ARTHROCARE ELECTROSURGERY WANDS

K012519 · Arthrocare Corp. · GEI · Oct 25, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K012519
• Device Name: ARTHROCARE ELECTROSURGERY WANDS
• Applicant: Arthrocare Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 25, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Electrosurgery Wands arc 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 may include the following: General Surgery • cholecystectomy • lysis of adhesions • upper Gl • 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 single-use, disposable bipolar electrosurgical devices; used with ArthroCare Electrosurgery System (System 2000). Device delivers electrical energy to soft tissue for resection, ablation, and coagulation; achieves hemostasis of blood vessels. Operated by surgeons in OR settings during general and gynecological procedures. Output provides controlled tissue effect; assists surgeon in tissue removal and bleeding control. Benefits include precise tissue management during surgery.

Clinical Evidence

Bench testing only. Performance testing completed to demonstrate safe and effective use in resection and ablation of soft tissue.

Technological Characteristics

Single-use, disposable bipolar electrosurgical device. Designed for use with ArthroCare Electrosurgery System (System 2000). Energy source: bipolar electrical energy. Intended for soft tissue resection, ablation, and coagulation.

Indications for Use

Indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels 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 System (K001302)
• Ethicon PowerStar Bipolar Scissors (K981361)
• Coherent VersaPulse Select Single Wavelength (Ho:YAG) Dual Wavelength (Ho:YAG/Nd:YAG) Laser System (K990947)

Submission Summary (Full Text)

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OCT 2 5 2001

# 510(k) Summary of Safety and Effectiveness ArthroCare Corporation ArthroCare® Electrosurgery Wands

| | K012519 | |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------|--|
| General Information<br>Manufacturer: | ArthroCare, Corporation<br>595 North Pastoria Avenue<br>Sunnyvale, CA 94085-2936 | |
| Establishment Registration Number: | 2951580 | |
| Contact Person: | Bruce Prothro<br>Vice President Regulatory Affairs, Quality<br>Assurance, and Clinical Research | |
| Date Prepared: | August 3, 2001 | |
| Device Description<br>Classification Name: | Electrosurgical Cutting and Coagulation<br>Device and Accessorics (21 CFR 878.4400) | |
| Trade Name: | ArthroCare® Electrosurgery Wand | |
| Generic/Common Name: | Electrosurgical Device and Accessories | |
| Predicate Devices | | |
| • ArthroCare Electrosurgery System | K001302 | |
| • Ethicon PowerStar Bipolar Scissors | K981361 | |
| • Coherent VersaPulse Select Single Wavelength (Ho:YAG) Dual | | |

- . Conerent Versuruise Sciect Single Wavelchigh |
Wavelcngth (Ho:YAG/Nd:YAG) Laser System ﺎ K990947
.

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#### Intended Use

The Electrosurgery Wands arc 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 may include the following:

| General Surgery |
|-------------------------|
| • cholecystectomy |
| • lysis of adhesions |
| • upper Gl |
| • 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 |

#### Product Description

The ArthroCarc Electrosurgery Wands are single use, disposable bipolar electrosurgical devices designed to be used in conjunction with the ArthroCare Electrosurgery System (System 2000).

#### Substantial Equivalence

In establishing substantial equivalence to the prodicate devices, ArthroCare evaluated the indications for use, materials, technology, product specifications, and energy requirements of those systems. Additionally, performance testing has been completed to demonstrate the safe and effective use of the Electrosurgery Wands in the resection and ablation of soft tissue. The performance testing and device comparison demonstrated that the subject devices are substantially equivalent to the prodicate devices, and are safe and effective for their intended use.

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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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is rendered in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 5 2001

Mr. Bruce Prothro Vice President Regulatory Affairs, Ouality Assurance and Clinical Research ArthroCare Corporation 595 North Pastoria Avenue Sunnyvale, California 94085

Re: K012519

Trade/Device Name: ArthroCare® Electrosurgery Wand Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 3, 2001 Received: August 6, 2001

Dear Mr. Prothro:

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 - Mr. Bruce Prothro

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 premaired predicated 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 Compination at [phone] Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation entired, "Thison on your responsibilities under the Act may be obtained from the Oiner general mioninational 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,

Susan Walker, MD

Image /page/3/Picture/5 description: The image shows a close-up of a handwritten symbol or character. It features a curved line that resembles a loop or a stylized letter. The stroke is thick and dark, suggesting it was written with a pen or marker. The overall impression is abstract and calligraphic.

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 Statement

| Device Name: | ArthroCare® Electrosurgery Wands |
|----------------|----------------------------------|
| 510(k) Number: | K012519 |

Indications for use:

The ArthroCare 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 may 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 (OD

Prescription Use (Per 21 CFR 801.109) OR

X

(Division Sign-Off)
Over-the-Counter Use
Division of ether, Restorative
and Neurological Devices

510(k) Number.