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510(k) Data Aggregation

    K Number
    K961088
    Device Name
    NON-CORING NEEDLE
    Manufacturer
    ARROW INTL., INC.
    Date Cleared
    1996-07-02

    (105 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    K151341
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K960698
    Device Name
    NON-CORING NEEDLE
    Manufacturer
    MED INSTITUTE, INC.
    Date Cleared
    1996-04-15

    (55 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    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 Non-Coring Needle is used for accessing a subcutaneous port to administer or withdraw fluids.

    Device Description

    The Non-Coring Needle is used for accessing a subcutaneous port to administer or withdraw fluids. The device is supplied sterile and is intended for one-time use. Reasonable assurance of biocompatibility of the materials comprising the Non-Coring Needle is provided by their established history of use in medical product manufacturing.

    AI/ML Overview

    The provided document is a 510(k) summary for a "Non-Coring Needle" submitted in 1996. It describes the device, its intended use, and its substantial equivalence to predicate devices.

    However, the document does not contain any information regarding performance studies, acceptance criteria, or any of the detailed data points requested in your prompt. This 510(k) summary focuses on establishing substantial equivalence based on materials, intended use, and manufacturing processes, typical for devices of this nature and era, rather than providing data from clinical performance studies.

    Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, study types (MRMC or standalone AI), or training set details because this information is not present in the provided text.

    The closest relevant information is:

    • Intended Use: "accessing a subcutaneous port to administer or withdraw fluids."
    • Predicate Devices: Mentioned as "non-coring needles that are currently marketed, having the same intended use... and being of similar technology, having a stainless steel cannula and Luer hub."
    • Substantial Equivalence: Claims similarity in "indications for use, materials and physical construction to predicate devices."

    This document does not describe the type of performance study you're asking about, which typically involves quantitative metrics and human-in-the-loop assessments for diagnostic or AI-assisted devices.

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