SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315)

The SelectSite C304 Deflectable Catheter System and C315 Delivery System are non-therapeutic delivery devices designed to aid in the introduction and placement of cardiac leads into the right chambers of the heart for patients requiring cardiac implantable electronic devices (CIEDs) to treat heart rhythm disorders. The C315 contains a catheter and dilator for lead introduction, while the C304 is a deflectable catheter system with additional components like a guidewire, needle, and syringe for accessing the coronary sinus and heart chambers.

The subject devices are technologically identical to their respective predicates in design, physical characteristics, materials, packaging, and sterilization. Both devices maintain the same intended use, operating principle, design features, device functionality, biological safety, packaging materials, and shelf life as their predicates. The only difference is that the subject devices include updated instructions for use with warnings for potential small-bore misconnection, making them compliant with ISO 80369-7 clause 7f.

ISO 80369-7 is cited as the consensus standard for small-bore connector safety, which the updated labeling now addresses in compliance with clause 7f of that standard.

Substantial equivalence is established because the subject devices have identical indications for use, intended use (introducing transvenous devices to the heart), device functionality, and technological characteristics as their predicates. The only modification is a labeling update to warn of potential small-bore misconnection, which is a safety enhancement supported by verification activities and brings the devices into compliance with an applicable international standard, rather than introducing new risks or changing device performance.