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510(k) Data Aggregation

    K Number
    K981804
    Device Name
    XENON LIGHT SOURCE MODEL LS6000
    Manufacturer
    CONTEC MEDICAL VISION, LTD.
    Date Cleared
    1998-07-24

    (64 days)

    Product Code
    GCT
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K944821,K944607,K954561
    Predicate For
    K982962
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Xenon Light Source Model LS6000 is designed to supply light for endoscopic diagnostic observation and surgical procedures.

    Device Description

    The Model LS 6000 is an electronic light source using a 100Watt Xenon lamp, to provide light for endoscopic procedures.

    AI/ML Overview

    This document is a 510(k) summary for a Xenon Light Source Model LS 6000 and the FDA's response. It is a declaration of substantial equivalence to already marketed devices, not a study proving the device meets specific acceptance criteria in the way a medical AI or diagnostic device would.

    Therefore, many of the requested points are not applicable to this type of submission. This 510(k) relies on the existing safety and effectiveness of predicate devices rather than a new standalone study with performance metrics.

    Here's an attempt to answer the questions based on the provided text, indicating where information is not applicable (N/A):

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Substantial Equivalence to Predicate Devices:The device is substantially equivalent to legally marketed devices such as the Richard Wolf Model 5141 (K944821), Model 5135 (K944607), the Karl Storz Model 201315-20 (K954561), and the Linvatec Model 8430.
    Design: Designed the same as predicate devices."Each Xenon Light Source is designed the same."
    Specifications: Meets the same specifications as predicate devices."...meets the same specifications..."
    Intended Use: Same indication as predicate devices."...and its indication is the same."
    Technological Characteristics: No significant difference in technological characteristics compared to existing devices."There is no significant technological characteristics of the Model LS 6000 compared to existing, legally marketed devices..."
    Lamp Wattage (Distinguishing Feature): Uses a 100-Watt Xenon lamp."The lamp utilized with the LS 6000 is a 100 Watt lamp." (This is noted as the only difference to predicates, implying meeting other criteria makes this acceptable.)

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

    • Sample size: N/A. This is a 510(k) submission asserting substantial equivalence based on device characteristics, not a clinical study with a test set of data.
    • Data provenance: N/A.

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

    • N/A. Ground truth establishment for a test set is not relevant for this 510(k) submission.

    4. Adjudication Method for the Test Set

    • N/A.

    5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    • N/A. This device is a light source for endoscopy, not an AI or diagnostic tool.

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

    • N/A. This is not an algorithm.

    7. The type of ground truth used

    • N/A. The "ground truth" for this submission is the established safety and effectiveness of the legally marketed predicate devices through their prior 510(k) clearances or pre-amendments status.

    8. The sample size for the training set

    • N/A. This is not a machine learning model.

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

    • N/A.
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