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510(k) Data Aggregation

    K Number
    K152857
    Device Name
    NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps
    Manufacturer
    NEOMED, INC.
    Date Cleared
    2015-12-17

    (78 days)

    Product Code
    PNR
    Regulation Number
    876.5980
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K143344,K142128
    Why did this record match?
    Device Name :

    NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps

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

    NeoConnectTM Enteral Syringe with ENFit™ Connector:
    The device is indicated for use as a dispenser, a measuring device. It is used to deliver fluids into the body enterally. It is intended to be used in clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) in all age groups.

    NeoConnect™ NeoSecure™ Tip Cap:
    A NeoConnect™ Enteral Syringe with ENFit™ connector accessory used to prevent fluid loss and contamination of syringe contents until ready for use.

    Device Description

    The NeoMed NeoConnect™ Enteral Syringes with ENFit™ connector are standard piston style syringes consisting of a syringe barrel with an integral ENFit™ syringe tip, syringe plunger, syringe gasket, and supplied with or without a syringe tip cap. They are provided in varying sizes ranging from 0.5 mL to 100 mL nominal capacity. The integral syringe tip is a female ENFit™ connector which is compatible only with enteral access devices having ENFit™ male connectors to form a dedicated system that prevents wrong-route administration of fluids. They possess translucent barrels to provide visualization of fluid contents and volume.

    The NeoConnect™ NeoSecure™ Tip Cap is supplied with the NeoConnect™ Enteral Syringe with ENFit™ connector or sold separately (sterile or non-sterile). It is an ENFit™ compatible closure cap for the tip of the syringe.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) premarket notification letter and a summary for an enteral syringe and tip caps. It discusses substantial equivalence to predicate devices and lists various performance tests conducted. However, it does not provide acceptance criteria, reported device performance in a comparative table, details about specific study designs (like sample sizes for test/training sets, data provenance, expert qualifications, or adjudication methods), or information about MRMC comparative effectiveness studies or standalone algorithm performance.

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