GYRUS PLASMACISION AND PLASMABLEND ELECTRODES

K050460 · Gyrus Medical, Inc. · GEI · Oct 25, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050460
• Device Name: GYRUS PLASMACISION AND PLASMABLEND ELECTRODES
• Applicant: Gyrus Medical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The instruments are indicated for Bipolar electrosurgical resection and coagulation of soft tissue and blood vessels in laparoscopic or general surgical procedures.

Device Story

Bipolar electrosurgical instrument for cutting and coagulating soft tissue and blood vessels; used in laparoscopic or general surgery. Device passes through 5mm cannula or laparoscope working channel. Operated by physician via footswitch; requires Gyrus General Surgery RF Workstation. Variants include aspiration/irrigation lines with lumen/Y-connector. Three individually isolated conductors act as tissue effectors. PlasmaBlend output provides user-selectable cut/coagulation ratio for controlled hemostasis. Benefits include precise tissue resection and coagulation during surgery.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Bipolar electrosurgical instrument; three individually isolated conductors; multipole arrangement at patient interface. Available with/without aspiration/irrigation lines. Compatible with Gyrus General Surgery RF Workstation. Energy source: RF. Form factor: various shaft lengths/diameters for 5mm access.

Indications for Use

Indicated for bipolar electrosurgical resection and coagulation of soft tissue and blood vessels in laparoscopic or general surgical procedures. Intended for use by qualified medical personnel trained in electrosurgical equipment.

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

• PK Bipolar L Hook (K031082)
• Gyrus G3 System (K041285)

Submission Summary (Full Text)

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510(k) Premarket Notification Plasmacision and Plasmablend Electrodes

OCT 24 2005

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# K050460

510(k) Summary of Safety and Effectiveness Gyrus L09 Instrument

| 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 Regulatory Affairs/Quality<br>Assurance |
| | Telephone: [phone] |
| | Facsimile: 763 416 3070 |
| Date Summary Prepared: | October 18, 2005 |
| Name of the Device: | |
| Proprietary Name: | Gyrus PlasmaCision and PlasmaBlend electrodes |
| Project Name: | L09 Instrument |
| Common/Usual Name: | Electrosurgical Accessory |
| Classification Name: | Electrosurgical Cutting & Coagulation Device<br>and Accessories (per 21 CFR 878.4400) |
| Brand Name: | Not yet assigned |
| Predicate Devices: | K031082 - PK Bipolar L Hook<br>K041285 - Gyrus G3 System (Generator<br>and<br>Accessories) |

## Description

General:

The Gyrus PlasmaCision and PlasmaBlend electrodes are bipolar electrosurgical instruments with the capability to cut and coagulate soft tissue and blood vessels in laparoscopic surgery under carbon dioxide gas or air insufflation. The instrument will pass through a 5mm cannula or through an operating laparoscope working channel of 5mm or larger diameter. The PlasmaCision and PlasmaBlend electrodes may also be used in general surgical procedures.

The instruments are to be used only with the Gyrus General Surgery RF Workstation. Activation of the instruments is achieved via footswitch control.

#### Variants available:

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510(k) Premarket Notification Plasmacision and Plasmablend Electrodes

K 050 460

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The Instruments are available with and without aspiration (suction) / irrigation lines. On such equipped instruments, this provides additional functionality to the device by increasing its range of capabilities within the procedure. The suction / irrigation capable versions incorporate a lumen / Y connector and male connector with polymeric tubing for adaptation to suction / irrigation systems.

The instruments are, like other Gyrus bipolar electrosurgical instruments, available in a number of different shaft lengths and diameters, chosen by the surgeon to be most appropriate for the procedure to be undertaken.

#### Indication:

The instruments are indicated for Bipolar electrosurgical resection and coagulation of soft tissue and blood vessels in laparoscopic or general surgical procedures.

#### Construction:

The instruments have a multipole arrangement at the patient interface. The instruments consist of three individually isolated conductors that act as the tissue effectors.

#### E07 Generator Output to the L09 Instrument

A PlasmaBlend output is a blended cut and coagulation output that is delivered to the L09 instrument. The ratio of cut to coagulation of this output is selectable by the user and this allows the user to select the amount of haemostasis created during cutting. This output is controlled by the Gyrus General Surgery RF Workstation.

#### Classification:

The instruments are Class II medical devices.

The system and therefore these instruments are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

#### Comparison to Predicate Devices:

The instruments are a development of a previously cleared electrosurgical instrument the PK Bipolar L Hook, cleared in 510(k) No. K031082. The instruments has the same intended use of Electrosurgical coagulation, cutting and dissection with aspiration (suction) and irrigation. Its functionality is the same as the previously cleared Gyrus ENT PlasmaCision Electrode, the OPI, cleared in 510(k) No. K041285 with suction (aspiration).

The instruments has been carefully compared to the legally marketed devices with respect to intended use and technological characteristics. In addition, performance testing has been done to validate the performance of the device. The comparison and validation results presented in this 510(k) notification to the FDA show that the device is substantially equivalent to predicate devices and is safe and effective in its intended use,

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of four abstract human figures, arranged in a way that suggests movement or progress. The figures are depicted in black against a white background.

OCT 2 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mark A. Jensen Group Vice President Regulatory Affairs/Quality Assurance Gyrus Medical, Incorporate 6655 Wedgwood Road, Suite 160 Maple Grove, Minnesota 55311-3602

Re: K050460

Trade/Device Name: Plasmacision and Plasmablend Electrodes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 22, 2005 Received: September 23, 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 (2 l 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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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,

Barbara Pruchus
tor

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

Enclosure

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### Indications for Use

K050460 510(k) Number (if known):

Plasmacision and Plasmablend Electrodes Device Name:

The Plasmacision and Plasmablend Electrodes are Indications For Use: indicated for Bipolar electrosurgical resection and coagulation of soft tissue and blood vessels in laparoscopic or general surgical procedures.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (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

ODE)
Laubara Buemud for MPM
Division Sign Off

Division of General, Restorative, and Neurological Devices

510(k) Numl

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