Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1)

The Surgify Halo is a sterile, single-use surgical burr made from high-grade metallic materials designed to cut bone and hard tissue while minimizing chattering. It features a ring mechanism in the burr head that can toggle between hard tissue mode (ring protrudes to prevent cutting edge engagement) and soft tissue mode (ring shields the cutting edge). It is indicated for shaping and removal of hard tissue and bone in neurosurgical, spinal, ENT, and general surgical procedures.

The subject device maintains identical intended use, environment of use (hospital), and operating principle as the predicate (K250380). The key modification is the addition of new 4 mm burr size models alongside existing 5.4 mm dual-edge configurations. Both subject and predicate are compatible with commonly marketed high-speed surgical drill systems, use gamma sterilization, and incorporate the same self-centering ring and spring safety mechanism. Materials, design configuration, and sterility method remain unchanged.

IEC 62366-1:2015 (Human Factors and Risk Management), FDA 2000 Guidance on Medical Device Use-Safety and Human Factors Engineering (February 2016 version), and 21 CFR §882.4310 performance standards. Design verification testing addressed durability, cutting effectiveness, chatter rate, noise, and thermal parameters.

The subject device is substantially equivalent because it shares the identical intended use and operating principle as the predicate K250380. Performance testing (durability, chattering, compatibility, cutting effectiveness) demonstrated all new 4 mm models meet the same design input requirements as the predicate. Design validation and summative usability testing with production-equivalent devices confirmed user requirements and hazard mitigation aligned with the predicate's evaluation approach. Since the technological characteristics, materials, mechanism of action, and performance envelope remain substantively unchanged, the addition of alternative burr sizes does not introduce new safety or effectiveness concerns.