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510(k) Data Aggregation

    K Number
    K231875
    Device Name
    Vaginal Tactile Ultrasound Imager
    Manufacturer
    Advanced Tactile Imaging Inc.
    Date Cleared
    2024-02-22

    (241 days)

    Product Code
    HIR, IYN, IYO
    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 Ultrasound Imager obtains high-resolution mapping of pressures, ultrasound images and assesses the strength of pelvic floor muscles within the vagina. It is used in a medical setting to acquire the pressures, ultrasound images and store the corresponding data. It also provides visualization, analysis tools and information. The real time data as well as 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 Ultrasound Imager (TIUSv) acquires ultrasound images and tactile images (pressure maps) from within the vagina and assesses the strength of pelvic floor muscles within the vagina. The device provides data on the pressures applied to vaginal walls along with the probe location to visualize pelvic floor support structures, and to record pelvic floor muscle contraction. The TIUSv software provides measurement, imaging, and reporting tools. The acquired data and the analysis results provided by TIUSv software can be used by a physician for quantitative biomechanical assessment of the vagina and pelvic floor conditions. The TIUSv probe is equipped with 96 pressure (tactile) sensors, 192 ultrasound transducers, an orientation sensor (accelerometer), temperature sensors, and micro-heaters. During the clinical procedure, the probe is used to acquire dynamic ultrasound images and pressure responses from the vaginal walls under applied loads. The TIUSv examination procedure includes data collection from all segments of the vagina. Real-time data are sampled from the probe sensors via the interface electronics. The TIUSv software displays the acquired data in real time. The resulting pressure maps (tactile images) of the vagina integrate all the acquired pressure and positioning data for each of the pressure sensing elements. The TIUSv records the dynamic contraction for pelvic floor muscle(s). The probe surfaces that contact the vaginal walls are preheated to human body temperature. The TIUSv 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 TIUSv also provides data and graphs such as pressure applied to the probe and location, resting pressures, muscle contraction pressures and calculated pressure gradients.
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