EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE

K031079 · Gyrus Medical, Inc. · GEI · May 21, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K031079
• Device Name: EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE
• Applicant: Gyrus Medical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: May 21, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Electrosurgical cutting and mechanical dissection of tissue, during the performance of laparoscopic and general surgical procedures.

Device Story

Bipolar needle electrode for electrosurgical cutting and mechanical dissection. Device utilizes bipolar electrosurgical energy; cutting electrode electrically isolated from return electrode, eliminating need for external return pad. Used in laparoscopic and general surgical procedures by clinicians. Modification of predicate device (K904993) involves change in shaft length; construction and materials remain identical. Device provides localized energy delivery for tissue dissection; benefits include elimination of return pad requirement.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and functional similarity to predicate device.

Technological Characteristics

Bipolar needle electrode; electrosurgical energy source. Construction materials identical to predicate K904993. Features electrically isolated cutting and return electrodes. Form factor modified for shaft length. No software or complex electronics.

Indications for Use

Indicated for electrosurgical cutting and mechanical dissection of tissue during laparoscopic and general surgical procedures.

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

• K904993

Submission Summary (Full Text)

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March 31, 2003

Gvrus Medical, Inc. Company: 6655Wedgwood Road Maple Grove, MN 55311-3602 Tel. No. [phone] FAX. No. [phone]

- Contact: Mercedes Bayani Director, Requlatory Affairs
- Electrosurgical Instruments Common/Usual Name:
- Electrosuraical Cutting and Coagulation Device Classification Name: and Accessories (21 CFR 878.4400)
- Proprietary Name: Everest Bipolar Needle Electrode and Gvrus Bipolar Needle Electrode

The device is a Class II medical device. The Bipolar Needle Electrode is a modification to the predicate device cleared under K904993. The bipolar Needle Electrodes are identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device. The cutting electrode is electrically isolated from the return electrode, enabling one electrode to act as a return electrode, eliminating the need for a return pad. The modification has not altered the fundamental technology of the predicate device cleared under K904993. The intended use, electrosurgical cutting, and mechanical dissection are identical to the predicate devices cleared under K904993. The energy source, bipolar electrosurgical energy, is the same energy type as used for the predicate devices.

In conclusion, as the design, materials of construction, function and intended use of the modified bipolar needle electrode is similar to that of the predicate devices currently cleared. Gyrus Medical Inc. believes that no new issues of safety and effectiveness are raised and that the submitted device is substantially equivalent.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circumference of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 21 2003

Ms. Mercedes Bayani Director, Regulatory Affairs Gyrus Medical, Inc. 6655 Wedgwood Road Maple Grove, Minnesota 55311

Re: K031079

Trade/Device Name: Everest Bipolar Needle Electrode and Gyrus Bipolar Needle Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 31, 2003 Received: April 24, 2003

Dear Ms. Bayani:

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. Mercedes Bayani

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]. 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) you may obtain. 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 vours.

Sincererly, yours,

Mark N Milliman

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): __ K031079 Device Name: Everest Bipolar Needle Electrode & Gyrus Bipolar Needle Electrode

Indications for Use:

Electrosurgical cutting and mechanical dissection of tissue, during the performance of laparoscopic and general surgical procedures.

Mark N. Millerson

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

Number KOS1077