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    K Number
    K032934
    Device Name
    MPS ACACIA SAFEGUARD HUBER DEVICE
    Manufacturer
    MPS ACACIA
    Date Cleared
    2003-11-13

    (52 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K982047,K993848,K021565,K013871
    Why did this record match?
    Device Name :

    MPS ACACIA SAFEGUARD HUBER DEVICE

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

    The MPS Acacia Safeguard Huber Device is intended: a) for use with implanted infusion ports for continuous or intermittent infusion therapy; and b) for infusion or withdrawal of I.V. fluids, blood, blood products, and drugs. The MPS Acacia Safeguard Huber Device should be changed per CDC guidelines or per hospital protocol.

    Device Description

    The MPS Safeguard Huber Device is a family of sterile and non-pyrogenic devices used for transdermal infusion via subcutaneous access ports. These devices consist of angled non-coring stainless steel needle bonded to infusion tubing ending with a standard female luer lock connector. Each set is provided with a needle tip protector, and luer cap. Various configurations may also include Y-injections sites, needleless injection sites, and clamps associated with standard tubing infusion sets. The MPS Acacia Safeguard Huber Device is designed to allow the clinician to activate a trigger on the device that will deploy a protective sheath to cover the entire needle once the device is removed from the patient. The device is designed to help minimize accidental needlestick injuries.

    AI/ML Overview

    The provided submission focuses on establishing substantial equivalence for a medical device (MPS Acacia Safeguard Huber Device) to existing predicate devices, rather than an AI-powered diagnostic tool. Therefore, many of the requested categories related to AI performance metrics, such as MRMC studies, effect size, standalone performance, and ground truth methodologies for training data, are not applicable here.

    The document describes non-clinical testing to demonstrate safety and performance for a medical device with a sharps injury prevention feature.

    1. Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Sterility: Meets FDA requirements, method per AAMI/ANSI/ISO 11135-1994, SAL of 10⁻⁶Sterilized by ethylene oxide (EO). Maximum residual levels: EO 25ppm, ECH 25ppm, EG 250ppm. Labeled "Non-Pyrogenic" (LAL testing). Sterility assurance level (SAL) of 10⁻⁸ achieved during validation, exceeding minimum requirement.
    Biocompatibility: Meets ISO 10993-1 and FDA G95-1 guidelines for external communicating devices, blood path indirect, contact duration B (>24 hours to
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