(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.
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.