VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT

{0} Sorin Biomedical Inc. Venomidicard / Midicard 510(k) Notification # 510(k) SUMMARY *Aug. 21, 1997* ## A. Name and Address of Submitter Sorin Biomedical Inc. 17600 Gillette Avenue Irvine, California 92614-5751 ## B. Telephone and Fax Numbers of Submitter Telephone: (714) 250-8320 Fax: (714) 250-1524 ## C. Name of Contact Person Richard J. DeRisio Vice President Quality & Regulatory Affairs ## D. Date Summary was Prepared SORIN BIOMEDICAL INC. CONFIDENTIAL 30 {1} Sorin Biomedical Inc. Venomidicard / Midicard 510(k) Notification # 510(k) SUMMARY (cont.) AUG 21 ## E. Device Name Trade or Proprietary Name: Venomidicard Pediatric Venous Reservoir with Integral Cardiotomy Filter Midicard Pediatric Cardiotomy Reservoir Common Name: Cardiotomy Reservoir, Venous Reservoir with Integral Cardiotomy Filter Classification Name: Cardiopulmonary Bypass Blood Reservoir Cardiopulmonary Bypass Cardiotomy Suction Line Blood Filter ## F. Summary of Substantial Equivalence The Venomidicard and Midicard reservoirs are judged to be substantially equivalent in intended use, materials, design, and performance characteristics to the Sorin Hardshell Venous Reservoir (HSVRF). The HSVRF was cleared for chest drainage on September 30, 1987 (K872719). These devices were designed for use in chest drainage and are marketed by DIDECO for that intended use outside the United States. ## G. Device Description The Venomidicard and Midicard are sterile, nonpyrogenic, disposable, hardshell reservoirs that contain an integral cardiotomy filter. Each device contains a polyurethane defoamer sponge and outer gross filter screen. ## H. Intended Use The Venomidicard and Midicard reservoirs are intended to allow for the collection and autotransfusion of shed mediastinal blood following cardiopulmonary bypass procedures. ## I. Summary of Comparison of Technological Characteristics The technological characteristics of the Venomidicard and Midicard are similar to the Sorin Hardshell Venous Reservoir with respect to chest drainage autotransfusion. These devices have a similar number of cardiotomy inlet ports, have similar filter elements, and are similar in setup and use for chest drainage. SORIN BIOMEDICAL INC. CONFIDENTIAL {2} Sorin Biomedical Inc. Venomidicard / Midicard 510(k) Notification # 510(k) SUMMARY (cont.) ## J. Summary of Nonclinical Tests Substantial equivalence was based on a comparison of test results from the following *in vitro* physical and functional tests: **Physical Tests** Vacuum Integrity **Functional Tests** Hemolysis Residual Volume Filter Pressurization All testing was conducted on nonaged, sterile devices. Test results show similar performance characteristics between the Venomidicard and Midicard and the Sorin Hardshell Venous Reservoir with respect to the expanded use of chest drainage autotransfusion. **Biocompatibility** Biocompatibility testing was previously performed on a finished, sterilized device in accordance with the Tripartite Guidelines for Biocompatibility testing for short term blood contacting materials. All test results were comparable to the negative control groups. Therefore, the materials used in these devices are considered acceptable for their intended use. ## K. Conclusions Based upon the above information, Sorin Biomedical Inc. concludes that the Venomidicard Pediatric Venous Reservoir with Integral Cardiotomy Filter and the Midicard Pediatric Cardiotomy Reservoir are substantially equivalent to the Sorin Hardshell Venous Reservoir for use in chest drainage autotransfusion. SORIN BIOMEDICAL INC. CONFIDENTIAL {3} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856 Mr. Paul Butorac Manager, Quality Engineering Department Sorin Biomedical Inc. 17600 Gillette Avenue P.O. Box 19503 Irvine, California 92713-9503 Re: K964907 Venomidicard Pediatric Venous Reservoir with Integral Cardiotomy Filter Regulatory Class: II (two) Product Code: 74 DTN Dated: June 10, 1997 Received: June 12, 1997 Dear Mr. Butorac: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {4} Page 2 - Mr. Paul Butorac This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html." Sincerely yours,  Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5} 870.4400 - DTN II - Cartiotomy Reservoir Page 1 of 1 510(k) Number (if known): K964907 Device Name: VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER Indications for Use: The Dideco Venomidicard and Midicard are hardshell blood collection reservoirs intended for use in CPB circuits and postoperative blood salvage procedures. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Bette D. Rempere (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number K964907 Prescription Use ☑ (Per 21 CFR 801.109) OR Over-The-Counter Use ☐ (Optional Format 1-2-96)