Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)

The Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing (SR180C) is a single-use sterile tubing pack designed for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures lasting up to 6 hours. The device consists of DOP-free polyvinyl chloride (PVC) tubing with a 9.5mm inner diameter, coated with a proprietary Camouflage coating, and is intended for adult patients requiring CPB.

The device is substantially equivalent to the predicate (Medtronic Tubing Pack K171979) in indications for use, materials, technological characteristics, performance criteria, and sterilization methods. The key difference is that this device uses DOP-free PVC coated with Smart Reactors' proprietary Camouflage coating, whereas the predicate uses uncoated DOP-free PVC and polycarbonate with various surface coatings (Cortiva, Trillium, Balance). Both are single-use, sterile, EtO-sterilized devices with 2-year shelf lives.

The device was tested per ISO 15676:2016 (CPB tubing pack requirements), ISO 18193:2021 (extracorporeal circulation cannulae), EN 13868:2002 (catheter kinking test methods), and ISO 11658:2012 (blood/tissue contact surface modifications). Biocompatibility testing was performed to ISO 10993 series standards.

Smart Reactors' device is substantially equivalent to the predicate because it has identical intended use and indications for use, the same target population and user, comparable materials and technological characteristics, equivalent biocompatibility, and the same sterilization method and shelf life. The proprietary Camouflage coating does not raise new safety or effectiveness questions, and biocompatibility testing confirmed the device is safe for its intended use.