LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K041845
    Device Name
    NEXUS PAV LUER LOCK DEVICE, MODEL NIS-4
    Manufacturer
    NEXUS MEDICAL, LLC
    Date Cleared
    2004-08-24

    (47 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Nexus PAV TM Luer Lock (NIS-4) is to be used for the delivery of drugs and fluids as an accessory to intravascular administration sets. The Nexus PAV TM Luer Lock Device (NIS-4) may aid in the prevention of needle stick injuries.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets those criteria.

    The document is a 510(k) premarket notification letter from the FDA to Nexus Medical, LLC regarding their Nexus PAV™ Luer Lock Device (NIS-4). It confirms that the device has been found substantially equivalent to legally marketed predicate devices. The letter also includes an "Indications For Use Statement" for the device.

    However, it does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Details on sample sizes, data provenance, number of experts, qualifications of experts, or adjudication methods for any test set.
    3. Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
    4. The type of ground truth used, training set sample size, or how ground truth for the training set was established.

    This document is a regulatory approval letter, not a scientific study report or clinical trial summary.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1