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    K Number
    K240286
    Device Name
    PRIMED Surgical Masks and PRIMED Procedure Masks
    Manufacturer
    Primed Medical Products Inc.
    Date Cleared
    2024-08-26

    (207 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K081633
    Why did this record match?
    Device Name :

    PRIMED Surgical Masks and PRIMED Procedure Masks

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

    PRIMED Surgical Masks and PRIMED Procedure Masks are single use, non-sterile products intended to be worn by operating room and health care personnel in health care setting and during surgical procedures to protect both the patient and the operating room personnel from transfer of microorganisms, body fluids and particulate materials.

    Device Description

    PRIMED Surgical masks and PRIMED Procedure masks are single use, non-sterile masks composed of a melt-blown filter layer placed between layers of non-woven inner and SS outer layer(s) material. PRIMED Medical Products Inc. offers various models in two main categories: Procedure masks with ear loops and Surgical masks with head ties. The level of protection varies based on the basis weight of the inner layer and the number of outer layers used in the mask's construction, in accordance with ASTM F2100:2023 specifications.

    AI/ML Overview

    The provided text is an FDA 510(k) summary for PRIMED Surgical Masks and PRIMED Procedure Masks. It describes the acceptance criteria and the study that proves the device meets those criteria. However, it does not include information about a complex AI-driven medical device, a multi-reader multi-case (MRMC) study, or detailed information about ground truth establishment by experts as would be relevant for an AI/CADe system.

    Therefore, the following response will be tailored to the information available in the provided document, which pertains to a physical medical device (surgical masks) and its performance against established standards, rather than an AI/software device.

    Here's the information as extracted and interpreted from the document:

    Acceptance Criteria and Device Performance for PRIMED Surgical Masks and PRIMED Procedure Masks

    The device under review is PRIMED Surgical Masks and PRIMED Procedure Masks. The performance of these masks is evaluated against established physical and biocompatibility standards rather than a typical AI/CADe performance criteria.

    1. Table of Acceptance Criteria and the Reported Device Performance

    The acceptance criteria are derived from ASTM F2100-23 standards for medical face masks and other relevant ISO and CFR standards for biocompatibility and flammability.

    Test PerformedTest MethodAcceptance Criteria (Level 1 Masks)Acceptance Criteria (Level 3 Masks)Results (All Variants)
    Bacterial Filtration EfficiencyASTM F2101≥ 95%≥ 98%Pass
    Sub-micron Particulate FiltrationASTM F3502≥ 80%≥ 85%Pass
    Differential Pressure (Breathability)EN 14683
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