ARTHROCARE ELECTROSURGERY SYSTEM

K971532 · Arthrocare Corp. · GEI · Jul 23, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K971532
• Device Name: ARTHROCARE ELECTROSURGERY SYSTEM
• Applicant: Arthrocare Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jul 23, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ArthroCare Electrosurgery System is intended for use in general surgical procedures to remove soft tissue and to control bleeding.

Device Story

Electrosurgical system comprising a probe, probe cable, and controller (high-frequency generator). Bipolar design with integral return electrode on probe shaft; eliminates need for external return pad; prevents energy penetration through patient body. Probe provided sterile for single-patient use; cable reusable via ethylene oxide or steam sterilization. Used in general surgery for soft tissue removal and hemostasis. Operated by clinicians. Controller delivers high-frequency energy to probe tip (straight or angled; multi-electrode or loop configurations) to perform resection, ablation, or coagulation. System provides localized energy delivery, minimizing collateral tissue damage compared to monopolar systems.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design comparison to legally marketed predicate devices.

Technological Characteristics

Bipolar electrosurgical system. Components: Probe (sterile, single-use), Probe Cable (reusable), Controller (high-frequency generator). Energy source: High-frequency electrical energy. Design: Integral return electrode on probe shaft. Sterilization: Ethylene oxide or steam autoclave for cables. No software utilized.

Indications for Use

Indicated for soft tissue resection, ablation, and coagulation of blood vessels during general surgical procedures. Prescription use only.

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 Bipolar Loop Electrosurgery System (K955531)
• ArthroCare Urologic Multi-electrode Electrosurgery System (K961069)
• ArthroCare Dental Wand System (K962445)
• ArthroCare Electrosurgery System 980 (K963123)
• ArthroCare General Dermatology Electrosurgery System (K964849)
• Conmed Hyfrecator (K800617, K850668)

Submission Summary (Full Text)

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ArthroCare Corporation Sunnyvale, California Premarket Notification April 25, 1997

JUL 2 3 1997

### X. 510(k) Summary

# 971532

#### Name of Device A.

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| Trade name: | ArthroCare Electrosurgery System |
|-------------------------|----------------------------------------------------------------------------------------|
| Common name: | Electrosurgical System |
| Classification<br>name: | Electrosurgical Cutting and Coagulation Device and<br>Accessories<br>(21 CFR 878.4400) |

#### B. Predicate devices

| Device | Premarket<br>Notification |
|--------------------------------------------------------------|----------------------------------------|
| ArthroCare Arthroscopic Electrosurgery System 970 | K943450, 03/10/95 |
| ArthroCare Bipolar Loop Electrosurgery System | K955531, 02/21/96 |
| ArthroCare Urologic Multi-electrode Electrosurgery<br>System | K961069, 05/28/96 |
| ArthroCare Dental Wand System | K962445, 07/30/96 |
| ArthroCare Electrosurgery System 980 | K963123, 10/08/96 |
| ArthroCare General Dermatology Electrosurgery<br>System | K964849, 04/14/97 |
| Conmed Hyfrecator | K800617, 05/02/80<br>K850668, 05/20/85 |

#### C. Device description

The ArthroCare Electrosurgery System 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 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 as a loop electrode. 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

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ArthroCare Corporation Sunnyvale, California Premarket Notification April 25, 1997

frequency electronic instrument. There is no software utilized in the operation of the Controller.

The ArthroCare 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 Electrosurgery System is intended for use in general surgical procedures to remove soft tissue and to control bleeding.

#### E. Technological characteristics

The technological characteristics of the ArthroCare Electrosurgery System are identical to those of the predicate ArthroCare devices, as well as the devices distributed by other manufacturers. These devices are 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 Electrosurgery System is substantially equivalent to devices currently marketed in the United States.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human figures or forms that are interconnected and flowing upwards, representing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Cheryl L. Shea Director-Regulatory and Clinical Affairs ArthroCare Corporation . . . . . . . . . . . . . . 595 North Pastoria Avenue Sunnyvale. California 94086

JUL 2 3 1997

Re: K971532

Trade Name: ArthroCare Electrosurgery System Regulatory Class: II Product Code: GEI Dated: April 25, 1997 Received: April 28, 1997

Dear Ms. Shea:

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 requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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 - Ms. Cheryl L. Shea

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,

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ArthroCare Corporation Sunnyvale, California Premarket Notification April 25, 1997

## Indications Statement

Device Name: ArthroCare Electrosurgery System 510(k) Number: ---------------------------------------------------------------------------------------------------------------------------------------------------------------

Indications for use:

The ArthroCare Electrosurgery System is indicated for soft tissue resection and ablation and coagulation of blood vessels during general surgical procedures.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

tion (OBE)

Prescription Use X (Per 21 CFR 801.109)

OR

Over-the-Counter Use