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510(k) Data Aggregation

    K Number
    K130819
    Device Name
    CLL- V1 LIGHT SOURCE
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Date Cleared
    2013-06-19

    (86 days)

    Product Code
    NTN,FCW
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K082813,K091968
    Why did this record match?
    Device Name :

    CLL- V1 LIGHT SOURCE

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

    This light source has been designed to be used with Olympus-designated endoscopes, camera heads, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

    Device Description

    The Olympus CLL-V1 is a desk top device which consists of a LED light source designed and intended to be used with Olympus-designated endoscopes, camera heads, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

    AI/ML Overview

    The provided 510(k) summary (K130819) describes an LED light source, the Olympus CLL-V1, and its substantial equivalence to predicate devices. However, this document does not contain acceptance criteria, device performance data, details of a clinical study, or information about ground truth establishment.

    The summary focuses on:

    • Technological characteristics: States the CLL-V1 uses LED technology, offering a long-lasting LED "bulb," reduced energy consumption, no need for additional fan cooling (making it silent), and optimized light intensity for higher contrast and brightness compared to existing Halogen bulbs.
    • Non-clinical testing: Mentions risk analysis per ISO-14971:2007, and software validation per FDA guidance for a "Minor Level of Concern" device. It also lists several applied standards (ISO 14971:2007, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 60601-1-6).
    • Conclusion: States that the CLL-V1 is substantially equivalent to predicate devices with respect to general design, function, and indications for use, and raises no new concerns regarding safety or efficacy.

    Therefore, based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets them because this information is not present in the document.

    The document addresses compliance with standards and non-clinical aspects for regulatory clearance, but it does not detail a clinical study with performance metrics as typically expected for algorithms, diagnostics, or other devices requiring specific sensitivity/specificity, accuracy, or other outcome-based performance criteria. This device (a light source for endoscopy) would typically focus on electrical safety, EMC, light output specifications, and biocompatibility rather than a clinical performance study with human readers or ground truth analysis as might be done for an AI diagnostic device.

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