ARTHROCARE DERMATOLOGIC ELECTROSURGERY SYSTEM

K964849 · Arthrocare Corp. · GEI · Apr 14, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K964849
• Device Name: ARTHROCARE DERMATOLOGIC ELECTROSURGERY SYSTEM
• Applicant: Arthrocare Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ArthoCare Dermal Electrosurgery System and ConMed Hyfrecator are intended for use in dermatologic surgical procedures to remove soft tissue and to control bleeding.

Device Story

System comprises electrosurgical generator (Controller), reusable handpiece/cable, and disposable multi-electrode tips (0.5mm-2.5mm diameter, straight or angled). Bipolar design with return electrode on device shaft; eliminates need for patient return pad. Energy does not penetrate patient body as in monopolar systems. Used by clinicians in dermatologic procedures for lesion removal and bleeding control. Controller provides high-frequency electrical energy to handpiece tip for tissue cutting/coagulation. Handpiece/cable sterilized via ethylene oxide or steam autoclave; tips supplied sterile for single use.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Bipolar electrosurgical system. High-frequency electronic generator. Multi-electrode tips (0.5-2.5mm). Reusable handpiece/cable (EtO or steam sterilization). Disposable sterile tips. No software.

Indications for Use

Indicated for dermatologic surgical procedures requiring soft tissue removal and hemostasis.

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

• ArthroCare Arthroscopic Electrosurgery System (K943450)
• ArthroCare Dental Electrosurgery System (K962445)
• ArthroCare Bipolar Loop Electrosurgery System (K955531)
• ArthroCare Urologic Multi-electrode Electrosurgery System (K961069)
• ConMed Hyfrecator Plus (K800617)

Submission Summary (Full Text)

{0}

ArthoCare Corporation
Sunnyvale, California
Premarket Notification
November 29, 1996

APR 14 1997

X. 510(k) Summary

k964849

## A. Name of Device

Trade name: ArthoCare Dermal Electrosurgery System

Common name: Electrosurgical Unit and Accessories

Classification name: Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400)

## B. Predicate devices

| Device | Premarket Notification |
| --- | --- |
| ArthroCare Arthroscopic Electrosurgery System | K943450 |
| ArthroCare Dental Electrosurgery System | K962445 |
| ArthroCare Bipolar Loop Electrosurgery System | K955531 |
| ArthroCare Urologic Multi-electrode Electrosurgery System | K961069 |
| ConMed Hyfrecator Plus | K800617 |

## C. Device description

The ArthroCare Dermal Electrosurgery System is comprised of three components: the Dermal Handpiece with Cable unit, the disposable Dermal Handpiece Tip, and an electrosurgical generator called the Controller. The Dermal Handpiece Tip attaches to the distal end of the Dermal Handpiece and Cable. The proximal end of the Dermal Handpiece and Cable unit connects to the Controller. The Dermal Handpiece Tip is provided in a variety of models, ranging in diameters from $0.5\mathrm{mm}$ to $2.5\mathrm{mm}$ with the distal tip of the dermal Handpiece as straight or bent at angles up to 90 degrees. The distal tip is configured with multi-electrodes. The Dermal Handpiece Tip is supplied sterile and intended for single patient use. The Dermal Handpiece and Cable unit are designed for repeat sterilization by either ethylene oxide gas or steam autoclaving methods. The Controller is a high frequency electronic instrument. There is no software utilized in the operation of the Controller.

{1}

ArthroCare Corporation
Sunnyvale, California
Premarket Notification
November 29, 1996

The ArthroCare Dermal Electrosurgery System is bipolar, incorporating a return electrode on the shaft of the device. This means that a return pad is not required for operation. The return energy in a bipolar device with an integral return electrode does not penetrate the tissue as in a monopolar device. In a monopolar device, the energy passes through the patient's body to reach the return pad.

## D. Intended use

The ArthroCare Dermal Electrosurgery System and ConMed Hyfrecator are intended for use in dermatologic surgical procedures to remove soft tissue and to control bleeding.

## E. Technological characteristics

The technological characteristics of the ArthroCare Dermal Electrosurgery System are the same as those of the ConMed Hyfrecator Plus as well as the ArthroCare Arthroscopic System, Bipolar Loop, Dental, and Urologic Multi-electrode Systems. These devices are equivalent in terms of materials, principle of operation and sterilization.

## F. Summary

By virtue of design, principle of operation, materials and intended use, we believe the ArthroCare Dermal Electrosurgery System is substantially equivalent to devices currently marketed in the United States. We believe that the ArthroCare Dermatologic Electrosurgery System, which is intended for removal of dermatologic lesions and hemostasis in dermatologic surgical procedures, does not raise any new issues of safety and/or effectiveness.

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