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510(k) Data Aggregation

    K Number
    K191359

    Validate with FDA (Live)

    Device Name
    Nipro Syringe
    Manufacturer
    Nipro Medical Corporation
    Date Cleared
    2019-10-09

    (141 days)

    Product Code
    FMF,FMI
    Regulation Number
    880.5860
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K173029
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To inject fluids into or withdraw fluids from the body.

    Device Description

    The NIPRO Syringe is a piston syringe consisting of graduated barrel, plunger rod, and gasket. It is provided in luer slip, luer lock and eccentric luer slip tips, with and without attached hypodermic needles are available in ranges of 20-27G, and 3/8 to 1 ½" in length. Gauges are color coded for easy differentiation. Its function is mechanical. The syringe is sterile, single use only, non-toxic, non-pyrogenic and sterilized by Ebeam radiation. The shelf-life has been determined to be 5 years.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device, specifically a Nipro Syringe. It describes a conventional medical device, not an AI/ML-driven device. Therefore, the information requested in the prompt regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/ML device is not present in the provided document.

    The document discusses:

    • Device Description: A piston syringe with varied sizes, gauges, and tips.
    • Indications for Use: To inject or withdraw fluids from the body.
    • Technological Characteristics: Materials, design, sterilization, expiry dating, and dimensions.
    • Non-Clinical Performance Testing: A comprehensive list of biocompatibility, visual inspection, dimensional, mechanical, chemical, sterilization, transportation, pyrogen, and shelf-life tests performed to demonstrate substantial equivalence to a predicate device.
    • Clinical Study Conclusion: Explicitly states "No clinical Study is included in this submission."

    Since the prompt is specifically about the acceptance criteria and study that proves the device meets the acceptance criteria (implying an AI/ML device context), and the document describes a physical medical device (syringe), it does not contain the information necessary to answer the questions about AI/ML device performance, ground truth, expert consensus, or MRMC studies.

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