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510(k) Data Aggregation
(157 days)
The Fresenius F Series Hemoconcentrators are indicated to relieve or mitigate overhydration in patients undergoing cardiopulmonary procedures and to increase the concentration of cells and proteins in the blood.
The Fresenius Hemoflow Series Dialyzer, the same product as the F Series Hemoconcentrators, is a hollow fiber-type filter. Fresenius-produced polysulfone capillary fibers are bundled and potted with polyurethane into an artificial kidney jacket manufactured from polyurethane. Screw-type end caps, manufactured from polyurethane, have twist lock connectors for the connection of venous and arterial blood lines. Two filtrate ports are located on the filter adjacent to the filtrate chambers. The ports have Hansen-type fittings for connection of filtrate tubing. For hemoconcentration, only the filtrate port on the venous end of the filter is used; the other port on the arterial end is capped. There are four (4) models within the F Series Hemoconcentrators family. The difference between the four models in the F Series Hemoconcentrators is the number of fibers contained within the artificial kidney jacket. As the number of fibers contained in the filter increases, the diameter of the filter and the filtration capacity increases proportionally. Each model will be manufactured with a tubing set (F400TS, F500TS, F700TS, F800TS); other models will be manufactured with tubing adapter, only (F400, F500, F700, F800).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Metric) | Reported Device Performance |
|---|---|
| Biocompatibility | Passed biocompatibility testing consistent with FDA's modified ISO standards. |
| End-to-end pressure drop | Tested and characterized against predicate devices (F40 and F60). Performance was consistent. |
| Ultrafiltration rates | Rates are relatively consistent with predicate devices. Differences attributed to Active Surface Area. |
| Concentration rates of cellular blood components | No cellular blood components lost in the ultrafiltrate. |
| Sieving coefficients of large/small molecular weight plasma proteins | Molecular weight cutoff approximately 65,000 Daltons (minimal albumin loss, beta-2-microglobulin filtered). |
| Hemolysis (production of plasma hemoglobin) | Statistically the same for all devices evaluated. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific numerical sample size for the test set. However, it indicates that "Comparative in vitro testing" was performed on the Fresenius F40, F50, F70, and F80 hemoconcentrators. This suggests a test set comprising various models of the subject device.
The data provenance is in vitro testing. The country of origin of the data is not explicitly stated, but given that Fresenius USA submitted the 510(k), it is likely the testing was conducted in the US or by a facility associated with Fresenius USA. The testing was prospective as it was conducted to characterize the performance of the new devices.
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 study focuses on in vitro performance comparison, which typically relies on established laboratory measurement techniques and standards rather than expert human interpretation for raw data.
4. Adjudication Method for the Test Set
This information is not applicable/provided. As explained above, the study involved in vitro testing and performance measurements, not expert human assessment that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The study described is an in vitro performance comparison of the device itself, not an evaluation of human readers (clinicians) using the device with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
N/A. The device is a medical apparatus (hemoconcentrator), not an AI algorithm. Therefore, the concept of "standalone algorithm performance" is not applicable in this context. The study did evaluate the standalone performance of the device in vitro.
7. The Type of Ground Truth Used
The ground truth used was established laboratory measurements and scientific principles. Specifically, performance characteristics were measured against:
- Draft specifications for the products.
- A recognized international standard, EN 1283, Haemodialyzers, Haemodiafilters, Haemoconcentrators and Their Extracorporeal Circuits.
- Performance of legally marketed predicate devices (F40, F60, Bard HC40, Amicon Diafilter 30, Minntech Hemocor HPH 1000, Baxter Bentley Quick Prime HQ 7000, Research Medical Biofilter 140) under similar operating conditions.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical device, not an AI algorithm that requires a training set. The term "training set" doesn't apply to the development or evaluation of this type of product.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no training set for this type of device.
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