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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.

This document describes the regulatory submission for the AmeriWater MediQA Reverse Osmosis System, Model MSP3HF. It is a Special 510(k) submission for the addition of a new model to an existing product line (K131904). The new model, MSP3HF, is largely identical to the predicate device, Model MSP3, with the primary difference being an upgrade to the RO pump to achieve a higher flow rate.

Here's an analysis of the acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance

The submission doesn't explicitly list "acceptance criteria" in a tabulated format with pass/fail results for the new model MSP3HF in the same way one might expect for a novel device. Instead, it demonstrates substantial equivalence to a predicate device (MSP3) by showing that the new model meets the same performance standards and that the design change (pump upgrade) does not negatively impact safety or effectiveness. The implicit acceptance criteria are that the device continues to meet the requirements of relevant standards and functions as intended.

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of individual patient data or a specific number of devices tested for the new model MSP3HF.

• For the original predicate device (K131904): Non-clinical testing was conducted to verify and validate performance. The details of samples used for these initial tests are not provided in this summary.
• For the new model (MSP3HF): Verification and validation testing was conducted. This included "complete system testing" where the device's performance was observed under various conditions. The sample size for this testing is implicitly "one device" (the MSP3HF model) or a representative number of units for its functional verification. The data provenance is internal testing by AmeriWater, LLC.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as this is a medical device (water purification system), not an AI/imaging device requiring expert interpretation for ground truth. Technical performance against established industry standards is the primary assessment.

4. Adjudication method for the test set

This information is not applicable for the same reason as point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable as this is a medical device (water purification system), not an AI/imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable as this is a physical medical device, not a software algorithm. The device operates autonomously to purify water.

7. The type of ground truth used

The "ground truth" for this device's performance is established by its ability to meet the specified performance parameters outlined in ANSI/AAMI/ISO 23500-1:2019 (for water quality) and ANSI AAMI ISO 23500-2:2019 and ANSI AAMI ISO 23500-3:2019 (for equipment and water standards for hemodialysis). Additionally, microbiological testing for the predicate device proved the effectiveness of the heat sanitization function.

8. The sample size for the training set

This information is not applicable as this is a physical medical device, not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable for the same reason as point 8.

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