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510(k) Data Aggregation

    K Number
    K182765
    Device Name
    5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial Additive Slip Tip Glass Syringe,10cc Neuraxial Slip Tip Glass Syringe,10cc Neuraxial Lock Tip Glass Syringe
    Manufacturer
    TOP Corporation
    Date Cleared
    2019-09-03

    (340 days)

    Product Code
    FMF,OEH
    Regulation Number
    880.5860
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K170218,K843414
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Top NRFit Lock Tip and Slip Tip LOR Syringes and the Additive Slip Tip Syringe are intended to be used with the ISO 80369-6 NRFit neuraxial compliant epidural needles for locating the epidural space, for local administration, and regional administration excluding subarachnoid/spinal block.

    Device Description

    The TOP NRFit™ Tip Syringes are provided sterile. They are single use devices consisting of rigid USP 2 glass plungers and glass barrels with metal slip tips designed as the ISO 80369 - 6 compliant neuraxial connector which allows for connections of neuraxial specific applications while reducing the likelihood of misconnections to non-neuraxial devices. The syringe barrels are printed with graduated markings in cc (milliliters) indicating the volume of liquid inside the syringe barrel.

    AI/ML Overview

    This document, a 510(k) Summary for the TOP Corporation NRFit™ Tip Glass Syringes (K182765), outlines the device's characteristics and performance testing to demonstrate substantial equivalence to predicate devices. However, it does not describe a study involving an AI or algorithm-driven device.

    The document details the physical characteristics and performance of syringes, which are mechanical medical devices. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and biocompatibility tests for the syringes, not a study of an AI's performance.

    Therefore, I cannot provide the information requested in the prompt as it pertains to AI/algorithm performance. The document explicitly states: "Clinical tests were not required to demonstrate performance of between the subject and predicate devices. Product functionality has been adequately assessed by nonclinical tests." This further confirms the absence of a study that would involve the elements of AI performance evaluation you've listed (e.g., sample size for test/training sets, expert consensus for ground truth, MRMC studies, standalone performance).

    Instead, the document focuses on demonstrating that the TOP Corporation NRFit™ Tip Glass Syringes meet established industry standards for mechanical and material properties, as well as biocompatibility. The performance testing section lists numerous non-clinical tests based on ISO standards for medical devices and syringes.

    If you have a document describing an AI or algorithm-driven medical device, I would be happy to analyze it for the requested information.

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