UPT Series Medical RO Water Treatment System

The UPT Series Medical RO Water Treatment System is a reverse osmosis water purification system designed to remove organic and inorganic contaminants from tap water for use in hemodialysis treatment. It includes pretreatment (sediment filtration, carbon removal, water softening), reverse osmosis membrane separation (removing 95-99% of dissolved solids and bacteria), and post-treatment/distribution components. It is intended for multi-patient use in dialysis clinics or hospitals.

The device shares identical technological characteristics with its predicates in regulation number (21 CFR §876.5665), product code (FIP), pre-treatment options, operational features, safety features, and post-treatment design. The subject device uses the same reverse osmosis membrane separation process and water quality standards as the predicates.

Not stated in this summary.

The Indications for Use were clarified by removing inadvertent limitations for certain hemodialysis applications that existed in the predicate device, representing a minor labeling correction with no impact on actual device use or intended use. Since the technological characteristics are identical between the subject device and both predicates, and the intended use remains the same, no different questions of safety or effectiveness are raised. This satisfies the dual requirements of FD&C Act section 513(i): same intended use and identical technological characteristics.