(56 days)
The C.A.T.S (Continuous Autotransfusion Svstem) by Frescruus 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 (electromechanical microprocessor controlled device) and Disposable AT1 Autotransfusion Set.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Fresenius C.A.T.S Autotransfusion System Plasma Sequestration-Direct Draw Program and PSQ Set (Direct Draw).
It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than a full clinical study report designed to prove novel efficacy or safety with predefined criteria and detailed performance metrics. As such, some of the requested information (like specific effect sizes for MRMC studies, number of training set samples, or direct performance statistics for clinical outcomes) is not explicitly present.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are not presented in a quantitative, pass/fail table as might be seen for a new device claiming specific performance metrics. Instead, the "acceptance criteria" are implied by demonstrating that the new components (PSQ Set (DD) and the direct draw software module) meet established standards and operate equivalently to predicate devices and the existing C.A.T.S system.
| Acceptance Criterion (Implied) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility: Materials in contact with blood are safe. | All blood/fluid contacting materials of the PSQ Set (DD) subjected to biocompatibility testing consistent with FDA's modified ISO standards for biological evaluation of medical devices. Fresenius has demonstrated the materials are suitable for intended use. |
| Structural Integrity: PSQ Set (DD) can withstand intended use. | The PSQ Set (DD) satisfies requirements of the AAMI/ANSI standards for autotransfusion devices with respect to structural integrity. Shelf-life validation studies determined structural integrity will be maintained for the labeled shelf-life. |
| Shelf-life Validation: Maintains performance over time. | Shelf-life validation studies pertinent to the PSQ Set (Direct Draw) have determined that biocompatibility, structural integrity, packaging integrity, and sterility will be maintained for the labeled shelf-life. |
| Software Performance: Direct draw program module functions correctly. | The plasma sequestration direct draw program module of the C.A.T.S system software has undergone testing to assure that system software requirements are met. Through system software testing, it has been established that the program module will meet the requirements as set forth in the Software Requirements Specification. |
| Substantial Equivalence: To predicate devices and existing C.A.T.S system. | The direct draw plasma sequestration program and disposable PSQ Set (DD) of the Fresenius C.A.T.S autotransfusion device is substantially equivalent to the currently marketed plasma sequestration program and PSQ Set, and to the direct draw programs and accessories of the Sequestra 1000 and Cell Saver 5 autotransfusion systems. (This is the overarching conclusion rather than a direct performance metric). |
Study Details
Based on the provided K973378 510(k) Summary, here's what can be inferred about the "study" (which consists of multiple tests to support substantial equivalence):
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in terms of patient numbers or blood samples. The testing appears to be primarily in vitro or bench testing on the device itself and its components (biocompatibility, structural integrity, software testing).
- Data Provenance: Not specified. Given the nature of the tests (biocompatibility, structural integrity, software), it would likely be laboratory or bench test data, not necessarily country-specific clinical data. It is a retrospective compilation of test results.
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Number of Experts used to Establish the Ground Truth for the Test Set and the Qualifications of those Experts:
- Number of Experts: Not applicable or not specified. This document describes testing against engineering standards (AAMI/ANSI) and internal software requirements, and biocompatibility standards (FDA/ISO). Ground truth, in the sense of clinical expert consensus for diagnosis or interpretation, is not relevant here as the device processes blood, it doesn't make clinical diagnoses.
- Qualifications of Experts: The experts involved would be those performing the biocompatibility, materials, structural, and software engineering tests. Their specific titles or experience are not detailed.
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Adjudication Method for the Test Set:
- Method: Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers interpret medical images or data against a consensus ground truth. Here, the "test set" involves measurable physical and software performance against defined standards.
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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:
- MRMC Study: No. This is not an AI/imaging device and an MRMC study is not relevant to its purpose. The device is an autotransfusion system, not an interpretive diagnostic tool.
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If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: The "standalone" performance here refers to the device's operational capabilities without direct human intervention once started. The software testing confirms the automated functions of the plasma sequestration direct draw program module meet requirements without human-in-the-loop comparison for efficacy. However, the device itself is an automated system for blood processing, so "standalone" performance in the AI context isn't directly applicable.
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The Type of Ground Truth Used:
- Ground Truth: The "ground truth" for the tests described are:
- Biocompatibility: Compliance with FDA's modified ISO standards for biological evaluation of medical devices.
- Structural Integrity: Compliance with AAMI/ANSI standards for autotransfusion devices.
- Software Functionality: Meeting the requirements as set forth in the internal "Software Requirements Specification."
- Shelf-life: Maintenance of biocompatibility, structural integrity, packaging integrity, and sterility over time, as tested according to internal protocols often based on industry standards.
- Ground Truth: The "ground truth" for the tests described are:
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The Sample Size for the Training Set:
- Training Set Sample Size: Not applicable. This device is not an AI/machine learning device that requires a "training set" in the conventional sense. The "development" and "validation" would refer to engineering design, manufacturing, and testing processes.
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How the Ground Truth for the Training Set Was Established:
- Training Set Ground Truth: Not applicable, as there is no "training set" for an AI model. The "ground truth" for the device's engineering and performance validation comes from established engineering standards, material science principles, and software development best practices.
§ 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).