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510(k) Data Aggregation

    K Number
    K972595
    Device Name
    ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCER
    Manufacturer
    AVID N.I.T., INC.
    Date Cleared
    1998-05-20

    (313 days)

    Product Code
    BSP
    Regulation Number
    868.5150
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCER

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

    The Aldrete Single Shot Epidural Needle is intended to be used for the injection of local anesthetics to provide regional anesthesia.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a letter from the FDA regarding a 510(k) premarket notification for the "Aldrete Single Shot Epidural Needle." It states that the device has been found substantially equivalent to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

    The letter is a regulatory approval document and does not detail the technical performance specifications or validation studies. It focuses on the legal and regulatory aspects of marketing the device based on its substantial equivalence to previously approved devices.

    Therefore, I cannot extract the requested information (acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from this document.

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