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The CAPIOX® Flexible Venous Reservoir is intended for use as a blood collection and storage device during cardiopulmonary bypass procedures. The device is intended for use in conjunction with blood-gas oxygenators in the extra-corporeal circuit.

The device may be used in procedures lasting up to 6 hours.

The Capiox Flexible Venous Reservoir is used as a blood storage device during cardiopulmonary bypass procedures.

The reservoir bag is to be positioned at a level that is below patient (blood supply) level. When the bag is properly positioned, the blood that is drawn from the patient enters the reservoir via gravity into the blood inlet ports that are positioned at the base edge of the reservoir bag. As the patient's blood enters the device, it passes through a mesh filter that facilitates the removal of air from the blood. This removal of air via the mesh filter is accomplished when an air bolus makes contact with the mesh and is subsequently disintegrated. Additionally, there is an air purge feature at the upper region of the bag that allows for the collection and subsequent aspiration of air from the bag.

Blood exits the device via gravity through the blood outlet port and is subsequently pumped through the remainder of the cardiopulmonary bypass circuit.

The provided text describes a 510(k) premarket notification for the CAPIOX® Flexible Venous Reservoir, a Class II device intended for use as a blood collection and storage device during cardiopulmonary bypass procedures. The submission claims substantial equivalence to a predicate device (K040023).

However, the provided text does not contain any information regarding specific acceptance criteria, study details, performance metrics, sample sizes for test or training sets, ground truth establishment, expert qualifications, or adjudication methods. The document focuses solely on regulatory approval based on substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information from the given text. The K070839 submission appears to be a regulatory filing establishing substantial equivalence, not a detailed performance study with explicit acceptance criteria and corresponding data.

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