Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)

The Single Use Aspiration Needle NA-201SX-4021 and NA-201SX-4022 are sterile, single-use, disposable needles designed for ultrasound-guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree. They are used in combination with ultrasound endoscopes to obtain tissue samples for diagnostic purposes.

The subject devices differ from the predicate (NA-U401SX-4025N) in needle gauge (21G/22G vs. 25G) and maximum insertion portion diameter (1.9mm/1.8mm vs. 1.5mm). They share identical indications for use, working length (700mm), needle length range (20-40mm), sterilization method (ethylene oxide), shelf life (3 years), mechanism of sampling (aspiration), materials (SUS304, NiTi, PTFE), and connector type (Luer lock). The subject devices are optimized for 2.2mm endoscope channels whereas the predicate supports 2.0-2.2mm channels.

Biocompatibility testing was conducted in accordance with ISO 10993-1. Sterilization validation achieved a sterility assurance level of 10⁻⁶ using ethylene oxide.

The subject devices are substantially equivalent because they share the same intended use (ultrasound-guided FNA of tracheobronchial lesions), same product code and regulatory classification (Class II, KTI), and nearly identical technological characteristics and operational features as the predicate device. Performance testing confirmed the subject devices meet or exceed acceptance criteria for insertion, piercing, visibility, aspiration, and structural integrity. Although the needle gauges and diameters differ, bench testing demonstrated that these changes do not introduce new safety or effectiveness risks, and biocompatibility testing showed no new biocompatibility concerns. The differences in needle specifications represent refinements optimized for current endoscope technology rather than fundamental design changes that would alter the device's safety or performance profile.