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510(k) Data Aggregation

    K Number
    K251433
    Device Name
    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)
    Manufacturer
    Surgify Medical Oy
    Date Cleared
    2025-06-04

    (27 days)

    Product Code
    HBE
    Regulation Number
    882.4310
    Type
    Special
    Panel
    Neurology
    Reference & Predicate Devices
    K232684,K250380
    Why did this record match?
    Reference Devices :

    K232684

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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.

    Device Description

    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.

    AI/ML Overview

    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 TypeAcceptance Criteria (Design Input Requirements)Reported Device Performance (Results)
    Functional Testing
    DurabilityDevice functions as intended, all design and functional specifications metAll tests fulfilled Design input requirements
    Cutting EffectivenessDevice functions as intended, all design and functional specifications metAll tests fulfilled Design input requirements
    Chatter RateDevice functions as intended, all design and functional specifications metAll tests fulfilled Design input requirements
    NoiseDevice functions as intended, all design and functional specifications metAll tests fulfilled Design input requirements
    ThermalDevice functions as intended, all design and functional specifications metAll tests fulfilled Design input requirements
    Design Validation/Summative Evaluation
    Summative Usability TestingUser 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

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