(112 days)
NxStage PureFlow Solution is indicated for use with NxStage renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis for chronic care patients.
The NxStage PureFlow Solution is a family of premixed dialysate solution formulations which are sterile, non-pyrogenic, fully constituted dialysate solutions provided in 5L single use flexible bags.
The provided text describes the 510(k) premarket notification for the NxStage PureFlow Solution, a pre-mixed dialysate for hemodialysis. However, the document does not contain information about a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
The document discusses performance testing for the NxStage PureFlow Solution, which is a physical medical device (a liquid solution in a bag), not a software or AI-driven diagnostic device. Therefore, the acceptance criteria and study details requested in the prompt (e.g., sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance) are not applicable to the content of this document.
The performance data mentioned in the document for the NxStage PureFlow Solution are related to:
- Analytical testing: per device specifications and applicable sections of USP and EP.
- Physical testing of container (bag): per device specifications.
- Container closure integrity testing: per ISO 11607-1.
- Temperature excursion testing: per device specifications.
- Stability/Shelf-life testing: per ICH Q1A to support a 24-month shelf life.
- Ship testing: per ASTM D4169-22.
- Biocompatibility testing: in accordance with ISO 10993-1 and FDA guidance, including chemical characterization, toxicological risk assessment, cytotoxicity, sensitization, irritation, pyrogenicity, hemocompatibility, and systemic toxicity.
- Human Factors Validation Testing: in accordance with FDA guidance and AAMI/ANSI/EC 62366-1.
- Electrical Safety and EMC: Not Applicable (the device has no electronic features).
- Software Verification and Validation Testing: Not Applicable (the device has no software features).
- Animal Studies: Not Applicable.
- Clinical Studies: Not Applicable.
The conclusion states that "Verification and validation was conducted to characterize the proposed device and the predetermined acceptance criteria were met." However, the document does not enumerate specific quantitative acceptance criteria or the specific performance metrics achieved in these tests, only the types of tests conducted.
Therefore, I cannot provide the requested information about AI acceptance criteria and study details based on the provided document.
§ 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.