Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)

The Injector Force Max Single Use Injector (NM-400/401 series) is a sterile, disposable injection needle device designed for use with Olympus endoscopes to perform endoscopic vascular or submucosal injections in the digestive tract. The device comprises a handle, needle, and sheath section with a slider mechanism that extends and retracts the needle to deliver fluids to targeted tissue.

The NM-400/401 offers both lancet and flat bevel needle options (versus lancet-only in the predicate NM-600/610), smaller insertion diameters as small as 1.9 mm (versus 2.6 mm), and longer working lengths up to 2700 mm. Materials differ: the subject uses polypropylene (PP) outer tube and perfluoroalkoxy (PFA) inner tube versus polytetrafluoroethylene (PTFE) for both in the predicate. The handle design is more ergonomic, and packaging film material differs with tested seal integrity.

Testing performed per ISO 10993 (biocompatibility), ASTM F1980-21 (accelerated aging), ISO 11607-1/2:2019 (sterilization and shelf life), and ISO 9626 (corrosion resistance). Performance bench tests included insertion/withdrawal, needle advancement/retraction, puncture, repeated operations, and fluid supply.

The NM-400/401 is substantially equivalent to the NM-600/610 predicate because both share the same intended use (endoscopic vascular/submucosal injection in the digestive tract), same FDA classification (Class II, 21 CFR 876.1500, product code FBK), same sterilization method (ethylene oxide), and same operational mechanism. Although the subject device incorporates design enhancements and material modifications, all changes were evaluated through comprehensive biocompatibility and performance testing, and no new safety or effectiveness issues were raised.