Retrograde Coronary Sinus Perfusion Cannulae

The Retrograde Coronary Sinus Perfusion (RCSP) Cannulae are medical devices used during cardiopulmonary bypass (CPB) procedures to deliver cardioplegia solution in a retrograde direction through the coronary sinus for up to 6 hours. The cannulae consist of a wire-wound silicone body with a beveled tip, side holes, an inflatable balloon, and integral pressure monitoring lines, designed for both adult and pediatric patient populations.

The device features a wire-wound silicone cannula body with beveled tip (6-Fr models are non-wire wound), two side holes near the tip, a locking female luer connection, integral pressure monitoring line, inflatable distal balloon, and inflation assembly with female slip luer and one-way valve. Cannulae include either a guidewire or solid stylet with male luer handle or TruTouch handle. Same sterilization methods, shelf-life, and packaging materials as predicate devices.

Not stated in this summary. The document references ISO 13485, ISO 13484, and ISO 13485 in the regulatory requirements section but does not cite specific test standards for the performance and biocompatibility testing conducted.

The RCSP Cannulae are substantially equivalent to predicate devices K860149 and K953945 based on identical intended use, operating principles, design features, technological characteristics, sterilization requirements, shelf-life, and packaging. The primary modification is expanded patient population to include pediatric patients, supported by pre-clinical bench testing and biocompatibility testing demonstrating conformance to design requirements without raising new safety or effectiveness questions.