AURA 70 WATT BIPOLAR ELECTROSURGICAL COAGULATORS, MODELS 28-2000 AND 28-2600

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a logo for KIRVAN SURGICAL PRODUCTS. The logo includes a medical symbol to the left of the company name. The image also includes the date OCT 20 2005 and the text "Page 1 of 2". # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS {as required by 21 CFR, section 807.92( c )} #### FOR ### MODELS 28-2000 & 28-2600, AURA, 70 WATT SERIES BIPOLAR ELECTROSURGICAL COAGULATORS Common name: Electrical Surgical unit (ESU) / Electrosurgical Generator. Classification name: Electrosurgical Cutting and Coagulation Device and Accessories (§878.4400) Product code: GEI The model 28-2000, Aura, 70 Watt Bipolar Electrosurgical Coagulator and the model 28-2600, Auraplus, 70 Watt Irrigating Bipolar Electrosurgical Coagulator model 20 2.000, haraphid state bipolar generators used to supply the RF signal to electrosurgical hand-pieces used on soft body tissues where a wide range of tissue types, patient conditions, and load impedances are encountered. Where applicable (i.e., Auraplus) a peristaltic irrigation pump controls flow rate individually or simultaneously while coagulating. Technological safety and effectiveness is established by the fact that the Aura 70, like its predicates, offers well-proven, basic electrosurgical unit technology. Its fike to productivation and solid state circuitry delivers low voltage RF/bipolar energy, interfacing with electrosurgical accessories via its standard 4mm female banana jacks. The Aura 70 differs technologically from its predicates with only minor operational features designed to enhance user interface. The following are some of those features. - While operating on both 115 and 230 VAC mains supply as its predicates, . the Aura 70 does not require the placement of an external jumper in order to select between the two different voltage levels. Kirwan Surgical Products, Inc. 180 Enterprise Drive Marshfield, MA 02050 Phone: (781) 834-9500 Fax: (781) 834-0022 Contact: Kevin P. Prario,Regulatory Affairs Manager Date prepared: 8/5/2005 {1}------------------------------------------------ 052203 Page 2 of 2 - Activation of the Aura 70 is via footswitch only, eliminating the optional s hand switch activation of its 28-1000 predicate, which is viewed as a littleused option and expendable in order to simplify construction, and limit size. - While similarly relying on solid-state electronics, the Aura 70 has been 트 greatly simplified over some of its predicates by the use of microprocessor technology and modular medical-grade power supply. - The Aura 70 uses membrane keypads instead of potentiometers (knobs) . as adjustable controls for tonal volume and power level settings. Performance safety has been tested in accordance with, and found to comply with, the requirements of the applicable sections of the following standards and quidelines: - ANSI/AAMI/IEC 60601-1-2 (2001), Medical Electrical Equipment Part 1; 를 General Requirements for the Safety. - IEC 60601-2-2 (1998), Medical Electrical Equipment Part 2; particular . Requirements for the safety of High Frequency Surgical Equipment. - ANSI/AAMI HF 18 (2001), American National Standard for Electrosurgical Devices - ANSI/AAMI/ISO 14971:2000, Medical devices Application of risk . management to medical devices. - General Principles of Software Validation; Final Guidance for Industry and 트 FDA Staff (issued January 11, 2002). - Guidance for FDA Reviewers and Industry. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued May 29, 1998). #### Safety and hazard analysis has determined that the hazard conditions for the Aura 70 range in the low-to-moderate level and for this reason are acceptable. Therefore, the Aura 70 is substantially equivalent in intended use, technological safety and effectiveness, and performance to the following predicates; - 28-1000, Kirwan 50 Watt Bipolar Generator, l - 26-2500, Aura, 20 Watt Bipolar Electrosurgical Coagulator, 내 - RF111, Pegasys Electrosurgical Generator, and 에 - 80-1170, Malis™ Bipolar Electrosurgical System CMC-III. 트 {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three heads, representing health, human services, and well-being. The eagle is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" in a circular arrangement. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 2 0 2005 Kevin P. Prario Regulatory Affairs Manager Kirwan Surgical Products, Inc. 180 Enterprise Drive Marshfield, Massachusetts 02050 Re: K052203 Trade/Device Name: Models 28-2000 and 28-2600, Aura 70 Watt Bipolar Electrosurgical Coagulators Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 12, 2005 Received: August 16, 2005 Dear Mr. Prario: 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. {3}------------------------------------------------ #### Page 2- Kevin P. Prario This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with and in yourse FDA finding of substantial equivalence of your device to a legally premative noticated on "Tresults 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), please if you deale office of Compliance at (240) 276-0115. Also, please note the regulation entitled, Conider the Ories of Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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/industry/support/index.html Sincerely vours. Barbara Buemo to Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): _KOS2203 Device Name: Models 28-2000 and 28-2600, Aura 70 Watt Bipolar Electrosurgical Coagulators Indications for Use: General purpose solid state bipolar generator to supply RF signal to General purpose oona otals used on soft body tissue where a wide electrosurgiour hardent conditions and load impedances are runge of thouse type applicable (i.e., Aurap/us, 28-2600) a peristaltic irrigation pump controls flow rate individually or simultaneously while coagulating. X Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use __ (21 CFR 801 Subpart C) (Please Do not WRITE Below This LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Cailane theund foruken (Divis . Restorative. Division of Gener and Neurological Devices Page 1 of 1 510(k) Number J052203