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POLYFLUX R is indicated for use in hemodialysis for the treatment of chronic or acute renal failure. The choice of the filter is the responsibility of the physician. Special attention must be paid in connection with pediatric use. CAUTION! If POLYFLUX R is reused, the procedure and disinfection specified in the RENATRON INSTRUCTION MANUAL must be followed. The POLYFLUX R may be reprocessed for reuse on the same patient.

The Gambro Polyflux 17R and 21R, Capillary Dialyzers/Filters labeled for multiple use (reuse) are identical in construction in function to Gambro Polyflux 17S and 21S Hemodialyzers / Hemofilters labeled for single use which are currently marketed in the United States and have been previously cleared by the FDA under 510(k) Notification K981414. Only the product designation "R" has been changed from "S" to designate that they are labeled for multiple use (reuse). These devices are intended for use in hemodialysis for the treatment of acute and chronic renal failure and for certain types of intoxications for both single when reprocessed for reuse for a maximum of 15 reprocessing reuse cycles on the same patient. If reprocessing and reuse is practiced, it is recommended that the reuse be done under the conditions as existed in the in vitro and confirmatory clinical studies undertaken by Gambro and presented in the labeling for this device. It may also be used in cases of acute fluid overload for the removal of plasma water. The membrane used in these devices is polyethersulfone (PES) which is identical to the membrane utilized in the Gambro Polyflux 17S and 21S Hemodialyzers / Hemofitters for labeled for single use which have been previously approved for marketing in the United States under a 510K Notification (K982414). Blood enters a blood inlet port where it is distributed to polyethersulfone hollow fibers. Each hollow fiber has an inner diameter of approximately 215 microns (wet hollow fiber internal diameter) and a wall thickness of 50 microns. The number of polyethersulfone hollow fibers in each hemodialyzer / hemofilter is 10,000 for the Polyflux 17R and 12,500 for the 21R. These dialyzers have an effective membrane length of 250 mm. The effective membrane surface area is 1.7 square meters for the 17R and 2.1 square meters for the 21R. The housing and end caps of these hemodialyzers / hemofiters are made of polycarbonate. The fibers used in the Gambro Polyflux 17R and 21R are identical in design and materials to the previously approved Gambro Polyflux 17S and 21S Hemodialyzers / Hemofilters for labeled for single use (K982414). The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port. By means of a hydrostatic pressure or transmembrane pressure which is created by a combination of positive and negative pressures across the polyethersulfone membrane, plasma water along with certain lower molecular weight solutes of plasma water pass through the membrane and into the dialysate or filtrate compartment of the device. Removal of uremic toxins and waste products are removed from the patient's blood in this device by means of both diffusion and convection through polyethersulfone membrane and into the counter current flowing dialysis solution during hemodialysis. The dialysate exits the devices via a dialysate outlet port.

This document describes the 510(k) Notification for the Gambro Polyflux 17R & 21R Capillary Dialyzers/Filters, labeled for multiple use. This submission seeks clearance for the multiple-use labeling of these devices, which are identical in construction and function to the previously cleared single-use Gambro Polyflux 17S & 21S Hemodialyzers/Hemofilters (K981414).

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that the proposed devices (Polyflux 17R & 21R for multiple use) are identical in construction and function to the predicate devices (Polyflux 17S & 21S for single use), with the only difference being the labeling for multiple use. Therefore, the acceptance criteria are implicitly linked to demonstrating that the reprocessing for reuse does not compromise the device's original performance, safety, and effectiveness.

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: The document simply states that "Clinical data was collected according to the FDA Guidance for Hemodialyzer Reuse Labeling," and refers to "confirmatory clinical studies undertaken by Gambro." However, no specific sample sizes (number of devices or patients) for the clinical test set are provided within the excerpt.
• Data Provenance: The country of origin of the data is not explicitly stated. The nature of the studies ("confirmatory clinical studies undertaken by Gambro") suggests they were prospective studies, as they were conducted to support the multiple-use claim.

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):

This information is not provided in the given excerpts. For medical devices like dialyzers, ground truth often relates to measurable clinical and laboratory parameters (e.g., solute clearance, ultrafiltration rates, patient outcomes), rather than interpretation by a panel of experts in the same way an imaging study would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable/provided for this type of device and study. Adjudication methods like 2+1 or 3+1 are typically used in imaging studies where subjective interpretation is involved. For a hemodialyzer, the performance is assessed through objective measurements.

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:

Not applicable. This excerpt describes a 510(k) submission for a medical device (hemodialyzer) for multiple use, not an AI or imaging diagnostic device. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is entirely irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a hardware medical device, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Based on the nature of the device (hemodialyzer), the ground truth for performance and safety would have been established through a combination of:

• In vitro performance criteria: Objective measurements of device function (e.g., solvent removal, solute clearance, fiber integrity, pressure drop, biocompatibility measures like membrane integrity after reprocessing challenges).
• Clinical outcomes data: Patient safety data and clinical effectiveness parameters (e.g., maintaining patient electrolyte balance, fluid removal, absence of adverse events related to reprocessing) over the course of multiple reuse cycles. The document refers to "in vitro and confirmatory clinical studies."

8. The sample size for the training set:

Not applicable. As this is a medical device, not an AI algorithm, there is no "training set" in the computational learning sense. The "training" for the device's design and manufacturing would come from extensive engineering design, material science, and manufacturing process validation, which are not detailed in this excerpt.

9. How the ground truth for the training set was established:

Not applicable. As there is no "training set" for an AI algorithm, this question does not apply. The "ground truth" for the device's initial design and subsequent multiple-use validation is based on established engineering principles, regulatory standards (like the FDA Guidance for Hemodialyzer Reuse Labeling), and clinical guidelines for hemodialysis treatment.

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