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510(k) Data Aggregation

    K Number
    K123151
    Device Name
    ENDOSEE MODEL 8000 U-SCOPE
    Manufacturer
    ENDOSEE CORP
    Date Cleared
    2013-03-08

    (150 days)

    Product Code
    HIH
    Regulation Number
    884.1690
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K961688,K092278
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENDOSEE CORP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The U-Scope device is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures. Generally recognized indications for diagnostic hysteroscopy include: abnormal bleeding; infertility and pregnancy wastage; evaluation of abnormal hysterosalpingogram; intrauterine foreign body; amenorrhea; and pelvic pain.

    Device Description

    The EndoSee U-Scope Model 8000 is a handheld, battery-operated portable hysteroscope. It includes a sterile single use disposable hysteroscopic cannula and a reusable handle. The disposable cannula contains a miniature CMOS camera and a light-emitting diode (LED) illumination module at the tip and a channel for infusion of irrigating fluid. The disposable cannula is sterilized and packaged in a sealed bag. The handle is light weight and ergonomically designed. It has a connector and locking mechanism for attaching and detaching the cannula. The handle contains the remaining electronics including a power on/off button, a video processor, a display unit (LCD display), a rechargeable battery, management electronics, microcontrollers and firmware.

    AI/ML Overview

    The provided text describes the U-Scope Model 8000 hysteroscope and its substantial equivalence to predicate devices. However, the document primarily focuses on regulatory approval (510(k) submission) and does not contain information about acceptance criteria for an AI/algorithm-based device, nor a study proving general device performance against such criteria, nor any of the specific details requested in points 2-9 for an AI device study.

    The "Performance Data" section (Page 4-5) lists various bench tests conducted to ensure compliance with standards for biocompatibility (ISO 10993), electrical safety (ISO 60601-1, ISO 60601-1-2, IEC 60601-2-18), thermal safety, mechanical characteristics, software verification and validation, sterilization validation (ISO 11135-1, ISO 11607, AAMI TIR12:2010), handling reprocessing (AAMI TIR30:2011), battery specifications, durability, and a general mention of optics performance and image quality testing. These are standard performance tests for the physical device, not an AI or algorithm's diagnostic performance.

    Therefore, I cannot fulfill the request as the provided text does not contain the necessary information regarding:

    • Acceptance criteria for an AI/algorithm. The document discusses acceptance criteria for physical components and compliance with medical device standards.
    • A study proving the device meets AI-specific acceptance criteria. The "Performance Data" describes bench testing for device safety and functionality.
    • Sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as they pertain to an AI algorithm.

    The device described is a physical hysteroscope, not an AI or algorithm-based diagnostic tool.

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