(255 days)
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 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 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. This version of CATSmart is also capable of perioperative separation of blood into PRP and PLS. 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 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. In the Plasma Sequestration (PSQ) procedure, the patient's blood is separated into packed red cells (PRCs), plasma (PLS) and platelet rich plasma (PRP). The principle of separation during plasma sequestration is the same as it is for autotransfusion i.e. physical separation of cellular components in the centrifugal field based on the differences in density and particle size. There is no change to system hardware or disposable sets described previously in K160735. The system includes the disposables AT1. AT3. ATS. ATY. ATO. ATR40 and ATR120. ATV-70 and ATV-180, ATF40 and ATF120. An ATV-F140 disposable set has been created (Class I 510(k) exempt). Also, PSQ disposable cleared under K971274 has also been qualified for use with the CATSmart System for the PSQ procedure. An additional wash program has been developed and added to the software to manage the PSO procedure.
The provided text describes the 510(k) summary for the Fresenius Kabi CATSmart Autotransfusion System, but it does not contain a detailed study section with acceptance criteria and device performance information.
Based on the available text, here's what can be inferred and what information is missing:
1. Table of acceptance criteria and the reported device performance:
This information is not explicitly stated in the provided text. The text mentions "in vitro blood quality studies in direct comparison to the predicate device C.A.T.S." and that "the validation tests passed for the new PSQ wash program on the CATSmart device with the PSQ set and AT3 tubing set." However, it does not detail the specific acceptance criteria (e.g., target ranges for red cell recovery, platelet removal, etc.) or the quantitative results from these studies.
2. Sample size used for the test set and the data provenance:
This information is not provided. The text only mentions "in vitro blood quality studies."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. Given that this is an autotransfusion device primarily processing blood, the "ground truth" would likely be laboratory measurements of blood component quality, not expert consensus on images or diagnoses.
4. Adjudication method for the test set:
This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 typically refer to expert review processes for qualitative data (e.g., imaging interpretation), which is not the primary focus for validating an autotransfusion device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. An MRMC study is relevant for AI-powered diagnostic devices that assist human readers. The CATSmart system is an autotransfusion apparatus, not a diagnostic AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The CATSmart system itself is a device that processes blood, not an algorithm that performs a standalone diagnostic or interpretive function.
7. The type of ground truth used:
Based on the context of "in vitro blood quality studies," the ground truth likely involved laboratory measurements of various blood parameters (e.g., hematocrit, red cell recovery percentage, plasma volume, platelet count, etc.) obtained through standard analytical techniques.
8. The sample size for the training set:
This information is not provided. The device uses a continuous flow centrifuge principle, and typically such devices are validated through engineering and in vitro performance studies, rather than "training" on a dataset in the way a machine learning algorithm would be. The "new PSQ wash program" implies software, but the document does not specify if it involves machine learning.
9. How the ground truth for the training set was established:
This information is not provided and is likely not applicable in the context of this device as it's not a machine learning-based system that requires a "training set" in the conventional sense. The "ground truth" for evaluating the performance of the wash program would be established through laboratory analysis of the processed blood.
§ 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).