ARTHROCARE ARTHROSCOPIC ELETROSURGERY SYSTEM (MODEL 980)

K963123 · Arthrocare Corp. · GEI · Oct 8, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K963123
• Device Name: ARTHROCARE ARTHROSCOPIC ELETROSURGERY SYSTEM (MODEL 980)
• Applicant: Arthrocare Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 8, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ArthroCare Arthroscopic Electrosurgery System 980 is intended for use in arthroscopic surgical procedures of the knee, shoulder, ankle, elbow, hip and wrist for soft tissue resection and hemostasis.

Device Story

ArthroCare Arthroscopic Electrosurgery System 980; electrosurgical generator system for arthroscopic soft tissue resection and hemostasis. Components: Controller (generator), Probe, Probe Cable. Bipolar design with integral return electrode on probe shaft; eliminates need for patient return pad; energy localized to distal tip. Probe diameters 1.5-4.5 mm; straight or angled tips (up to 90 degrees); multi-electrode or loop configurations. Used in OR by orthopedic surgeons. Controller provides high-frequency energy; no software involved. System benefits: precise tissue resection and hemostasis without deep tissue energy penetration characteristic of monopolar devices.

Clinical Evidence

No clinical data provided; substantial equivalence established via design and technological comparison to predicate.

Technological Characteristics

Bipolar electrosurgical system; integral return electrode on probe shaft. Probe diameters 1.5-4.5 mm; straight or angled (up to 90 degrees) tips; multi-electrode or loop configurations. High-frequency electronic generator. Probe is sterile, single-use. Probe cable reusable via ethylene oxide or steam autoclaving. No software.

Indications for Use

Indicated for patients undergoing arthroscopic surgical procedures of the knee, shoulder, ankle, elbow, hip, or wrist requiring soft tissue resection 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 970 (K943450)
• ArthroCare Arthroscopic Electrosurgery System 970 (Addition of Hip Indication) (K961747)
• ArthroCare Arthroscopic Electrosurgery System 970 (Addition of Wrist Indication) (K962321)

Submission Summary (Full Text)

{0}

OCT - 8 1996
ArthroCare Corporation
Sunnyvale, California
Premarket Notification
August 9, 1996

# X. 510(k) Summary

k963123

## A. Name of Device

Trade name: ArthroCare Arthroscopic Electrosurgery System 980

Common name: Electrosurgical Generator

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

Accessory to an Arthroscope (21 CFR 888.1100

## B. Predicate devices

| Device | Premarket Notification |
| --- | --- |
| ArthroCare Arthroscopic Electrosurgery System 970 | K943450 |
| ArthroCare Arthroscopic Electrosurgery System 970
(Addition of Hip Indication) | K961747 |
| ArthroCare Arthroscopic Electrosurgery System 970
(Addition of Wrist Indication) | K962321 |

## C. Device description

The ArthroCare Arthroscopic Electrosurgery System 980 is comprised of three components: the Probe, the Probe Cable, and an electrosurgical generator called the Controller. The Probe Cable connects the Controller to the Probe. The Probe is provided in a variety of models, ranging in diameters from 1.5 mm to 4.5 mm with the distal tip of the probe as straight or bent at angles up to 90 degrees. The distal tip may be configured with multi-electrodes or loop electrodes. The Probe is supplied sterile and intended for single patient use. The Probe Cable is designed for repeat sterilization by either ethylene oxide gas or steam autoclaving methods, as selected by the user. The Controller is a high frequency electronic instrument. There is no software utilized in the operation of the Controller.

023

{1}

ArthroCare Corporation
Sunnyvale, California
Premarket Notification
August 9, 1996

The ArthroCare Arthroscopic Electrosurgery System 980 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 Arthroscopic Electrosurgery System 980 is intended for use in arthroscopic surgical procedures of the knee, shoulder, ankle, elbow, hip and wrist for soft tissue resection and hemostasis.

## E. Technological characteristics

The technological characteristics of the ArthroCare Arthroscopic Electrosurgery System 980 are the same as those of the ArthroCare Arthroscopic Electrosurgery System 970. The devices are substantially equivalent in terms of design, materials, principle of operation, product specifications and sterilization.

## F. Summary

By virtue of design, materials, function and intended use, the ArthroCare Arthroscopic Electrosurgery System 980 is substantially equivalent to the ArthroCare Arthroscopic Electrosurgery System 970 which is currently marketed in the United States.