MODIFICATION TO ARTHROCARE PERC-D SPINEWAND

K061259 · Arthrocare Corp. · GEI · May 18, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K061259
• Device Name: MODIFICATION TO ARTHROCARE PERC-D SPINEWAND
• Applicant: Arthrocare Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: May 18, 2006
• 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

The ArthroCare Perc-D SpineWand is a bipolar, single-use, high-frequency electrosurgical device. It is used for the ablation, coagulation, and decompression of disc material in patients suffering from symptomatic contained herniated discs. The device functions by delivering high-frequency energy to the target tissue to achieve the intended surgical effect. It is intended for use by clinicians in a surgical setting. The device is a modification of a previously cleared predicate, focusing on changes to packaging and labeling while maintaining the original technological and operational characteristics.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, technological, and performance specifications identical to the predicate device.

Technological Characteristics

Bipolar, single-use, high-frequency electrosurgical device. Operates via electrosurgical ablation, coagulation, and decompression. Sterilization and materials are identical to 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 (K053447)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for ArthroCare Corporation. The logo consists of a stylized graphic to the left of the company name. The graphic is composed of curved lines that resemble a wave or a stylized representation of a joint. The text "ArthroCare" is in a bold, sans-serif font, with "Corporation" written in a smaller font size below it.

MAY 18 2005

### 510(k) Summary 0 bl ArthroCare Corporation ArthroCare® PercD™ SpineWand™

| General Information | |
|------------------------------------|----------------------------------------------------------------------------------------|
| Submitter Name/Address: | ArthroCare Corporation<br>680 Vaqueros Avenue<br>Sunnyvale, CA 94085-2936 |
| Establishment Registration Number: | 2951580 |
| Contact Person: | Valerie Defiesta-Ng<br>Director, Regulatory Affairs |
| Date Prepared: | May 3, 2006 |
| Device Description | |
| Trade Name: | ArthroCare ^® PercD ^™ SpineWand ^™ |
| Generic/Common Name: | Electrosurgical Device and Accessories |
| Classification Name: | Electrosurgical Cutting and Coagulation<br>Device and Accessories (21 CFR<br>878.4400) |
| Predicate Devices | |

ArthroCare PercD SpineWand

### 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.

K053447

#### Substantial Equivalence

This Special 510(k) proposes modifications to the packaging and labeling of the ArthroCare PercD SpineWand. The indications for use, materials, technology, sterilization, principle of operation, and performance specifications of the SpineWands remain the same as in the predicate cleared 510(k).

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K 061259

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# Summary of Safety and Effectiveness

. .

The proposed modifications to the SpineWands are not substantial changes, and do not significantly affect the safety or efficacy of the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 18 2006

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

Re: K061259

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Trade/Device Name: ArthroCare® Perc-D™ SpineWand™ Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: May 3, 2006 Received: May 5, 2006 ﺮ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ

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

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Page 2 - Ms. Valerie Defiesta-Ng

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. 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,

Hubert Lenoir

fr

Mark N. Melkerson 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

510(k) Number:

K_061259

Device Name:

ArthroCare® Perc-D™ SpineWand™

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.

Prescription Use

X

AND/OR

(Part 21 CFR 801 Subpart D)

Over-the-Counter Use (21 CFR 807 Subpart ಿ)

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

Herbert Lemons

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

510(k) Number K061259

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