DIASAFEplusUS (F00013010)

The DIASAFEplusUS is a dialysis fluid filter that produces ultrapure dialysis fluid and sterile, non-pyrogenic substitution fluid from pretreated water for use in chronic and acute hemodialysis and hemodiafiltration. It reduces microbial contaminants and endotoxin in dialysate during treatments and is compatible with 2008-series and 5008X hemodialysis machines.

The device has identical principle of operation, materials, design specifications, and performance requirements as the predicate device (K243505). It features a polysulfone-polyvinylpyrrolidone fiber bundle, polypropylene housing, 2.1 m² surface area, filtration rate ≥300 mL/hr/mmHg, and maximum use life of 90 days. The only changes proposed are limited to labeling with no impact on performance.

The device is classified according to FDA guidance on ISO 10993-1 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, dated 08 September 2023) as an externally communicating, blood path indirect, long-term contact (>30 days) Class II device.

The proposed DIASAFEplusUS is substantially equivalent to the predicate device because it has the same intended use, indications for use, principle of operation, technological characteristics, design, materials, and performance requirements. The device is identical to the predicate with respect to manufacturing, design, and materials, with only labeling changes that do not impact device performance or biological safety.