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510(k) Data Aggregation

    K Number
    K113541
    Device Name
    CLEARSTART SVM SYSTEM
    Manufacturer
    INTIO INC.
    Date Cleared
    2011-12-16

    (15 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTIO INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The INTIO ClearStart.SVM™ system is a self-contained image analysis desktop workstation addressing the needs of physicians performing diagnostic oncologic imaging, treatment planning, and post-procedure or systemic therapy follow-up assessment. ClearStart.SVM™ provides semi-automated tools for segmentation of suspicious lesions including primary and metastatic lung and liver tumors, and lymph node assessment using non-contrast and contrast CT images. Following lesion segmentation, ClearStart.SVM™'s automated volumetric, RECIST and WHO lesion measurements provide the user with data on the time-course of patient response to therapy. An on-board large disk storage capacity allows the user to easily track each patient's CT data from initial diagnosis through therapeutic interventions and follow up exams and includes a reporting package to aid in the assessment of response to therapy.
    Device Description
    The ClearStart•SVM™ product consists of a custom-configured desktop computer system consisting of high-performance commercial-off-the-shelf computer components, and INTIO proprietary software running on a Linux operating system. CT data is read into the system from a CD or DVD and stored uncompressed into a database which allows easy retrieval for follow up assessments. The ClearStart.SVM™ system uses data from contrast and non-contrast CT examinations of patients presenting with solid tumors. SVM segments the turnor within the organ and determines measurements such as longest tumor length in axial views and tumor volume. Diagnostic CT scans are viewed in both multiplanar reformatted (MPR) views and 3D volume rendered (VR) views, allowing the user to choose the best visualization of selected tumors to be treated. Typically tumors are best visualized in the contrast CT exam which is used for analysis. User selected lesions are segmented with minimal user input. The user places a cursor over the tumor and by clicking a mouse button inserts one or more region-growing seed points in the tumor to be segmented. Feedback of the seed location is shown in graphical overlays on the MPR views. After the seed or seeds are placed, the user activates a computer determined bounding box surrounding the marked lesion, with the surrounding tissue demonstrating a contrast difference to the marked tumor. The lesion is then segmented using 3D active contour methodology. As a follow up to a specific therapy the ClearStart+SVM™ system provides tools to help assess the effectiveness of image-guided loco-regional or systemic therapies for solid or semi-solid tumors throughout the body. Users are able to review changes in tumor dimensions based on follow up CT scans with computer-assisted segmentation and automated measurement of lesions to determine tumor response to therapy over time. The ClearStart SVM system is designed to semi-automatically segment and automatically measure tumors of the liver, lung, and lymph nodes. INTIO engineers have developed ClearStart-SVM™'s image processing and display software which provides both 2D (MPR) image display and 3D volume-rendered (VR) display capability. Response of tumors to therapy, either loco-regional or systemic, is facilitated by lesion segmentation and automated measurement leveraging INTIO's proprietary image segmentation algorithm. The automated measurements include both conventional and specific quantitative measurements such as RECIST, WHO and volumetric CT measurements.
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