multiFlux 130 (F00013123); multiFlux 160 (F00013124)

The multiFlux 130 and 160 are single-use, high-flux hemofilters intended for extracorporeal blood purification in acute kidney injury patients. They remove uremic toxins, excess water, and correct electrolytes and acid-base balance using semipermeable hollow fiber membranes during continuous veno-venous hemofiltration (CVVH), hemodialysis (CVVHD), or hemodiafiltration (CVVHDF).

The devices are high-flux, steam-sterilized filters with 1.3 m² and 1.6 m² surface areas respectively, composed of polysulfone-polyvinylpyrrolidone fiber membranes with vitamin E, polypropylene housing, and polyurethane potting resin. They utilize counter-current flow design with typical urea clearance rates of 34 mL/min (multiFlux 130) and 67 mL/min (multiFlux 160).

Performance testing conducted per ISO 8637 First Edition 2017-11 and FDA Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers (August 1998). Biocompatibility assessed per FDA guidance Use of International Standard ISO 10993-1, and human factors validation per FDA guidance Applying Human Factors and Usability Engineering to Medical Devices (2016).

The multiFlux 130 and 160 are substantially equivalent because they share identical intended use, principle of operation, design, materials, sterilization method, and performance requirements as the predicate multiFlux 1000 (K240394) and secondary predicate FX CorAL dialyzers (K243784). The proposed labeling and sieving coefficient changes do not impact biological safety, and no animal or clinical studies were needed due to material identity with cleared predicates.