Ball Joint Guide Array (66295)

The Ball Joint Guide Array (BJGA) is a skull-mounted, single-use stereotactic neurosurgical guidance device that helps neurosurgeons plan trajectories and guide surgical instruments to specific brain locations. It uses a ball-and-socket joint design fixed to the skull with four bone screws and works with MRI imaging to confirm accurate instrument placement during procedures including laser coagulation, biopsies, catheter placement, and electrode placement.

The BJGA has equivalent technological characteristics to the predicate V-TAG device: both use ball-and-socket joint design fixed with four bone screws, are MRI-compatible, provide frameless stereotaxy, are single-use disposables provided sterile, achieve placement accuracy of X/Y/Z errors ≤2mm and angular error ≤2°, and support 14Ga and 16Ga instruments. Both are biocompatible per ISO-10993.

Performance testing included verification against acceptance criteria for placement accuracy, instrument compatibility, angular range of motion, and MRI compatibility. Biocompatibility testing followed ISO 10993-1:2018 per FDA guidance. Sterility and shelf-life validation used ISO 11137-1 and ISO 11137-2. Human factors and usability testing evaluated device operability and labeling comprehensibility.

The BJGA is substantially equivalent because it shares identical intended use with the predicate V-TAG (stereotactic guidance for the same neurological procedures), employs the same fundamental design principle (ball-and-socket joint fixed with bone screws), achieves identical performance specifications (placement accuracy and instrument compatibility), and demonstrates equivalent safety through biocompatibility and sterility testing. Although design differences exist, they do not raise different questions of safety or effectiveness, and performance data demonstrate the BJGA performs as well as or better than the predicate.