ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000); ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; AND WANDS

{0}------------------------------------------------ ArthroCare CORPORATION MAR 2 8 2002 . # 510(k) Summary KO206222 ArthroCare Corporation Electrosurgery Wands General Information Submitters Name/Address: ArthroCare, Corporation 680 Vaqueros Ave Sunnyvale, CA 94085-2936 Establishment Registration Number: 2951580 (408) 736-0224 February 25, 2002 Valerie Defiesta-Ng Director, Regulatory Affairs Phone Number: Contact Person: Date Prepared: Device Description Trade Name: Generic/Common Name: Classification Name: ArthroCare® Electrosurgery Wands Electrosurgical Device and Accessories Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400) #### Predicate Devices ArthroCare Electrosurgery System Wands K014222; cleared on January 18, 2002 #### Product Description The Wands are bipolar, single use, high frequency electrosurgical devices designed for specific indications. {1}------------------------------------------------ #### 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 tisse and neinveral 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 a modification in dimensional and performance specifications, materials, and labeling for the Wands, which were previously cleared under K014222 on Janurary 18, 2002. The indications for use, technology, principle of operation, packaging, and sterilization parameters of the Wands remain the same as in the predicate cleared 510(k)s. {2}------------------------------------------------ # Summary of Safety and Effectiveness The Electrosurgery System modified Wands, as described in this submission, are The Enchrosargery Dystent in the predicate, unmodified Wands. The proposed modification Substantially equivalent to the predications, materials, and labeling are not substantial n unficitsional and performance opet significantly affect the safety or efficacy of the devices. {3}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human profiles in a row, with a snake-like form intertwined. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Public Health Service 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: K020622 Trade Name: ArthroCare® Electrosurgery Wands Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories; Regulatory Class: II Product Code: GEI 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 we have reviewed your bootion is soking is substantially equivalent (for the referenced above and we have acterinaure) to devices marketed in interstate commerce prior to indications for use success in the envice Medical Device Amendments, or to devices that have May 26, 1970, the charment date of the provisions of the Federal Food, Drug, and Cosmetic Act been reclassified in accordance with the provisions of the Federal W becal recrassmed in accoration of a premarket approval application (PMA). You may, (Act) that do not require upprovated to the general controls provisions of the Act. The general therefore, marker the device, sabject to equirements for annual registration, listing of devices, Controls provisions or the free heating, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it ri your device is classified (600 a0010) als. Existing major regulations affecting your device can may be subject to such additional controls. Existing major regulations af may be subject to such adaterial eculations, Title 21, Parts 800 to 898. In addition, FDA may of found in the Outs occements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean i Tease of advised that I Drisonalise cour device complies with other requirements of the Act that I Dri has made a actor regulations administered by other Federal agencies. You must of any I cacal statuted und registents, including, but not limited to: registration and listing (21 comply with an the 11et 31equirements) 01); good manufacturing practice requirements as set Of It in the quality systems (21 CFR Part 820); and if applicable, the electronic form in and qualis) by selling (Sections 531-542 of the Act); 21 CFR 1000-1050. {4}------------------------------------------------ #### 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Muriam C. Provost Col 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 {5}------------------------------------------------ ## Indications for Use Statement Device Name: ArthroCare® Electrosurgery Wands 510(k) Number: K 020622 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 (Per 21 CFR 801.109) X (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number K020622 viii