We will need to provide the following on a 510(k) PMA
Substantial equivalence to a predicate IVUS device and OCT device
IVUS device
Potential predicate devices
K161125, opticross X, an IVUS catheter
K141453 ILUMIEN OPTIS, DRAGONFLY OPTIS IMAGING CATHETER
FDA Required Test
Tip Tensile Testing
Torque Strength Test (Torsional Strength)
Particulate Evaluation
Flexibility and Kink Test
Bio-compatibility testing
