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510(k) Data Aggregation

    K Number
    K031593
    Device Name
    SOPRO 61D
    Manufacturer
    SOPRO
    Date Cleared
    2003-09-16

    (118 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K000424,K936071
    Predicate For
    K070102
    Why did this record match?
    Reference Devices :

    K000424

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

    Provide access, illumination and allow observation or manipulation of body cavities, hollow organs and canals. The device(s) consist of various rigid or flexible instruments inserted into these spaces and includes an optical system for conveying an image to the users eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the device.

    Device Description

    The SOPRO 61D is a high resolution, digital processing camera system utilizing a CCD image sensor. It provides high quality images with excellent resolution and colour contrast. This makes the camera a multidiciplinary tool.

    AI/ML Overview

    The provided text does not contain any information about acceptance criteria, device performance, a study to prove acceptance, or details regarding ground truth, expert opinions, or sample sizes.

    The document is a 510(k) summary for the SOPRO 61D camera, detailing its submission to the FDA for market clearance. It primarily focuses on:

    • Submitter and Device Information: Company contact, device name (SOPRO 61D), classification name (Laparoscope and Accessories, General & Plastic Surgery).
    • Predicate Device: Smith & Nephew Dyonics cameras (K936071) and SOPRO 51D (K000424).
    • Device Description: High-resolution digital processing camera system utilizing a CCD image sensor, providing high-quality images with excellent resolution and color contrast.
    • Intended Use: "Provide access, illumination and allow observation or manipulation of body cavities, hollow organs and canals. The device(s) consist of various rigid or flexible instruments inserted into these spaces and includes an optical system for conveying an image to the users eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the device."
    • Substantial Equivalence: Claims virtual identity to the SOPRO 51D and other existing camera systems in terms of intended use, composition, safety, and effectiveness.
    • FDA Clearance Letter: Confirms substantial equivalence to legally marketed predicate devices.

    Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, ground truth, or expert involvement because this information is not present in the provided text.

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