CONMED HEATWAVE HAND-CONTROLLED ELETRODE

K021299 · Conmedcorp · GEI · Jun 26, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K021299
• Device Name: CONMED HEATWAVE HAND-CONTROLLED ELETRODE
• Applicant: Conmedcorp
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jun 26, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For electrosurgical cutting and coagulation in shoulder, ankle, wrist, elbow, and knee arthroscopic procedures. Additionally, the SI version also has suction capability.

Device Story

Conmed HeatWave Hand-Controlled Electrode is an electrosurgical accessory used during arthroscopic procedures. Device delivers high-frequency electrical energy to tissue for cutting and coagulation; SI version integrates suction capability for fluid/debris removal. Operated by surgeons in clinical/OR settings; hand-controlled interface allows direct manipulation by the physician. Device functions as an extension of an electrosurgical generator; output affects tissue impedance to achieve desired surgical effect. Benefits include precise tissue management and improved visualization during minimally invasive joint surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrosurgical electrode for cutting and coagulation; includes hand-control interface. SI version features integrated suction port. Device connects to standard electrosurgical generators. Materials and sterilization methods are consistent with established standards for arthroscopic electrosurgical accessories.

Indications for Use

Indicated for patients undergoing arthroscopic surgical procedures of the shoulder, ankle, wrist, elbow, and knee requiring electrosurgical cutting and coagulation. The SI version is indicated for procedures requiring concurrent suction.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 6 2002

Conmed Corporation Ira D. Duesler, Jr. Quality Manager 525 French Road Utica. New York 13502

Re: K021299

Trade Name: Conmed Heatwave Hand-Controlled Electrode Regulation Number: 878.4400; 888.1100 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI; HRX Dated: April 19, 2002 Received: April 24, 2002

Dear Mr. Duesler:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is 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) 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 (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 - Mr. Ira Duesler

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

ia 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 (if known):

CONMED HeatWave™ Hand-Controlled Electrode Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

For electrosurgical cutting and coagulation in shoulder, ankle, wrist, elbow, and knee arthroscopic procedures. Additionally, the SI version also has suction capability.

RECEIVED

APR 24 2:21 PM '02

FDA/CDRH

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stipt Rhodes

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

510(k) Number_KO21799

Prescription Use

OR

Over-the-Counter Use

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