ARTHROCARE CAVITY SPINEWAND

K063172 · Arthrocare Corp. · GEI · Apr 27, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K063172
• Device Name: ARTHROCARE CAVITY SPINEWAND
• Applicant: Arthrocare Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 27, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ArthroCare Cavity SpineWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in percutaneous, intraoperative or spinal procedures including the creation of a cavity in malignant lesions in a vertebral body.

Device Story

ArthroCare Cavity SpineWands are bipolar, single-use, high-frequency electrosurgical devices. Used in percutaneous, intraoperative, or spinal procedures to resect, ablate, and coagulate soft tissue and achieve hemostasis. Enables creation of cavities in malignant vertebral body lesions. Operated by physicians in clinical settings. Device utilizes high-frequency electrical energy to perform tissue effects. Benefits include precise tissue management during spinal interventions.

Clinical Evidence

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

Technological Characteristics

Bipolar, high-frequency electrosurgical device. Single-use. Design and materials are identical to previously cleared ArthroCare Wands. Sterilization parameters remain unchanged.

Indications for Use

Indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in percutaneous, intraoperative, or spinal procedures, including creation of a cavity in malignant vertebral body lesions.

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 Wands (K001588, K060823)
• RITA System (K040989)

Submission Summary (Full Text)

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# 14063172 510(k) Summary

## APR 2 7 2007

## ArthroCare Corporation ArthroCare® Cavity SpineWands®

#### General Information

Submitter Name/Address:

ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-3523

Establishment Registration Number: Contact Person:

2951580

Valerie Defiesta-Ng Director, Regulatory Affairs October 17, 2006

Date Prepared:

Device Description

Trade Name:

Generic/Common Name:

Classification Name:

ArthroCare® Cavity SpineWands®

Electrosurgical Device and Accessories

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

#### Predicate Devices

ArthroCare® Wands RITA System

K001588 and K060823 K040989

#### Product Description

The ArthroCare Cavity SpineWands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in spinal procedures.

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#### Intended Uses

The ArthroCare Cavity SpineWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in percutaneous, intraoperative or spinal procedures including the creation of a cavity in malignant lesions in a vertebral body.

## Substantial Equivalence

This 510(k) proposes a new indication and labeling for the ArthroCare Cavity The technology, principle of operation, materials, and sterilization SpineWands. parameters of the ArthroCare Cavity SpineWands remain the same as those Wands cleared in the ArthroCare predicate 510(k)s. The ArthroCare Cavity SpineWands are also substantially to the RITA System in indications for use and technology.

## Summary of Safety and Effectiveness

The ArthroCare Cavity SpineWands, as described in this 510(k), are substantially equivalent to the predicate devices. The new proposed indication 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 Department of Health and Human Services (HHS). The logo consists of a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

APR 2 7 2007

Re: K063172

Trade/Device Name: ArthroCare® Cavity SpineWands® Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 14, 2007 Received: March 15, 2007

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/industry/support/index.html.

Sincerely yours. Mark N. Me 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:

KO63172

Device Name:

ArthroCare® Cavity SpineWands®

Indications for Use:

The ArthroCare Cavity SpineWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in percutaneous, intraoperative or spinal procedures including the creation of a cavity in malignant lesions in a vertebral body.

Prescription Use (Part 21 CFR 801 Subpart D)

X

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

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

**510(k) Number** L063172