ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)

The ALARA BMA Neuro Access Kit is a minimally invasive surgical instrument that includes needles for aspirating bone marrow or autologous blood. It also incorporates neuromonitoring to provide surgeons with nerve/root location feedback during pedicle approach procedures, and includes a needle for harvesting core biopsy samples of cancellous bone and bone marrow.

The device is manufactured from stainless steel and ABS plastic with an 11-gauge, 3mm diameter cannula and stylet design. It features a 12.8cm length, includes plastic molded handles that mate to prevent separation, has a needle depth stop at bone, is packaged and sterilized as a single-use device, and includes a Luer lock connection per ISO 80369.

ISO 80369 (Luer Lock verification). Additionally, the device underwent cannula handle torque and pull testing, stylet handle pull testing, needle strength testing from impaction and compression, needle particle aspiration testing, needle cell viability testing, packaging validation, sterilization validation, and biocompatibility assessment.

The ALARA BMA Neuro Access Kit shares identical materials (stainless steel and ABS), similar design features (cannulated versions with comparable lengths and diameters), and the same principles of operation as the predicate devices. The non-clinical performance testing demonstrates equivalent mechanical strength, sterility, and biocompatibility. The intended uses—bone marrow aspiration, autologous blood aspiration, and core biopsy sampling—are functionally identical to the predicate devices, differing only in the addition of neuromonitoring feedback, which does not change the fundamental aspiration mechanism or safety profile.