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510(k) Data Aggregation

    K Number
    K032337
    Device Name
    HEMEDEX CRANIAL BOLT MODELS, 3601, 3602
    Manufacturer
    HEMEDEX INCORPORATED
    Date Cleared
    2003-10-21

    (84 days)

    Product Code
    GWM
    Regulation Number
    882.1620
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K992591,K974088,K002765
    Why did this record match?
    Device Name :

    HEMEDEX CRANIAL BOLT MODELS, 3601, 3602

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

    The Hemedex Single and Double Lumen Bolts are designed to achieve cranial access and to introduce and secure a sensor in place for intracranial monitoring.

    Device Description

    The Hemedex Cranial Bolts are stainless steel threaded cranial access devices with standard tuohy borst compression fittings.

    AI/ML Overview

    The Hemedex Cranial Bolts are designed to achieve cranial access and to introduce and secure a sensor in place for intracranial monitoring. Bench testing was conducted to demonstrate that this device meets the requirements of its intended use and meets the specified performance criteria. The Hemedex Cranial Bolts and the predicate devices use identical technology and materials.

    Acceptance Criteria and Device Performance:

    Acceptance CriteriaReported Device Performance
    Meet requirements of intended useBench testing demonstrated the device meets these requirements
    Meet specified performance criteriaBench testing demonstrated the device meets these criteria
    Identical technology to predicate devicesConfirmed as identical
    Identical materials to predicate devicesConfirmed as identical

    Study Information:

    1. Sample size used for the test set and the data provenance: Not specified.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this was bench testing.
    3. Adjudication method: Not applicable.
    4. Multi-reader multi-case (MRMC) comparative effectiveness study: No.
    5. Standalone performance study: Yes, bench testing was conducted.
    6. Type of ground truth used: Bench testing results against specified performance criteria and intended use requirements.
    7. Sample size for the training set: Not applicable, as this was bench testing for a physical device.
    8. How the ground truth for the training set was established: Not applicable.
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