ARTHROCARE CONTROLLER, PATIENT CABLE, FOOT CONTROL, POWER CORD

K014222 · Arthrocare Corp. · GEI · Jan 18, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K014222
• Device Name: ARTHROCARE CONTROLLER, PATIENT CABLE, FOOT CONTROL, POWER CORD
• Applicant: Arthrocare Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 18, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Electrosurgery System is intended for resection, and coagulation of soft The Elouroburgery By clean is vessels in open, laparoscopic, and endoscopic general tissue 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.

Device Story

Bipolar, high-frequency electrosurgical system; consists of electrosurgical generator (Controller), disposable bipolar Wands, and reusable Patient Cable. Used in OR for general and gynecological surgeries (e.g., cholecystectomy, hysterectomy). Physician-operated; device delivers electrical energy to target tissue via Wands to perform resection, ablation, and coagulation. System provides hemostasis and tissue removal; benefits patient through controlled surgical intervention. Modifications in this submission involve performance and dimensional specifications.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Bipolar, high-frequency electrosurgical system. Components: Controller (generator), disposable bipolar Wands, reusable Patient Cable. Energy source: electrical. Sterilization: not specified (disposable wands).

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 and gynecological surgical 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 (K012519)

Submission Summary (Full Text)

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'JAN 1 8 2002

ArthroCare
CORPORATION

## 510(k) Summary KO14222 ArthroCare Corporation Electrosurgery System

#### General Information

Submitter Name/Address:

Phone Number:

Contact Person:

ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936

[phone]

December 20, 2001

Bruce Prothro Vice President, Regulatory Affairs, Quality Assurance, and Clinical Research

Date Prepared:

Device Description

Trade Name:

Generic/Common Name:

Classification Name:

ArthroCare® Electrosurgery System

Electrosurgical Device and Accessories

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

#### Predicate Devices

K012519 ArthroCare® Electrosurgery Wands

#### Product Description

The Electrosurgery System is a bipolar, high frequency electrosurgical system consisting of three components: an electrosurgical generator called the Controller; a family of disposable, bipolar, single use Wands; and a reusable Patient Cable.

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#### Intended Uses

The Electrosurgery System is intended for resection, and coagulation of soft The Elouroburgery By clean is vessels in open, laparoscopic, and endoscopic general tissue 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 |

#### Substantial Equivalence

This Special 510(k) proposes a modification in the performance specifications, I imensional specifications, and labeling for the Electrosurgery System, which was previously cleared in K012519 on October 25, 2001. The indications for use, technology, principle of operation, materials, packaging, and sterilization parameters of the Electrosurgery System remain the same as in the predicate cleared 510(k).

### Summary of Safety and Effectiveness

The modified Electrosurgery System, as described in this Special 510(k), is substantially equivalent to the predicate device. The proposed modifications in performance specifications, dimensional specifications, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the System.

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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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 8 2002

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

Re: K014222 Trade/Device Name: ArthroCare® Electrosurgery System Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 20, 2001 Received: December 26, 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 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,

Ro. Merle N. Wilkinson

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

Electrosurgery System Device Name

K_014 222 510(k) Number:

Indications for Use:

The Electrosurgery System is intended for resection, ablation, and coagulation of soft I he Electrosurgery System is included for readers, accopic, and endoscopic, and endoscopic general tissue and nemostasis of blood vessels in open, tapares 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 (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | X | OR Over-the-Counter Use | |
|------------------------------------------|---|-------------------------|--|
|------------------------------------------|---|-------------------------|--|

for *Mark N Millison*

(Division Sign-Off)

Division of General, Restorative

and Neurological Devices

| 510(k) Number: | K014222 |
|----------------|---------|
|----------------|---------|

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