(89 days)
Surgify Halo is a sterile surgical burr indicated for shaping and bone in neurosurgical, spinal, ENT, and general surgical procedures.
The Surgify Halo is a rotary cutting device made of high-grade metallic materials. It cuts bone and other hard tissues selectively while reducing chattering. The device is similar to conventional surgical cutting burrs with the addition of a ring mechanism installed in the burr head to reduce chattering. Similar to conventional burrs, the device is designed for use with compatible high-speed surgical drill systems. The Surgify Halo comprises: A shank, which transfers rotary movement of the drill motor to the head. Locking features at the distal end of the shank which allow the burr shank to be locked to a high-speed surgical drill. A head that is shaped to have two cutting edges to cut bone and hard tissue. A safety mechanism consisting of a ring and spring installed in the burr head. The mechanism is self-centering and comprises a spring and a moving ring that is bigger than the burr head. The moving ring can have two different positions: In the first position, the ring protrudes to a level higher than cutting edges and prevents the cutting edges from cutting into the work material. In the second position, the ring retracts into the groove to a level lower than the cutting edges to allow the burr to cut the work material
The provided text describes the Surgify Halo, a sterile surgical burr, and its performance evaluation to demonstrate substantial equivalence to a predicate device (Adeor HiCut Highspeed Instrument).
Here's an analysis of the acceptance criteria and the study details:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of formal acceptance criteria with specific numerical thresholds. Instead, it states that "All tests fulfilled Design input requirements" and that the "performance of the Surgify Halo burr was comparable to that of the conventional diamond and fluted burrs." This implies that the acceptance criteria were defined by the product's design input requirements and the performance of established devices.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Design Verification | All tests fulfilled Design input requirements (Device performance parameters, Durability Cutter Efficiency, Chatter, Thermal Noise, Metallic Contact, Geometrical features). |
| Noise Testing | All tests fulfilled Design input requirements. |
| Design Validation | All tests fulfilled Design input requirements (Summative Usability Testing for Nurses and Surgeons based on hazard-related use scenarios and user interfaces). |
| Performance Testing | The performance of the Surgify Halo burr was comparable to that of conventional diamond and fluted burrs. |
| Biocompatibility | Acceptable per ISO10993-01 (2018). |
| Sterilization & Shelf Life | Gamma irradiation method ensures effective conditions (Sterility Assurance Level (SAL) |
§ 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).