(27 days)
Surgify Halo is a sterile surgical burr indicated for shaping and removal of hard tissue and bone in Neurosurgical, Spinal, ENT, and General Surgical procedures.
The Surgify Halo is a sterile-packaged, single-use rotary cutting device (a burr) made from high-grade metallic materials, designed to cut bone and other hard tissues selectively while minimizing chattering. The device is similar to conventional surgical cutting burrs but includes a ring mechanism in the burr head to reduce chattering. Like traditional burrs, the device is designed to be compatible with commonly marketed, high-speed, surgical drill systems. The Surgify Halo comprises: Shank, Locking Features, Burr Head, and Safety Mechanism (a self-centering ring and spring mechanism installed in the burr head). The moving ring, larger than the burr head, can adopt two positions: First Position (Hard Tissue Mode) where the ring protrudes, preventing cutting edges from engaging, and Second Position (Soft Tissue Mode) where the ring extends beyond the cutting edge, shielding it to minimize accidental soft tissues and an exposed position for cutting hard surfaces like bone.
The Surgify Halo is a sterile surgical burr used for shaping and removing hard tissue and bone in neurosurgical, spinal, ENT, and general surgical procedures. The company performed performance testing and design validation/summative evaluation to demonstrate substantial equivalence to its predicate device (K250380).
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Design Input Requirements) | Reported Device Performance (Results) |
|---|---|---|
| Functional Testing | ||
| Durability | Device functions as intended, all design and functional specifications met | All tests fulfilled Design input requirements |
| Cutting Effectiveness | Device functions as intended, all design and functional specifications met | All tests fulfilled Design input requirements |
| Chatter Rate | Device functions as intended, all design and functional specifications met | All tests fulfilled Design input requirements |
| Noise | Device functions as intended, all design and functional specifications met | All tests fulfilled Design input requirements |
| Thermal | Device functions as intended, all design and functional specifications met | All tests fulfilled Design input requirements |
| Design Validation/Summative Evaluation | ||
| Summative Usability Testing | User requirements met, consistent with predicate evaluation approach, addressed use errors and hazard-related use scenarios, in accordance with IEC 62366-1:2015 and FDA's 2000 Guidance "Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management." | All tests fulfilled Design input and user requirements |
Note: The provided text states that "All tests fulfilled Design input requirements" and "All tests fulfilled Design input and user requirements." It does not explicitly state numerical acceptance criteria for each parameter (e.g., "chatter rate
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).