Moda-flx Hemodialysis System™ Cartridge (102121-001 )

The Moda-flx Hemodialysis System™ Cartridge is a single-use, disposable blood tubing set containing arterial and venous bloodlines with dialysate tubing. It is designed to provide extracorporeal vascular access during hemodialysis and is compatible only with the Moda-flx Hemodialysis System™.

The fundamental technological characteristics are consistent between the subject device and predicate devices. The modifications to the Moda-flx Hemodialysis System Cartridge represent design refinements rather than fundamental changes to the underlying technology or function.

Not stated in this summary. The document references performance testing including mechanically-induced hemolysis testing, air bolus testing, continuous air infusion testing, blood flow rate testing, tensile testing of tubing joints, pressure leak testing, and simulated use testing, but does not cite specific consensus standards or test method numbers.

The device demonstrates substantial equivalence through design verification and validation testing showing that the modifications to the Moda-flx Hemodialysis System Cartridge maintain the same fundamental function and performance characteristics as the predicate device (K233798). The performance data validate that the subject device achieves equivalent results to the predicate across all critical safety and functional parameters.