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The CATSmart System by Fresenius Kabi is an autotransfusion device indicated for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed red blood cells for reinfusion. Additionally, it can be used for perioperative separation of blood into Packed Red Cells (PRC), Plasma (PLS) and Platelet Rich Plasma (PRP).

The Fresenius Kabi CATSmart device is an intraoperative autotransfusion system for intra- and/or postoperative processing of blood lost through surgery or trauma. The CATSmart device operates on the principle of a continuous flow centrifuge, comparable to continuous systems for hemapheresis which, for decades, have been widely used in blood banks.

In a typical CATSmart procedure, the shed blood, which is anticoagulated and collected in a sterile reservoir, is processed in a continuous washing process to obtain washed packed red cells for reinfusion to the patient. During this process all plasmatic and nonerythrocytic cellular components of the collected blood, and thus activated coagulation factors, products of fibrinolysis and cell trauma as well as the anticoagulant are removed. The packed red cells are collected in a reinfusion bag from which they can be reinfused to the patient via a transfusion set when needed.

The system includes disposable sets and accessories previously cleared by FDA in respective 510(k)'s.

This document is a 510(k) summary for the Fresenius Kabi CATSmart device, an autotransfusion system. It is a notification of intent to market a device that the manufacturer believes is substantially equivalent to legally marketed predicate devices.

The document does not contain detailed acceptance criteria for a study showing device performance. Instead, it describes general claims of substantial equivalence based on the device's design, materials, specifications, technological characteristics, and function being unchanged from previously cleared devices, and that manufacturing and sterilization methods at a new site remain the same.

Therefore, the requested information for acceptance criteria and a study proving the device meets them, including specific details about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set details, is not available in the provided text.

The document specifically states: "No clinical data was required to support the changes described in this submission." This indicates that a study demonstrating performance against specific criteria was not conducted for this particular submission. The substantial equivalence is based on the device being inherently the same as a previously cleared one.

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