Dispersive Electrode

Indications For Use:

......dispersive electrode used for the dispersion and return to the electrosurgical generator of therapeutic (RF) energy introduced to the patient at the active --------electrode during electrosurgical procedures.

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Concurrence of CDRH. Office of Device Evaluation (ODE) n Sign-Off) n of Goneral Restorative Davices 972228 OR

Prescription Use J (Per 21 CFR 801.109

Over-The-Counter Use

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Revised December 17. 1996