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510(k) Data Aggregation

    K Number
    K233249
    Device Name
    APPRAISE-HRI
    Date Cleared
    2024-04-05

    (190 days)

    Product Code
    Regulation Number
    870.2220
    Why did this record match?
    Applicant Name (Manufacturer) :

    The Surgeon General, Department of the Army (TSG-DA)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The APPRAISE-HRI is a mobile health app intended to provide a means for military healthcare providers to screen U.S. Service members for hemorrhage risk after a physically traumatic event and stratify casualties who need immediate attention and emergency evacuation from those who are injured but may not be at risk for hemorrhage. The APPRAISE-HRI is not intended to diagnose or direct treatment. Rather, it is intended to provide situational awareness and inform clinical management of potentially hemorrhagic casualties by identifying those at the greatest risk of hemorrhage.
    Device Description
    The Automated Processing of the Physiological Registry for Assessment of Injury Severity (APPRAISE)-Hemorrhage Risk Index (HRI) is an Android application developed by the U.S. Army Medical Research and Development Command (USAMRDC) that uses vital-sign data collected from a trauma patient to provide a risk score that stratifies the patient's risk of hemorrhage. When the application runs, heart rate (HR), systolic blood pressure (SBP), and diastolic blood pressure (DBP) vital-sign data are collected from an external monitor [currently only the ZOLL Propaq M (K202375) is supported]. The ZOLL Propaq M monitor connects via Bluetooth with the Android platform running the APPRAISE-HRI application. The APPRAISE-HRI application continuously pulls data from the ZOLL Propaq M monitor to gather the required vital signs (HR, SBP, and DBP) and then runs the hemorrhage risk stratification algorithm to generate an output every one minute. Once the vital-sign data from the ZOLL Propaq M monitor are transferred, the APPRAISE-HRI provides a stratification of hemorrhage into three Risk Level categories: Low (I), Average (II), or High (II). The APPRAISE-HRI application continuously displays both the input vital signs (HR, SBP, and DBP) and the Risk Level score to the caregiver to provide situational awareness and to inform clinical management of potentially hemorrhagic casualties by identifying those at the greatest risk of hemorrhage.
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    K Number
    K143592
    Device Name
    GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC
    Date Cleared
    2015-04-16

    (119 days)

    Product Code
    Regulation Number
    866.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE SURGEON GENERAL, DEPARTMENT OF THE ARMY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Gamma Phage assay is a lytic phage assay specific for Bacillus anthracis. The Gamma Phage assay (common name) can be used on suspect non-hemolytic, aerobic, gram-positive, "ground-glass"- appearing colonies from sheep blood agar in conjunction with other markers and testing for the identification of Bacillus anthracis. The assay is not intended for screening of blood or plasma donors. Use of this assay is limited to designated laboratory Response Network (LRN) and Department of Defense (D0D).
    Device Description
    The gamma phage is a lytic bacteriophage which binds to specific cell-surface components of susceptible bacteria. Their DNA is injected into the bacterium. The gamma phage replicate within the bacterium and produce PlyG lysine (2), resulting in lysis of the infected cell and release of phage. The release of newly synthesized phage leads to another round of phage infection and lysis. Materials Supplied: - Bacillus anthracis Gamma Phage Suspension, 0.5 ml - . Positive Control, Bacillus anthracis Pasteur Strain Spore Suspension, 1.0 ml - Negative Control, Bacillus cereus Spore Suspension, 1.0 ml ● Materials required but not supplied: - . 5% Sheep Blood Agar plate - . Inoculating loops, 1ul and 10 ul - Aerosol resistant pipette tips - . Disinfectant Equipment required: - Pipettor, 5-50 µ1 - Incubator, 35+/- 2 °C - Biological Safety Cabinet, Class II - Refrigerator, 2-8 ℃ .
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    K Number
    K140387
    Device Name
    Burn Resuscitation Decision Support System - Clinical (BRDSS-C)
    Date Cleared
    2014-12-23

    (312 days)

    Product Code
    Regulation Number
    868.1890
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE SURGEON GENERAL, DEPARTMENT OF THE ARMY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BRDSS-C is indicated for use in the care of adult patients and adolescent patients 17 years of age or older who weigh 40kg (88lbs) or more with 20% or more Total Body Surface Area (TBSA) burned, as a fluid resuscitation calculator for fluid recommendations. The BRDSS-C is intended to be initiated within 24 hours of the burn incident and completed by 72 hours post burn. The BRDSS-C is not indicated for use in patients who are less than 17 years of age.
    Device Description
    The Burn Resuscitation Decision Support System – Clinical (BRDSS-C) is a burn decision support software application for assisting healthcare professionals in managing fluid resuscitation of burn patients during the initial 24 - 72 hours post burn. The system provides hourly (or half-hour) fluid calculations and recommendations for patients with 20% or greater Total Body Surface Area (TBSA) burn injuries, in addition to providing users with a graphical user interface to display volume status, Intake and Output (I/O) volumes, and other relevant fluid balance information.
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