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510(k) Data Aggregation

    K Number
    K212544

    Validate with FDA (Live)

    Device Name
    MiniLoad Syringe
    Manufacturer
    OcuJect, LLC
    Date Cleared
    2021-10-13

    (62 days)

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

    The MiniLoad Syringe is used to facilitate injections into or withdraw fluids from the body.

    Device Description

    The MiniLoad Syringe is a device intended to provide a means of fluid injection and aspiration. The device is comprised of a hollow barrel with gradient markings and a plunger. The barrel component is available in two configurations: 1) with a male slip tip end 2) with a luer-lock end; both for the fitting of a compatible needle. The device is available in a 1ml volume.

    AI/ML Overview

    This document is a 510(k) summary for a medical device (MiniLoad Syringe) and primarily focuses on demonstrating substantial equivalence to a predicate device. It does not describe a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it provide the detailed types of information requested in your prompt regarding AI model performance, training sets, ground truth establishment, or expert adjudication.

    The document discusses acceptance criteria and device performance in the context of bench testing for a standard medical device (a syringe), not an AI-powered diagnostic or assistive technology.

    Therefore, I cannot extract the requested information as it is not present in the provided text. The document details:

    • Acceptance Criteria and Device Performance (Bench Testing for a Syringe): The table on pages 4-5 compares the subject device to a predicate device regarding physical characteristics, materials, and some performance specifications. Page 6 lists general performance data categories and Biocompatibility standards used to support substantial equivalence.
    • Sample Size, Data Provenance, Expert Information, Adjudication Method, MRMC Studies, Standalone Performance, Ground Truth Type, Training Set Sample Size/Ground Truth: None of this information is provided because the submission is for a physical medical device (syringe), not an AI/ML system. The "performance data" refers to standard mechanical and material tests for the syringe, not diagnostic accuracy based on human image interpretation.
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