Dual Stage Venous Cannulae

The Dual Stage Venous Return Cannulae are single-use, sterile medical devices composed of PVC polymer tubing with wire reinforcement in the distal section. They are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery for up to six hours. The cannula features a lighthouse-shaped distal tip with multiple perforations to facilitate blood flow, and a clear proximal section that can accommodate a barbed connector for standard cardiopulmonary bypass tubing.

The Dual Stage Venous Return Cannulae have the same fundamental technological characteristics, principles of operation, and control mechanisms as the unmodified predicate devices. Both are composed of PVC polymer tube with distal wire reinforcement, feature a lighthouse-shaped tip with multi-stage perforations, are ethylene oxide sterilized, and have a non-pyrogenic fluid path for single use only.

ISO 18193 ed. 2021 was used for verification and validation testing, including visual inspection, connector pull testing, clamp testing, blood pathway integrity, flow rate and pressure drop analysis, kink resistance, label legibility, collapse resistance, pull strength, blood trauma characterization, and biocompatibility testing.

Substantial equivalence is established based on equivalent intended use and technological characteristics to the predicate device (unmodified Venous cannulae cleared under K943934), which has been on the market for several years with proven safety and efficacy. The modified Dual Stage Venous Return Cannulae do not raise new questions regarding safety and effectiveness and passed all non-clinical testing in accordance with applicable standards.