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510(k) Data Aggregation

    K Number
    K982215
    Device Name
    MANUAL RESUSCITATOR WITH ACE
    Manufacturer
    MEDICAL MARKETING CONCEPTS
    Date Cleared
    1998-09-18

    (87 days)

    Product Code
    BTM
    Regulation Number
    868.5915
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Manual ventilation and assist in verification of endotracheal tube placement

    Device Description

    Manual Resuscitator with ACE

    AI/ML Overview

    I am sorry, but the provided text from the FDA document (K982215) is a letter regarding the substantial equivalence determination for a "Manual Resuscitator with ACE" device. It does not contain any information about acceptance criteria, study data, sample sizes, ground truth establishment, or any performance metrics for the device.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given information. The document is a regulatory approval letter, not a scientific study report.

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    K Number
    K963848
    Device Name
    MANUAL RESUSCITATOR
    Manufacturer
    OWENS-BRIGAM MEDICAL CO.
    Date Cleared
    1997-07-07

    (285 days)

    Product Code
    BTM
    Regulation Number
    868.5915
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use for this device is to provide emergency respiratory support for Adult, Child and Infant.

    Device Description

    The device is a disposable, single patient use manual resuscitator that includes a compression bag, intake and patient valve, and a closed vinyl oxygen reservoir bag, (options: open corrugated tubing or open expandable tubing in lieu of closed vinyl oxygen reservoir bag), and an optional peep valve and/or face mask.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the BriGam Manual Resuscitator (K963848):

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided document describes tests performed on components of the manual resuscitator, rather than overall device performance metrics like efficacy in ventilation. The tests are focused on biocompatibility and physicochemical characteristics of materials in indirect contact with the patient.

    ItemTestAcceptance Criteria (Implicit)Reported Device Performance
    Rubber Compression Bag (A)1. CytotoxicityMinimal or no cytotoxicity"slight" cytotoxic
    Rubber Compression Bag (A)2. Physiochemical (Elastomeric Closures)Appropriate physicochemical extraction characteristics (implied for safety/material integrity)Performed, but specific results not quantified beyond "pertinent" characteristics
    Rubber Compression Bag (A)3. ASTM Protein AnalysisProtein levels below a safe threshold
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