EVEREST BIPOLAR MACRO, MICRO & MOLLY FORCEPS & GYRUS BIPOLAR MACRO, MICRO & MOLLY FORCEPS

K031078 · Gyrus Medical, Inc. · GEI · May 16, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K031078
• Device Name: EVEREST BIPOLAR MACRO, MICRO & MOLLY FORCEPS & GYRUS BIPOLAR MACRO, MICRO & MOLLY FORCEPS
• Applicant: Gyrus Medical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: May 16, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical procedures.

Device Story

The Everest and Gyrus Bipolar MACRO, MICRO, and MOLLY Forceps are electrosurgical instruments used for grasping, dissecting, and coagulating tissue. The device utilizes bipolar electrosurgical energy, where the forceps jaws are electrically isolated to function as active and return electrodes, eliminating the need for a patient return electrode pad. The device is intended for use by surgeons during laparoscopic and general surgical procedures. The forceps are a modification of a previously cleared predicate, featuring identical construction and materials, with the exception of varied shaft lengths. The device provides the surgeon with a means to manipulate and treat tissue via electrical energy, facilitating surgical hemostasis and tissue management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Bipolar electrosurgical forceps. Energy source: Bipolar electrosurgical energy. Design features electrically isolated jaws acting as active and return electrodes. Materials of construction are identical to the predicate device. Form factor: Forceps with varying shaft lengths.

Indications for Use

Indicated for electrosurgical coagulation, dissection, and grasping 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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F: 510(k) Summary

K031078

March 31, 2003

| Company: | Gyrus Medical, Inc.<br>6655Wedgwood Road<br>Maple Grove, MN<br>Tel. No. [phone]<br>FAX. No. [phone] |
|----------------------|-------------------------------------------------------------------------------------------------------------------|
| Contact: | Mercedes Bayani<br>Director, Regulatory & Clinical Affairs |
| Common/Usual Name: | Electrosurgical Instruments |
| Classification Name: | Electrosurgical Cutting and Coagulation Device And<br>Accessories (21 CFR 878.4400) |
| Proprietary Name: | Everest Bipolar MACRO, MICRO & MOLLY Forceps and<br>Gyrus Bipolar MACRO, MICRO & MOLLY Forceps |

The device is a Class II medical device. The Everest Bipolar MACRO, MICRO & MOLLY Forceps and Gyrus Bipolar MACRO, MICRO & MOLLY Forceps is a modification to the predicate device cleared under K904993. The Everest Bipolar MACRO, MICRO & MOLLY Forceps and Gyrus Bipolar MACRO, MICRO & MOLLY Forceps is identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device. The forceps jaws are electrically isolated from each other enabling one jaw 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 K90493. The intended use, Electrosurgical Coagulation, Grasping and Dissection, during surgical procedures is similar 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 and intended use of the Modified Everest Bipolar MACRO, MICRO & MOLLY Forceps and Gyrus Bipolar MACRO, MICRO & MOLLY Forceps 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with three stylized lines forming the body and wings. The logo is black and white.

Public Health Service

MAY 1 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Mercedes Bayani Director, Regulatory Affairs Gyrus Medical, Inc. 6655 Wedgwood Road Maple Grove, Minnesota 55311-3602

Re: K031078

Trade/Device Name: Everest Bipolar MACRO, MICRO & MOLLY Forceps and Gyrus Bipolar MACRO, MICRO & MOLL Y Forceps 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 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): ____________________________________________________________________________________________________________________________________________________

## Everest Bipolar MACRO,MICRO & MOLLY Forceps and Gyrus Device Name: Bipolar MACRO, MICRO, & MOLLY Forceps

Indications for Use:

Electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical procedures.

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Concurence of CDRH, Office of Device Evaulation (ODE) (Optional Format 3-10-98)

(Posted July 1, 1998)

Muriam C. Provost

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

510(k) Number K631678