(259 days)
The AmeriWater Solution Mix and Distribution System for Hemodialysis is intended to be used in a hemodialysis facility to mix and deliver, to the point(s) of use, bicarbonate and acid solutions necessary for hemodialysis. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications.
AmeriWater Bicarb Mix and Distribution System, Models 00BC55-55, 00BC100-100, and 00BC100-200 (Dual Tanks): The AmeriWater Bicarb Mix and Distribution System for Hemodialysis is intended to be used in a hemodialysis facility to mix and deliver, to the point(s) of use, bicarbonate solutions necessary for hemodialysis. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications.
AmeriWater Solution Mixing System, Model 00BC100 (Single Tank): The AmeriWater Solution Mixing System is intended to be used in a hemodialysis facility to mix and deliver, to the point(s) of use, bicarbonate solutions necessary for hemodialysis. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications.
AmeriWater Acid Concentrate Distribution System, Models 00AS130, 00AS300, and 00AS500: The AmeriWater Acid Concentrate Distribution System is intended to be used in a hemodialysis facility to store and deliver, to the point(s) of use, acid concentrate solutions necessary for hemodialysis. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications.
AmeriWater Wallboxes for Dialysis: The AmeriWater Wallbox for Dialysis is intended to be used in a hemodialysis facility as the point of connection for purified water, bicarbonate, and acid solution, for use in hemodialysis applications. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications.
The AmeriWater Bicarb Mix and Distribution System utilizes purified water from the dialysis facility's water purification system to mix bicarbonate solution and to distribute the solution to the point(s) of use. The system features automatic fill and mix, high vortex pumped mixing action, lightly pressurized distribution, and efficient disinfection. A single tank version, the AmeriWater Solution Mixing System, is also available to mix solutions from concentrate.
The AmeriWater Acid Concentrate Distribution System is used to store and distribute the acid concentrate(s) required for hemodialysis to the point(s) of use. Solution stored in and distributed by the Acid Concentrate Distribution System is mixed prior to being transferred to the system. Lightly pressurized distribution and recirculation provides steady, consistent delivery.
AmeriWater Wall Boxes are recessed boxes located at the point(s) of use that are intended to provide acid, bicarb, and/or water connections for the dialysis machine fittings used in the hemodialysis facility. Wall boxes are available in several configurations. Wall dialysis machine fittings are professionally installed by AmeriWater.
I am sorry, but the provided text describes a medical device, the "AmeriWater Solution Mix and Distribution System for Hemodialysis," and its regulatory clearance (510(k) K051031). It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. This document is a regulatory submission for substantial equivalence, not a scientific study report.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as that information is not present in the provided text.
§ 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.