VALUPEN,PROFILE

K041868 · Conmed Corporation · GEI · Sep 28, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041868
• Device Name: VALUPEN,PROFILE
• Applicant: Conmed Corporation
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Single-use hand-switching electrosurgical accessory handpiece used in conjunction with an electrosurgical generator for delivery of RF electrosurgical current through an electrode for cutting and coagulation at the operative site.

Device Story

Disposable electrosurgical pencil; hand-switching accessory for electrosurgical generators. Device connects to generator via cable; delivers high-frequency (HF) electrosurgical current to electrode tip. Clinician activates cut/coagulation via handpiece buttons. Used in general surgery for tissue cutting and coagulation. Single-use; sterile distribution. Benefits patient by providing precise energy delivery for surgical site management.

Clinical Evidence

Bench testing only. Compliance with ANSI/AAMI HF-18, IEC 60601-2-2, ISO 11137, and ISO 10993 standards demonstrated.

Technological Characteristics

Hand-switching electrosurgical accessory; RF energy source; various electrode types and cable lengths. Complies with ANSI/AAMI HF-18, IEC 60601-2-2, ISO 11137 (radiation sterilization), and ISO 10993 (biocompatibility).

Indications for Use

Indicated for use in general surgical procedures requiring cutting and coagulation of tissue via RF electrosurgical current. Intended for use by clinicians in an operative setting.

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.

Predicate Devices

• Disposable Electrosurgical Pencils (K936304)

Submission Summary (Full Text)

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## Summary of Safety and Effectiveness

| Submitted by: | CONMED Electrosurgery Division<br>14603 East Fremont Avenue<br>Centennial, CO 80112 USA<br>Telephone: [phone]<br>Facsimile: 303-699-9854 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Pamela L. Vetter |
| Date Prepared: | July 8, 2004 |
| Proprietary Name: | ValuPen TM, Profile® and other trade names as established |
| Common Name: | Disposable Electrosurgical Pencil |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and accessories (21 CFR<br>878.4400)<br>79 GEI |
| Predicate Device: | Disposable Electrosurgical Pencils<br>510(k) # K936304 |

Device Description: This pencil has applications in general surgical procedures to provide a means of cutting and coagulation using electrosurgical current. The device consists of a cable for connection to the output of an electrosurgical generator unit, to carry high-frequency (HF) electrosurgical current to an electrode tip at the distal end of the handpiece is provided with various electrode types and cable lengths and acts as a hand-switching conduit in delivering the HF energy from the electrosurgical generator unit through an electrode to produce the therapeutic affect. Current is activated by the cut/coagulation switching element buttons on the handpiece. The devices will be distributed sterile for single-use applications.

Intended Use of Device: Single-use hand-switching electrosurgical accessory handpiece used in conjunction with an electrosurgical generator for delivery of RF electrosurgical current through an electrode for cutting and coagulation at the operative site.

Technological Characteristics: The proposed device is equivalent to the identified predicate device with respect to technological characteristics and function. The device has been designed to comply with the applicable sections of ANSI/AAMI American National Standard for Electrosurgical Devices HF-18, the International Electrotechnical Commission Standard for Electrosurgical Devices, IEC 60601-2-2, Sterilization of health care products – Requirements for validation and routine control – Radiation Sterilization, ISO 11137 and Biocompatibility, ISO 10993.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 8 2004

Ms. Pamela Vetter Regulatory Affairs Manager ConMed Electrosurgery 14603 East Fremont Avenue Centennial, Colorado 80112

Re: K041868

Trade/Device Name: Disposable Electrosurgical Pencil Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: July 8, 2004 Received: July 9, 2004

Dear Ms. Vetter:

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 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 - Ms. Pamela Vetter

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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

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):

Disposable Electrosurgical Pencil Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Single-use hand-switching electrosurgical accessory handpiece used in conjunction with an electrosurgical generator for delivery of RF electrosurgical current through an electrode for cutting and coagulation at the operative site.

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter_

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

510(k) Number_K04 / 868