ARTHROCARE PERC-D SPINEWAND

K053447 · Arthrocare Corp. · GEI · Dec 27, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K053447
• Device Name: ARTHROCARE PERC-D SPINEWAND
• Applicant: Arthrocare Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 27, 2005
• 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 PercD SpineWand is a bipolar, single-use, high-frequency electrosurgical device. It is used for the ablation, coagulation, and decompression of disc material in patients with contained herniated discs. The device operates via high-frequency electrical energy to perform tissue modification. It is intended for use by clinicians in a surgical setting. The device is a modification of the previously cleared PercD SpineWand (K030954), involving changes to device materials. The output of the device allows the surgeon to perform minimally invasive spinal procedures, potentially benefiting patients by providing a method for disc decompression.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparison of technological characteristics.

Technological Characteristics

Bipolar, single-use, high-frequency electrosurgical device. Materials modified from predicate. Energy source: high-frequency electrical. Sterilization: parameters remain consistent with predicate.

Indications for Use

Indicated for ablation, coagulation, and decompression of disc material in symptomatic patients with contained herniated discs. 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 PercD SpineWand (K030954)

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 several curved lines that resemble a stylized wave or abstract design. The text "ArthroCare" is written in a bold, sans-serif font, with the word "Corporation" appearing in a smaller font size below it.

DEC 2 7 2005

K 053447

510(k) Summary

Page 1 of ②

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: | December 9, 2005 |
| 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 | K030954 |

### Product Description

The Wands are bipolar, single use, high frequency clectrosurgical 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.

#### Substantial Equivalence

This Special 510(k) proposes modifications in materials for the ArthroCare PercD SpineWand, which were previously cleared under K030954 on April 16, 2003. The indications for use, technology, principle of operation, performance specifications, packaging, and sterilization parameters of the SpineWands remam the same as in the predicate cleared 510(k)

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K053 447

## Summary of Safety and Effectiveness

Page 2 of 2

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

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the eagle symbol.

DEC 2 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K053447

K055447
Trade/Device Name: ArthoCare® PercD™ SpineWand™ Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and Coagulation device and accessories. Regulatory Class: II

Product Code: GEI Dated: December 9, 2005 Received: December 9, 2005

Dear Ms. Defiesta-Ng:

We have reviewed your Section 510(k) premarket notification of intent to market the indicati We have reviewed your Section 9 ro(x) premainer is substantially equivalent (for the indications referenced above and nave decemblicated predicate devices marketed in interstate for use stated in the encrosule) to regally mances provided Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Foderal Food. Drug commerce prior to May 28, 1970, the charger with the provisions of the Federal Food, Drug, devices that have been reclassified in acceraance while to premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premissions of the A and Cosment Act (Act) that do not require approvince of the general controls provisions of the Act. The
You may, therefore, market the device, subject to the general contr You may, therefore, market the devree, bacyer to the go
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the Feet merelate read prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (Sec above) into e. Existing major regulations affecting your device. [UA it may be subject to such additional controls: "Litering Sty" and 800 to 898. In addition, FDA can be found in the Code of Featur Regarming your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination and mean Please be advised that FDA s issualled of a basedia.complies with other requirements of the Act
that FDA has made a determination that your device complies with other may that TDA has Inade a delemination administered by other Federal agencies. You must or any Federal Statutes and regulations daminding, but not limited to: registration and listing (21
comply with all the Act's requirements, including, but not limited to: reg comply with an the Act s requirements, mercuses,
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice destractively attacted CPK Part 807), labeling (21 CFR Part 820); good and fapplicable, the clectronic form in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Ms. Defiesta-Ng

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing your averace of your device of your device to a legally
premarket notification. The FDA finding of substantial equivales of you premarket nouncation. The PDA miding of Subscanian or 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 note the requiration entitled If you desire specific advice for your device of the success note the regulation entitled, the move obtain contact the Office of Compliance at (216) 276 - 151 (216) FR Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (212) - 1 Sugar the Division "Misbranding by reference to premarket notification" (1) os tost from the Division of Small other general information on your responsionnes and to toll-fire mumber (800) 638-204 or manufacturers, html Manufacturers, Internet address http://www.fda.cov/cdrh/industry/support/index.html.

Sincerely yours,

farbare Bnehub
FN

Mark N. Melkerson Acting 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

KO534-47 510(k) Number:

Device Name:

ArthroCare® Perc-D™ SpineWand™

Indications for use:

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

Over-the-Counter AND/OR X Prescription Usc Usc (21 CFR 807 Subpart (Part 21 CFR 801 ਂ Subpart D)

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

Laubane Buchund for MXM

Division of General, Restornine, and Neurological Devices

510(k) Number K053447