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510(k) Data Aggregation

    K Number
    K991051
    Device Name
    KSEA EPIDUROSCOPE
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Cleared
    1999-06-01

    (63 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Epiduroscope is indicated for use in the lumbar and sacral spine for observing epidural anatomy and pathology.

    Device Description

    The KSEA Epiduroscope is a manually operated surgical devices. The KSEA Epiduroscope is a flexible fiberoptic telescope which utilize fiber-optic technology. The body contact portions of the KSEA Epiduroscope are composed of medical grade polyurethane.

    AI/ML Overview

    This 510(k) summary does not contain information related to specific acceptance criteria or a study proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

    Therefore, I cannot provide the requested information in the format specified. The document primarily addresses:

    1. Device Identification: KSEA Epiduroscope
    2. Indication: For use in the lumbar and sacral spine for observing epidural anatomy and pathology.
    3. Device Description: A manually operated, flexible fiberoptic telescope utilizing fiber-optic technology, with body contact portions made of medical-grade polyurethane.
    4. Substantial Equivalence: Claimed based on the basic features, design, and intended uses being the same as predicate devices, with minor differences raising no new issues of safety and effectiveness.

    There is no mention of performance metrics, clinical studies, test sets, ground truth establishment, or sample sizes related to proving the device's efficacy or safety against specific acceptance criteria. The FDA letter confirms the substantial equivalence determination but does not detail efficacy study results.

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