(169 days)
The COM.TEC Blood Cell Separator is a blood component separator which utilizes centrifugal force as the basis of operation. The fields of application are as follows:
- plasma exchange
- plasma treatment
The COM.TEC Blood Cell Separator is a blood component separator, which utilizes , centrifugal force as the basis of operation. The fields of application are as follows:
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- Therapeutic plasma exchange - In plasmapheresis, the blood cell separator is used for the replacement of the blood plasma in the blood circuit by a plasma substitution solution or the reinfusion of the plasma after appropriate processing.
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- Therapeutic plasma therapy- In plasmapheresis therapy additional plasma treatment is performed through specific commercially available separation columns prior to return to the patient.
This document is a 510(k) Premarket Notification for the Fresenius COM.TEC Blood Cell Separator. It seeks to demonstrate substantial equivalence to predicate devices, not to set or prove acceptance criteria for a new type of device. Therefore, much of the requested information regarding acceptance criteria and a study proving they are met is not present in this type of submission.
Here's a breakdown of what can be extracted and what is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
This document, being a 510(k) submission, focuses on demonstrating substantial equivalence to pre-existing predicate devices rather than defining and meeting specific quantitative acceptance criteria for a novel device performance study. The core claim is that the COM.TEC performs "as expected" and is "safe and effective for its intended use" based on various tests, but no specific performance metrics or acceptance thresholds are provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The document states that the COM.TEC has undergone "performance testing, including clinical testing." However, it does not provide specific details on the sample size of this clinical testing, the country of origin of the data, or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. Ground truth establishment for a diagnostic device usually involves expert review. Since this is for a blood cell separator, the "ground truth" would likely relate to the effectiveness of separation and safety outcomes, which would be assessed through various clinical and laboratory measures, not expert interpretation of images or similar data.
4. Adjudication Method for the Test Set
Not applicable and not provided. Adjudication methods (like 2+1 or 3+1) are typically used for establishing ground truth in diagnostic accuracy studies where there's a subjective element, often with image interpretation. For a blood cell separator, performance would be measured objectively (e.g., cell yields, plasma purity, patient outcomes).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done, as this type of study is specifically designed for evaluating diagnostic imaging algorithms, not a blood cell separation device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical medical device (blood cell separator), not an AI algorithm. Its performance is inherent in its operation, not an algorithm's output.
7. The Type of Ground Truth Used
The document mentions "clinical testing" and implies that the device's performance was evaluated against its intended use for therapeutic plasma exchange and therapeutic plasma therapy. The "ground truth" would therefore be the actual performance and safety outcomes of the device in these applications, likely measured through:
* Laboratory analysis: Quantifying separation efficiency, cell yields, plasma purity.
* Patient outcomes data: Monitoring for adverse events, effectiveness of treatment.
* Biocompatibility testing: Ensuring safety of components.
* Software and hardware validation and verification: To confirm functional integrity.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
Summary of Relevant Information from the Document:
While the detailed specifics of a performance study with acceptance criteria are not in this summary, the document states:
- Device Description: Fresenius COM.TEC Blood Cell Separator, which utilizes centrifugal force.
- Intended Use: Therapeutic plasma exchange and therapeutic plasma therapy.
- Predicate Devices: Fresenius AS104 Blood Cell Separator (#K895435) and Fresenius P1R Plasma Treatment Set (#K961706).
- Substantial Equivalence Claim: The COM.TEC is substantially equivalent to the predicate devices and raises no new types of safety or effectiveness questions.
- Safety Summary: "The Fresenius COM.TEC blood cell separator has undergone rigorous software validation and performance testing, including clinical testing, software and hardware validation and verification, and biocompatibility testing of disposables. The results of this testing indicate that the Fresenius COM.TEC and associated disposables are safe and effective for their intended use and perform as expected."
Conclusion:
This 510(k) summary provides a high-level overview of the device and its claimed equivalence to predicate devices, supported by general statements about testing. It does not provide the detailed acceptance criteria and study particulars typically found when a new device makes specific performance claims against predefined metrics. The FDA's letter ultimately confirms substantial equivalence, allowing the device to be marketed.
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