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510(k) Data Aggregation

    K Number
    K220956
    Device Name
    Libby Echo:Prio
    Manufacturer
    Date Cleared
    2022-07-20

    (110 days)

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

    Dyad Medical, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Libby™ Echo:Prio is software that is used to process previously acquired DICOM-compliant cardiac ultrasound images, and to make measurements on these images in order to provide automated estimation of several cardiac measurements. The data produced by this software is intended to be used to support qualified cardiologists, sonographers, or other licensed professional healthcare practitioners for clinical decision-making. Libby™ Echo:Prio is indicated for use in adult patients.
    Device Description
    Echo:Prio is an image post-processing analysis software device used for viewing and quantifying cardiovascular ultrasound images. The device is intended to aid diagnostic review and analysis of echocardiographic data, patient record management and reporting. The software provides an interface for a skilled sonographer to perform the necessary markup on the echocardiographic image prior to review by the prescribing physician. The markup includes: the cardiac segments captured, measurements of distance, time, area, quantitative analysis of cardiac function, and a summary report. The software allows the sonographer to enter their markup manually and/or manually correct automatically generated results. It also provides automated markup and analysis, which the sonographer may choose to accept outright, to accept partially and modify, or to reject and ignore. Machine learning based view classification and border segmentation form the basis for this automated analysis. Additionally, the software has features for organizing, displaying, and comparing to reference guidelines the quantitative data from cardiovascular images acquired from ultrasound scanners.
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    K Number
    K210931
    Device Name
    Libby IAAA v1.0
    Manufacturer
    Date Cleared
    2021-12-17

    (263 days)

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

    Dyad Medical, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Libby IAAA is intended to review and analyze Intravascular optical coherence tomography (OCT) images in raw OCT file format. IAAA enables quantification of artery and/or stent dimensions. The software is intended to be used by or under supervision of a Cardiologist.
    Device Description
    The Libby IAAA v1.0 platform is a web-accessible post-processing analysis device used for viewing and quantifying intravascular OCT images. The device is intended to visualize and quantify OCT pullback data in raw OCT file format. The device enables lumen, stent, and stent strut detection and has features for loading, saving, and report generation of aggregated quantitative data. The device allows for analysis of raw Intravascular optical coherence tomography (OCT) files obtained from the Abbott Laboratories C7-XR system and compatible imaging catheters. The web-based platform can be used in common desktop web browsers. A user opens an intravascular image pullback file using the platform and has the ability to use various modules to perform image analysis on areas of interest. The platform includes the following module panels for visualization, quantification, and report generation: Visualization: - 2D cross-sectional view - 2D longitudinal view - Image navigation tools - Measurement and annotation tools - Bookmark areas of interest Quantification: - Distance and area measurements - Guidewire detection - Lumen and Stent area quantification - Stent and strut detection (pullback level and frame level) - Strut classification (covered versus uncovered, apposed, and malapposed) Data Reporting: Study information, lumen areas, stent areas, reference areas, percent stenosis, along with usercreated annotations are displayed to the user within the software automatically saves all data and the user has the option to generate a report in .xlsx format. The product is intended to be used by or under supervision of a board-certified Cardiologist.
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