(435 days)
Hemodialysis with a PUREFLUXTM-L hemodialyzer is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.
The device is for prescription use only.
This product is intended for single use only. The performance properties of reused dialyzers have not been established.
The PUREFLUXTM-L hemodialyzer is a medical device used as an artificial kidney system for the treatment of patients with renal failure. 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 PUREFLUXTM-L hemodialyzer is composed of polyethersulfone fiber and is available in various sizes, which are differentiated by membrane surface area.
The provided document is a 510(k) summary for the Nipro PUREFLUX™-L Hemodialyzer. It details the device's description, intended use, and a comparison to predicate devices, but it does not contain the information requested in points 1-9 regarding specific acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a device performance study that would typically be associated with AI or diagnostic imaging devices.
The document discusses non-clinical studies for "analyte clearance (urea, creatinine, phosphate, Vitamin B12), ultrafiltration coefficient and pressure drop" to establish substantial equivalence to predicate devices (K062079 Baxter Xenium Hemodialyzer, K926005 Fresenius Hemoflow, K043244 Fresenius Optiflux). However, it does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number/qualifications of experts for ground truth.
- Adjudication methods.
- Results from multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size or ground truth establishment for a training set.
This type of information is generally not relevant for 510(k) submissions of hemodialyzers, which rely on demonstrating substantial equivalence in physical and performance characteristics (like clearance rates and ultrafiltration) to already approved predicate devices, rather than the types of clinical performance evaluations and AI model validation studies relevant to the provided questions.
§ 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.