MEDOS HILITE RESERVOIR, MODEL: 4030

{0}------------------------------------------------ Gish Biomedical, Inc. 1083131/ Traditional 510(k) Section 5, 510(k) Summary # 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: JUL 8 0 2009 | Name: | Gish BioMedical, Inc.<br>A member of the MEDOS group | | | |------------|---------------------------------------------------------------------|--|--| | Address: | 22942 Arroyo Vista<br>Rancho Santa Margarita, CA 92688-<br>2600 | | | | Telephone: | 949-635-6200 voice<br>949-635-6294 fax<br>janetp@gishbiomedical.com | | | | Contact: | Janet Peets<br>Regulatory & Clinical Affairs<br>Specialist | | | #### 2. Device: | Proprietary Name: | Medos Hilite MVC 4030 Hardshell Venous Reservoir | |----------------------|-------------------------------------------------------------------------------| | Common Name: | Cardiopulmonary Blood Reservoir | | Classification Name: | Extracorpeal Circuit Blood Defoamer<br>Cardiopulmonary Bypass Blood Reservoir | ### 3. Predicate Devices: Gish CAPVRF45 Hardshell Venous Reservoir, K964973, manufactured by Gish Biomedical, Inc. #### Classifications Names & Citations: 4. 21 CFR 870.4230, 21 CFR 870.4400, Extracorpeal circuit blood defoamers, Cardiopulmonary bypass blood reservoir, Cardiopulmonary Bypass, Class II, DTN, Cardiovascular. #### 5. Description: The MEDOS HILITE MVC 4030 Hardshell Venous Reservoirs are sterile, non-pyrogenic, single use, disposable, device designed for collection, storage and filtration of blood during cardiopulmonary bypass. The MEDOS HILITE MVC 4030 has a clear polycarbonate shell and an internal defoamer filter cartridge. Venous drainage enters the 1/2' venous inlet at the center top section of the lid. Venous suctioned blood enters the top section of the defoamer/filter cartridge and passed through a defoamer sponge and 30 micron filter. The maximum venous flow rate is 7 lpm. The maximum cardiotomy flow rate is 4 lpm. Section 5 510(k) Submission Page # {1}------------------------------------------------ ### 6. Indications for use: The MEDOS HILITE MVC 4030 Hardshell Venous Reservoir is indicated for use during cardiopulmonary bypass surgery as a storage reservoir for gravity and augmented venous return blood and to filter and defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit at flow rates of one (1.0) to seven (7.0) liters per minute for periods up to six hours (6.0) hours. # 7. Contra-indications: No contra-indications have been noted. #### 8. Comparison: The Medos Hilite MVC 4030 Hardshell Venous Reservoir has the same device characteristics as the predicate devices. #### 9. Test Data: : The MEDOS HILITE MVC 4030 Hardshell Venous Reservoir has been subjected to extensive safety, performance, and validations prior to release. Final testing for the system includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications. Safety tests have further been performed to ensure the device complies with applicable industry and safety standards. #### 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 MEDOS HILITE MVC 4030 Hardshell Venous Reservoir. #### 11. Conclusions: Based upon the testing and comparison to the predicate device the Medos Hilite MVC 4030 Hardshell Venous Reservoir 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. Confidential Summary.doc {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The logo is black and white. # DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # JUL 3 0 2009 Gish Biomedical, Inc. c/o Ms. Janet Peets 22942 Arroyo Vista Rancho Santa Margarita, CA 92688 Re: K083131 Medos Hilite MVC 4030 Reservoir Regulation Number: 21 CFR 870.4400 Regulation Name: Reservoir, blood, cardiopulmonary bypass Regulatory Class: Class II (two) Product Code: DTN Dated: June 10, 2009 Received: June 11, 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 Office of Compliance at (240) 276-0120. 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 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, R. D. Anderson, M.D. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Gish Biomedical, Inc. 510(k) Number K_083/3 | Device Name: MEDOS HILITE MVC 4030 Hardshell Venous Reservoir #### Indications for use: The MEDOS HILITE MVC 4030 Hardshell Venous Reservoir is indicated for use during cardiopulmonary bypass surgery as a storage reservoir for gravity and augmented venous return blood and to filter and defoam intrathoracic suctioned blood prior to the extracorporeal circuit at flow rates of one (1.0) to seven (7.0) liters per minute for periods up to six hours (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) Concurrence of CDRH, Office of Device Evaluation (ODE) R HOH L'Avision of Wardlovascular Devices iki Number # Section 4 510(k) Submission Page # Confidential Indications forUso.dov