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510(k) Data Aggregation
(190 days)
GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR
POLYFLUX LR is intended for use in hemodialysis for the treatment of acute and chronic renal failure. The POLYFLUX LR may be reprocessed for reuse on the same patient.
The Gambro POLYFLUX 6 LR, 8 LR, and 10 LR, Capillary Dialyzers labeled for multiple use / reuse are identical in design, materials, function and intended use to the Gambro POLYFLUX 6L, 8L, and 10L Capillary Dialyzers/ Filters labeled for single use which have been previously cleared by the FDA under a 510(k) Notification for single use (510(k) Notification K010985). These devices are intended for use in hemodialysis for the treatment of acute and chronic renal failure and for certain types of intoxications. They may also be used in cases of acute fluid overload for the removal of plasma water. The membrane used in this device is polyarylethersulfone (PES) which is identical to the membrane utilized in the Gambro POLYFLUX 6L, 8L, and 10L Capillary Dialyzers/ Filters labeled for single use which have been previously cleared for marketing in the United States under 510K Notifications (K010985). Blood enters a blood inlet port where it is distributed to the 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 hollow fibers in each hemodialyzer / filter is 10,00 for the POLYFLUX 6 LR, 10,000 for the POLYFLUX 8 LR, and 12,500 for the POLYFLUX 10 LR. This effective membrane length is 210 mm for the POLYFLUX 6 LR, and 250 mm for the POLYFLUX 8 LR and 10 LR. The effective membrane surface area is 1.4 square meters for the POLYFLUX 6 LR, 1.7 square meters for the 8 LR and 2.1 square meters for the 10 LR. The housing and end caps of this hemodialyzer / filter are made of polycarbonate. The fibers used in the Gambro POLYFLUX 6 LR, 8 LR, and 10 LR are of the same composition as those previously approved for the Gambro POLYFLUX L 6L, 8L, and 10L Capillary Dialyzers/ Filters labeled for single use and multiple use (K010985). 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 membrane, plasma water along with certain lower molecular weight solutes 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 the membrane and into the counter current flowing dialysis solution during hemodialysis. The dialysate exits the devices via a dialysate outlet port.
The provided text does not contain detailed acceptance criteria or a specific study proving the device meets these criteria in the format requested for AI/software-based devices. Instead, this document is a 510(k) summary for a medical device (hemodialyzer/filter) under the traditional regulatory pathway (K023615).
The core of this submission is to demonstrate "substantial equivalence" to a predicate device, not necessarily to meet pre-defined performance acceptance criteria through independent studies as would be typical for novel AI/software devices.
However, I can extract information related to the device's performance based on the provided text, interpreting "acceptance criteria" in the context of substantial equivalence to the predicate device.
Here's an attempt to answer using the provided information, noting where the requested details are not applicable or unavailable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (POLYFLUX 6LR, 8LR, 10LR) |
|---|---|
| Identical design, materials, function, and intended use as predicate device (POLYFLUX 6L, 8L, 10L single-use) and predicate device (POLYFLUX L 6L, 8L, 10L single and multiple use) | Stated as "identical in design, materials, function and intended use" to K010985 (POLYFLUX 6L, 8L, 10L single use). Also stated as "identical in design, materials, intended use and construction" to the currently marketed POLYFLUX 6L, 8L, 10L (single-use). The only stated difference is the addition of "multiple use". |
| Performance characteristics substantially equivalent to predicate devices. | "Both the predicate and the proposed devices, incorporate identical membranes and other blood and non-blood contact materials and have identical performance characteristics." "With respect to performance, these hemodialyzer/filters perform in a manner substantially equivalent to each other." |
| Safety and effectiveness. | "Testing performed on the Gambro POLYFLUX LR Capillary Dialyzers indicates that they are safe, effective, and perform as well as the predicate devices, when used in accordance with the instructions for use." |
| Compliance with FDA Guidance for Hemodialyzer Reuse Labeling (for multi-use). | "In vitro data was collected according to the FDA Guidance for Hemodialyzer Reuse Labeling." "Clinical data was collected according to the FDA Guidance for Hemodialyzer Reuse Labeling." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "In vitro data" and "Clinical data" were collected, but it does not specify the sample size for either. The data provenance (country of origin, retrospective/prospective) is not mentioned.
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 is not applicable to this type of device and submission. The "ground truth" for a hemodialyzer's performance is typically established through direct measurement of physical and chemical parameters (clearance, ultrafiltration, etc.) in mechanical or biological models, rather than expert interpretation of data points.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the evaluation of a hemodialyzer does not involve subjective expert adjudication in the way AI model performance is often assessed.
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
This is not applicable. This submission is for a physical medical device (hemodialyzer/filter), not an AI algorithm. Therefore, no MRMC study involving human readers and AI assistance was conducted or would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for a hemodialyzer's performance typically comes from:
- In vitro measurements: Direct quantitative measurements of device parameters such as urea clearance, creatinine clearance, ultrafiltration rate, sieving coefficients, etc., using standardized test solutions and conditions.
- Clinical outcomes: Observations of patient physiological parameters (e.g., reduction in uremic toxins) during actual use, compared to expected performance or to the predicate device.
The document states "In vitro data was collected" and "Clinical data was collected."
8. The sample size for the training set
This is not applicable as this is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as above.
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