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The Dideco D903 Avant Hollow Fiber Oxygenator is intended for use in adults who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation . It provides oxygenation and carbon dioxide removal from venous blood. The integrated heat exchanger provides blood temperature control and allows the use of hypothermia or aids in the maintenance of normothermia during surgery. The venous reservoir with cardiotomy filter is intended to collect blood aspirated from the operating field during surgical procedures and the blood from patients' veins during normal operation to assure the proper oxygenation capability of the device. The D903 Avant is intended to be used for six hours or less.

The Dideco D903 Avant membrane oxygenator is a high efficiency membrane oxygenator of hollow fiber design with an integral heat exchanger and an attached hardshell cardiotomy/venous reservoir. The device will be available both as an integrated device and as separate devices; a single sterile oxygenator module and the venous/cardiotomy reservoir. The fiber bundle within the oxygenator consists of a polycarbonate core wound with microporous polypropylene hollow fibers. The core is encapsulated on both ends with polyurethane and contained within a polycarbonate housing. Two versions of the oxygenator will be offered in two configurations having different affective gas exchange surface. The first has an effective gas exchange surface of 1.6 m², while the latter has an effective gas exchange surface of 2.0 m². The integral heat exchanger is comprised of a grooved and plated stainless steel sheet. The hardshell cardiotomy/venous reservoir of the integrated version is attached to the top of the oxygenator by means of a molded fitted joint and is comprised of a rigid polycarbonate housing with an internal support. The filtering system surrounds the internal support. Suctioned blood enters the cardiotomy section by two rotatable turrets equipped with %" and 1/2" connectors. The blood enters the reservoir by gravity drainage from the cardiotomy, through the venous inlet placed in the bottom of the reservoir or by means of a recirculation line (allowing oxygenated blood to be recirculated and purged back to the reservoir). A self-purging four-way stopcock located beside the oxygenation module of the D903 Avant allows for arterial and venous blood sampling. The blood sampling system consists of three coiled PVC tubes connected to a four-way stopcock. The tubes allow for either sampling or purging of arterial and venous blood or delivery of drugs into the venous line. The D903 Avant includes arterial and venous temperature probe sites for monitoring of blood temperature. A holder is available for use with the oxygenator. The holder is comprised of a stainless steel rotating arm secured to the IV pole by means of a knob. This allows for independent rotation of the device. On the bottom of the holder are two integrated Hansen water connectors securing the Oxygenator in a locked position.

Acceptance Criteria and Study for D903 Avant Hollow Fiber Oxygenator

The D903 Avant Hollow Fiber Oxygenator underwent a series of in vitro and clinical studies to demonstrate its performance and substantial equivalence to a predicate device (MONOLYTH Oxygenator). The acceptance criteria were largely based on comparison to this predicate device and conformance with the proposed 1991 AAMI-ISO Draft Standard for blood-gas oxygenators.

1. Table of Acceptance Criteria and Reported Device Performance

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