Bone Marrow Biopsy Needle

The Bone Marrow Biopsy Needle is a manual, sterile, single-use disposable device designed to aspirate bone marrow and obtain core biopsy samples of bone and/or bone marrow. It consists of a stylet and cannula that work together to penetrate tissue, extract samples, and is supplied in two models (BNMAB-1 and BNMA/CB-1), with the latter including extraction accessories.

The subject device differs from the predicate in four ways: broader needle gauge range (9G–18G vs. 8G–13G), shorter needle lengths available (25–150 mm vs. 50–200 mm), a three-edge stylet tip instead of two-edge, and inclusion of additional biocompatibility test standards (ISO 10993-23). Core materials, cannula design, handle, sterilization method, and overall operation remain identical.

ASTM F1980:2016 (packaging and shelf-life); ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-11:2017, and ISO 10993-23:2021 (biocompatibility); ISO 11135:2014 and ISO 11138-1:2017 (sterilization validation); ISO 10993-7:2008 (EO residuals); ISO 11737-2:2019 (sterility testing). Bench tests included puncture, torque, stiffness, toughness, and corrosion resistance.

The devices share identical indications for use, same classification, materials, and operational mechanics. Design differences (gauge, length, stylet configuration) do not introduce new safety risks: larger gauges are tested and perform adequately, shorter needles are inherently safer than longer ones for the same diameter, and three-edge stylets are common in medicine with improved cutting efficiency. Biocompatibility testing covers the predicate's scope and exceeds it. Ex vivo sample quality comparison testing demonstrates substantial equivalence in performance.