HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM;MODEL #CP-1H

{0}------------------------------------------------ ## NOV 0 9 2001 # 510(k) SUMMARY OF SAFET EFFECTIVENESS This 510(k) Summary details sufficient information to provide an understanding of the basis for a determination of substantial equivalence. For convenience, the summary is formatted pursuant to 21 CFR §807.92. This section may be used, as presented, to provide a substantial equivalence summary to anyone requesting it from the Agency. #### 21 CFR §807.92 a (1) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Submitter: | |------------| |------------| A-Med Systems, Inc 2491 Boatman Avenue West Sacramento, CA 95691-3817 (916) 375-7400 ext. 5316 Contact person: Cynthia G. Royster Date prepared: 11 October 2001 #### 21 CFR §807.92 a (2) | Trade name: | A-Med Heparin Coated Miniature Centrifugal<br>Pump System | |--------------|-----------------------------------------------------------| | Common name: | Centrifugal Pump | | Common name: | Centrifugal Pump | |----------------------|-----------------------------------------------| | Classification name: | "Non-roller type Cardiopulmonary Bypass Blood | | Pumps"870.4360 | | #### 21 CFR 8807.92 a (3) Identification of predicate(s): Substantial equivalence for the A-Med Heparin Coated Miniature Centrifugal Pump is based on its similarities to the predicate devices, A-Med Miniature Centrifugal Blood Pump System (K992592). The modified A-Med Heparin Coated Centrifugal Blood Pump is substantially equivalent to the uncoated A-Med Miniature Centrifugal Blood Pump System in intended use, material, design, performance and physical characteristics. The modification adding heparin coating is the only change to the existing device. #### 21 CFR \$807.92 a (4) Device Description-parts and function/concept: The A-Med Heparin Coated Miniature Centrifugal Blood Pump is a sterile, disposable, non-pulsatile, {1}------------------------------------------------ non-roller pump that utilizes an impeller to impart energy to the blood through centrifugal forces. The flow of the pump is "demand responsive" by automatically responding to the resistance against which it is pumping and to the amount of fluid returned to the large pump with the appropriate changes in flow and pressure. A drive cable and magnetic coupling are hermetically sealed components of the pump. The coating which A-Med propose to add to the pump will be a photoactivated hydrogel surface modification. The process uses light activated chemistry to coat the device. A motor ultrasonic flow sensor and a microcomputer-based control console are available separately. #### 21 CFR §807.92 a (5) Intended use and relationship to predicate(s): The A-Med Heparin Coated Miniature Centrifugal Blood Pump is indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring artificial oxygenation (e.g., valvuloplasty, circulatory support during surgery of the vena cava or aorta, liver transplants, etc). The A-Med Heparin Coated Miniature Centrifugal Blood Pump is indicated for use only with the A-Med Blood Pump Controller. The addition of the heparin coating does not impact the currently cleared indication for the existing device. #### CFR §807.92 a (6) Technological characteristics and relationship to predicate(s): The A-Med Heparin Coated Miniature Centrifugal Pump is identical in design, material, intended use and technological characteristics to the uncoated predicate device. The difference between the two devices is the heparin coating only. #### 21 CFR 8807.92 b This substantial equivalence is based on similarities to the predicate device in terms of intended uses and technological characteristics. #### 21 CFR 8807.92 c In accordance with the specifications of this subsection, this summary (two pages) is its own section, and has been clearly identified as such. {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is in a simple, sans-serif font and is easy to read. NOV 0 9 2001 Ms. Cynthia G. Royster Director, Regulatory Affairs A-Med Systems, Inc. 2491 Boatman Avenye West Sacramento, CA 95691-3817 Re: K013393 > Trade Name: A-Med Heparin Coated Minature Centrifugal Blood Pump Regulation Number: 21 CFR 870.4360 Regulation Name: Nonroller-type cardiopulmonary bypass blood pump Regulatory Class: II Product Code: KFM Dated: October 11, 2001 Received: October 15, 2001 Dear Ms. Royster: 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. 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 {3}------------------------------------------------ Page 2 - Ms. Cynthia G. Royster forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (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) I ins letter will anow you to begin mailering of substantial equivalence of your device to a legally prematication: The PDF misms of casion 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 IT you desire specific arrice for your avitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of Compliance at (301) 594-1500. The of Compliance at (301) 594-4639. Also, please note the your device, pitted, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation entined, "Mischanges of esponsibilities under the Act may be obtained from the Outer general information on your respectional 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, James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indication Statement K013393 NOV 0 9 2001 of Page 510(k) Number (if known): N/A Device Name: A-Med Heparin Coated Miniature Centrifugal Blood Pump #### Indications for Use The A-Med Heparin Coated Miniature Centrifugal Blood Pump System is indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring artificial oxygenation (e.g., valvuloplasty, circulatory support during surgery of the vena cava or aorta, liver transplants, etc). The A-Med Heparin Coated Miniature Centrifugal Blood Pump is indicated for use only with the A-Med Blood Pump Controller. ### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use Use (Per 21 CFR 801.109) OR Over-The-Counter Optional Format 1- W. Jobe Division for Cardiovascular & Respiratory Devices 510(k) Number K01393 CONFIDENTIAL