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510(k) Data Aggregation

    K Number
    K220060
    Device Name
    Pre-filled Syringe with Saline
    Manufacturer
    Jiangsu Caina Medical Co., Ltd.
    Date Cleared
    2022-06-10

    (151 days)

    Product Code
    NGT
    Regulation Number
    880.5200
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Pre-filled Syringe with Saline

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

    The Pre-filled Syringe with Saline is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for a "Pre-filled Syringe with Saline." It does not contain any information about acceptance criteria or a study proving device performance as would be relevant for an AI/ML or diagnostic device.

    The provided text deals with:

    • The FDA's determination of substantial equivalence for a medical device (a pre-filled saline syringe).
    • Regulatory classifications and requirements for medical devices.
    • Indications for Use for the specific device.

    Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance because the document does not discuss these aspects for an AI/ML or diagnostic device. The device in question is a simple medical device (a saline syringe), not one that would typically undergo the kind of performance studies involving AI, ground truth, expert readers, or MRMC studies.

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