NON-STICK BIPOLAR FORCEPS

K992931 · Silverglide Surgical Technologies · GEI · Nov 17, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K992931
• Device Name: NON-STICK BIPOLAR FORCEPS
• Applicant: Silverglide Surgical Technologies
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Nov 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This product is intended to facilitate grasping and manipulation of soft tissue and blood vessels and provide electrocautery in surgical procedures.

Device Story

Electrosurgical tool in tweezers configuration; used for grasping/manipulating soft tissue and blood vessels and providing electrocautery. Device consists of stainless steel body with electrical insulation and proprietary metallurgical alloy plating on tips to provide non-stick properties. Compatible with standard OEM electrosurgical generators and bipolar cables. Used by surgeons in clinical/surgical settings. Output is electrical current for coagulation/cutting; effect on clinical decision-making involves enabling precise tissue management and hemostasis during surgery. Benefits include reduced tissue adhesion to forceps tips during electrocautery.

Clinical Evidence

Bench testing only. Biocompatibility defined through material selection based on established history of safe use, literature research, and studies meeting ISO 10993-1 standards.

Technological Characteristics

Stainless steel construction with electrical insulation; tips plated with proprietary metallurgical alloy. Bipolar electrosurgical configuration. Compatible with standard OEM electrosurgical generators. Reusable; provided non-sterile, requires user-validated cleaning and sterilization.

Indications for Use

Indicated for use in surgical procedures requiring grasping, manipulation of soft tissue and blood vessels, and electrocautery.

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

• Ball Tip Electrode, Fusion Technologies, Inc. (K970987)
• Midas Touch Bipolar Electrodes, ITI Medical Technologies, Inc. (K982705)

Submission Summary (Full Text)

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NOV 17 1999

K99 2931

# 510(k) Summary Link Technology, Inc. Non-Stick Bipolar Forceps

## Submitter (Consultant) Name and Address

Morningstar Consulting Group, Inc. P. O. Box 219 Indian Hills, CO 80454

#### Submitter (Consultant) Contact Person

Kevin Morningstar, Senior Consultant [phone] phone: [phone] fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax:

#### Manufacturer Name and Address

Link Technology, Inc. 4001 Discovery Drive, Suite 390 Boulder, CO 80303

## Manufacturer Contact Person

Jonathan Thorne, CEO phone: [phone] (303) 4446237 fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax:

# Common, Classification & Proprietary Names

Common Name: electrosurgical electrode electrosurgical cutting and coagulation device and Classification Name: accessories Proprietary Name: non-stick bipolar forceps

#### Predicate Devices

Ball Tip Electrode, Fusion Technologies, Inc., K970987 Midas Touch Bipolar Electrodes, ITI Medical Technologies, Inc., K982705

#### Device Description

The Link Technology Non-Stick Bipolar Forceps electrosurgical tool in the typical tweezers configuration. The forceps are constructed with stainless steel and coated with an electrical insulator. The uninsulated forceps tip is plated with a proprietary metallurgical alloy. The forceps are compatible with standard OEM (original equipment manufacturer) electrosurgical generators and bipolar electrode cables.

#### Indications for Use

This product is intended to facilitate grasping and manipulation of soft tissue and blood vessels and provide electrocautery in surgical procedures.

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# Technological Characteristics Comparison

This claim of substantial equivalence to the Fusion Ball Tip electrode is specifically in relation to the proprietary non-stick metal, and the claim of substantial equivalence to the ITI Midas Touch Bipolar Forceps is in relation to non-stick bipolar forceps in general.

The proprietary non-stick metal used in the Fusion Ball Tip Electrode is the same as that plated onto the tip of the Link Technology Non-Stick Bipolar Forceps Electrode. Therefore, the characteristics of the material which comes into contact with tissue during surgical use, such as non-stick properties, biocompatibility, and thermal and electrical conductivity, are identical.

In general design, configuration and intended use, the Link Technology Non-Stick Bipolar Forceps Electrode is substantially equivalent to the ITI Midas Touch Bipolar Forceps, except as explained above regarding the choice of surface material. The two forceps designs utilize different surface materials in order to achieve the desired nonstick performance. Otherwise they are interchangeable.

## Performance and Safety

The biological safety of the Non-Stick Bipolar Forceps has been defined through the selection of materials which demonstrate the appropriate levels of biocompatibility for its clinical use. This demonstration is based upon choosing materials that have an established history of safe use in similar medical devices, literature research, and biocompatibility studies that meet the standards outlined in ISO 10993-1.

The Non-Stick Bipolar Forceps are re-usable surgical devices, provided non-sterile to the user. The Instructions for Use provide instructions for the cleaning, decontamination, and sterilization of the device before each use. The instructions for reprocessing of the device will be validated before the device is marketed.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol that resembles three stylized human figures or waves, stacked on top of each other.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 7 1999

Link Technology, Inc. c/o Mr. Kevin Morningstar President and Senior Consultant Morningstar Consulting Group, Inc. P.O. Box 219 Indian Hills, Colorado 80454

K992931 Re: Trade Name: Non-Stick Bipolar Forceps Regulatory Class: II Product Code: GEI Dated: August 28, 1999 Received: August 31, 1999

Dear Mr. Morningstar:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. Kevin Morningstar

This letter will allow you to begin marketing your device as described in your 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 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K 992931 510(k) Number (if known): __

Device Name Link Technology Non-Stick Bipolar Forceps

Indications for Use:

The Link Technology Non-Stick Bipolar Forceps product is intended to facilitate grasping and The Life Technology Non Odok Biped. Perssport provide electrocautery in surgical procedures.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division | |
|---------------|---------------------|
| Division of | Restorative Devices |
| 510(k) Number | K992931 |

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use __________ |
|------------------------------------------|----|---------------------------------|
|------------------------------------------|----|---------------------------------|

(Optional Format 1-2-96