AquaA

The AquaA is a modular reverse osmosis water purification system designed to remove organic, inorganic, and microbial contaminants from water used in hemodialysis treatment. It can be configured with optional modules (AquaA2 for dual-stage RO, AquaHT for heat disinfection, AquaUF for ultrafiltration) and includes accessories like a Visual LED Indicator for remote monitoring and an optional AquaDETECTOR leakage monitoring system.

The AquaA maintains the same intended use, indications, design specifications, principle of operation, and performance requirements as the predicate device. Changes include hardware modifications (increased motor protection switch and power contactor spacing, increased switching current rating, and larger wire gauge for connectors) and a material substitution (platinum-catalyzed silicone tubing for disinfectant connection and fluid fly loop).

ISO 10993-1:2018 for biocompatibility testing evaluating cytotoxicity, sensitization, irritation, pyrogenicity, hemocompatibility, and chemical characterization. The device is classified per FDA guidance on biological evaluation of medical devices.

The proposed device is substantially equivalent because the hardware changes and material substitution do not alter the device's fundamental function, safety profile, or effectiveness. Verification testing confirmed the changes do not raise new safety or effectiveness concerns. Since the intended use, operating modes, and performance characteristics remain identical to the predicate AquaA (K213507), and the modifications only enhance component durability and reliability, substantial equivalence is supported.