Inspire HCR and HCR DUAL cardiotomy reservoirs

The Inspire HCR and Inspire HCR DUAL cardiotomy reservoirs are single-use, sterile devices designed for suction blood recovery during extracorporeal circulation (heart-lung machine) procedures. They collect and store suctioned blood, support system priming, and filter and defoam blood, with a maximum use time of 6 hours or less.

The devices have the same fundamental technological characteristics and principles of operation as their predicate devices, except they lack venous blood filtering components (venous return connector and filter). Two material changes were made: the hot melt glue used to seal the cardiotomy filter was changed, and the polypropylene conveyor material in the non-activated blood section of the HCR DUAL was changed.

The devices comply with applicable voluntary standards related to cardiovascular systems. Testing performed included blood trauma, pressure integrity, pressure drop, leak/connector integrity, defoaming/maximum operating volumes, and flow rate capacity assessments in accordance with national and international standards.

The Inspire HCR and HCR DUAL are substantially equivalent to their predicate devices (Inspire HVR, K130433, and Inspire HVR DUAL, K122844) based on equivalent intended use, identical technological characteristics except for removal of venous filtering components, and equivalent performance testing demonstrating no new safety or effectiveness concerns.