Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)

The Easyflow and Easyflow Duo are single-use cannulae designed for arterial return during cardiopulmonary bypass procedures. The Easyflow is used for aortic perfusion during cardiovascular surgery, while the Easyflow Duo with guidewire is used as a femoral arterial return cannula. Both devices are rated for up to 6 hours of use during extracorporeal cardiopulmonary bypass.

The modified Easyflow and Easyflow Duo retain the same fundamental design and function as their predicate devices but with a material change: the PVC body, tip, and suture ring were reformulated to remove phthalate plasticizers (DEHP and DnHP). No other design changes were made. Both devices remain PVC tubes with wire reinforcement in distal sections, perforated holes for fluid flow, and a 3/8 inch barbed connector for standard bypass tubing.

Not stated in this summary. The document indicates tests were performed in accordance with national and international standards but does not cite specific standard designations (ISO, ASTM, IEC, etc.).

The devices are substantially equivalent because they maintain identical intended use, technological function, and control mechanisms as the predicate devices (K060101 for Easyflow and K091542 for Easyflow Duo), which have been safely used for several years. The sole modification—removal of phthalates from PVC materials—does not alter performance or safety, as demonstrated by comprehensive biocompatibility and verification/validation testing showing the reformulated materials maintain all required functional characteristics including blood pathway integrity, flow rates, pressure resistance, and hemocompatibility.