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510(k) Data Aggregation

    K Number
    K091070
    Device Name
    MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM
    Manufacturer
    SIERRA SCIENTIFIC INSTRUMENTS, INC.
    Date Cleared
    2009-05-19

    (35 days)

    Product Code
    FFX
    Regulation Number
    876.1725
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIERRA SCIENTIFIC INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ManoScan Motility with Impedance Visualization System obtains a high resolution mapping of pressures and impedance levels within organs of the human gastrointestinal tract. These include the pharynx, upper esophageal sphincter (UES), esophagus, lower esophageal sphincter (LES), stomach, sphincter of oddi, small bowel, colon, duodenum and anorectal organs. It is used in a medical clinical setting to acquire pressures, impedance levels and video and store the corresponding data. The system also provides visualization and analysis tools and information. The real time data as well as the analysis information can be viewed for diagnostic and analysis purposes with an intention of assisting in the diagnosis and evaluation of gastrointestinal and swallowing disorders. The device is intended for use by gastroenterologists, surgeons and medically trained personnel.
    Device Description
    The ManoScan Motility with Impedance Visualization System is used to acquire gastrointestinal tract data in order to present a high-resolution mapping of pressures with Impedance levels within tubular organs. It includes the ability to acquire, display and replay video data captured from within the gastrointestinal tract organs. The ManoScan Motility with Impedance Visualization can be used with either or both of the video with Impedance data capture features disabled. The System is used in a medical clinical setting to sense pressure and Impedance levels, acquire and store the corresponding data and enable viewing or analyzing in real time or anytime after the data is acquired and stored. Accordingly, the System provides visualization and analysis tools that can be used for evaluation of the data and analytic diagnosis. The system includes a catheter probe that can be configured with a variety of pressure sensing element with Impedance sensor channels. During the clinical procedure, the catheter is inserted transorally or via rectal intubation and pressure with Impedance levels from inside the gastrointestinal tract are monitored. Data collection can include acquisition of data from different segments of the GI tract, including the pharynx, upper esophageal sphincter (UES), esophagus, lower esophageal sphincter (LES), stomach, sphincter of oddi, small bowel, colon, duodenum and anorectal area. Real-time data is sampled from each sensing channel via the interface electronics and made available to the software during each sample period. The software displays the data in real-time to support the clinical procedure.
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    K Number
    K031169
    Device Name
    MOTILITY VISUALIZATION SYSTEM
    Manufacturer
    SIERRA SCIENTIFIC INSTRUMENTS, INC.
    Date Cleared
    2003-12-12

    (242 days)

    Product Code
    FFX
    Regulation Number
    876.1725
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIERRA SCIENTIFIC INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Motility Visualization System obtains a high resolution mapping of pressures within tubular organs of the gastrointestinal tract. These organs include the esophagus from the pharyngeal region to the stomach, the proximal gut (stomach/duodenum), and the anus/recturn. It is used in a medical clinical setting to sense the pressures and store the corresponding data. The system also provides analysis information. The real time data as well as the analysis information can then be viewed by a physician for diagnostic and analysis purposes.
    Device Description
    The Motility Visualization System (MVS) obtains a high resolution mapping of pressures within tubular organs of the gastrointestinal tract. It is used in a medical clinical setting to sense the pressures along the gastrointestinal tract and stores the corresponding data. The system also provides analysis information. The real time data as well as the analysis information can be viewed by a physician for diagnostic and analysis purposes. The system includes a catheter probe with 36 pressure sensing elements. During the clinical procedure, the catheter is inserted transnasally and pressures inside the upper esophageal sphincter (UES), esophagus, lower esophageal sphincter (LES), and proximal gut are measured as the patient typically swallows small amounts of water. Alternatively, the catheter may be inserted in the anus/rectum for measurement of contractile pressures in that region. Real-time data is sampled from each sensing element via the MVS interface electronics and made available to the MVS 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 an interface for operating the pressure calibration system. It obtains the catheter sensor and calibration chamber data during the calibration process and determines the correction factors to be used in subsequent data collection. The MVS supports physician diagnosis and analysis by means of a playback function, which replays a stored session using previously recorded data instead of real-time data. The MVS also indicates estimated parameters such as LES location, LES resting pressure, LES relaxation, LES residual pressure inversion point (PIP) location, UES pressure, and motility metrics such as peristaltic wave amplitude, duration and velocity.
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