GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR

K050550 · Gyrus Medical, Inc. · GEI · Nov 9, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050550
• Device Name: GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR
• Applicant: Gyrus Medical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Nov 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The generator is indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in surgery. This device is intended for use by qualified medical personnel trained in the use of electrosurgery.

Device Story

Electrosurgical generator system for soft tissue ablation, resection, coagulation, and hemostasis. Operates exclusively in bipolar mode. Features front-panel controls for output waveform and power, with digital readouts for settings. Connects to PlasmaCision and PlasmaKinetic bipolar instruments via 9-way connectors; foot pedal interface on rear panel. Used in surgical settings by trained medical personnel. Provides electrical energy to instruments to achieve desired tissue effects. Benefits include controlled tissue interaction and vessel hemostasis.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Bipolar electrosurgical generator. Features two 9-way custom connectors for PlasmaCision and PlasmaKinetic instruments. Includes footswitch and power cable. Controls for output waveform and power with visual readouts. Class II device.

Indications for Use

Indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in surgery. Intended for use by qualified medical personnel trained in electrosurgery.

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

• Gyrus ENT G3 System (K041285)
• Gyrus Superpulse® System (K031085)
• Harmonic Scalpel® (K002906)

Submission Summary (Full Text)

{0}------------------------------------------------

510(k) Pre-market Notification Gyrus General Purpose Electrosurgical Generator System

NOV - 9 2001

Page 1 of (2)

510(k) Su ffectiveness

# Gyrus General Purpose Electrosurgical System (Generator & Accessories)

| Submitted by: | Gyrus Medical, Inc.<br>6655 Wedgwood Road, Suite 160<br>Maple Grove, MN 55311-3602 |
|------------------------|----------------------------------------------------------------------------------------------------|
| Contact Person: | Mark A. Jensen<br>Group Vice President RA/QA |
| | Telephone:<br>763 416 3005<br>Facsimile:<br>763 416 3070 |
| Date Summary Prepared: | October 18, 2005 |
| Name of the Device: | |
| Proprietary Name: | Gyrus General Purpose Electrosurgical System |
| Project Name: | E07 General Purpose Electrosurgical Generator |
| Common/Usual Name: | Electrosurgical Generator and Accessories |
| Classification Name: | Electrosurgical Cutting & Coagulation Device and<br>Accessories (per 21 CFR 878.4400) |
| Brand Name: | Not yet assigned |
| Predicate Devices: | K041285 (Gyrus ENT G3 System)<br>K031085 (Gyrus Superpulse® System)<br>K002906 (Harmonic Scalpel®) |

### Description:

The Gyrus General Purpose Electrosurgical Generator operates only in bipolar mode. It has controls for output waveform type and power. The unit has readouts for set power and waveform.

There are two custom 9-way connectors on the front panel for PlasmaCision instruments and PlasmaKinetic bipolar instruments. The foot pedal is connected on the back panel.

Accessories included with the generator are the disposable instruments, footswitch and a power cable.

{1}------------------------------------------------

510(k) Pre-market Notification

Gyrus General Purpose Electrosurgical Generator System

K050550

page 2 of (2)

### Statement of Intended Use:

The generator is indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in surgery.

## Classification:

The Gyrus General Purpose Electrosurgical Generator is a Class II medical device.

This device is intended for use by qualified medical personnel trained in the use of electrosurgery.

# Comparison to Predicate Devices:

The Gyrus General Purpose Electrosurgical Generator has been carefully compared to legally marketed devices with respect to intended use and technological characteristics. Performance testing has been done to validate the performance of the device. The comparison and validation results presented in this 510(k) notification demonstrate that the device is substantially equivalent to predicate devices and is safe and effective in its intended use.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 9 2005

Mark Jensen Group Vice President RA/QA Gyrus Medical, Inc. 6655 Wedgwood Road, Suite 160 Maple Grove, Minnesota 55311-3602

Re: K050550

Trade/Device Name: Gyrus General Purpose Electrosurgical Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 1, 2005 Received: November 1, 2005

Dear Mr. Jensen:

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.

{3}------------------------------------------------

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/industry/support/index.html

Sincerely yours,

Axirbaye Buehmo
for

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known):

K050550

Device Name:

Indications For Use:

Gyrus General Purpose Electrosurgical Generator

The generator is indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in surgery.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

barbare Buend

(Division Division of General, Restorative, and Neurological Devices

510(k) Number K050550