(231 days)
Mueller Water Conditioning's Water Purification System for Hemodialysis is intended for use in hemodialysis treatment. The System is used to dilute dialysate concentrate to form dialysate and to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate. When used to produce purified water for dialyzer reprocessing, equipment rinse and disinfection. When used as a medical device, Federal law restricts this device to sale by or on the order of a physician.
The Mueller RO/Di system for hemodialysis treats incoming facility water to provide water conforming to AAMI standards for hemodialysis use in respect to organic and inorganic substances as well as microbial. The water is intended for use as dilute dialysate, as dilute dialysate, as dilute dialysate, bicarbonate, acetate and sterilant for dialyzer reprocessing.
The core components of the system include carbon filters along with reverse osmosis (RO) unit and portable exchange deionization tanks along with alarms to remove oxidants from the water that are harmful to patient health. The specific configuration of the equipment will depend upon the customer's water quality desires (specifications) beyond the minimum AAMI standards.
Pretreatment is used before the RO unit to match the specific influent water quality to those required by the RO unit manufacturer's specifications. Pretreatment will include multi-media filtration, water softening, carbon filtration, and sediment filtration.
Post treatment is used after the RO unit to polish and monitor the water of any remaining contaminants. Deionization tanks, final filters, UV lamps, storage tanks, repressurization and recirculation pumps, flow meters, and resistivity monitors are examples of post treatment machines.
The Mueller Water Conditioning, Inc. (MWCI) water purification system utilizes no new water treatment technologies. Multimedia filtration, cartridge filtration, carbon filtration, reverse osmosis (R.O.), deionization, ultraviolet light and particulate filtration are the core methods of treatment for this system. The storage, piping, repressurization, recirculation, emergency bypasses, sanitization, labeling, training and customer service round out the efforts to ensure proper delivery of the treated water. All components of the claimed device use identical scientific principles to perform their function.
Here's an analysis of the provided text regarding the Mueller RO/DI System for Hemodialysis, focusing on acceptance criteria and the study proving it.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Mueller RO/DI System for Hemodialysis are the AAMI (Association for the Advancement of Medical Instrumentation) standards for water used in hemodialysis. The reported device performance is presented as a list of chemical component concentrations in the treated water.
| Component | Acceptance Criteria (Reference/AAMI Standard) | Reported Device Performance (Result) | Units | Meets or Exceeds AAMI Standards |
|---|---|---|---|---|
| Sodium Water | 70 | 0.054 | mg/L | Yes |
| Potassium, Water | 0.8 |
§ 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.