Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2)

The Surgify Halo is a sterile, single-use surgical burr made from high-grade metallic materials designed to cut and shape bone and hard tissue. It is indicated for use in neurosurgical, spinal, ENT, and general surgical procedures and is compatible with standard high-speed surgical drill systems.

The device features a dynamically positioned protective ring surrounding the burr head that controls cutting edge exposure to reduce chattering and enable tissue-selective cutting. It operates on the same fundamental principle as the predicate device, with a cylindrical shank, precision cutting edges, and locking features for attachment to drill handpieces. The subject device adds new models with a 3.0 mm burr size option while maintaining the same operational mechanism as the predicate.

Testing was performed in accordance with risk management principles outlined in IEC 62366-1:2015 and FDA's 2000 Guidance on Medical Device Use-Safety and Human Factors Engineering into Risk Management. Performance testing included design verification and design validation/summative evaluation covering durability, cutting effectiveness, chatter rate, noise, thermal properties, and tissue selectivity.

The subject device is substantially equivalent to the predicate (K251433) because it has identical intended use, indications for use, environment of use, and operating principle. Both devices employ controlled exposure of cutting edges through a dynamically positioned protective ring. The proposed modifications of adding 3.0 mm burr size models do not alter safety or effectiveness, and all design verification and validation testing confirmed equivalent performance to the predicate device.