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510(k) Data Aggregation

    K Number
    K990777
    Device Name
    MED-RX EXTENSION SETS
    Manufacturer
    BENLAN, INC.
    Date Cleared
    1999-08-25

    (169 days)

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

    MED-RX EXTENSION SETS

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

    These extension sets are sterile, single use, medical devices intended for use in LV. therapy when extended fluid path is required for fluid or drug administration. Benlan Inc. does not cause or promote new intended uses for these devices.

    Device Description

    The Med-RX® Extension Sets consist mainly of a fluid delivery tubing provided with capped luer connectors at the proximal ends. The extension sets can thus be connected to an I.V. administration sets whereby extending infusion site(s) of a primary I.V. catheter. The fluid delivery tubing can vary in lengths as well as bore sizes, i.e. standard bore, mini-bore and micro-bore. The extension sets may include pinch or slide clamps.

    AI/ML Overview

    The provided text describes a 510(k) summary for the Med-Rx® Extension Sets, but it does not contain information about acceptance criteria or a study that proves the device meets such criteria.

    The 510(k) summary focuses on demonstrating substantial equivalence to a legally marketed predicate device (Medex Extension Sets) based on materials, packaging, sterilization, and intended use. It does not include:

    1. A table of acceptance criteria and reported device performance: This document primarily details intended use, classification, and claims of substantial equivalence, not performance metrics.
    2. Sample size, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, or type of ground truth for a test set.
    3. Sample size or ground truth establishment for a training set.

    The document states: "There are no differences in the characteristics of the subject device and the predicate(s)." This statement, along with the subsequent FDA letter granting substantial equivalence, indicates that the approval was based on the device being comparable to a pre-existing, legally marketed product, rather than on new performance studies against specific acceptance criteria.

    Therefore, I cannot provide the requested information from the given text as it is not present in the document.

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