VIKING™ Fixed Curve Diagnostic Catheter

The VIKING Fixed Curve Diagnostic Catheter is an intracardiac electrode recording catheter used to diagnose cardiac arrhythmias. It records electrical signals from heart tissue, transmits them through electrode wiring and connectors to an EP recording system, and allows physicians to perform temporary intracardiac sensing, recording, stimulation, and pacing during evaluation of cardiac arrhythmias in adult patients.

The subject device incorporates substantially equivalent design, packaging, fundamental technology, manufacturing processes, and sterilization process (ethylene oxide) as the predicate device. The only differences are minor modifications to certain design requirements and test methods to align with current standards and Boston Scientific's quality system.

ISO 11737-1 (Microbiological Methods for determining microorganism population), ISO 11607-1 (Packaging Sterility), and applicable product specifications. Design verification testing was conducted at baseline and 25 months accelerated aging to support labeled shelf life.

The subject device is substantially equivalent because it has identical indications for use, design, product function, materials, and sterility characteristics as the predicate Viking Diagnostic Electrode Catheter. Performance data demonstrate that the device meets all applicable product specifications and performs equivalently when tested under baseline and accelerated aging conditions. The minor design and test method modifications do not affect the fundamental intended use or safety and effectiveness profile.