ARTHROCARE PERCD SPINEWAND

K030954 · Arthrocare Corp. · GEI · Apr 16, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K030954
• Device Name: ARTHROCARE PERCD SPINEWAND
• Applicant: Arthrocare Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 16, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Perc-D™ SpineWand™ is indicated for ablation, coagulation, and decompression, of disc material to treat symptomatic patients with contained herniated discs.

Device Story

ArthroCare PercD SpineWand is a bipolar, single-use, high-frequency electrosurgical device. Used for ablation, coagulation, and decompression of disc material in patients with contained herniated discs. Operated by physicians in a clinical setting. Device delivers high-frequency energy to target tissue to achieve therapeutic effect. Output is controlled by the clinician to manage disc material volume and coagulation. Benefits include minimally invasive decompression of herniated discs.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material modifications to a previously cleared predicate device.

Technological Characteristics

Bipolar, high-frequency electrosurgical device. Single-use. Characteristics include specific dimensions and materials modified from the predicate. Sterilization parameters remain consistent with the predicate device.

Indications for Use

Indicated for ablation, coagulation, and decompression of disc material in symptomatic patients with contained herniated discs.

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 PercD SpineWand (K020621)

Submission Summary (Full Text)

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ArthroCare
CORPORATION

APR 1 6 2003

K030954

# 510(k) Summary

## ArthroCare Corporation ArthroCare® PercD™ SpineWand™

#### General Information

Submitter Name/Address: ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936 Establishment Registration Number: 2951580 Contact Person: Valerie Defiesta-Ng Director, Regulatory Affairs Date Prepared: March 25, 2003 Device Description ArthroCare® PercD™ SpineWand™ Trade Name: Generic/Common Name: Electrosurgical Device and Accessories Classification Name: Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400) Predicate Devices ArthroCare PercD SpineWand K020621

#### Product Description

The Wands are bipolar, single use, high frequency electrosurgical devices.

#### Intended Use

The Perc-D™ SpineWand™ is indicated for ablation, coagulation, and decompression, of disc material to treat symptomatic patients with contained herniated discs.

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### Substantial Equivalence

This Special 510(k) proposes modifications in dimensional specifications, materials, and labeling for the ArthroCare PercD SpineWand, which were previously cleared under K020621 on March 28, 2002. The indications for use, technology, principle of operation, performance specifications, packaging, or sterilization parameters of the SpineWands remain the same as in the predicate cleared 510(k).

### Summary of Safety and Effectiveness

The modified SpineWands, as described in this submission, are substantially equivalent to the predicate SpineWands. The proposed modification in dimensional specifications, materials, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices.

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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 features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the symbol in a circular fashion. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 6 2003

Ms. Valerie Defiesta-Ng Director. Regulatory Affairs ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, California 94085-2936

Re: K030954

Trade/Device Name: ArthroCare® PercD™ SpineWandTM Regulation Number: 21 CFR 878.4400 Regulation Names: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Codes: GEI Dated: March 26, 2003 Received: March 27, 2003

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]. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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.

Miriam C. Provost

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

.

ArthroCare® Perc-D™ SpineWand™ Device Name:

K030954 510(k) Number:

Indications for use:

The Perc-D™ SpineWand™ is indicated for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated discs.

Muriam C. Provost

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

510(k) Number K630954

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

Prescription Use

X

OR

Over-the-Counter Use

(Per 21 CFR 801.109)