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510(k) Data Aggregation
(172 days)
The capillary dialyzer is intended for use in hemodialysis and associated modalities for the treatment of chronic and acute renal failure.
The Gambro Polyflux family Capillary Dialyzers/Filters, labeled for single and multiple use, have the same design, materials, intended use and function as other hemodialyzers / filters currently marketed in the United States. These devices are intended for use in hemodialysis for the treatment of acute and chronic renal failure. They may also be used in cases of acute fluid overload for the removal of plasma water. The membrane used in this device is a blend of polyarylethersulfone (PAES), PVP, and Polyamide. Blood enters a blood inlet port where it is distributed to the hollow fibers. 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 and middle molecular weight solutes pass through the membrane and into the dialysate or filtrate compartment of the device. 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 countercurrent flowing dialysis solution during hemodialysis. The dialysate exits the devices via a dialysate outlet port.
This device is a hemodialyzer, not an AI/ML device, so many of the requested fields are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance) | Reported Device Performance |
|---|---|
| Same performance as predicate devices for hemodialysis and associated modalities. | The proposed Polyflux Dialyzers/Filters meet the same acceptance criteria as the predicate devices based on clinical studies. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable for this type of medical device which relies on physical and clinical performance rather than a data-driven model.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. Ground truth for a hemodialyzer's performance is established through in-vitro and clinical testing (e.g., clearance rates, ultrafiltration rates, safety), not expert consensus on interpretations of data.
4. Adjudication Method for the Test Set
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, this is not an AI/ML device that requires human readers for interpretation.
6. Standalone Performance Study
Yes, the device underwent "in vitro testing... to compare the performance of the proposed device configurations to the predicate configurations." This represents a standalone study of the device's technical specifications and performance characteristics.
7. Type of Ground Truth Used
The ground truth for the device's performance is established through:
- In-vitro testing: Measuring direct physical and chemical performance characteristics of the dialyzer (e.g., membrane permeability, solute clearance).
- Clinical studies: Observing the device's effectiveness and safety in real-world patient use. The comparison is against the performance of legally marketed predicate devices.
8. Sample Size for the Training Set
Not applicable, as this is not an AI/ML device that uses a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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