MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula

The MC2™ Two-Stage Venous Cannula and MC2X™ Three-Stage Venous Cannula are wire-wound PVC devices used for venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery, with a maximum duration of six hours or less. Each cannula features side ports in the distal tip, a ported atrial basket drainage site, and insertion depth marks for positioning.

The devices are substantially similar to the predicate device in all respects except for one modification: a cannula body material formulation change. All other characteristics remain equivalent, including the operating principle, design features, sterilization method (ethylene oxide), shelf-life, packaging, and overall dimensions (approximately 15¼ inches long with 3/8 to 1/2 inch connection sites).

Not stated in this summary.

The applicant argues substantial equivalence based on the fact that the only modification from the predicate is a material formulation change to the cannula body. Pre-clinical bench testing on both accelerated and real-time aged samples confirmed that this material change does not impact performance (pressure integrity, kink resistance, tensile strength), blood trauma characteristics (hemoglobin, hemolysis, platelet effects), or biocompatibility (cytotoxicity, sensitization, pyrogenicity, complement activation). Since design outputs conform to design inputs and the material change does not introduce new safety or effectiveness concerns, the modified device maintains substantial equivalence.