ARTHROCARE CONTROLLER, CABLE, FOOT CONTROL, POWER CORD, WANDS, MODELS H0970-02, H2000-04, H2000-05, H0970-06

K040338 · Arthrocare Corp. · GEI · Mar 1, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040338
• Device Name: ARTHROCARE CONTROLLER, CABLE, FOOT CONTROL, POWER CORD, WANDS, MODELS H0970-02, H2000-04, H2000-05, H0970-06
• Applicant: Arthrocare Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 1, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ArthroCare System is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurological procedures. The ArthroCare System is indicated for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated discs.

Device Story

ArthroCare System is a bipolar, high-frequency electrosurgical device. Components include a controller (generator), disposable bipolar wands, and a reusable patient cable. Used in orthopedic, arthroscopic, spinal, and neurological procedures for soft tissue resection, ablation, coagulation, and hemostasis, as well as disc decompression for contained herniated discs. Operated by clinicians in surgical settings. The system delivers high-frequency energy to the target tissue via the wand to achieve the desired surgical effect. The device is a modification of previously cleared systems, maintaining the same principle of operation and technological characteristics.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological and performance specification comparisons to predicate devices.

Technological Characteristics

Bipolar, high-frequency electrosurgical system. Components: electrosurgical generator (Controller), disposable bipolar wands, and reusable patient cable. Operates via high-frequency energy for tissue ablation/coagulation.

Indications for Use

Indicated for symptomatic patients with contained herniated discs requiring disc decompression, and patients undergoing orthopedic, arthroscopic, spinal, or neurological procedures requiring soft tissue resection, ablation, coagulation, or 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 System 2000 (K020832)
• ArthroCare System (K030954)

Submission Summary (Full Text)

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040338
ArthroCare
CORPORATION

MAR - 1 2004

510(k) Summary

040338

Page 1 of 2

# ArthroCare Corporation ArthroCare System

2951580

### General Information

Submitter Name/Address:

ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-3523

Director, Regulatory Affairs

Establishment Registration Number:

Contact Person:

Date Prepared:

Device Description

Trade Name:

Generic/Common Name:

Classification Name:

Predicate Devices ArthroCare® System 2000 ArthroCare® System

Valerie Defiesta-Ng

February 9, 2004

Electrosurgical Device and Accessories

Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400)

K020832 and K030954

### Product Description

The ArthroCare System is a bipolar, high frequency electrosurgical system consisting of three components: an electrosurgical generator called the Controller; a family of disposable, bipolar, single use Wands; and a reusable Patient Cable.

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### Intended Uses

The ArthroCare System is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurological procedures.

The ArthroCare System is indicated for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated discs.

#### Substantial Equivalence

This Special 510(k) proposes a modification in the performance specifications and labeling for the ArthroCare System 2000, which was previously cleared in K020832 on April 9, 2002 and K030954 on April 16, 2003. The indications for use, technology, principle of operation, materials, packaging, and sterilization parameters of the ArthroCare System remain the same as in the predicate cleared 510(k).

#### Summary of Safety and Effectiveness

The modified ArthroCarc System, as described in this Special 510(k), is substantially equivalent to the predicate device. The proposed modifications in performance specifications and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the System.

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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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 1 2004

Ms. Valerie Defiesta-Ng Director, Regulatory Affairs ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, California 94085-3523

Re: K040338

Trade/Device Name: ArthroCare System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: February 9, 2004 Received: February 11, 2004

Dear Ms. Defiesta-Ng:

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 (21 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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#### Page 2 - Ms. Valerie Defiesta-Ng

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/dsma/dsmamain.html

Sincerely yours,

Mark N Milburn

Celia M. Witten, Ph.D., M.D. 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 Statement

K040338

ArthroCare System Device Name

510(k) Number: KO40338

Indications for Use:

- 요 The ArthroCare System is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurological procedures.
- The ArthroCare System is indicated for ablation, coagulation, and decompression of 트 disc material to treat symptomatic patients with contained herniated discs.

Mark N Milham

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

KOYO338

**510(k) Number**

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDSED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

OR

Over-the-Counter Use