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510(k) Data Aggregation

    K Number
    K133134
    Device Name
    X-PORTE ULTRASOUND SYSTEM
    Manufacturer
    FUJIFILM SONOSITE,INC.
    Date Cleared
    2013-11-04

    (34 days)

    Product Code
    IYN,ITX,IYO
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K113156
    Predicate For
    K142017,K160674
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The FUJIFILM SonoSite X-Porte Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include:

    Ophthalmic
    Fetal - OB/GYN
    Abdominal
    Intra-operative (Abdominal organs and vascular)
    Pediatric
    Small Organ (breast, thyroid, testicles, prostate)
    Trans-vaginal
    Musculo-skel. (Convent.)
    Musculo-skel. (Superfic.)
    Cardiac Adult
    Cardiac Pediatric
    Peripheral vessel

    Device Description

    The SonoSite X-Porte Ultrasound System is a highly mobile, full featured, general purposic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. X-Porte is a custom fabricated digital electronic design that readly lends itself to be configured for specific ultrasound imaging applications through different system feature selections. The system interface can be customized for the user and controlled using a backlit touchscreen much like what is used in consumer tablet products. X-Porte can be operated in two different configurations, standbased with AC power or battery, and desktop-based with AC power only. In desktop configuration the ultrasound engine can be removed from the stand and used by itself with a single transducer and external monitor.

    AI/ML Overview

    The provided text appears to be a 510(k) summary for a medical device (ultrasound system) and does not contain information about acceptance criteria or a study proving device performance against such criteria. The document mainly focuses on establishing substantial equivalence to a predicate device based on technological characteristics and general safety standards.

    Therefore, I cannot fulfill your request for:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for a test set.
    3. Number of experts or their qualifications for ground truth.
    4. Adjudication method.
    5. MRMC comparative effectiveness study results.
    6. Standalone performance study results.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    The document explicitly states: "The SonoSite X-Porte Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." This means no clinical performance studies were conducted or reported for this submission to demonstrate device performance against specific acceptance criteria. The approval was based on demonstrating equivalence to an existing marketed device through non-clinical tests (electrical safety, thermal, mechanical, EMC, biocompatibility, acoustic output, etc.) and shared technological characteristics.

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