MAGiC Sweep™ EP Mapping Catheter

The MAGiC Sweep™ EP Mapping Catheter is a diagnostic electrophysiology catheter designed for intracardiac electrophysiological recording and/or stimulation for pacing in the heart. It is a flexible, biocompatible catheter 130 cm long with 20 electrodes (1 tip, 19 ring) that can be magnetically guided through the vasculature using Stereotaxis robotic magnetic navigation systems to map cardiac tissue.

The MAGiC Sweep catheter has an 8F diameter tapering to 5F, with 20 total electrodes compared to the predicate Niobe's 2 electrodes. It offers 3 different electrode spacing configurations and 20 different magnet spacing configurations versus the Niobe's single configuration. Both use thermoplastic elastomer shafts, platinum-iridium electrodes, and encapsulated magnets, and both are 130 cm in length. The MAGiC Sweep has a larger proximal diameter (8F vs 7F) but similar materials and principles of operation.

Not stated in this summary. The document references testing based on 'existing standards and test methods' including visual, dimensional, electrical performance, mechanical performance, biocompatibility, and packaging evaluations, but does not cite specific standard numbers (ISO, IEC, ASTM, etc.).

The device is substantially equivalent because it shares the same indications for use, overall design principles, materials composition, and operational technology as the predicate Niobe catheter. Although the MAGiC Sweep has more electrodes and multiple spacing configurations for enhanced functionality, these are enhancements to the same fundamental design of a magnetically-navigated diagnostic catheter. Bench and animal testing demonstrated the device met specifications with no new safety or effectiveness concerns, confirming it performs the same intended function as the predicate despite added capability.