REPROCESSED SOFT TISSUE ABLATORS

{0}------------------------------------------------ DEC 0 6 2001 K 012631 # 510(k) Summary of Safety and Effectiveness | Submitter: | Alliance Medical Corporation<br>10232 South 51st Street<br>Phoenix, Arizona 85044 | |---------------------------------|------------------------------------------------------------------------------------------| | Contact: | Don Selvey<br>Vice President, Regulatory Affairs and Quality Assurance<br>(480) 763-5300 | | Date of | 9 August 2001 | | preparation:<br>Name of device: | Reprocessed Soft Tissue Ablators | | Common Name: | Soft Tissue Ablators | | Classification<br>Name: | Electrosurgical Cutting and Coagulation Device and Accessories | | Reprocessed device(s): | | | Manufacturer | Description | Model Number | |--------------|--------------------------|--------------| | AthroCare® | Arthro Wand® Right Angle | A 1325-01 | | AthroCare® | Arthro Wand® Right Angle | A 1330-01 | | AthroCare® | Arthro Wand® Right Angle | A 1335-01 | | AthroCare® | Arthro Wand® Right Angle | A 1336-01 | | AthroCare® | Arthro Wand® Right Angle | A 1345-01 | | AthroCare® | Arthro Wand® Dome | A 3625-01 | | AthroCare® | Arthro Wand® Dome | A 3525-01 | | AthroCare® | Arthro Wand® Dome | A 3630-01 | | AthroCare® | Arthro Wand® Dome | A 3430-01 | | AthroCare® | Arthro Wand® Dome | A 3530-01 | | AthroCare® | Arthro Wand® Bevel | A 2630-01 | | AthroCare® | Arthro Wand® Bevel | A 2430-01 | | AthroCare® | Arthro Wand® Bevel | A 2530-01 | | AthroCare® | Arthro Wand® Small Joint | A 2723-01 | | AthroCare® | Arthro Wand® Small Joint | A 2823-01 | | AthroCare® | Arthro Wand® Small Joint | A 1115-01 | | AthroCare® | Arthro Wand® Bisector | A 4330-01 | | AthroCare® | Arthro Wand® Straight | A 1125-01 | | AthroCare® | Arthro Wand® Straight | A 1130-01 | | AthroCare® | Arthro Wand® Angle | A 1225-01 | | AthroCare® | Arthro Wand® Angle | A 1230-01 | {1}------------------------------------------------ | Mitek® | VAPR™ Thermal Side Effect Electrode (3.5mm) | 225101 | |--------|----------------------------------------------------------------|--------| | Mitek® | VAPR™ Thermal Reversed Angled Side Effect Electrode<br>(3.5mm) | 225112 | | Mitek® | VAPR™ Thermal Angled End Effect Electrode (3.5mm) | 225104 | | Mitek® | VAPR™ Side Effect Electrode (3.5mm) | 225301 | | Mitek® | VAPR™ Angled Side Effect Electrode (21°, 3.5mm) | 225302 | | Mitek® | VAPR™ End Effect Electrode (3.5mm) | 225303 | | Mitek® | VAPR™ Angled End Effect Electrode (21°, 3.5mm) | 225304 | | Mitek® | VAPR™ 90° Hook Electrode (3.5mm) | 225305 | | Mitek® | VAPR™ Flexible Side Effect Electrode (3.5mm) | 225312 | Predicate device(s): Image /page/1/Picture/2 description: The image contains a check mark. The check mark is black and is on a white background. The check mark is oriented from the bottom left to the top right. The check mark is used to indicate that something is correct or has been completed. | K000036 | ArthroCare, ArthroCare® ENTec™ ReFlex™ Wand | |---------|-----------------------------------------------------------------------------------------------------------------------------------------------| | K000044 | ArthroCare, ArthroCare® Orthopedic Electrosurgery<br>System | | K000074 | ArthroCare, ArthroCare® Electrosurgery System | | K000228 | ArthroCare® ENTec™ Surgery System | | K000511 | ArthroCare® Orthopedic Electrosurgery System | | K000936 | Mitek, VAPR™ 2.3mm Wedge Electrode | | K001302 | ArthroCare, ArthroCare® Electrosurgery System | | K001936 | ArthroCare ENTec® Surgery system, ArthroCare®<br>Orthopedic Surgery System, and ArthroCare®<br>Electrosurgery System (Electrosurgery Systems) | | K943450 | ArthroCare, ArthroCare® Arthroscopic Electrosurgery<br>System 970 | | K955531 | ArthroCare® Bipolar Loop Electrosurgery System | | K960169 | ArthroCare® Urologic Multi-electrode Electrosurgery<br>System | | K962445 | ArthroCare® Dental Wand Electrosugery System | | K963123 | Arthrocare, ArthroCare® Arthroscopic Electrosurgery<br>System 980 (Model 2000) | | K963783 | Mitek, VAPR™ Electrosurgical System | | K964849 | ArthroCare® Dermatology Electrosurgery System | | K971532 | ArthroCare® Electrosurgery System | | K973478 | ArthroCare®, AccENT Head and Neck Electrosurgery<br>System | | K974022 | Mitek, VAPR™ T Thermal Electrode | | K981870 | ArthroCare® Visage Cosmetic Surgery System | | K992180 | ArthroCare® Visage™ Cosmetic Surgery System | | K992406 | Mitek, VAPR™ 2.3mm End Effect Electrode | | K992581 | ArthroCare, ArthroCare® Orthopedic Electrosurgery<br>System | | K992972 | ArthroCare, ArthroCare® Electrosurgery System | #### Device description: Soft tissue ablators are radiofrequency (RF) surgical tools designed for removal and dissection of tissue in arthroscopic surgeries. A generator or controller serves as the power unit. Soft tissue ablators are available in a wide range of sizes and angles; some models include thermal or suction functions. {2}------------------------------------------------ - Reprocessed Soft Tissue Ablators are intended to remove soft tissue and Intended use: control bleeding by providing tissue ablation and coagulaiton utilizing high-frequency electrical current in patients requiring general or arthroscopic surgery. Reprocessed soft tissue ablators are to be used in patients requiring Indications arthroscopic surgery of the knee, shoulder, ankle, hip, wrist and elbow statement: to resect, ablate and excise soft tissue. The design, materials, and intended use of the Reprocessed Soft Tissue Technological Ablators are identical to the predicate devices. The mechanism of action characteristics: of the Reprocessed Soft Tissue Ablator is identical to the predicate devices in that the same standard mechanical design, materials, shapes and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. Bench and laboratory testing was conducted to demonstrate Performance data: performance (safety and effectiveness) of the Reprocessed Soft Tissue Ablators. Biocompatibility ● . Validation of reprocessing Function test(s) . Performance testing demonstrates that Reprocessed Soft Tissue Ablators perform as originally intended. Conclusion: In accordance with the Federal Food, Drug and Cosmetic Act 21 CFR Part 807 and based on the information provided in this premarket notification, Alliance Medical Corporation concludes that the modified device (the Reprocessed Soft Tissue Ablator) is safe, effective and substantially equivalent to the predicate devices as described herein. {3}------------------------------------------------ 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 eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## DEC 0 6 2001 Alliance Medical Corporation Mr. Don Selvey Vice President Regulatory Affairs and Quality Assurance 10232 South 51ª Street Phoenix, Arizona 85044 Re: K012631 Trade Name: Reprocessed Soft Tissue Ablators Regulation Number: 888.1100, 878.4400 Regulation Name: Arthroscope, Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: HRX, GEI Dated: November 13, 2001 Received: November 20, 2001 Dear Mr. Selvey: We have reviewed your Section 510(k) premarket notification of intent to market the device we have it viewed your boouse evermined the device is substantially equivalent (for the iteleficed above and we have done) to devices marketed in interstate commerce prior to may 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have May 26, 1970, the chartence with the provisions of the Federal Food, Drug, and Cosmetic Act been reclassified in accordance with the provisions of the Federal Food, Drug, and occh reclassified in accessarproval of a premarket approval application (PMA). You may, (Act) that do not require upper to the general controls provisions of the Act. The general thorefore, maniot the act include requirements for annual registration, listing of devices, Controls provisions or the rev 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 If your device to such additional controls. Existing major regulations affecting your device can thay be subject to sacherital resillations, Title 21, Parts 800 to 898. In addition, FDA may ou found in the Ood ucements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc devisou that I Dr Unesan that your device complies with other requirements of the Act that I Dri has intace a and regulations administered by other Federal agencies. You must or any 1 odolar batates and registements, 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. {4}------------------------------------------------ ### Page 2 & Mr. Don Selvey This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you've begal finding of substantial equivalence of your device to a legally premated notification: "The 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 11 you desire specific acrison. I for in vitro diagnostic devices), please contact the Office of additionally 21 31 31 594-4659. Additionally, for questions on the promotion and advertising of Compliance at (301) 591-1007 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 Outler general 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, Susan Walker, MD Image /page/4/Picture/5 description: The image contains a handwritten symbol or character. It appears to be a cursive letter or a stylized mark, possibly part of a signature or logo. The character is formed with a loop at the top and a downward stroke, giving it a flowing appearance. 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 510(k) Number (if-known): .. . . . . . . . . . . . . . . . KO12631 Device Name: Alliance Medical Corporation Reprocessed Soft Tissue Ablators Indications for Use: Reprocessed soft tissue ablators are to be used in patients requiring Indications for Ose. "Reprocessed both assubtions as to to a common to resect, ablate and excise soft tissue. | Manufacturer | Description | Model Number | Manufacturer | Description | Model Number | |--------------|--------------------------|--------------|--------------|-------------------------------------------------------------|--------------| | AthroCare® | Arthro Wand® Right Angle | A 1325-01 | AthroCare® | Arthro Wand® Small Joint | A 1115-01 | | AthroCare® | Arthro Wand® Right Angle | A 1330-01 | AthroCare® | Arthro Wand® Bisector | A 4330-01 | | AthroCare® | Arthro Wand® Right Angle | A 1335-01 | AthroCare® | Arthro Wand® Straight | A 1125-01 | | AthroCare® | Arthro Wand® Right Angle | A 1336-01 | AthroCare® | Arthro Wand® Straight | A 1130-01 | | AthroCare® | Arthro Wand® Right Angle | A 1345-01 | AthroCare® | Arthro Wand® Angle | A 1225-01 | | AthroCare® | Arthro Wand® Dome | A 3625-01 | AthroCare® | Arthro Wand® Angle | A 1230-01 | | AthroCare® | Arthro Wand® Dome | A 3525-01 | Mitek® | VAPR™ Thermal Side Effect Electrode (3.5mm) | 225101 | | AthroCare® | Arthro Wand® Dome | A 3630-01 | Mitek® | VAPR™ Thermal Reversed Angled Side Effect Electrode (3.5mm) | 225112 | | AthroCare® | Arthro Wand® Dome | A 3430-01 | Mitek® | VAPR™ Thermal Angled End Effect Electrode (3.5mm) | 225104 | | AthroCare® | Arthro Wand® Dome | A 3530-01 | Mitek® | VAPR™ Side Effect Electrode (3.5mm) | 225301 | | AthroCare® | Arthro Wand® Bevel | A 2630-01 | Mitek® | VAPR™ Angled Side Effect Electrode (21°, 3.5mm) | 225302 | | AthroCare® | Arthro Wand® Bevel | A 2430-01 | Mitek® | VAPR™ End Effect Electrode (3.5mm) | 225303 | | AthroCare® | Arthro Wand® Bevel | A 2530-01 | Mitek® | VAPR™ Angled End Effect Electrode (21°, 3.5mm) | 225304 | | AthroCare® | Arthro Wand® Small Joint | A 2723-01 | Mitek® | VAPR™ 90° Hook Electrode (3.5mm) | 225305 | | AthroCare® | Arthro Wand® Small Joint | A 2823-01 | Mitek® | VAPR™ Flexible Side Effect Electrode (3.5mm) | 225312 | Concurrence of CDRH, Office of Device Evaluation (ODE) Susan Walker. (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number K012631 Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use (per 21 CFR 801.109) CONFIDENTIAL Alliance Medical Corporation Reprocessed Soft Tissue Ablators Traditional 510(k) or 65