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510(k) Data Aggregation

    K Number
    K954258
    Date Cleared
    1996-05-24

    (262 days)

    Product Code
    Regulation Number
    880.5965
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Gerard Medical, Inc. TrimPort Implantable Access System is precision engineered to provide repeated access to the vascular system for both parenteral delivery of fluids and the withdrawal of venous blood.

    Device Description

    The implantable segments of the TrimPort System and comparable devices are the portal, the radiopaque catheter, and a locking catheter connector.

    AI/ML Overview

    The provided text describes a medical device called TrimPort (K954258), an implanted vascular access system. However, it does not contain information about acceptance criteria, device performance metrics, or a study that proves the device meets specific acceptance criteria in the manner requested by the prompt (e.g., sample size, expert qualifications, adjudication methods).

    The text focuses on:

    • Device Description and Intended Usage: Explains what the TrimPort is and how it's used.
    • Device Design, Testing, and Potential Adverse Occurrences: Discusses design considerations and instructions to mitigate potential issues like catheter disconnection, system leaks, and system occlusions. It mentions internal testing ("standard usage and extreme misuse tests") but provides no specific data or methodology.

    Therefore, I cannot generate the requested table and study details. The information required (acceptance criteria, specific performance metrics, sample sizes for testing/training, ground truth establishment, expert details, study design like MRMC or standalone performance) is not present in the provided text.

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