(11 days)
The Fresenius AT1 Autotransfusion Set is a component of the C.A.T.S Continuous Autotransfusion System that is an Autotranfusion device for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion.
The Fresenius Plasma Sequestration Set is a component of the C.A.T.S Continuous Autotransfusion System that is an Autotranfusion device for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion. Additionally, it can be used for perioperative separation of blood into Packed Red Cells (PRC), Plasma (PLS) and Platelet Reich Plasma (PRP).
The Fresenius Plasma Sequestration Direction Draw Set is a component of the C.A.T.S Continuous Autotransfusion System that is an Autotranfusion device 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 Reich Plasma (PRP).
The AT1 Autotransfusion Set includes the blood-washing chamber, adapters for mounting the set into the C.A.T.S. device, blood inlet line with stepped adapter, fluid lines; and the waste and reinfusion bags.
The Plasma Sequestration Set (PSQ) includes the bags required for collection of plasma and platelet rich plasma and the lines/connectors for connection to the whole blood bag and connection to the AT1 Autotransfusion Set.
The Plasma Sequestration Direct Draw Set (PSQ-DD) includes all the components included in the standard PSQ Set and additionally, a blood drawing/anticoagulant line assembly.
The C.A.T.S Continuous Autotransfusion System device is an autotransfusion device for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion. Additionally, it can be used for perioperative separation of blood into Pack Red Cells (PRC), Plasma (PLS) and Platelet i Rich Plasma (PRP).
The provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the Fresenius Modified C.A.T.S Continuous Autotransfusion System, stating its substantial equivalence to a predicate device. It details the device description, intended use, and indicates its clearance by the FDA without providing specific performance metrics or study results.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for establishing ground truth.
- Adjudication method.
- MRMC comparative effectiveness study details or effect size.
- Standalone performance information.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 868.5830 Autotransfusion apparatus.
(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).