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510(k) Data Aggregation

    K Number
    K142355
    Device Name
    Vaginal Tactile Imager
    Manufacturer
    Advanced Tactile Imaging, Inc.
    Date Cleared
    2015-05-28

    (276 days)

    Product Code
    HIR
    Regulation Number
    884.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    Advanced Tactile Imaging, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vaginal Tactile Imager obtains a high resolution mapping of pressures and assesses the strength of pelvic floor muscles within the vagina. It is used in a medical setting to acquire the pressures and store the corresponding data. It also provides visualization, analysis tools and information. The real time data as well the analysis information can then be viewed with an intention of assisting in the diagnosis and evaluation. The device is intended for use by physicians, surgeons and medically trained personnel.
    Device Description
    The Vaginal Tactile Imager (VTI) obtains a high resolution mapping of pressures and assesses the strength of pelvic floor muscles within the vagina. It is used in a medical clinical setting to sense the pressure along the vagina and store the corresponding data. The VTI also provides analysis information. The real time data as well the analysis information can then be viewed by a physician as a tool for diagnosis and analysis. During the clinical procedure, the probe is inserted in the vagina for measurement of pressures on the vaginal wall at rest and pelvic floor muscle contractile pressures. Real time data is sampled from each sensing element via the VTI interface electronics and made available to the VTI software during each sample period. The software displays the data in real time to support the clinical procedure. The software also supports operational utility functions such as providing the user with an interface for operating the pressure calibration system. It obtains the probe sensor and calibration chamber data during the calibration process and determines the correction factors to be used in subsequent data collection. The VTI supports physician data analysis by means of a playback function, which replays a stored session using previously recorded data instead of the real time data. The VTI also indicates measured parameters such as high pressure zone location and size, resting pressures, muscle contraction pressures and calculated pressure gradients.
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