MODIFICATION TO ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD, WANDS

K022475 · Arthrocare Corp. · GEI · Oct 3, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K022475
• Device Name: MODIFICATION TO ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD, WANDS
• Applicant: Arthrocare Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 3, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Electrosurgery Wands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in open, laparoscopic, and endoscopic general surgery and general gynecology procedures. Representative procedures include the following: General Surgery: cholecystectomy, lysis of adhesions, upper GI, GI (other), splenectomy, thyroidectomy, herniorrhaphy, breast biopsy, bowel resection, pelvic adhesiolysis, removal of lesions, removal of polyps, tumor biopsy. Gynecological Surgery: lysis of adhesions, hysterectomy, salpingo-oophorectomy, burch colposuspension, myomectomy, endometriosis, ovariohysterectomy, removal of tumors.

Device Story

ArthroCare Electrosurgery Wands are bipolar, single-use, high-frequency electrosurgical devices. Used in open, laparoscopic, and endoscopic general and gynecological surgeries; operated by surgeons. Devices perform soft tissue resection, ablation, coagulation, and hemostasis. Principle of operation involves high-frequency electrical energy delivery to target tissue. Wands are used in clinical settings to assist in procedures such as cholecystectomy, hysterectomy, and tumor biopsies. Output is controlled by the surgeon to achieve desired tissue effects, directly impacting surgical outcomes by facilitating precise tissue management.

Clinical Evidence

Bench testing only.

Technological Characteristics

Bipolar, single-use, high-frequency electrosurgical wand. Designed for soft tissue resection, ablation, and coagulation. Operates as part of an electrosurgical system.

Indications for Use

Indicated for soft tissue resection, ablation, coagulation, and hemostasis in patients undergoing open, laparoscopic, or endoscopic general surgery and gynecological procedures.

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 Electrosurgery Wands (K020622)

Submission Summary (Full Text)

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ArthroCare
CORPORATION

Image /page/0/Picture/1 description: The image shows handwritten text. The text at the top reads 'K022475'. Below that, the text reads 'page 1 of 2'. The handwriting appears to be casual and the text is slightly slanted.

# OCT 0 3 2002

# 510(k) Summary

# ArthroCare Corporation ArthroCare® Electrosurgery Wands

## 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: | July 26, 2002 |
| Device Description | |
| Trade Name | ArthroCare Electrosurgery Wands |
| 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 Electrosurgery Wands

K020622; cleared on March 28, 2002

#### Product Description

The Wands are bipolar, single use, high frequency electrosurgical device designed for specific indications.

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K022475
page 2 of 2

## Intended Use

The Electrosurgery Wands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in open, laparoscopic, and endoscopic general surgery and general gynecology procedures. Representative procedures include the following:

| General Surgery |
|-----------------------|
| cholecystectomy |
| lysis of adhesions |
| upper GI |
| GI (other) |
| splenectomy |
| thyroidectomy |
| herniorrhaphy |
| breast biopsy |
| bowel resection |
| pelvic adhesiolysis |
| removal of lesions |
| removal of polyps |
| tumor biopsy |
| Gynecological Surgery |
| lysis of adhesions |
| hysterectomy |
| salpingo-oophorectomy |
| burch colposuspension |
| myomectomy |
| endometriosis |
| ovariohysterectomy |
| removal of tumors |

#### Substantial Equivalence

This Special 510(k) proposes modification in material for the Electrosurgery Wands, which were previously cleared under K020662, on March 28, 2002. The indications for use, technology, principle of operation, design, performance and dimensional specifications, labeling, packaging, and sterilization parameters of the ArthroCare Electrosurgery Wands remain the same as in the predicate cleared 510(k).

#### Summary of Safety and Effectiveness

The modified Electrosurgery Wands, as described in this submission, are substantially equivalent to the predicate Electrosurgery Wands. The proposed modification in material is not a substantial change or modification, and does not significantly affect the safety or efficacy of the devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 03 2002

Arthocare Corporation Valerie Defiesta-Ng Director, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085

Re: K022475

Trade/Device Name: Modification to Arthrocare Controller (System 2000 and 8000) Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: September 11, 2002 Received: September 12, 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 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" (21 CFR 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.

sincerely yours,

elia 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
Indications for Use Statement

ArthroCare® Electrosurgery Wands Device Name:

510(k) Number:

K (22475

Indications for use:

The Electrosurgery Wands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in open, laparoscopic, and endoscopic general surgery and general gynecology procedures. Representative procedures include the following:

| General Surgery |
|-----------------------|
| cholecystectomy |
| lysis of adhesions |
| upper GI |
| GI (other) |
| splenectomy |
| thyroidectomy |
| herniorrhaphy |
| breast biopsy |
| bowel resection |
| pelvic adhesiolysis |
| removal of lesions |
| removal of polyps |
| tumor biopsy |
| Gynecological Surgery |
| lysis of adhesions |
| hysterectomy |
| salpingo-oophorectomy |
| burch colposuspension |
| myomectomy |
| endometriosis |
| ovariohysterectomy |
| removal of tumors |

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

| Prescription Use | <b>X</b> |
|----------------------|-----------------------------------------------------------|
| (Per 21 CFR 801.109) | |
| | Over-the-Counter |
| | (Division Sign-Off) |
| | Division of General, Restorative and Neurological Devices |
| 510(k) Number | K022475 |