EVEREST BIPOLAR CUTTING FORCEPS AND GYRUS BIPOLAR CUTTING FORCEPS

K023492 · Gyrus Medical, Inc. · GEI · Nov 13, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K023492
• Device Name: EVEREST BIPOLAR CUTTING FORCEPS AND GYRUS BIPOLAR CUTTING FORCEPS
• Applicant: Gyrus Medical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Nov 13, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Bipolar electrosurgical forceps for use in laparoscopic and general surgery; operated by surgeons. Device utilizes bipolar electrosurgical energy for coagulation; features electrically isolated jaws acting as return electrodes, eliminating need for external return pad. Mechanical cutting blade actuates between jaws to transect tissue. Device enables grasping, dissection, and mechanical cutting. Benefits include integrated coagulation and cutting functionality in a single instrument.

Clinical Evidence

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

Technological Characteristics

Bipolar electrosurgical forceps; energy source: bipolar electrosurgical energy; features electrically isolated jaws for return electrode function; includes integrated mechanical cutting blade. No software or electronic algorithms.

Indications for Use

Indicated for electrosurgical coagulation, mechanical cutting, 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

• Bipolar Cutting Forceps (K904993)

Submission Summary (Full Text)

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## NOV 1 3 2002

# F: 510(k) Summary 023492

October 16, 2002

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

This device is a Class II medical device. The Bipolar Cutting Forceps is a modification to the predicate devices cleared under K904993. The Bipolar Cutting Forceps is similar 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. To transect tissue a cutting blade is actuated and moves between the electrode jaws. The modification has not altered the fundamental technology of the predicate devices. The intended use, electrosurgical coagulation, grasping, dissection and mechanical cutting of tissue during surgical procedures is 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 cutting 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 features a stylized caduceus symbol with three intertwined strands representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

#### Public Health Service

NOV 13 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Gyrus Medical, Inc. Frederick G. Mades Regulatory Affairs Manager 6655 Wedgwood Road. # 105 Maple Grove, Minnesota 55311-3602

Re: K023492

Trade/Device Name: Everest Bipolar Cutting Forceps and Gyrus Bipolar Cutting Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories; Regulatory Class: Class II Product Code: GEI Dated: October 16, 2002 Received: October 18, 2002

Dear Mr. Mades:

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 - Mr. Frederick G. Mades

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" (21 CFR 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 vours.

Miriam C. Parrot

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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Page

510(k) Number (if known): KO23492 Device Name: Everest Bipolar Cutting Forceps and Gyrus Bipolar Cutting Forceps Indications for Use:

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

Prescription Use

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

Concurence of CDRH, Office of Device Evaulation (ODE) (Optional Format 3-10-98) (Posted July 1, 1998)

Meriam C. Parrott

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

510(k) Number K023492