GYRUS ACMI GENERAL SURGERY WORKSTATION, MODEL G400, AND DUAL FOOTSWITCH CONNECTOR CABLE

K081954 · Gyrus Acmi, Inc. · GEI · Jul 31, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K081954
• Device Name: GYRUS ACMI GENERAL SURGERY WORKSTATION, MODEL G400, AND DUAL FOOTSWITCH CONNECTOR CABLE
• Applicant: Gyrus Acmi, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jul 31, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Gyrus ACMI General Surgery Workstation is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in surgery.

Device Story

Bipolar RF generator; utilizes PlasmaKinetic (PK) or PlasmaCision (PC) waveforms for soft tissue surgery. System features automatic instrument detection via resistor in handpiece connector to ensure appropriate power/waveform output. Generator face includes two sockets; only one active at a time. New accessory: Dual Footswitch Connector Cable allows connection of two footswitches to one generator for multi-surgeon environments. Used in surgical settings; operated by surgeons. Output provides electrosurgical energy for tissue effect; aids in hemostasis and tissue management.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Bipolar RF electrosurgical generator; utilizes PlasmaKinetic (PK) and PlasmaCision (PC) waveforms. Features automatic instrument detection via resistor-based sensing in handpiece connector. Includes dual-socket interface (one active at a time). Accessories include power cable, footswitch, and optional dual footswitch connector cable. Reusable device requiring cleaning/disinfection/sterilization.

Indications for Use

Indicated for patients requiring soft tissue ablation, resection, coagulation, or hemostasis of blood vessels during 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

• Gyrus General Purpose Electrosurgical System (K050550)

Reference Devices

• Gyrus ACMI SuperPulse generator (K031085)

Submission Summary (Full Text)

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Gyrus ACMI General Surgery Workstation ? Gyrus ACMI, Inc. 136 Turnpike Rd. Southborough, MA 01772

Special 510(k) Notification 510(k) Summary of Safety and Effectiveness July 2, 2008

# JUL 3 1 2008

# 510(k) Summary of Safety and Effectiveness Gyrus ACMI, Inc. Gyrus ACMI Y-Connector

K 081954

## General Information

Manufacturer:

જ

Gyrus Medical Ltd. Fortran Road, St. Mellons Cardiff, United Kingdom

Establishment Registration Number:

Submitter:

Establishment Registration Number:

Contact Person:

Date Prepared:

Trade Name:

### Device Description

Classification Name:

9617070

Gyrus ACMI, Inc. 136 Turnpike Rd. Southborough, MA 01772-2104

3003790304

Terrence E. Sullivan Vice President, Regulatory Affairs

July 2, 2008

Electrosurgical Cutting & Coagulation Device and Accessories (21 CFR 878.4400), Class II General & Plastic Surgery Panel

Gyrus ACMI General Surgery (G400) Workstation

Electrosurgical Generator and Accessories

# Predicate Device

Generic/Common Name:

Gyrus General Purpose Electrosurgical System

K050550

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Special 510(k) Notification 510(k) Summary of afety and Effectiveness Inly 2, 2008

K081954

#### Intended Uses

Page 2 of (2)

The Gyrus ACMI General Surgery Workstation is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in surgery.

These devices are marketed as reusable devices; methods for cleaning, disinfecting and sterilization are included in latter sections of this submission under Section 12.0, "Cleaning".

#### Product Description

The currently marketed Gyrus ACMI General Surgery Workstation is a bipolar RF generator that accepts a variety of disposable hand pieces that utilize a PlasmaKinetic (PK) or PlasmaCision (PC) waveform. The generator face includes two sockets that allow a range of hand pieces to be utilized in a dry field environment, although only one socket may be active at any given time.

The Gyrus ACMI General Surgery Workstation General Purpose Electrosurgical Generator employs a system of automatic instrument detection, through a resistor located in the hand piece connector plug. This ensures that only the allowable range of waveform output and power level can only be applied to the instrument irrespective of the output socket. Accessories presently provided with the Gyrus ACMI General Surgery Workstation include a power cable and a foot switch. It should be noted that this footswitch is also used with the Gyrus ACMI SuperPulse generator (cleared under K031085).

This Special 510(k) proposes the addition of a new optional accessory, the Dual Footswitch Connector Cable. The Dual Footswitch Connector Cable allows for easier use of the Gyrus ACMI General Surgery Workstation when multiple surgeons are present. This is achieved by allowing the connection and use of two footswitches on the same generator. The indications for use, principles of operation, energy waveform outputs, and accessories of the Gyrus ACMI General Surgery Workstation with the Dual Footswitch Connector Cable accessory remain the same as the currently marketed Gyrus ACMI General Surgery Workstation.

#### Summary of Safety and Effectiveness

The proposed modifications for the Gyrus ACMI General Surgery Workstation, as described in this submission, are substantially equivalent to the predicate device. The proposed addition of the Dual Footswitch Connector Cable as an accessory is not a substantial change or modification, and do not significantly affect the safety or efficacy of the devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Gyrus ACMI, Inc. % Mr. Terrence E. Sullivan VP, Regulatory Affairs 136 Turnpike Road Southborough, Massachusetts, 01772

JUL 3 1 2008

Re: K081954

Trade/Device Name: Gyrus ACMI General Surgery (G400) Workstation Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: July 02, 2008 Received: July 09, 2008

Dear Mr. Sullivan:

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 adultcration.

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. Terrence E. Sullivan

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilitics 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,

Mark M Wilkinson

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

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Device Name: Gyrus ACMI General Surgery (G400) Workstation

510(k) Number:

### Intended use:

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: X

OR Over-the-Counter Use:

7

(Per 21 CFR 801.109)

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

510(k) Number k081957