CARDEON COBRA CATHETER

{0}------------------------------------------------ ## 510(k) SUMMARY 510(k) number: This summary of information is being provided in accordance with 21 CFR 807.92(a). | Applicant Information: | Cardeon Corporation<br>10600 N. Tantau Avenue<br>Cupertino, CA 95014 | |------------------------|----------------------------------------------------------------------| | Contact Person: | Jane Beggs<br>Regulatory Affairs<br>Cardeon Corporation | | Date: | 9 August 2004 | | Device Trade Name: | Cobra™ Catheter | | Device Common Name | Catheter, cannula and tubing, vascular, cardiopulmonary | | Regulation No.: | bypass 870.4210 | | Classification / Code: | Class II / DWF | Indications for Use: The Cardeon Cobra Catheter is indicated for use in open chest surgery on cardiopulmonary bypass up to 6 hours. It is used to cannulate the aorta and provide hypothermic arch perfusate and normothermic corporeal perfusate. Summary of Substantial Equivalence: The Cobra Catheter is substantially equivalent to currently marketed devices used to directly cannulate the aorta and return perfusion to patients undergoing general cardiac surgery. Perfusion is achieved through standard connections to the extracorporeal circuit. ). Intended use and indications for the subject and predicate devices are substantially equivalent for arterial return during CPB. Substantial equivalence is also supported through comparison with several marketed devices with the same indications for use, including arterial return cannulae with directed flow (i.e., specified flow patterns). Directed flow is a feature offered by devices cleared through premarket notification and currently marketed for CPB and peripheral vascular thrombectomy. Selective perfusion systems have been reported on extensively and safely used for over two decades. These selective perfusion systems utilize predicate cannulae and standard perfusion circuitry for cooling the brain independently from the rest of the body. Arterial line pressures, nasopharyngeal and rectal temperatures, radial arterial pressures, oxygen saturation, etc. are standard clinical practices for monitoring the patient used in predicate selective perfusion systems. Technological characteristics (design and materials) of the Cobra Catheter are substantially equivalent to arterial return devices currently marketed for CPB. Differences between the Cobra Catheter and currently marketed devices do not substantially alter arterial return during cardiopulmonary bypass. Substantial equivalence with regard to safety and effectiveness has also been Product Testing: demonstrated through standardized in vitro and in vivo tests as well clinical study. The Cobra Catheter is an externally communicating device in limited contact with circulating blood. Tests were conducted and inspected in accordance with Good Laboratory Practice Regulation, 21 CFR Part 58. Based on the test results, the Cobra Catheter is biologically compatible, non-toxic and safe for use in limited contact (up to 6 hours) with circulating blood. {1}------------------------------------------------ In vitro and in vivo testing was designed to ensure device structural integrity, key device functionality and ease of use. Device in vivo performance was evaluated using standard surgical techniques and und case. Dor cardiopulmonary bypass and patient monitoring. Test results provided a high degree of confidence that the Cobra Catheter function as intended. Many of the tests allowed direct comparison to currently marketed devices. Clinical studies were conducted to demonstrate the safety and effectiveness of the Cobra Catheter. Feasibility and randomized clinical studies demonstrated that adequate venous oxygen saturation was delivered with differential temperatures indicating the preservation of cerebral autoregulation. Thus, the Cobra Catheter is substantially equivalent to predicate arterial return devices with regard to intended use, technological characteristics and device performance. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an abstract human figure with three flowing lines representing the human form. OCT 6 - 2004 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Cardeon Corp. c/o Ms. Jane Beggs Regulatory Affairs 10600 N. Tantau Avenue Cupertino, CA 95014 Re: K042156 Cardeon® Cobra™ Catheter Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Catheter, Cannula, or Tubing Regulatory Class: Class II (two) Product Code: DWF Dated: August 9, 2004 Received: August 10, 2004 Dear Ms. Beggs; 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 for ass based or 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. {3}------------------------------------------------ ## Page 2 - Ms. Jane Beggs Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be actived that I broundevice complies with other requirements of the Act that I Drinas Intact a and regulations administered by other Federal agencies. You must or any I eath 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 CI It Fart 6077; accems (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. product in the 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 premaired predicated 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 (301) 594-4646. 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) you may obtain. 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, Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 510(k) Number (if known): _________ Page 1 of 1 Device Name: Cardeon® Cobra™ Catheter Indications for Use: The Cardeon Cobra Catheter is indicated for use in open chest surgery on cardiopulmonary bypass up to 6 hours. It is used to provide separated perfusion of the arch and distal thoracic aorta with temperature differential, if desired. Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use Over-the Counter Use __________ (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number k042156 OR