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    K Number
    K122225
    Device Name
    STERILE RADIOLUCENT SKULL PINS
    Manufacturer
    BRAINLAB AG
    Date Cleared
    2013-04-26

    (275 days)

    Product Code
    HBL
    Regulation Number
    882.4460
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K954789
    Why did this record match?
    Device Name :

    STERILE RADIOLUCENT SKULL PINS

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

    Sterile Radiolucent Skull Pins are designed for the fixation of a compatible head-holder unit to the patient's skull. This allows the fixation of the head and neck during craniotomy and subsequent neurosurgical procedures. These pins reduce the incidence of artifacts in images acquired intra- operatively using CT, MR (Conditional) or fluoroscopy

    Device Description

    The Sterile Radiolucent Skull Pins are part of a fixation system which provides rigid immobilization of the patient's skull during surgery. The Pins are the components which get in direct contact with the patient and are made of Carbon-Fiber Reinforced PEEK. The Pins are designed to penetrate the skull tabula externa to provide rigid fixation to compatible head-holder units while significantly reducing imaging artifacts.
    The Sterile Radiolucent Skull Pins are intended for use by physicians or their assistants in a hospital environment only. The product may not be used repeatedly and is a single-use device accordingly. A compatible head- holder unit is required for the safe and effective use of the device.
    The use scenario is primarily rigid fixation of the patient's skull during surgery e.g. percutaneous craniotomy. The device requires the same user actions as the listed predicate device, namely insertion and removal from the head-holder unit. A valid fixation setup with a compatible head- holder unit consists of exactly three sterile pins.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study information for the Sterile Radiolucent Skull Pins, based on the provided text:

    Acceptance Criteria and Device Performance

    Test ProtocolAcceptance Criteria (Stated)Reported Device Performance
    Mechanical Performance TestingPins have the required performance and properties to meet the intended use.Verified in cadaver studies and non-clinical mechanical tests.
    Compatibility Testing with Head-Holder UnitsCompatible with specified head-holder units for safe and effective rigid head fixation.Verified for head holder units listed in the instruction leaflet.
    Image Artifact Testing (MR Image Artifacts)Minimize artifacts.Worst artifacts for spin echo sequence = 1.45mm / 1.47mm. Worst artifacts for gradient echo sequence = 2.14mm / 1.94mm.
    Image Artifact Testing (CT Artifacts)Minimize artifacts (implied comparison to predicate).Brainlab Radiolucent Skull Pins = 490 HU (Significantly lower than predicate and other devices).
    Magnetically Induced Displacement Force on Medical Device in MR Environment (ASTM F2052-06e1)No significant magnetically induced displacement force.No magnetically induced displacement force was detectable.
    Magnetically Induced Torque on Medical Devices in MR Environment (ASTM F2213-06)Magnetically induced torque below a certain threshold (implied safe for use).Magnetically induced torque of $10\mu Nm$ (worst case torque due to gravity of $\approx 1.077mNm$).
    Radio Frequency Induced Heating Near Passive Implants during MR Imaging - 1.5 Tesla (ASTM F2182-11a)Temperature rise within safe limits (implied:
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