EPICOR ABLATION SYSTEM

{0}------------------------------------------------ K080292 Page 1 of 2 | 510(k) Summary for Public Disclosure | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------| | St. Jude Medical<br>240 Santa Ana Court<br>Sunnyvale, CA 94085-4512 USA<br>Phone: 651-632-9454 ext. 2024<br>Fax:<br>651-644-7897 | JUL 2 5 2008 | | Karen J. McKelvey<br>Principal Regulatory Compliance Engineer | | | February 1, 2008 | | | Epicor™ Medical Ablation Control System (ACS)<br>Epicor™ UltraCinch™ LP Ablation Device<br>Epicor™ UltraWand™ LP Tissue Ablation Wand<br>Epicor™ LP Positioning and Sizing (LP PASTM) System<br>Epicor™ LP Oblique Introducer<br>Epicor™ LP Connecting Cable | | | Ultrasonic Surgical Instrument | | | System, Ablation, Ultrasound and Accessories<br>(21 CFR 878.4400) | | | | | | | U(K) Numb | | | K022894 | | UltraCinch Tissue Ablation Device | K040641 | | UltraWand Ablation Device | K022894 | | UltraCinch Accessory Pack | K040641 | | UltraMaze Connecting Cable | K040641 | | | Epicor Ablation Control System (ACS) | Device Description: The Epicor Ablation System is designed to deliver ultrasound energy to tissue in order to create an ablation lesion. Specifically, the system is intended for the ablation of cardiac tissue during cardiac surgery. The Ablation System consists of the Ablation Control System instrument, a reusable connecting cable, a family of sterile, disposable ablation devices, and accessories. {1}------------------------------------------------ K080292 Page 2 of 2 : | Epicor Ablation<br>Control System<br>Intended use: | The Epicor Medical Ablation Control System is intended for the<br>ablation of cardiac tissue during cardiac surgery | |----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | UltraCinch LP<br>Intended use: | The UltraCinch LP is intended for the ablation of cardiac tissue<br>during cardiac surgery | | UltraWand LP<br>Intended use: | The UltraWand LP is intended for the ablation of cardiac tissue<br>during cardiac surgery | | LP PAS System<br>Intended use: | The items in LP PAS System are part of the Epicor Cardiac<br>Ablation System. The System is intended for the ablation of<br>cardiac tissue during cardiac surgery | | LP Oblique Introducer<br>Intended use: | The LP Oblique Introducer is part of the Epicor Cardiac Ablation<br>System. The System is intended for the ablation of cardiac tissue<br>during cardiac surgery | | LP Connecting Cable<br>Intended use: | The LP Connecting Cable is part of the Epicor Cardiac Ablation<br>System. The System is intended for the ablation of cardiac tissue<br>during cardiac surgery | | Technological<br>Characteristics: | The new device has the same technological characteristics as the<br>legally marketed predicate device. | | Non-clinical<br>Performance Data: | The changes made to the Epicor Ablation System underwent a<br>battery of bench and user tests. Device validation testing was<br>conducted in accordance with in-house procedures. | | Conclusion: | An evaluation of the device changes indicates that the devices<br>are as safe and effective as the previously marketed device to<br>which they are being compared and do not raise any new issues<br>of safety and effectiveness. | 1. September 19. : . : : {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract emblem that resembles an eagle or other bird-like figure, composed of three curved lines above a ribbon-like element. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 2 5 2008 St. Jude Medical c/o Ms. Karen McKelvey Principal Regulatory Compliance Engineer 1350 Energy Lane, Suite 110 St. Paul, MN 55108 Re: K080292 Trade Name: Epicor Ablation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: OCL Dated: July 14, 2008 Received: July 17, 2008 Dear Ms. McKelvey: 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 {3}------------------------------------------------ Page 2 - Ms. Karen J. McKelvey 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. 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Qomell Bram D. Zuckerman M.D. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## 9. Indications for Use ## 510(k) Number (if known): N/A Ko80292- Device Name: The Epicor™ Ablation System, including - ♥ Epicor Medical Ablation Control System (ACS) - Epicor™ UltraCinch™ LP Ablation Device . - Epicor™ UltraWand™ LP Tissue Ablation Wand � - Epicor™ LP Positioning and Sizing (LP PAS™) System . - Epicor™ LP Oblique Introducer . - Epicor™ LP Connecting Cable . ## Indications for Use: The Epicor Medical Ablation Control System is intended for the ablation of cardiac tissue during cardiac surgery Indications for Use: The UltraCinch LP is intended for the ablation of cardiac tissue during cardiac surgery Indications for Use: The UltraWand LP is intended for the ablation of cardiac tissue during cardiac surgery Indications for Use: The items in LP PAS System are part of the Epicor Cardiac Ablation System. The System is intended for the ablation of cardiac tissue during cardiac surgery Indications for Use: The LP Oblique Introducer is part of the Epicor Cardiac Ablation System. The System is intended for the ablation of cardiac tissue during cardiac surgery ## Indications for Use: The LP Connecting Cable is part of the Epicor Cardiac Ablation System. The System is intended for the ablation of cardiac tissue during cardiac surgery স Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use AND/OR (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)  (Division Sign-Off) Division of Cardiovascular Devices | 510(k) Number | K080292 | |---------------|---------| |---------------|---------| SJM Response to FDA Request 16 Page 2 of 2