(67 days)
The C.A.T.S (Continuous Autotransfusion System) by Fresenius 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 C.A.T.S is a continuous autotransfusion system working on the principle of a continuous flow centrifuge. In this continuous system, the blood to be processed passes through a separation chamber that can be divided into several compartments in which different steps of the autotransfusion process (i.e; plasma separation, resuspension with saline and reconcentration) are performed simultaneously, creating a continuous flow of blood through the system. The C.A.T.S device is comprised of two major components:
Reusable Autotransfusion Device: The C.A.T.S machine is an electromechanical a) microprocessor controlled device which incorporate the following major system components: the user display and function keys, centrifuge housing, centrifuge rotors; blood, packed red cell (PRC) and saline roller pumps; blood, saline and PRC sensors; leakage detector, and power supply unit. Additionally, the system includes the electronic components and system software which control and monitor the blood processing procedure.
b) Disposable AT1 Autotransfusion Set: This disposable set incorporates the continuous washing chamber, adapters for mounting the set into the C.A.T.S device, blood inlet line with stepped adapter, pump tubing, fluid lines; and the waste and reinfusion bags.
In order to perform plasma sequestration procedures a second disposable set is necessary:
c) PSQ Set: a single use, disposable set, includes bags for collection of plasma and platelet concentrates. Additionally, the PSQ Set includes lines/connections for connection to the whole blood bag and connection to the C.A.T.S AT 1 Autotransfusion Set.
The provided text covers the 510(k) summary for the Fresenius C.A.T.S Autotransfusion System. It details the device's intended use, features, and technological characteristics compared to predicate devices. The document focuses on demonstrating substantial equivalence to existing devices rather than defining specific acceptance criteria as quantitative thresholds for performance.
Therefore, many of the requested sections (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types for test and training sets) are not explicitly present in the provided text. The document refers to "studies" that were undertaken to demonstrate equivalence but does not provide the detailed methodology or results of these studies in the format requested.
However, I can extract information related to the studies that prove the device meets the general requirements for substantial equivalence to predicate devices.
Here's a breakdown of the information that can be extracted, and where fields are not explicitly addressed by the provided text, I will state that:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of quantitative acceptance criteria with corresponding performance metrics. Instead, it concludes that the device performance for plasma sequestration is "substantially equivalent" to the predicate device and that the products prepared are "suitable for reinfusion." It also states that the PSQ Set satisfies AAMI/ANSI standards for structural integrity and that materials are suitable. Software requirements were also met.
| Aspect of Performance | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Blood Processing | Substantially equivalent to predicate devices (Medtronic Sequestra 1000) for plasma sequestration; suitability for reinfusion. | Demonstrated as substantially equivalent to the plasma sequestration program of the predicate device, Medtronic Sequestra 1000 Autotransfusion System. Products prepared using C.A.T.S device would be suitable for reinfusion. |
| PSQ Set | Satisfy requirements of AAMI/ANSI standards for autotransfusion devices (structural integrity), suitable materials for intended use. | Satisfies requirements of the AAMI/ANSI standards for autotransfusion devices with respect to structural integrity. Materials used to manufacture the disposable set are suitable for the intended use. |
| Shelf-life | Maintain biocompatibility, structural integrity, packaging integrity, and sterility for the labeled shelf-life. | Shelf-life validation studies determined that these aspects will be maintained for the labeled shelf-life. |
| Software | Meet requirements as set forth in the Software Requirements Specification. | Through system software testing, it has been established that the plasma sequestration program module incorporated into the C.A.T.S's system software will meet the requirements. |
| Biocompatibility | Consistent with FDA's modified ISO standards for biological evaluation of medical devices. | All blood/fluid contacting materials of the PSQ Set have been subjected to biocompatibility testing consistent with FDA's modified ISO standards. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). The text only mentions "studies have been undertaken."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not specified. The assessment primarily relied on comparative performance metrics of the device with a predicate device and adherence to standards for materials and software, rather than expert-established ground truth on individual cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified.
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
- No, this is not an MRMC study. The device is a medical apparatus (autotransfusion system), not an AI-assisted diagnostic tool that would involve human readers interpreting AI output. The study compares the performance of the C.A.T.S device (hardware and software) in processing blood to a predicate device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, the performance studies described are for the device (C.A.T.S system) functioning in a standalone manner for blood processing and plasma sequestration, comparing its outputs and operational characteristics to those of a predicate device. The device itself is an automated system where human intervention is primarily for setup and monitoring, not for interpreting results in a way that would require a human-in-the-loop performance study in the context of diagnostic AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for device performance appears to be established through:
- Comparative performance data: Comparing key metrics (e.g., red cell, platelet, plasma recovery rates, quality of separated products) with a legally marketed predicate device (Medtronic Sequestra 1000).
- Industry standards and FDA guidance: For biocompatibility (FDA's modified ISO standards), structural integrity (AAMI/ANSI standards), and software performance (Software Requirements Specification).
- In vitro blood quality testing: To evaluate the safety and effectiveness of the plasma sequestration process parameters.
8. The sample size for the training set
- Not applicable/Not specified. This is a hardware/software system for blood processing, not a machine learning model that requires a distinct "training set" in the conventional sense. The "training" of the software would be its development and internal testing against specifications.
9. How the ground truth for the training set was established
- Not applicable. The software's "ground truth" would be its adherence to the "Software Requirements Specification" which would have been established during the design and development phase. The document states, "the plasma sequestration module of the C.A.T.S system software has undergone testing to assure that system software requirements are met."
§ 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).