EVEREST LP BIPOLAR SCISSORS AND GYRUS LP BIPOLAR SCISSORS

K031081 · Gyrus Medical, Inc. · GEI · May 21, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K031081
• Device Name: EVEREST LP BIPOLAR SCISSORS AND GYRUS LP BIPOLAR SCISSORS
• 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

Mechanical cutting and electrosurgical coagulation of tissue during the performance of laparoscopic and general surgical procedures.

Device Story

Everest LP Bipolar Scissors and Gyrus LP Bipolar Scissors are electrosurgical instruments for laparoscopic and general surgery. Device utilizes bipolar electrosurgical energy to perform coagulation while simultaneously providing mechanical cutting. Scissors blades are electrically isolated; one blade functions as return electrode, eliminating need for external return pad. Operated by surgeons in clinical/OR settings. Device provides mechanical cutting and hemostasis, potentially reducing surgical time and improving patient outcomes by minimizing thermal spread compared to monopolar devices.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Bipolar electrosurgical scissors; electrically isolated blades; energy source: bipolar electrosurgical generator; form factor: laparoscopic instrument with modified shaft length; materials: identical to predicate.

Indications for Use

Indicated for patients undergoing laparoscopic or general surgical procedures requiring mechanical tissue cutting and electrosurgical coagulation.

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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K031081

F: 510(k) Summary (K031081)

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<br>And Accessories (21 CFR 878.4400) |
| Proprietary Name: | Everest LP Bipolar Scissors and Gyrus LP<br>Bipolar Scissors |

The device is a Class II medical device. The Everest LP Bipolar Scissors and Gyrus LP Scissors are a modification to the predicate device cleared under K904993. The Bipolar Bipolar LP Scissors are identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device. The scissors blades are electrically isolated from each other enabling one blade 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 coagulation and mechanical cutting during surgical procedures is similar to the predicate device 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 LP Bipolar Scissors 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 1 2003

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

Re: K031081

Trade/Device Name: Everest LP Bipolar Scissors and Gyrus LP Bipolar Scissors 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.

Mark A. Millener

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): ≤△3108 l

Device Name: __ Everest LP Bipolar Scissors and Gyrus LP Bipolar Scissors

Indications for Use:

Mechanical cutting and electrosurgical coagulation 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) | |
| <img alt="Signature" src="signature.png"/> | |
| (Division Sign-Off) | |
| Division of General, Restorative | |
| and Neurological Devices | |
| 510(k) Number | K031081 |