(148 days)
pureFLOW solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy.
pureFLOW solutions are single-use, sterile, ready-to-use dialysis solutions consisting of sodium chloride, potassium chloride, magnesium chloride, sodium bicarbonate, and glucose. The pureFLOW dialysis are available in four (4) formulations which differ in potassium chloride concentration.
The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/human reader study or standalone AI performance.
The document is a 510(k) summary for a medical device called "pureFLOW" solutions, which are dialysate solutions used in Continuous Renal Replacement Therapy (CRRT). The entire summary focuses on demonstrating substantial equivalence of the new pureFLOW solutions (manufactured in Mexico) to a predicate pureFLOW device (manufactured in Germany).
The performance data section (1.8 Performance Data) does detail various tests conducted to support substantial equivalence. However, these are engineering and chemical tests related to the physical properties and stability of the product and its packaging, not diagnostic performance of an AI or human readers.
Specifically, the "Performance Data" section discusses:
- 5 L Bag Hanging: Stability of eyelets.
- Shipping and Distribution: Integrity and robustness of packaging.
- Injection Port: Integrity and penetration force of septum and injection port.
- Temperature and Pressure Resistance: Performance of the bag under varying temperature and pressure.
- Gas Barrier: Integrity of the bag as a CO2 barrier.
- Biocompatibility Testing: Chemical characterization, cytotoxicity, sensitization, irritation, material mediated pyrogenicity, hemocompatibility, genotoxicity.
- Human Factors Validation Testing: Found safe and effective for intended users, uses, and environments (no specific details on methodology or metrics provided in this summary).
- Electrical Safety and Electromagnetic Compatibility (EMC): Not applicable.
- Software Verification and Validation Testing: Not applicable.
- Animal Studies: None performed.
- Clinical Studies: None performed.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving a device meets them in the context of AI performance, human reader performance, MRMC studies, or related ground truth establishment, as this information is not present in the provided document. The device in question is a medical solution, not a software device that would involve such studies.
§ 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.