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510(k) Data Aggregation

    K Number
    K021717
    Device Name
    ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5
    Manufacturer
    WORLD OF MEDICINE LEMKE GMBH
    Date Cleared
    2002-08-20

    (89 days)

    Product Code
    GCT
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K962595
    Why did this record match?
    Device Name :

    ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5

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

    The Endoscopic Light Source XL300/L5 is intended to be used with fiber optic endoscopes to provide illumination of body cavities, hollow organs and canals during endoscopic procedures.

    Device Description

    The Endoscopic Light Source XL300/L5 uses a 300 W xenon lamp to provide illumination during endoscopic diagnostic and surgical procedures through a fiber optic cable, which is connected to the device. Brightness can be adjusted manually. The color temperature of the xenon lamp is approximately 5600 °K and the lamp life is approximately 500 hours.

    AI/ML Overview

    The provided text describes a 510(k) summary for the Endoscopic Light Source XL300/L5. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and standalone algorithm performance as would be expected for an AI/ML device.

    Here's an analysis based on the provided text, highlighting the absence of information typically requested for AI/ML device studies:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Defined by Manufacturer or Regulatory Body)Reported Device Performance
    Compliance with International Standard IEC 60601-1Will comply
    Compliance with International Standard IEC 60601-1-2Will comply
    Conformity to Medical Device Directive 93/42/EECWill conform
    Compliance with Underwriters Laboratories Standard UL2601-1Will meet requirements
    Intended Use (illumination with fiber optic endoscopes)Met (similar to predicate)
    Design and Technological Characteristics (300 W Xenon lamp)Met (similar to predicate)

    Explanation: The "acceptance criteria" for this device are primarily regulatory and safety standards, and performance is evaluated based on its similarity to a legally marketed predicate device. There are no quantitative performance metrics (e.g., sensitivity, specificity, accuracy) provided as would be typical for an AI/ML diagnostic device.

    2. Sample Size Used for the Test Set and Data Provenance

    This information is not applicable/not provided in the document. The submission is a 510(k) summary for an endoscopic light source, which is a hardware device. It does not involve a "test set" of patient data for AI model evaluation. The demonstration of substantial equivalence is based on technical specifications and compliance with standards.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

    This information is not applicable/not provided. As there is no "test set" of patient data, there's no need for experts to establish ground truth for an AI model.

    4. Adjudication Method for the Test Set

    This information is not applicable/not provided.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

    This information is not applicable/not provided. MRMC studies are relevant for evaluating the impact of AI assistance on human readers, which is not the subject of this 510(k) submission for a light source.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) study was done.

    This information is not applicable/not provided. This device is a hardware component (a light source), not an AI algorithm.

    7. The type of ground truth used.

    This information is not applicable/not provided.

    8. The sample size for the training set.

    This information is not applicable/not provided.

    9. How the ground truth for the training set was established.

    This information is not applicable/not provided.

    Summary of the Study that Proves the Device Meets the Acceptance Criteria:

    The "study" described in the document is a demonstration of substantial equivalence to a predicate device and a commitment to comply with relevant safety and performance standards.

    • Predicate Device: Karl Storz Xenon 300 Light Source for Non-Flash Applications (K962595).
    • Methodology: The manufacturer states that the Endoscopic Light Source XL300/L5 is "similar in design and technological characteristics" to the predicate device. Both devices are intended to provide illumination for endoscopic procedures using a 300W Xenon lamp. The manufacturer asserts that the "differences... are minor and raise no new questions of safety and effectiveness."
    • Performance Data: The device "will comply" with international safety standards (IEC 60601-1, IEC 60601-1-2), will "conform" to the Medical Device Directive 93/42/EEC, and "will meet the requirements" of UL2601-1. This indicates adherence to established electrical, electromagnetic compatibility, and medical device safety standards.
    • Conclusion: The FDA reviewed the 510(k) submission and determined that the device is substantially equivalent to the legally marketed predicate device, allowing it to proceed to market. This determination is based on the provided technical specifications, intended use, and commitment to compliance with recognized standards, not on a clinical performance study with patient data or an AI algorithm evaluation.
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