Disposable Biopsy Needle

The Disposable Biopsy Needle is a sterile, single-use, spring-loaded percutaneous biopsy instrument intended for obtaining soft tissue samples from organs such as liver, kidney, and prostate under ultrasound guidance. It consists of a cannula, inner stylet, mechanical power device, and protective cover, and is not intended for bone biopsy.

The subject device is an 18-gauge biopsy needle available in 100mm, 150mm, and 200mm lengths with a 21mm penetration depth and 18mm sample notch. It uses spring-operated mechanics, ethylene oxide sterilization at 10⁻⁶ SAL, and includes materials such as stainless steel cannula/stylet, polydimethylsiloxane fluid, POM, ABS, and polypropylene. It has a 2-year shelf life and includes a locking safety feature.

ISO 10993 series (Parts 5, 10, 23, 11, 4) for biocompatibility; ISO 11135 and ISO 10993-7 for sterilization and ethylene oxide residuals; ISO 9626, ISO 7864, and ISO 6009 for needle specifications; ASTM standards (F1886, F1929, F88, F1980, D4169, F756) for packaging and seal integrity; USP tests for pyrogen and sterility; and DIN 58953-6 for microbial barrier testing.

The subject device is substantially equivalent because it shares the same intended use (soft tissue biopsy), same regulatory classification (Class II, 21 CFR 876.1075, Product Code KNW), identical spring-operated mechanism, and comparable performance characteristics to the predicate Bard Max-Core device. While the subject device covers only 18-gauge specification versus the predicate's 14G-20G range and uses ultrasound-only visualization versus the predicate's multiple modalities, these are restrictions rather than expansions of intended use. Non-clinical testing demonstrates biocompatibility, sterilization effectiveness, packaging integrity, and sampling performance matching the predicate, with documented testing confirming the safety lock function and tissue sampling capability across porcine and canine tissues.