Disposable Biopsy Needle

The Disposable Biopsy Needle is a single-use sterile device intended for obtaining soft tissue biopsies (liver, kidney, breast, thyroid, prostate, spleen, pancreas, lymph nodes, lung, and soft tissue tumors) under imaging guidance. It consists of a cutting cannula, inner stylet, operating handles, depth stopper, and protective sheath, available in five models with different tip types (Chiba or Greene), bevel angles, and various needle gauges and lengths.

The subject device differs from predicates in offering two additional needle gauges (17G, 24G), extended needle length options (40–250 mm vs. 50–200 mm), both Chiba and Greene tip types (predicates have Chiba only), polycarbonate operating handles instead of other materials, and expanded anatomical site indications. The subject device is also usable under ultrasound and X-ray but not CT guidance, whereas predicates mention CT.

ASTM F1980 (packaging/shelf-life), ISO 10993-1, 10993-5, 10993-7, 10993-10, 10993-11, 10993-23 (biocompatibility), ISO 11135:2014 (sterilization validation), and performance testing covering appearance, dimensions, sample collection, Luer connection, stiffness, corrosion resistance, ultrasound/X-ray detectability, puncture force, sterility, and bacterial endotoxin.

Both tip designs (Chiba and Greene) achieve puncture via the same combination mechanism of cutting cannula and inner stylet, with performance testing demonstrating no significant difference in sampling weight or cell integrity across all indicated tissues. Additional needle gauges and lengths fall within the dimensional ranges of predicate devices and provide clinically beneficial options without introducing new safety risks. The PC material does not contact patients, and broader anatomical site indications remain within soft tissue scope. Comparative testing across nine tissue types showed substantially equivalent results to predicates.