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The AmeriWater MediQA Reverse Osmosis System is one component of a water treatment system designed to pre-treat and purify potable water using reverse osmosis for making dialysate for hemodialysis applications. The device is intended to be a component in a complete water purification system, and is not a complete water treatment system. It must be preceded by pretreatment devices, and may need to be followed by post-treatment devices as well to meet current AAMI and Federal (U.S.) standards. The AmeriWater MediQA is intended for use in water rooms in a hospital, clinic, or dialysis center. The device includes an integrated heat sanitization process.

This Special 510(K) submission is for the addition of a new model to the AmeriWater MediQA Reverse Osmosis System product line originally cleared for market under 510(k) number K131904. The new model. MSP3HF is complementary to the rest of the product line and is not intended to replace or enhance features of any existing model. The MSP3HF is a single pass reverse osmosis (RO) that uses pretreated soft water to produce water for hemodialysis applications. The system is capable of producing dialysis quality water at a flow rate up to 16.0 gallons per minute (gpm). The new model, like the predicate device, includes heat sanitization capabilities for the reverse osmosis system. Model MSP3HF, is identical in design to the existing model MSP3 (K131904) with the exception of the RO pump. While model MSP3 includes a pump with a 20-stage impeller, the new model MSP3HF includes a pump with a 24-stage impeller (currently used on model MDP4). The increase in impeller stages results in the pump forcing more water through the existing membrane elements per unit time. Both the 20-stage pump and the 24-stage pump include the same pump motor. The increase in flow rate does not exceed the operating parameters of the membrane elements per the membrane manufacturer's specifications, and operating pressures remain the same as the predicate device. The increased flow rate does not change the product water quality (level of impurities), and the product water continues to meet all current AAMI/ISO and Federal requirements as confirmed by verification and validation testing. There are no changes to the software used in the device or to the water contacting materials. All software and materials used in the new model are identical to the predicate device. The new model does not result in any changes to the heat sanitization process. The temperatures, contact times, and operating pressures remain the same as the predicate device. During the heat sanitization process, the heated water is recirculated through the MediQA system for the duration of the contact time. The flow path, operating pressure, water temperature, and contact time are identical between the predicate device and the new device during heat sanitization. There are no new issues regarding safety or effectiveness of the heat sanitization process. The scientific concept for the operation of the AmeriWater MEDIQA Reverse Osmosis System is the principle of reverse osmosis. The MEDIQA system uses a pump (RO pump) to apply the pressure required for reverse osmosis. Pretreated soft water enters the MEDIQA through an inlet solenoid valve, filling the feed water tank. The RO pump forces water from the feed tank through the RO membrane elements. The water entering the RO membrane element exits the membrane element in two flow streams. The water forced through the RO membrane element is known as permeate water. It is purified water that meets all current AAMI/ISO and Federal requirements for water used in hemodialysis applications. The water rejected by the membrane contains an increased level of dissolved contaminants. It passes out of the RO module as the second flow stream called concentrate, and is sent to drain. The built in heat sanitization feature provides heat sanitization of the reverse osmosis membranes and the MEDIQA system's pipe work. Heat sanitization can be activated manually using the HEATSAN buttons on the touch screen display or automatically if timer clock settings are implemented. The frequency of heat sanitization will depend upon usage and application demands. Monitoring of the system for bacterial content is required at regular intervals to determine the optimum frequency for heat sanitization.