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510(k) Data Aggregation

    K Number
    K092527
    Device Name
    NEXUS INJECTION SITE, MODEL NIS-8
    Manufacturer
    NEXUS MEDICAL, LLC
    Date Cleared
    2010-02-04

    (170 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NEXUS INJECTION SITE, MODEL NIS-8

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

    The NIS is a needle-less device intended as an intravascular administration set accessory for the delivery of drugs and fluids. The NIS device may aid in the prevention of needle stick injuries.

    Device Description

    The NIS is a needle-less device intended as an intravascular administration set accessory for the delivery of drugs and fluids.

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Nexus Medical, L.L.C. regarding their Nexus Injection Site, NIS-8 device. This document confirms the device's substantial equivalence to a legally marketed predicate device and outlines regulatory requirements.

    Crucially, this document does not contain any information about acceptance criteria or specific study results for the device's performance.

    Therefore, I cannot provide the requested table or answer the questions related to studies, sample sizes, ground truth, or expert involvement based on the provided text. The letter focuses solely on the regulatory approval process and not on the technical performance data that would typically be included in a premarket submission.

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