LMA Fastrach ETT SU

The LMA Fastrach ETT SU is a disposable, sterile, single-use endotracheal tube designed specifically for use with the LMA Fastrach airway device. It is a straight, cuffed, wire-reinforced tube with a Murphy Eye, depth markers, and a 15mm connector for ventilation. An accessory Stabiliser Rod is included for keeping the tube in place during removal of the Fastrach device after intubation.

The subject device differs from the predicate in three material changes: the main tube material was changed to non-DEHP PVC, the 15mm connector material changed from polypropylene to polyamide, and ink formulation was modified to include a reducer. The subject device is also MR Conditional (predicate not declared) and has a reduced shelf-life of 1 year versus 2 years. Packaging was also updated. All other design features, dimensions, sterilization method, and biocompatibility remain the same.

ISO 10993-1 (biocompatibility), ISO 18562-1, and FDA Guidance on Application of 10993-1. Bench testing included visual inspection, dimensional testing, bonding strength, kink resistance, cuff herniation, resistance to collapse, and tracheal seal testing.

The subject device maintains identical intended use, size range (6.0-8.0 mm), cuffed design, radiopacity, sterilization method (ethylene oxide), and core functional characteristics as the predicate. Material changes to non-DEHP PVC and connector material were implemented for regulatory compliance and biocompatibility and have been verified through appropriate testing per ISO 10993-1. The reduced shelf-life and new MR Conditional designation are based on completed testing and do not affect fundamental performance or safety. All critical performance characteristics tested (bonding, kink resistance, tracheal seal) were substantially equivalent to the predicate.