V-BAG WITH GBS COATING

{0}------------------------------------------------ ## MAR 17 2005 K 050195 # Summary This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR part 807.92. - 1. Company making the submission: | Company | | |------------|------------------------| | Name: | Gish Biomedical, Inc. | | Address: | 22942 Arroyo Vista | | | Rancho Santa Margarita | | | CA 92688-2600 | | Telephone: | 949-635-6240 voice | | | 949-635-6294 fax | | Contact: | Edward F. Waddell | | | Director RA/QA | - 2. Device: | Proprietary Name: | Circulatory Technology Inc. V-BAG™ with GBS® Coating. | |----------------------|-------------------------------------------------------| | Common Name: | Soft Venous Reservoir | | Classification Name: | Reservoir, blood, cardiopulmonary bypass | - 3. Predicate Devices: Circulatory Technology Inc. V-BAG™. K001822 and Gish Soft Venous Reservoir SVR with GBS™ Coating, K024065, - Classifications Names & Citations: 4. - 21 CFR 870.4400, Reservoir, blood, cardiopulmonary bypass, Class II, DTN, Cardiovascular. 5. - 6. Description: The V-BAG™ with GBS® Coating is an expandable blood chamber having a polyester screen with a pore size of 105u separating the inlet from the outlet of the blood chamber. The inlet with a pore the blood chamber at its top and extends to the bottom of the screen. Blood flows table oncert the became the screen, and to the outlet port. The screen, once wet, allows mom the mid liguid but rejects most air bubbles float up and are removed through the purge line. Channels formed along the outside diameter of the tubes placed vertically, running parge inforcement of the inlet section to the top of the blood chamber, provide pathways for hrom the to move upward to the purge port. The inlet, outlet and gas purge tubes are threaded through, bonded to, and sealed within a rigid top-plate. The V-Bag™, is made by welding two polyvinyl chloride films to form an expandable blood chamber with a front and back wall. A polyester screen with a pore size of 105µ is sealed between the two walls along their vertical sides as well as along the front wall at the bottom thereby forming a pouch between the screen and the front wall. The inlet tube enters the blood chamber at its top and extends diagonally to the bottom of the pouch. Blood flows from across the screen to the outlet port. The screen, once wet, allows passage of liquid but rejects most air bubbles. Bubbles in the pouch float up and are removed through the purge line. 25 {1}------------------------------------------------ - 7. Indications for use: The Circulatory Technology Inc. V-BAG™ with GBS® Coating is a disposable soft shell The Circulatory Technology Inc. V-DAS With ODO Obailighters the removal of air venous reservoir mat accepts venous and caracomy presal support for up to six hours. When bubbles during surgical procedures requiring extracorporal for up to six hours. IVAV bublies during surgical procedures requiring oxicusively and opportunities and the enous Drainage (VAVD). - Contraindications: 8. For heparin coated devices, heparin has been reported, on rare occasions, to induce For heparin coated devices, hepanif has been reports and supers are routinely thrombocytopenia. Since patients undergoing cardiopulmonary bypass are routinely thrombocytopenia. Since patients undergoing careformedia on this device is systemically heparinized, and although the amount of heparing which a exerciaed when web systemically neparmized, and almough the arriven caution should be exercised when using very small in oompanse with known or suspected heparin sensitivity. - 9. Comparison: The Circulatory Technology Inc. V-BAG™ with GBS® Coating has the same device The Circulatory Technology inc. V-BAG, Circulatory Technology, Inc., K001822. - 10. Test Data: The Circulatory Technology Inc. V-BAG™ with GBS® Coating has been subjected to The Circulatory Technology Inc. V-DAO - with SBO-Socking has a subsition for the systems extensive safety, performance, and validations prior to release. Final testing for th includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications. - 11. Literature Review: A review of literature pertaining to the safety and effectiveness has been conducted. A review of literature perfailing to the safety of Circulatory Technology Inc. V-BAG™ with GBS® Coating. - 12. Conclusions: The conclusion drawn from these tests is that Circulatory Technology Inc. V-BAG™ with GBS® Coating is equivalent in safety and efficacy to its predicated devices. Edward Waddell Edward Wadde Director Regulatory Affairs Gish Biomedical. Inc Date: Jan 25, 2005 {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 and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. MAR 1 7 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Gish Biomedical, Inc. c/o Mr. J. Harvey Knauss Delphi Consulting Group 11874 South Evelyn Circle Houston, TX 77071-3404 Re: K050195 V-BAG™ with GBS® Coating Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiopulmonary Bypass Blood Reservoir Regulatory Class: Class II (two) Product Code: DTN Dated: March 1, 2005 Received: March 2, 2005 Dear Mr. Knauss: We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 310(x) premained is substantially equivalent (for the indications referenced above and nave decemblicated predicate devices marketed in interstate for use stated in the enclosure) to regarly manated provice Americal Device Amendments, or to commerce prior to May 28, 1976, the enactment date of the Federal Food . Drya commerce prior to May 26, 1976, the enaonine with the provisions of the Federal Food. Drug, devices that have been reclassified in accereanse with a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approval of a premaining of the Act, and Cosmelle Act (Act) that do not require approvisions of the general controls provisions of the Act. The You may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the free herals of the more of the manage inst misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (500 a0070) als. Existing major regulations affecting your device can may be subject to such additional centrely of Title 21, Parts 800 to 898. In addition, FDA may be found in the Code of Peachar Ing your device in the Federal Register. {3}------------------------------------------------ Page 2 -- Mr. J. Harvey Knauss Please be advised that FDA's issuance of a substantial equivalence determination does not mean r reaso or as 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 or uny reather statuates as a 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 Of It Part 80 73 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) rramarket notification. The FDA finding of substantial equivalence of your device to a legally premated 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 (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, parna R. Values E L Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ### Indications for Use Statement 510(k) Number K050195 Circulatory Technology Inc. V-BAG™ with GBS® Coating Device Name: Indications for use: The Circulatory Technology Inc. V-BAG™ with GBS® Coating is a disposable soft shell The Circulatory Technology inc. V BAO the cardiotomy blood and facilitates the removal of air venous reservoir that accepts vehous and our and survive arracorporeal support for up to six hours. bubbles during surgical procedures requiring extracorporeal support for up bubbles during surgical procedures roquiring oxiraces virus Drainage (VAVD). #### Prescription Device: Federal Law (US) restricts this device to sale by or on the order of a physician. × Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ 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) Dvina R. Vechner Division Sign-Off) ision of Cardiovascular Devices umber E050195