VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D)

The VeriSight and VeriSight Pro Intracardiac Echocardiography (ICE) catheters are sterile, single-use catheters with ultrasound transducers at the distal end for 2D and/or 3D imaging. They are designed to visualize cardiac and great vessel anatomy during cardiac interventional procedures in both adult and pediatric patients, providing imaging guidance only (not treatment delivery).

The subject devices are identical to the previously cleared VeriSight/VeriSight Pro ICE catheters in all materials, processing, assembly, and packaging. The VeriSight provides 2D imaging while VeriSight Pro provides 2D and/or 3D imaging depending on the connected Philips EPIQ ultrasound system. Both have a 9 French shaft, 90 cm usable length, four-way articulation, and are sterilized via ethylene oxide.

Not stated in this summary.

The submission adds pediatric indications to the already-cleared adult device without any hardware or design changes. Sterility testing data from the predicate device established safe weight thresholds for pediatric patients to avoid harmful ethylene oxide and ethylene chlorohydrin exposure, with appropriate warnings added to labeling. Since the device uses identical technology and operating principles, shares substantially similar indications, and involves only a labeling change to add pediatric use, no new questions of safety or effectiveness are raised.