Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle

This 510(k) clearance covers three related biopsy devices: an Automatic Core Biopsy Instrument (seven models with automatic and/or delay-firing options), a Semi-Automatic Core Biopsy Instrument (two models with manual plunger operation), and a Disposable Coaxial Biopsy Needle (two models used as a guiding needle). All are single-use, sterile, EO-sterilized devices intended for obtaining tissue samples from soft tissues including breast, liver, kidney, prostate, spleen, lymph nodes, thyroid, and various soft tissue tumors, but not bone.

The subject devices share the same fundamental design—inner stylet, cutting cannula, operating handle, depth stopper, and protective sheath—as their predicate devices. Key differences include: additional needle length options (80, 130, 180 mm for automatic; 8, 9, 13, 15, 18 cm for semi-automatic; 3–21.6 cm for coaxial needle); a 18.5 mm sample notch versus 18–20 mm in predicates; optional TPE depth stopper material in the coaxial needle; and ergonomic design refinements (rectangular handle with circular grip rings, safety switch, window indicator design). All use centimeter markings, color coding, and ultrasound enhancement for visibility.

ISO 10993 series (cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity); ISO 11135:2014 (EO sterilization validation); ISO 10993-7:2008 (biocompatibility of sterilization methods); ISO 11737-2:2019 (sterility testing); ASTM F1980:2016 (packaging and shelf-life). Sterilization assurance level (SAL) of 10⁻⁶ was validated.

The subject devices perform identical functions under the same clinical conditions as their predicates (BARD MAX-CORE K133948, Achieve K141552, BARD Mission K171953, and BARD TruGuide K171953), sharing the same mechanism of action and fundamental scientific technology. Differences in design (handle geometry, window markings, safety switches) are ergonomic improvements that do not affect safety or effectiveness. Extended needle length ranges address varying patient anatomy and lesion distances without introducing new safety concerns. The optional blunt needle and TPE materials have been biocompatibility-tested per ISO 10993 for externally communicating devices. Nonclinical performance testing (appearance, dimensions, sampling, stiffness, corrosion resistance, puncture force) demonstrated equivalence to predicates. The 18.5 mm sample notch falls within the predicate range of 18–20 mm, and all coaxial needle gauge sizes (13–19 G) overlap or are narrower than predicate offerings.