GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING

{0}------------------------------------------------ 510(k) (Traditional) Submission Section 5, 510(k) Summary #### FEB - 4 2009 Summary This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92. #### 1. Company making the submission: | Name: | Gish Biomedical, Inc. | | |------------|----------------------------------------------------------------------|------------------------------------------| | Address: | 22942 Arroyo Vista<br>Rancho Santa Margarita, CA<br>92688-2600 | FDA CDRH DMC<br>JUL 2 3 2008<br>Received | | Telephone: | 949-635-6200 voice<br>949-635-6291 fax<br>martins@gishbiomedical.com | | | Contact: | Martin Sellers<br>Director of Regulatory Affairs | | #### 2. Device: | Proprietary Name: | Soft Venous Reservoir (SVRXX) with HA Coating | |----------------------|-----------------------------------------------| | Common Name: | Soft Venous Reservoir | | Classification Name: | Reservoir, Blood, Cardiopulmonary Bypass | #### 3. Predicate Devices: Gish Soft Venous Reservoir, K955046 and Gish SVR Soft Venous Reservoir with GBS™ Coating, K024065. Both manufactured by Gish Biomedical, Inc. ## 4. Classifications Names & Citations: 21 CFR 870.4400, Reservoir, Blood, Cardiopulmonary Bypass, Class II, DTN, Cardiovascular. #### 5. Description: The Gish Soft Venous Reservoirs with HA Coating consist of a bag with three fluid ports and two aspiration ports and are intended to prevent venous air from entering the extracorporeal circuit. The design of the Soft Venous Reservoir reduces blood stagnation and will collapse if emptied; a built in safety mechanism that minimizes accidental air delivery to the oxygenator. Each Soft Venous Reservoir contains one ½" venous inlet (blue) with integral temperature port and luer port, one 3/8" cardiotomy inlet (white), one 3/8" arterial outlet (red) and two 1/8" aspiration ports with attached 3-way stopcocks. The components of this system which have contact with the fluid path are sterile and non-pyrogenic. {1}------------------------------------------------ All materials of the Soft Venous Reservoirs are biocompatible and coated with a proprietary coating. The Gish the Soft Venous Reservoirs with HA Coating may be purchased separately or pre-connected with tubing and other components of an extracorporeal circuit. ### 6. Indications for use: The Gish Soft Venous Reservoirs with HA Coating are indicated to collect systemic venous and cardiotomy return blood during cardiopulmonary bypass procedures. It is designed to operate at flow rates of one (1.0) to eight (8.0) liters per minute for periods up to six (6.0) hours. ### 7. Contra-indications: For HA coated soft venous reservoirs, no contra-indications have been noted. ### 8. Comparison: The Gish SVR Soft Venous Reservoir with HA Coating has the same device characteristics as the predicate devices. ### 9. Test Data: The Gish SVR Soft Venous Reservoirs with HA Coating have been subjected to extensive safety, performance, and validations prior to release. Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications. #### 10. Literature Review: A review of literature pertaining to the safety and effectiveness has been conducted. Appropriate safeguards have been incorporated in the design of Gish SVR Soft Venous Reservoirs with HA Coating. #### 11. Conclusions: Based upon the testing and comparison to the predict device the Gish Biomedical, Inc., Soft Venous Reservoir with HA Coating has the same intended use, with similar technological characteristics. Gish Biomedical, Inc., therefore posits that its device is equivalent in safety and effectiveness to predicate devices. {2}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. #### Public Health Service FEB-- 4 2009 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Gish Biomedical, Inc. c/o Ms. Janet Peets Regulatory & Clinical Affairs Specialist 22942 Arroyo Vista Rancho Santa Margarita, CA 92688 Re: K082082 > Gish Soft Venous Reservoir (SVR) with HA Coating Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiopulmonary Bypass Blood Reservoir Regulatory Class: Class II Product Code: DTN Dated: January 8, 2009 Received: January 12, 2009 Dear Ms. Peets: 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. {3}------------------------------------------------ #### Page 2 - Ms. Janet Peets 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 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 Biometrics' (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, Dana R. Buchner 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 K (){ 20} 2 Device Name: Gish Soft Venous Reservoir (SVR) with HA Coating #### Indications for use: The Gish Soft Venous Reservoir with HA Coating is indicated for use collecting systemic venous and cardiotomy return blood during cardiopulmonary bypass procedures. It is designed to operate at flow rates of one (1.0) to eight (8.0) liters per minute for periods up to six (6.0) hours. #### Prescription Device: Federal Law (US) restricts this device to sale by or on the order of a physician. Prescription Use : Yes OR Over-The-Counter Use: No # PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED) ﻨﺖ Concurrence of CDRH, Office of Device Evaluation (ODE) R. La Ines Division Sign-Off) (Division Sign-on) Division of Cardiovascular Devices 510(k) Number k082082 ndications forUse K082082.doc alphi Consulting Group Houston, TX 77071 #### Section 4 510(k) Submission Page #