SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING

{0}------------------------------------------------ ## Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR part 807.92. MAR 0 5 2003 - 1. Company making the submission: | | Company | or | Correspondent (contract): | |------------|------------------------|----|-----------------------------| | Name: | Gish BioMedical, Inc. | | Delphi Consulting Group | | Address: | 22942 Arroyo Vista | | 11874 South Evelyn Circle | | | Rancho Santa Margarita | | Houston, TX 77071-3404 | | | CA 92688-2600 | | | | Telephone: | 949-635-6240 voice | | 832-285-9423 voice | | | 949-635-6294 fax | | 775-429-9524 fax | | Contact: | Edward F. Waddell | | harvey@delphiconsulting.com | | | Director RA/QA | | J. Harvey Knauss | | | | | Consultant | ## 2. Device: | Proprietary Name: | Soft Venous Reservoir SVR with GBS™ Coating | |----------------------|---------------------------------------------| | Common Name: | Soft Venous Reservoir | | Classification Name: | Reservoir, Blood, Cardiopulmonary Bypass | - 3. Predicate Devices: Gish Soft Venous Reservoir, Gish Biomedical, Inc., K955046. - 4. Classifications Names & Citations: 21 CFR 870.4400, Reservoir, Blood, Cardiopulmonary Bypass, Class II, DTN, Cardiovascular. - 5. Description: The Gish Soft Venous Reservoirs with GBS™ 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 12" 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 nonpyrogenic. All materials of the Soft Venous Reservoirs are biocompatible and coated with a proprietary coating. The Gish the Soft Venous Reservoirs with GBS™ Coating may be purchased separately or pre-connected with tubing and other components of an extracorporeal circuit. {1}------------------------------------------------ - 6. Indications for use: The Gish Soft Venous Reservoirs with GBS™ 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 six (6.0) liters per minute for periods up to six (6.0) hours. - 7. Contraindications: For heparin coated devices, heparin has been reported, on rare occasions, to induce thrombocytopenia. Since patients undergoing cardiopulmonary bypass are routinely svstemically heparinized, and although the amount of heparin contributed by this device is very small in comparison to the typical dose given, caution should be exercised when using this device in patients with known or suspected heparin sensitivity. - 8. Comparison: The Soft Venous Reservoirs with GBS™ Coating have the same device characteristics as the predicate devices. - 9. Test Data: The Gish Soft Venous Reservoirs with GBS™ Coating has 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 Soft Venous Reservoirs with GBS™ Coating. - 11. Conclusions: The conclusion drawn from these tests is that Gish Soft Venous Reservoirs with GBS™ Coating is equivalent in safety and efficacy to its predicate device. {2}------------------------------------------------ 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 eagle with three stripes extending from its back, representing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 0 5 2003 Gish Biomedical, Inc. c/o Mr. J. Harvey Knauss Delphi Consulting Group 11874 South Evelyn Circle Houston, TX 77071 Re: K024065 Gish Soft Venous Reservoirs SVR with GBSTM Coating. Regulation Number: 21 CFR 870.4400 Regulation Name: Reservoir, Blood, Cardiopulmonary Bypass Regulatory Class: Class II (two) Product Code: DTN Dated: February 6, 2003 Received: February 10, 2003 Dear Mr. Knauss: 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. Iisting 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 – Mr. J. Harvey Knauss 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 (OS) 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 (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}------------------------------------------------ 024065 510(k) Number K_______________________________________________________________________________________________________________________________________________________________ Device Name: Gish Soft Venous Reservoirs SVR with GBS™ Coating ## Indications for use: The Gish Soft Venous Reservoirs with GBS™ 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 six (6.0) liters per minute for periods up to six (6.0) hours. Prescription Device: Yes ## PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE (IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use | ____________________ | |------------------|----------------------| |------------------|----------------------| OR | Over-The-Counter Use | ____________________ | |----------------------|----------------------| |----------------------|----------------------| (Per 21 CFR 801.109) (Division Sign-Off) Division of Cardiovas510(k) Number K061265 (Optional Format 1-2-96)