OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090)

The OptiCross Coronary Imaging Catheters are sterile, short rail imaging catheters available in 5F and 6F sizes. They contain a rotating drive cable with a 40 MHz or 60 MHz ultrasonic transducer at the distal tip for intravascular ultrasound imaging. The device is intended for ultrasound examination of coronary intravascular pathology in patients who are candidates for transluminal coronary interventional procedures.

The devices incorporate substantially equivalent design, materials, fundamental technology, and interface with the IVUS imaging system as the predicate OptiCross HD and OptiCross 6 HD Coronary Imaging Catheters. The OptiCross and OptiCross 6 utilize a 40 MHz transducer for imaging, while the HD versions utilize a 60 MHz transducer for higher definition imaging. Additional design control requirements were established to formally define acceptable torque transmission limits and kink resistance performance consistent with the existing device design.

Not stated in this summary.

Based on comparison of intended use, technological characteristics, and fundamental design technology, including non-clinical performance bench testing verification data, the modified devices (OptiCross, OptiCross 6, OptiCross HD, OptiCross 6 HD, and their bagless variants) are substantially equivalent to the predicate devices per K230453 and raise no new issues of safety and effectiveness.