Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter

The Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter is a reprocessed electrode recording catheter indicated for use to diagnose cardiac arrhythmia. It is intended for temporary intracardiac sensing, recording, stimulation, and temporary pacing during evaluation of cardiac arrhythmias in adult patients, excluding pregnant and/or nursing patients.

The device is a radiopaque, flexible, insulated catheter with a polymer shaft and mechanical operating mechanism. The polymer shaft connects to the catheter handle, with the curve or loop actuated by a single pull cable. Dynamic XT catheters feature a plunger mechanism that, when moved forward or back, results in curvature of the distal tip. The reprocessed device undergoes a validated process including cleaning, inspections, functional tests, packaging, and sterilization, with devices tracked to not exceed one reprocessing cycle.

Not stated in this summary.

The predicate and proposed devices have identical indications for use (diagnosing cardiac arrhythmia) and technological characteristics (radiopaque, flexible catheters with plunger-actuated distal tip curvature). The subject device underwent functional performance testing including visual inspection, dimensional measurement, electrical safety, mechanical characteristics, continuity/isolation/resistance, and corrosion resistance. Cleaning validation, biocompatibility, sterilization validation, and product stability testing were also performed. Because the reprocessed device maintains the same materials, design, and functional performance as the predicate, it is substantially equivalent.