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

K020832 · Arthrocare Corp. · GEI · Apr 9, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020832
• Device Name: ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOT CONTROL, POWER CORD, WANDS
• Applicant: Arthrocare Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 9, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ArthroCare System 2000 is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurosurgical procedures. The ArthroCare Orthopedic Electrosurgery System is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in in orthopedic, arthroscopic, and spinal procedures. The ArthroCare Bipolar Loop is indicated for resection, ablation, and excision, as well as hemostasis of blood vessels in patients requiring endoscopic surgery for general urological procedures including transurethral prostatectomy (TURP), transurethral incisions in the prostate (TUIP), and non-malignant tumors of the bladder wall.

Device Story

ArthroCare Wands are bipolar, single-use, high-frequency electrosurgical devices. They function by delivering high-frequency energy to soft tissue to perform resection, ablation, and coagulation, and to achieve hemostasis of blood vessels. Used in clinical settings (OR/endoscopic suites) by surgeons (orthopedic, neurosurgical, urological). The device transforms electrical energy into thermal effects at the tissue interface. Output is controlled by the surgeon to achieve precise tissue removal or vessel sealing. Benefits include controlled tissue management and reduced bleeding during minimally invasive procedures. This submission covers material and labeling modifications to previously cleared devices.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and labeling comparisons to the predicate device.

Technological Characteristics

Bipolar, high-frequency electrosurgical wand; single-use; intended for soft tissue resection, ablation, and coagulation. Technical specifications, sterilization parameters, and dimensional characteristics are identical to the predicate device (K011634).

Indications for Use

Indicated for patients requiring soft tissue resection, ablation, coagulation, and hemostasis during orthopedic, arthroscopic, spinal, neurosurgical, or endoscopic urological procedures (including TURP, TUIP, and bladder tumor excision).

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 System 2000, ArthroCare Orthopedic Electrosurgery System, and ArthroCare Bipolar Loop (K011634)

Submission Summary (Full Text)

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ArthroCare
CORPORATION

# 510(k) Summary

ArthroCare Corporation ArthroCare® System 2000 ArthroCare® Orthopedic Electrosurgery System ArthroCare® Bipolar Loop

KO20832

2951580

Valerie Defiesta-Ng

March 13, 2002

General Information

Submitter Name/Address:

ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936

Director, Regulatory Affairs

APR = 9 2002

Establishment Registration Number:

Contact Person:

Date Prepared:

Device Description

Trade Name:

ArthroCare System 2000 ArthroCare Orthopedic Electrosurgery System ArthroCare Bipolar Loop

Generic/Common Name:

Classification Name:

Electrosurgical Device and Accessories

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

# Predicate Devices

ArthroCare System 2000, ArthroCare Orthopedic Electrosurgery System, and ArthroCare Bipolar Loop

K011634

# Product Description

The ArthroCare Wands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in neurosurgical, spinal, and urological procedures.

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# Intended Use

# ArthroCare System 2000

- The ArthroCare System 2000 is indicated for resection, ablation, and coagulation of 프 soft tissue and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurosurgical procedures.
# ArthroCare Orthopedic Electrosurgery System

- The ArthroCare Orthopedic Electrosurgery System is indicated for resection, ablation, II and coagulation of soft tissue and hemostasis of blood vessels in in orthopedic, arthroscopic, and spinal procedures.
## ArthroCare Bipolar Loop

- The ArthroCare Bipolar Loop is indicated for resection, ablation, and excision, as 비 well as hemostasis of blood vessels in patients requiring endoscopic surgery for general urological procedures including transurethral prostatectomy (TURP), transurethral incisions in the prostate (TUIP), and non-malignant tumors of the bladder wall.
#### Substantial Equivalence

This Special 510(k) proposes modifications in materials and labeling for the ArthroCare Wands, which were previously cleared under K011634 on June 19, 2001. The indications for use, technology, principle of operation, performance and dimensional specifications, packaging, and sterilization parameters of the Wands remain the same as in the predicate cleared 510(k).

## Summary of Safety and Effectiveness

The modified Wands, as described in this submission, are substantially equivalent to the predicate Wands. The proposed modification in materials 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/0 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal features a stylized eagle with three heads facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 .

APR = 9 2002

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

Re: K020832

Trade/Device Name: ArthroCare® System 2000, ArthroCare® Orthopedic Electrosurgery System and ArthroCare® Bipolar Loop Regulation Number: 878.440 and 888.1100 Regulation Name: Electrosurgical Device, Cutting & Coagulation & Accessories and Arthroscope and Accessories Regulatory Class: II Product Code: GEI and HRX Dated: January 4, 2002 Received: January 7, 2002

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 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.

R. Mark N. Milliken

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

Device Name:

ArthroCare® System 2000 ArthroCare® Orthopedic Electrosurgery System ArthroCare® Bipolar Loop

K_020832 510(k) Number:

Indications for use:

#### ArthroCare System 2000

- The ArthroCare System 2000 is indicated for resection, ablation, and coagulation of 비 soft tissue and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurosurgical procedures.
# ArthroCare Orthopedic Electrosurgery System

- The ArthroCare Orthopedic Electrosurgery System is indicated for resection, ablation, .. and coagulation of soft tissue and hemostasis of blood vessels in in orthopedic, arthroscopic, and spinal procedures.
# ArthroCare Bipolar Loop

- The ArthroCare Bipolar Loop is indicated for resection, ablation, and excision, as # well as hemostasis of blood vessels in patients requiring endoscopic surgery for general urological procedures including transurethral prostatectomy (TURP), transurethral incisions in the prostate (TUIP), and non-malignant tumors of the bladder wall.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <b>X</b> | OR | Over-the-Counter Use | |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|----|----------------------|------|
| | <div> <p><i>Mark N Millman</i></p> <p>(Division Sign-Off)</p> <p>Division of General, Restorative<br/>and Neurological Devices</p> </div> | | | viii |
| 510(k) Number | K020833 | | | |