Venous Return Cannulae

The Venous Return Cannulae are single-use, sterile, non-toxic cannulas designed for drainage of the superior and inferior vena cava during cardiopulmonary bypass surgery for up to six hours. They consist of a PVC polymer tube with wire reinforcement in the distal section and a lighthouse-shaped tip to allow venous blood flow into the cannula.

The devices have the same fundamental technological characteristics and principles of operation as predicate devices. The primary change is replacement of the PVC material in the body and tip with a phthalate-free PVC formulation (removing DEHP and DnHP plasticizers). The devices are ethylene oxide sterilized, single-use only, with a non-pyrogenic fluid path, and available in multiple French sizes with straight or right-angle tip options.

Testing was conducted in accordance with ISO 18193, including visual inspection, connector testing, cannula clamp test, blood pathway integrity, flow rate and pressure drop measurements, kink resistance, label legibility, collapse resistance, pull strength, blood trauma characterization, and biocompatibility assessment.

The Venous Return Cannulae are substantially equivalent to five predicate devices (K943934, K890980, K861496, K994209, K120988) based on equivalent intended use, same fundamental technological characteristics, and principles of operation. The material change to remove phthalates does not raise new safety or effectiveness questions. No clinical testing was required because predicate devices have proven safety and efficacy with years of market use, and non-clinical testing supports substantial equivalence.