DCX Disposable Cassette (DCX)

The DCX Disposable Cassette is a sterile, single-use component of the RM4 Kidney Perfusion System designed for pulsatile hypothermic machine perfusion of kidneys during preservation and transplantation. It provides a sterile fluid pathway, houses and protects kidneys in an organ chamber, and circulates perfusate through a gravity flow system and pumphead to deliver oxygen and nutrients to the organ.

The DCX differs from the predicate DCM-100 cassette in four ways: (1) addition of connection luer for perfusion accessories; (2) direct oxygenation in the organ chamber instead of via an external membrane; (3) removable partition allowing single-organ perfusion with 1L perfusate instead of 2L; and (4) two removable lids instead of one. Storage conditions are narrower (2–25°C with temporary 40°C tolerance versus 5–50°C), though the temperature range is clinically similar.

ISO 11135 (sterilization validation); ISO 10993-7 (sterilization biocompatibility); ISO 10993 (biomaterial safety testing including cytotoxicity, skin sensitization, primary skin irritation, hemolysis, and acute systemic toxicity); stability testing per labeled storage conditions of 2–25°C for 24 months shelf life.

The technological differences do not raise new safety or effectiveness concerns because the modifications—direct oxygenation, removable partition, additional lid, and luer connections—either improve clinical usability or provide alternative means to achieve identical functional outcomes (organ perfusion and preservation). Non-clinical testing demonstrated the device meets all performance requirements when used with the RM4 control unit and accessories. The predicate (DCM-100) was already cleared for the same kidney preservation indication, and the DCX maintains identical principles of operation, sterilization method, shelf life, and compatibility with the control unit.