MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR

{0}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, with flowing lines representing hair or movement. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR - 9 1999 Ms. Sandra Perreand Regulatory Affairs Manager Bard Vascular Systems Division C.R. Bard, Inc. 25 Computer Drive 01832 Haverhill, MA Re : K990514 Bard® Quantum™ CVR Requlatory Class: III (Three) Product Code: 74 DTN and 74 DTP February 17, 1999 Dated: February 18, 1999 Received: Dear Ms. Perreand: 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 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). 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 aqainst 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 Requlations, 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 Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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. {1}------------------------------------------------ ### Page 2 - Ms. Sandra Perreand 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 oredicate 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" (21CFR 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/dsma/dsmamain.html." Sincerely yours, Thomas J. Callahon Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Bard® Quantum™ CVR "Special 510(k)" Premarket Notification ారా #### Indications for Use Statement Attachment 2 Device Name: Bard H-6770VR Quantum CVR ## Indications for Use: The Bard Quantum CVR is designed to function in an extracorporeal circuit. The filtered cardiotomy/reservoir receives dynamic blood from: - 1) Venous return; - 2) Intracardiac suction; - 3) Ventricular vent devices; - 4) Arterial-venous shunts. It defoams, filters and stores this blood prior to returning it to the circuit. # PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) | (Division Sign-Off) | | |------------------------------------------|---------| | Division of Cardiovascular, Respiratory, | | | Neurological Devices | | | (k) Number | K990514 | | Prescription Use | <div style="display:inline-block;">✓</div> | |------------------|--------------------------------------------| |------------------|--------------------------------------------| OR | Over-The-Counter Use | | |----------------------|--| |----------------------|--| Bard® Quantum CVR "Special 510(k)" Submission