SPINEWAND SURGICAL DEVICE

K100353 · Arthrocare Corp. · GEI · May 13, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K100353
• Device Name: SPINEWAND SURGICAL DEVICE
• Applicant: Arthrocare Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: May 13, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Bipolar, single-use, high-frequency electrosurgical device; used for ablation, coagulation, and decompression of disc material. Operates via coblation technology to remove tissue in contained herniated discs. Used by physicians in clinical settings. Output provides controlled tissue removal and coagulation to alleviate symptoms. Benefits include minimally invasive decompression of disc material.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and technological similarities to predicate devices.

Technological Characteristics

Bipolar, high-frequency electrosurgical device. Single-use. Includes DC, DLR, and DLG SpineWand variants. Principle of operation is coblation (electrosurgical ablation/coagulation).

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 Perc-D SpineWand (K053447)
• ArthroCare Perc-D SpineWand (K030954)
• ArthroCare Perc-D SpineWand (K020621)
• ArthroCare Perc-D SpineWand (K010811)

Submission Summary (Full Text)

{0}------------------------------------------------

K000353

MAY 1 3 2010

#### 510(k) Summary

### ArthroCare Corporation ArthroCare® Coblator IQTM Perc-D® SpineWand®

#### General Information

Submitter Name/Address:

ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936

Establishment Registration Number:

Contact Person:

Valerie Defiesta-Ng Director, Regulatory Affairs

Date Prepared:

Device Description

Trade Name:

Generic/Common Name:

Classification Name:

February 11, 2010

2951580

ArthroCare® Coblator IQTM Perc-D® SpineWand®

Electrosurgical Device and Accessories

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

#### Predicate Devices

K053447 (December 27, 2005) ArthroCare Perc-D SpineWand ArthroCare Perc-D SpineWand K030954 (April 16, 2003) ArthroCare Perc-D SpineWand K020621 (March 28, 2002) ArthroCare Perc-D SpineWand K010811 (May 30, 2001)

#### Product Description

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

The Coblator IQ Perc-D SpineWands include the following Wands: Coblator IQ DC SpineWand, Coblator IQ DLR SpineWand, and the Coblator IQ DLG SpineWand.

#### Intended Use

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

{1}------------------------------------------------

## Substantial Equivalence

This Special 510(k) proposes modifications to the performance specifications and
labeling of the ArthroCare Coblator IQ™ Perc-D® SpineWand". The indications for use, materials, technology, sterilization, and principle of operation of the SpineWands remain the same as in the predicate device.

## 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.

{2}------------------------------------------------

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 stylized eagle or bird symbol with three overlapping wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

ArthroCare® Corporation % Ms. Valerie Defiesta-Ng 680 Vaqueros Avenue Sunnyvale, CA 94085-3523

MAY 1 3 2010

Re: K100353

Trade/Device Name: ArthroCare® Coblator IQ™ 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: February 11, 2010 Received: February 12, 2010

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

{3}------------------------------------------------

Page 2 - Ms. Valerie Defiesta-Ng

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sincerely yours,

Mark A. Milburn

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use Statement

K 510(k) Number:

ArthroCare® Coblator IQ™ Perc-D® SpineWand® Device Name:

Indications for use:

The ArthroCare® Coblator IQ™ Perc-D® SpineWand® is indicated for ablation, I he Arthroome - Southere som of disc material to treat symptomatic patients with contained herniated discs.

Prescription Use (Part 21 CFR 801 Subpart D)

x AND/OR Over-the-Counter Use (21 CFR 807 Subpart C)

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

signature

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100353