ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS

K020621 · Arthrocare Corp. · GEY · Mar 28, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020621
• Device Name: ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS
• Applicant: Arthrocare Corp.
• Product Code: GEY · General, Plastic Surgery
• Decision Date: Mar 28, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4820
• Device Class: Class 1
• 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

Perc-D SpineWand is a bipolar, single-use, high-frequency electrosurgical device. It functions by delivering high-frequency energy to perform ablation, coagulation, and decompression of disc material. The device is intended for use in clinical settings to treat symptomatic patients suffering from contained herniated discs. It is operated by a physician. The device transforms electrical energy into thermal/electrosurgical effects at the target tissue site to achieve decompression. It does not involve complex software or AI algorithms.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and performance specifications.

Technological Characteristics

Bipolar, high-frequency electrosurgical device. Single-use. Designed for ablation, coagulation, and decompression. No software or electronic processing components described.

Indications for Use

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

Regulatory Classification

Identification

Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

Predicate Devices

• ArthroCare Perc-D SpineWand (K010811)

Submission Summary (Full Text)

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ArthrocCare
CORPORATION

MAR 2 8 2002

# 510(k) Summary K 020621 ArthroCare Corporation Perc-D™ SpineWand™

#### General Information

Contact Person:

Phone Number:

Date Prepared:

Trade Name:

Device Description

Generic/Common Name:

Classification Name:

Submitters Name/Address:

ArthroCare Corporation 680 Vaqueros Ave Sunnyvale, CA 94085-2936

Establishment Registration Number:

2951580

Valerie Defiesta-Ng Director, Regulatory Affairs

[phone]

February 25, 2002

Perc-DTM SpineWand™

Electrosurgical Device and Accessories

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

#### Predicate Devices

ArthroCare Perc-D SpineWand

K010811; cleared on May 30, 2001

### 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.

680 Vaqueros Avenue • Sunnyvale, CA 94085 • [phone] • Fax: [phone]

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### Substantial Equivalence

This Special 510(k) proposes a modification in dimensional and performance I mis bposted o receipes , and labeling for the Wands, which were previously cleared spoonlood 1 on May 30, 2001. The indications for use, technology, principle of under 1001 on 1127 of 1127 at 1127 of the Wands remain the same as in the predicate cleared 510(k)s.

# Summary of Safety and Effectiveness

The modified Perc-D Wands, as described in this submission, are substantially equivalent The modified Fore D Wands. The proposed modification in dimensional and to the producere, sifications, materials, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices.

X

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.

**MAR 8 2002**

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K020621

Trade Name: Perc-D™ SpineWand™ Regulation Number: 878.4400; 888.1100 Regulation Name: Electrosurgical cutting and coagulation device and accessories; Arthroscope Regulatory Class: II Product Code: GEI; HRX Dated: February 26, 2002 Received: February 26, 2002

Dear Ms. Defiesta-Ng:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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,

Muriam C. Provost

tol 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:

510(k) Number:

K_030621

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

KO20621 510(k) Number_

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

Prescription Use X (Per 21 CFR 801.109)

OR

Over-the-Counter Use

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