CONMED SYSTEM 5000 ESU

K020186 · Conmedcorp · GEI · Apr 12, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020186
• Device Name: CONMED SYSTEM 5000 ESU
• Applicant: Conmedcorp
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 12, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

General-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of any FF (radio frequency) electrosurgical current through an accessor selectrode for cutting and coagulation at the operative site.

Device Story

Conmed System 5000 ESU is a general-purpose electrosurgical generator; delivers radio frequency (RF) current to tissue via electrosurgical accessory handpieces and electrodes. Used in surgical settings (OR) by physicians/surgeons for cutting and coagulation. Device transforms electrical power into RF output; provides energy for tissue management during surgery. Benefits include precise tissue cutting and hemostasis. Output is controlled by the surgeon via handpiece or footswitch; affects clinical decision-making by enabling surgical access and bleeding control.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrosurgical generator; RF energy source; intended for use with standard electrosurgical accessories (handpieces/electrodes). Operates as a standalone unit for cutting and coagulation. No specific materials or software algorithms described.

Indications for Use

Indicated for use as a general-purpose electrosurgical generator for cutting and coagulation of tissue at the operative site in surgical procedures requiring radio frequency electrosurgical current.

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

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three profiles within its body, symbolizing health, human services, and the people served. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 2 2002

Conmed Corporation Mr. Charles M. Hart Director. RA/QA/Safety Conmed Electrosurgery 14603 Fremont Avenue Centennial. Colorado 80112

Re: K020186

Trade Name: Conmed System 5000 ESU Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: January 15, 2002 Received: January 18, 2002

Dear Mr. Hart:

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. Charles Hart

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 your 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,

Miriam C. Provost

Co 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 (if known): ___________________________________________________________________________________________________________________________________________________ K020186

CONMED SYSTEM 5000 ESU Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

General-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of any FF (radio frequency) electrosurgical current through an accessor selectrode for cutting and coagulation at the operative site.

OR/ODE/DMC

12 23 PM '02

RECEIVED

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Musiam C Parrot

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

Prescription Use (Per 21 CFR 801.109)

510(k) Number K02
OR

020186
Over-The-

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Over-The-Counter _