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510(k) Data Aggregation

    K Number
    K970448
    Device Name
    PCM 2000; ISOLAIR APR MODEL 2735
    Manufacturer
    TECNOL MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-04-30

    (83 days)

    Product Code
    MSH
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PCM 2000; ISOLAIR APR MODEL 2735

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

    Meets the CDC guidelines for TB exposure control. Has a filter efficiency level of 95% against solid particulate aerosols free of oil (Type N95 respirator). Designed to be fluid resistant to splash and spatter of blood and body fluids.

    Device Description

    Respirator consisting of nonwoven inter facing, filter media(s), a fluid barrier film, and an outer facing. It covers the nose and mouth of the wearer, and is held in place with two synthetic clastic headbands, conforming to the curvature of the wearer's nose with a malleable nosepiece.

    AI/ML Overview

    This document is a 510(k) Premarket Notification for a respirator and surgical mask. It primarily focuses on demonstrating equivalence to a predicate device through performance testing. Therefore, it does not involve the type of study design or criteria typically used for AI-driven medical devices, which the provided questions are geared towards.

    Here's an analysis based on the information provided, highlighting why many questions are not directly applicable:

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

    Acceptance Criteria (Implied)Reported Device Performance
    Filtration Efficiency ≥ 95% for 0.3 micron particles (NIOSH standard)Met NIOSH required sodium chloride test; no filtration efficiency drop below 95%.
    No fluid penetration with 2cc synthetic blood at arterial speedNo fluid penetration observed.
    Qualitative Face Fit test passedSamples tested successfully.
    Initial inhalation resistance
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