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510(k) Data Aggregation

    K Number
    K092739
    Device Name
    MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE
    Manufacturer
    C-LINK MICRO IMAGING, INC
    Date Cleared
    2010-01-12

    (126 days)

    Product Code
    ODF
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K011189
    Why did this record match?
    Applicant Name (Manufacturer) :

    C-LINK MICRO IMAGING, INC

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

    This device is to be used by a physician for viewing an interior cavity of the human body through either a natural opening or an incision.

    Device Description

    Like the predicate devices, the C-Link Microendoscope Model S-0001 Single Light Source and D-0001 Dual Light Source consist of a semi-rigid fiberscope with a separate irrigating outer sheath or introducer to view and assess/biopsy soft tissue.

    AI/ML Overview

    The provided text is a 510(k) summary for a microendoscope device and does not describe a clinical study or detailed acceptance criteria for device performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device. Therefore, I cannot generate the requested table and information about acceptance criteria and a study proving those criteria are met.

    Here's why and what information is available:

    • No Acceptance Criteria or Performance Data: The document explicitly states: "All necessary testing was or will be performed on the C-Link Microendoscope Model S-0001 Single Light Source and D-0001 Dual Light Source to ensure that the product is substantially equivalent to the predicate devices and to ensure that the new device does not have a significant effect on safety and effectiveness." This indicates that the specific test results and acceptance criteria were likely part of the internal design control and testing, but are not included in this public 510(k) summary. The submission relies on substantial equivalence rather than a detailed performance study with explicit acceptance criteria.
    • Substantial Equivalence: The primary method for demonstrating safety and effectiveness is by showing "substantial equivalence" to a legally marketed predicate device (Acueity ViaDuct Microendoscope, K011189). This means the new device is similar in intended use, principles of operation, anatomical site, safety characteristics, and physical characteristics.

    Therefore, I cannot populate the table or answer most of your specific questions as the information is not present in the provided text.

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