(458 days)
The AmeriWater Purification System for Hemodialysis is used to remove organic and inorganic substances and microbial contaminants from water. Purified (or treated) water will then be used to prepare and dilute dialysate concentrate to form dialysate and/or rinse dialyzers for multiple-use dialyzers. AmeriWater does not recommend nor endorse any other use for water treated with AmeriWater systems. AmeriWater further does not endorse any specific hemodialysis or reprocessing procedures or equipment.
The AmeriWater Purification System for Hemodialysis may include pretreatment components, reverse osmosis and/or deionization, post-treatment components, and a distribution system. All or some of the following components may be included in an AmeriWater Purification System for Hemodialysis based on the customer's needs: Tempering Valve, Float and Pressure Control, Temperature Gauge, Return Flow Diffuser, Backflow Preventor, Booster Pump(s), Multimedia Filter, Water Softener, Carbon Filtration, Micron Prefilter, Chemical Feed System, Reverse Osmosis, Pressure Gauges, Storage Vessel, Deionization, Submicron Filter, Distribution System, Distribution Pump(s), PVC Pipe and Fittings, PVC Ball Valves, PVC Labcock Valves, Automatic Lockout, and System Alarms.
System design is determined by the customer's needs and the water conditions at their facility. Components for the water system are selected based on a survey of the customer's requirements and a complete chemical analysis of the water to be treated. The system is complete with monitors and audible/visible alarms with remote activation in the area of patient care to notify staff of problems if they occur.
The AmeriWater Chemical Feed System is a pretreatment device that is designed to deliver chemicals to the city tap water in order to adjust various chemistries in the water. The chemical feed system is located at the front-end of a water treatment system and may be used for pH adjustment, or to mitigate certain water contaminants to help improve the performance of the complete water system.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets specific acceptance criteria.
The document is a 510(k) summary for the AmeriWater Purification System for Hemodialysis. It describes the device, its intended use, and lists components that can be included. It also details the specific components for which this 510(k) submission (K021560) is seeking clearance, primarily the AmeriWater Chemical Feed System and the combination of various previously cleared Reverse Osmosis (RO) units with the AmeriWater system.
The core of the document is the FDA's determination of substantial equivalence (K021560) to legally marketed predicate devices, which allows the device to be marketed. This is a regulatory clearance process, not a report on a performance study with acceptance criteria.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth, or details about a comparative effectiveness study.
§ 876.5665 Water purification system for hemodialysis.
(a)
Identification. A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.(b)
Classification. Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.