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510(k) Data Aggregation

    K Number
    K221209
    Device Name
    PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops
    Manufacturer
    PADM Medical Inc.
    Date Cleared
    2023-03-08

    (316 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K211762
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The PRECISION ECO™ Compostable / Plant Based Procedural Mask with Earloops is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The PRECISION ECO™ Compostable / Plant Based Procedural Mask with Earloops is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, non-sterile, disposable device.

    Device Description

    The PRECISION ECO™ Compostable / Plant Based Procedural Masks with Earloops are single use, ASTM Level 3 disposable devices, provided non-sterile. The mask has a four-layer, flat, pleated body with two earloops and a malleable nose piece. All components of the mask design are bonded together via ultrasonic welding, and it does not include any drugs, biologics, or nanoparticles. The mask comes in one configuration with two (2) different color schemes: black (100195), and white (100196).

    AI/ML Overview

    The provided text is a 510(k) summary for the PRECISION ECO™ Compostable / Plant Based Procedural Mask with Earloops. It details the device's characteristics, intended use, and a comparison to a predicate device, focusing on laboratory performance testing rather than studies involving AI or human readers for diagnostic purposes.

    Therefore, the requested information regarding acceptance criteria and study proving device meets acceptance criteria, in the context of an AI/human reader diagnostic device, cannot be extracted from this document. The document describes acceptance criteria and testing for a medical face mask, not a diagnostic AI device.

    However, I can provide the acceptance criteria and the (laboratory) study results for the medical face mask as presented in the document:

    1. A table of acceptance criteria and the reported device performance

    Based on the "TABLE V: STANDARDS AND ACCEPTANCE CRITERIA" and the statement "The device met the acceptance criteria for both production lots and artificially aged samples" in the document, we can infer that the reported performance met these criteria. The document does not provide specific numerical results for each test, only that the acceptance criteria were met.

    CharacteristicTest MethodAcceptance CriteriaReported Device Performance (Implied)
    Bacterial filtration Efficiency (BFE)ASTM F2101-19: Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus≥ 98%Met Criteria (≥ 98%)
    Sub-micron particulate efficiency at 0.1 µm (PFE)ASTM F2299: Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres≥ 98%Met Criteria (≥ 98%)
    Blood PenetrationASTM F1862: Standard Test Method for Resistance of Medical Face Masks to penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)@160 mm HgMet Criteria (@160 mm Hg)
    Differential PressureEN 14683:2019 Annex C: Medical face masks - Requirements and test methods
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