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510(k) Data Aggregation

    K Number
    K201479
    Device Name
    DemeMASK
    Manufacturer
    DemeTECH Corporation
    Date Cleared
    2020-07-24

    (50 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    K173062
    Why did this record match?
    Device Name :

    DemeMASK

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

    The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided non-sterile.

    Device Description

    The proposed devices are 3-ply, flat-pleated surgical masks. The devices are manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. There surgical masks to be secured on users via earloops made of spandex and nylon. The devices are sold non-sterile and are intended to be single use and disposable.

    AI/ML Overview

    This document is a 510(k) summary for the DemeMASK Surgical Mask. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the performance of an AI-powered device. Therefore, many of the requested categories related to AI device studies (like expert adjudication, MRMC studies, training set details) are not applicable to this document.

    However, I can extract the acceptance criteria and reported device performance for the physical properties of the surgical mask, along with details about the studies conducted to demonstrate these properties.

    1. Table of Acceptance Criteria and the Reported Device Performance (Bench Testing for DemeMASK Surgical Mask)

    TestAcceptance CriteriaReported Device PerformanceResult
    Resistance to penetration by synthetic blood (ASTM F1862)29 out of 32 passed in 160 mm Hg32 out of 32 passed in 160 mm HgPass
    Sub-micron particulate filtration efficiency at 0.1 micron (ASTM F2299)≥98%≥99%Pass
    Bacterial filtration efficiency (ASTM F2101-19)≥98%≥99%Pass
    Differential pressure (MIL-M-36954)
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