Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer

The Medline ReNewal Reprocessed Abbott Agilis NxT Steerable Introducer is a catheter introducer with a bi-directional steerable design used to guide cardiovascular catheters into the heart, including the left side, during cardiac arrhythmia treatment. It features a hemostasis valve, sideport for aspiration and monitoring, and distal vent holes for improved visualization and reduced cavitation.

The device is a reprocessed version of the predicate device with identical technological characteristics, materials, and fundamental scientific technology. It consists of braided stainless-steel wire covered with Pebax and Nylon, filled with barium sulfate, and includes a platinum/iridium marker. Each device undergoes one validated reprocessing cycle maximum, including cleaning, inspections, functional testing, sterilization, and tracking to prevent exceeding validated reprocessing limits.

Not stated in this summary.

Substantial equivalence is established because the subject reprocessed devices have identical indications for use and technological characteristics as the predicate device (Abbott Agilis NxT Steerable Introducer, K251211). Non-clinical testing demonstrates functional equivalence through performance testing including insertion force, torque response, kink resistance, cleaning validation, biocompatibility, and sterilization validation, all confirming that reprocessed devices maintain the predicate's safety and effectiveness profiles.