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510(k) Data Aggregation
(183 days)
The CATSmart (Continuous Autotransfusion System) device by Fresenius is an autotransfusion device indicated for the processing of autologous shed blood collected intraoperatively to obtain washed packed red blood cells for reinfusion.
The Fresenius Kabi CATSmart device is an intraoperative autotransfusion system for intraand/or postoperative processing of blood lost through surgery or trauma. The CATSmart device operates on the principle of a continuous flow centrifyge, comparable to continuous systems for hemapheresis which, for decades, have been widely used in blood banks. 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 non-erythrocytic 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.
This document describes the CATSmart (Continuous Autotransfusion System) device and its substantial equivalence to its predicate device, C.A.T.S., as per the FDA 510(k) submission. Below is the requested information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it states that "All three wash programs (emergency wash program, low volume wash, smart wash) were tested. Overall it was judged that all validation tests were passed for all wash programs on the CATSmart device with the AT3 tubing set. A separate in vitro evaluation demonstrated that fat and heparin were almost completely removed from the processed blood."
Based on this, the implied acceptance criteria are the successful execution and performance of the device's core functions (blood washing programs) to a similar or acceptable level as the predicate device, particularly concerning the removal of plasma, non-erythrocytic cellular components, activated coagulation factors, fibrinolysis products, cell trauma products, anticoagulant, fat, and heparin, all leading to washed packed red blood cells suitable for reinfusion.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Successful processing of autologous shed blood | "Overall it was judged that all validation tests were passed for all wash programs on the CATSmart device with the AT3 tubing set." The device processes anticoagulated shed blood in a continuous washing process to obtain washed packed red blood cells for reinfusion. |
| Effective removal of plasmatic and non-erythrocytic components | "During this process all plasmatic and non-erythrocytic cellular components of the collected blood, and thus activated coagulation factors, products of fibrinolysis and cell trauma as well as the anticoagulant are removed." This statement implies successful removal of these components, meeting a performance standard judged to be acceptable. |
| Effective removal of fat and heparin | "A separate in vitro evaluation demonstrated that fat and heparin were almost completely removed from the processed blood." This explicitly states the successful removal of these specific impurities. |
| Electrical safety compliance | "The electrical safety of the CATSmart device was tested according to the general requirements for basic safety and essential performance directive of IEC 60601-1-2:2007." The successful completion of this testing implies compliance with these safety standards. |
| Durability and resistance to vibration/shock | "Furthermore, vibration and shock resistance was tested as well as the durability." The successful completion of these tests implies the device meets internal durability and resistance standards. |
| Performance comparable to predicate device | "The performance of the CATSmart device was tested by in vitro blood quality studies in direct comparison to the predicate device C.A.T.S." The context suggests that the CATSmart performed comparably to the predicate, leading to the conclusion of substantial equivalence. The main functions of CATSmart and the underlying methodology remained unchanged compared to its predecessors. The only functional difference is the monitoring of the hematocrit value for informational purposes, not diagnostic. Electrical safety, vibration, shock, and durability also tested. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size (e.g., number of blood samples or test runs) used for the in-vitro performance testing. It only mentions "in vitro blood quality studies."
There is no information about data provenance in terms of country of origin or whether it was retrospective or prospective. Given it was "in vitro blood quality studies," it would inherently be a prospective experimental setup.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The document states "Overall it was judged that all validation tests were passed," implying internal assessment. There is no mention of external experts or their qualifications for establishing ground truth for the in-vitro studies.
4. Adjudication Method
The document does not specify an adjudication method. The statement "Overall it was judged that all validation tests were passed" suggests an internal evaluation without detailing a formal adjudication process involving multiple parties.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not conducted. The CATSmart device is an autotransfusion apparatus, not an image-reading or diagnostic device that would involve human readers. Its primary function is blood processing, and the "hematocrit monitoring function" is specifically noted as "only used to monitor the wash process for informational purposes and is not intended for diagnostic or quality control purpose." Therefore, there is no discussion of human reader improvement with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
The performance testing described is for the device as a whole, including its operational algorithms embedded in the software. The study focuses on the device's ability to process blood and remove impurities. While the document mentions a software update that includes the hematocrit function and touch screen control, it doesn't separate the "algorithm only" performance from the integrated system performance. However, since it's an automated system, its performance inherently represents an "algorithm only" or "device only" performance in its operational context. There is no human-in-the-loop interaction for the core blood processing function itself.
7. Type of Ground Truth Used
The ground truth for the device's performance (i.e., effective blood washing, removal of impurities) would have been established through analytical testing of the processed blood samples. This would likely involve laboratory measurements of various blood components, contaminants (e.g., plasma proteins, anticoagulants, fat, heparin), and red blood cell recovery, probably using established clinical laboratory standards and methods. The document mentions "in vitro blood quality studies," which supports this interpretation.
8. Sample Size for the Training Set
The document does not mention any "training set" or machine learning model development in the context of device performance testing. The main functional difference, the hematocrit monitoring, is an "additional technical feature" and its values are explicitly stated as "not a substitute for the hematocrit check on the product before it is reinfused... The sensors are not calibrated measuring instruments." This suggests that any algorithms related to hematocrit monitoring are rather simple estimations for informational display and are not based on complex machine learning requiring a "training set" in the typical sense. The device's core blood washing function is based on a continuous flow centrifuge, a well-established physical principle, rather than a learned algorithm needing an extensive training set.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or implied for the core functions or the hematocrit monitoring (which is for informational purposes only), the establishment of ground truth for a training set is not applicable to the information provided.
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