(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.
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”