SUPRACOR BALLOON CATHETER

{0}------------------------------------------------ DEC 1 4 2006 #### Section 5.0- 510(k) Summary (Prepared in accordance with 21 CFR Part 807.92) #### a. Submitted | Applicant Name: | ABIOMED, Inc.<br>22 Cherry Hill Drive, Danvers, MA 01923 | |-----------------------|----------------------------------------------------------| | Contact Person: | Robert T.V. Kung, Ph.D. | | Date Summary | August 30, 2006 | | Prepared: | | | b. Device information | | | Trade Name: | SupraCor Balloon Catheter | | Common Name: | Intra-Aortic Balloon Catheter and insertion kit | | Classification Name: | Intra-aortic Balloon (classified under CFR870.3535) | | Product Code: | 74DSP | #### c. Legally Marketed Predicate Devices Datascope Fidelity IAB catheter (K 980385), 8 F, 40 cc Intra-Aortic Balloon catheter Arrow Ultra 8 IAB catheter (K000729), 8 F, 40 cc Intra-Aortic Balloon catheter #### d. Device Description: The SupraCor Balloon Catheter is a 40cc symmetrical polyurethane balloon attached to an 8 Fr dual lumen catheter, designed to provide counterpulsation cardiac assist therapy. The outer lumen is a channel for helium used to inflate and deflate the balloon, and the inner lumen is used for a guidewire and blood pressure measurement. The balloon inflation and deflation cycle is synchronized (using a commercially available control console) with the ECG or arterial pressure to provide counterpulsation synchronized with the heartbeat. It is intended to increase coronary perfusion, decrease the workload of the left ventricle and allow healing of the myocardium. #### e. Intended Use: The SupraCor Balloon Catheter is placed in the descending aorta just below the subclavian artery and intended to improve cardiovascular functioning during the following situations: - Unstable refractory angina . - . Impending infarction - Post Infarction Angina or Threatening Extension of . Myocardial Infarction - . Refractory ventricular failure - . Mechanical complications because of myocardial infarction - Cardiogenic shock . {1}------------------------------------------------ - . Support and stabilization of high risk patients undergoing diagnostic and non-surgical procedures - . Ischemic related intractable ventricular arrhythmias - . Septic shock - Interoperative pulsatile flow generation . - . Weaning from cardiopulmonary bypass - Cardiac support for high risk surgical patients and coronary . angiography and angioplasty patients - . Prophylactic support in preparation for cardiac surgery - Post-surgical myocardial dysfunction . - Cardiac Contusion . - Mechanical bridge to other assist devices . - Cardiac support following correction of anatomical defects . - Support for failed angioplasty and valvuloplasty . # f. Technological Characteristics and Comparison to Predicate Device(s): The SupraCor Balloon Catheter is of similar design and made of materials commonly used in other marketed balloon catheters. The insertion kit contains instruments commonly provided for insertion of an IAB. Table 1 provides a comparison of the SupraCor Balloon Catheter with predicate balloon catheters, the Datascope 40cc Fidelity and Arrow 40cc Ultra 8. This table illustrates the equivalency of the SupraCor Balloon Catheter with the predicates. | Feature | SupraCor IAB | Fidelity IAB | Ultra 8 IAB | |-----------------------------|----------------------------------------|----------------------------------------|----------------------------------------| | 510(k) approval | This<br>Submission | K980385 | K000729 | | Duration of Use | Temporary<br>use: Approx. ≤<br>30 days | Temporary<br>use: Approx. ≤<br>30 days | Temporary<br>use: Approx. ≤<br>30 days | | Balloon:<br>Size | 40 cc | 40 cc | 40 cc | | Shape | Symmetric | Symmetric | Symmetric | | Material | Polyether<br>urethane | Polyether<br>urethane | Polyether<br>urethane | | Length (in) | 10.25 | 10.4 | 10.25 | | Catheter:<br>Type | Dual Lumen | Dual Lumen | Dual Lumen | | Outer wall material | Polyether<br>urethane | Polyether<br>urethane | Polyether<br>urethane | | Outer wall<br>circumference | 8 F | 8 F | 8 F | | Introducer Size | 8 F | 8 F | 8 F | Table 1- Comparison Table for SupraCor Balloon Catheter ABIOMED Confidential {2}------------------------------------------------ | Sterilization | EtO | EtO | EtO | |-----------------|---------------------------------|---------------------------------|---------------------------------| | Inner Packaging | Tray in<br>Tyvek/Mylar<br>Pouch | Tray in<br>Tyvek/Mylar<br>Pouch | Tray in<br>Tyvek/Mylar<br>Pouch | | Outer Packaging | Tyvek Mylar<br>Pouch | Tyvek Mylar<br>Pouch | Tyvek Mylar<br>Pouch | ## g. Pre-clinical Test Results: Three different types of pre-clinical testing were completed for the SupraCor Balloon Catheter: laboratory, biocompatibility and sterility tests. The laboratory tests demonstrated equivalence to the 2 predicate devices, and included performance and reliability testing in accordance with FDA's recommendations, as provided in the Guidance for the Preparation and Contents of Applications to the Food and Drug Administration for Determining the Equivalence of Intra-Aortic Balloon Catheters and Consoles under the 510(k) Regulations (12/8/1993 draft). The biocompatibility and sterility testing showed that the SupraCor Balloon Catheter complies with the requirements for this device classification. The pre-clinical test results demonstrate that the SupraCor Balloon Catheter is safe and effective. ### h. Conclusion: Based on the information presented in this 510(k) premarket notification, the SupraCor Balloon Catheter is considered substantially equivalent to the currently marketed predicate devices. {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 caduceus symbol, which features a staff with a snake entwined around it, and is accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 1 4 2006 Robert T.V. Kung, Ph.D. Chief Scientific Officer Abiomed, Inc. 22 Cherry Hill Drive Danvers, MA 01923 Re: K062582 Abiomed SupraCor Balloon Catheter Regulation Number: 21 CFR 870.3535 Regulation Name: Intra-Aortic Balloon and Control System Regulatory Class: Class III Product Code: DSP Dated: November 28, 2006 Received: November 29, 2006 Dear Dr. Kung: 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 devira 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. {4}------------------------------------------------ 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. 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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, suina R. Vochues Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ SupraCor Balloon Catheter - K062582 Response to FDA letter of November 9, 2006: received November 15, 2006 Indications for Use | 510(k) Number (if known): | K062582 | |---------------------------|---------------------------| | Device Name: | SupraCor Balloon Catheter | Indications for Use: The intra-aortic balloon is placed in the descending aorta just below the subclavian artery and intended to improve cardiovascular functioning during the following situations: - . Unstable refractory angina - Impending infarction . - Post Infarction Angina or Threatening Extension of Myocardial . Infarction - Refractory ventricular failure . - Mechanical complications because of myocardial infarction � - Cardiogenic shock . - Support and stabilization of high risk patients undergoing . diagnostic and non-surgical procedures - Ischemic related intractable ventricular arrhythmias . - Septic shock . - Interoperative pulsatile flow generation . - Weaning from cardiopulmonary bypass . - Cardiac support for high risk surgical patients and coronary . angiography and angioplasty patients - Prophylactic support in preparation for cardiac surgery . - Post-surgical myocardial dysfunction . - . Cardiac Contusion - . Mechanical bridge to other assist devices - . Cardiac support following correction of anatomical defects - Support for failed angioplasty and valvuloplasty . | Prescription Use _ X<br>(Part 21 CFR 801 Subpart D) | | |-----------------------------------------------------|--| |-----------------------------------------------------|--| AND/OR | Over-The-Counter Use<br>(21 CFR 807 Subpart C) | | |------------------------------------------------|--| |------------------------------------------------|--| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 2 R. Vochner (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number_K662582 ABIOMED Confidential