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510(k) Data Aggregation

    K Number
    K980734
    Device Name
    MYELOTEC VIDEO GUIDED CATHETER
    Manufacturer
    MYELOTEC, INC.
    Date Cleared
    1998-08-11

    (167 days)

    Product Code
    HRX,REG
    Regulation Number
    888.1100
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K954584
    Predicate For
    K150789,K151268,K201113
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    when used with a fiberoptic endoscope, this device can be used in the lumbar and sacral spine for observing epidural anatomy, pathology and delivery of drugs approved for epidural indications.

    Device Description

    The MYELOTEC VIDEO GUIDED CATHETER (VGC) consists of a flexible double lumen catheter, steering handle and associated ports for access to the lumens. The catheter has a built in steering mechanism that allows for guiding the soft tip through the epidural space and soft tissues for optimal access to the source of distress. Each lumen is one (1) mm in diameter. The design allows the use of a flexible fiber optic endoscope for visual examination of the area and surrounding tissues at the distal end of the catheter. This visual examination then allows the physician to diagnose the potential causes of neural distress and pain.

    The port on the second lumen allows the injection of saline to expand the space and expose the source of distress for viewing and treatment. The port also facilitates the connection of syringes to deliver physician selected therapeutic agents as appropriate to their diagnosis.

    AI/ML Overview

    The provided text is a 510(k) notification summary for the MYELOTEC VIDEO GUIDED CATHETER II. This document primarily focuses on establishing substantial equivalence to a predicate device and does not contain information about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications for the device.

    Therefore, I cannot provide the requested information from the given text.

    The document mainly includes:

    • Contact information and submission date
    • Device name, classification, and predicate device
    • Description and intended uses of the device
    • New indications for use
    • A comparison table between the MYELOTEC VGC and the RACZ Tun-L-Kath, highlighting differences in attributes like length, lumen diameter, number of lumens, endoscope capability, and steerability.
    • An FDA letter confirming the review and substantial equivalence determination.
    • An enclosure reiterating the intended use/indications.
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