Agilis NxT Steerable Introducer Dual-Reach

The Agilis NxT Steerable Introducer Dual-Reach is a sterile, single-use catheter introducer with a 13F inner diameter. It features a hemostasis valve, a rotating collar handle for deflecting the tip clockwise ≥180° and counterclockwise ≥90°, distal vent holes, and a radiopaque tip marker. It is indicated for introducing various cardiovascular catheters into the heart, including the left side, during treatment of cardiac arrhythmias.

Compared to the predicate device (K241370), the subject device includes additional curl in medium and large deflectable configurations, reduced distal tip wall thickness, larger pull ring/wires and braid wire, an improved pull wire lock mechanism, minor modification to hemostasis hub side port location, packaging tray adoption from 8.5F Agilis models, and a minor deflection angle modification.

ISO 80369-7, ANSI AAMI ISO 10993-1:2018 (biocompatibility), ANSI AAMI ISO 11135:2014/A1:2018 (ethylene oxide sterilization), ANSI AAMI ST72:2019 (bacterial endotoxins), ISO 11607-1 and -2 (packaging), ISO 15223-1 and ISO 20417 (labeling and symbols).

The subject and predicate devices share identical intended use and indications for use, and both employ the same fundamental scientific technology for catheter introduction. Design verification testing confirmed that all risks associated with the design modifications (enhanced deflectability, material sizing, mechanical improvements) were mitigated to acceptable levels with no new safety or effectiveness questions raised. The testing across performance, biocompatibility, sterility, and shelf-life validates functional and safety equivalence.