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    K Number
    K231005
    Device Name
    Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2
    Manufacturer
    Supermax Healthcare Canada-Supermax Medical
    Date Cleared
    2023-12-05

    (242 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K082258
    Why did this record match?
    Device Name :

    Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2

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

    The Aurelia Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Aurelia Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, provided nonsterile.

    Device Description

    The proposed device, Aurelia Surgical Masks are three-layer masks constructed of nonwoven polypropylene. The inner and outer layers are made of spun-bonded polypropylene. The middle layer consists of 25gsm melt-blown polypyrene. The mask contains an ear loop to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. Ear loops are made of polyurethane and nylon. The nose clip which is made of 3mm aluminum flat wire. The disposable surgical face mask is available in two different specifications: ASTM Level 1 and ASTM Level 2. The masks meet the following ASTM 1 and ASTM 2 Technical standards.

    AI/ML Overview

    The provided document is an FDA 510(k) premarket notification for surgical masks (Aurelia Surgical Mask ASTM Level 1 and Level 2). It focuses on demonstrating substantial equivalence to predicate devices based on performance testing against established ASTM standards for surgical masks.

    Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/Software as a Medical Device (SaMD) is not directly applicable to this document. The document describes a physical medical device (surgical masks) and its performance validation, not an AI or software product.

    However, I can extract and present the performance criteria and the reported performance for the surgical masks as per the ASTM standards mentioned, which function as acceptance criteria for these physical devices.

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

    The document provides the following "Acceptance Criteria per ASTM F2100-19" and "Results" for the Aurelia Surgical Masks:

    Table: Acceptance Criteria and Reported Device Performance

    TestPurposeAcceptance Criteria per ASTM F2100-19Reported Device Performance (Results)
    For Level 1 Mask
    Fluid Resistance (ASTM F1862)This test is performed to evaluate Personal Protective Equipment against fluid penetration. An arterial spray is simulated to test the PPE.Level 1: 80mmHgAurelia Mask Level 1: 80mmHg
    Differential Pressure (Delta-P) (ASTM F2100-19 EN 14683:2019)The purpose of this test is to ensure the drop in pressure is not too great so the user may breathe through the subject device.Level 1:
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