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The A-Med 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 Miniature Centrifugal Blood Pump is indicated for use only with the A-Med Blood Pump Controller.

The A-MED Miniature Centrifugal Pump is a sterile, disposable, non-roller pump which utilizes a rotor to impart energy to the blood through centrifugal forces. The flow of the miniature pump is "demand responsive" by automatically responding to the resistance against which it is pumping and to the amount of fluid returned to the miniature pump with the appropriate changes in flow and pressure. A drive cable and magnetic coupling are hermetically sealed components of the miniature pump.

The A-MED Miniature Centrifugal Pump System includes a motor, ultrasonic flow sensor and a microcomputer-based control console which are available separately. The Miniature pump consists of inner and outer housings containing a rotor which imparts energy to the pumping fluid through centrifugal forces. The inlet to the pump runs concentric with the axis of the rotor. The outlet of the pump is perpendicular to the inlet and tangent to the outer diameter. The shaft of the rotor is constrained by two sets of bearings that allow it to rotate freely. A lip seal is used just behind the rotor to seal fluid from entering into the bearing area.

A sheath cable assembly connects the pump to the drive motor. The pump end of the cable has a square drive shaft that is bonded and crimped to the cable. This drive shaft fits into a square opening in the end of the rotor. The other end of the cable is connected to a magnet rotor housed in a plastic shell. This end is assembled onto the motor-stator for operation. By assembling the magnet rotor into the end of the cable-sheath assembly, hermitic sealing of the pumping chamber is obtained.

A priming port (valve) is provided on the housing to clear the pump of air before starting circulation. The port is designed to open when a syringe is inserted and seals when the syringe is removed.

The pump is designed to be placed in the sterile field and operated from the A-Med remote motor and microcomputer based blood pump controller, located outside the sterile field. The A-Med Centrifugal Pump System also includes an ultrasonic flow meter, manufactured by Transonics, Inc.

This document is a 510(k) summary for the A-Med Miniature Centrifugal Pump System. It provides information about the device's substantial equivalence to predicate devices, but it does not contain acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting specific performance metrics and associated studies.

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