Shadow Catheter

The Shadow Catheter is a dual-lumen over-the-wire catheter designed to support and aim steerable guidewires during coronary and peripheral arterial interventions. It facilitates guidewire placement and exchange, enables two-guidewire procedures, and allows subselective infusion of diagnostic or therapeutic agents.

The subject device is a 4F catheter with uniform outer diameter and two full-length lumens (tracking and positioning guidewires exit distal and side ports respectively), compared to the predicate's 3.4F with asymmetrical distal end and mixed rapid-exchange/over-the-wire design. Both devices have hydrophilic coatings and accommodate two 0.014" guidewires, but the subject has coating only on the nosecone versus the predicate's longer working length coating.

ISO 10993-1 biocompatibility testing covering cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity, hemocompatibility, and genotoxicity. Non-clinical testing included dimensional verification, simulated use, bond strength, flexibility, torque, radiopacity, coating integrity, particulate evaluation, burst pressure, infusion flow rate, and corrosion resistance.

Although the subject and predicate devices differ in size, lumen configuration, and coating extent, both function similarly as dual-lumen guidewire-support catheters using 0.014" guidewires for coronary and peripheral access. The subject device's different technological characteristics do not raise new safety or effectiveness questions because it uses well-characterized common materials, passed comprehensive biocompatibility testing, and achieves the same intended purpose through comparable design principles despite dimensional and geometric differences.