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    K Number
    K072756
    Device Name
    NON-IV ADAPTER FOR INFANT NG TUBE
    Manufacturer
    PROMEDIC, INC.
    Date Cleared
    2007-12-19

    (83 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K052903
    Why did this record match?
    Device Name :

    NON-IV ADAPTER FOR INFANT NG TUBE

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

    A non-IV connector for use with Infant Feeding tubes that are intended to be placed into the stomach to permit the introduction of fluids as directed by the physician. Intended for nasogastric or orogastric placement. Limited to

    Device Description

    The proposed modification to Infant Feeding Tube is to change the fittings from a standard slip fit luer to a non-IV (luer) size connector. The feeding tubes are a small diameter tube of various diameters, 5, 6, and 8 French, and lengths, 14.5", 35" and 41". It has an integral female luer fitting. There are 2 eyelets near the tip of the tube. It has marking along the shaft of the tubing and an integral radiopaque line. It is provided sterile. We will offer a non-sterile syringe with the appropriate mating, non-IV connector as part of a kit.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a medical device called "Infant Feeding Tube with Non-IV fittings". This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving performance against specific acceptance criteria in the context of an AI/ML medical device.

    Therefore, the input does not contain the information requested for an AI/ML medical device study, such as acceptance criteria in the form of metrics (e.g., sensitivity, specificity, AUC), sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, types of ground truth, or training set details.

    The document is a regulatory submission for a physical medical device (an infant feeding tube) that has been modified to change the connector type. The "performance" section explicitly states "None under Section 514", indicating that specific performance data (like clinical trials or performance assessments with acceptance criteria) were not required for this type of submission. The comparison is primarily focused on design features, indications for use, and materials to establish substantial equivalence.

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