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510(k) Data Aggregation

    K Number
    K014149
    Device Name
    PAEDISCOPE, MODEL # P010A AND PF011A
    Manufacturer
    AESCULAP, INC.
    Date Cleared
    2002-03-18

    (90 days)

    Product Code
    GWG
    Regulation Number
    882.1480
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K983365,K954394,K954899,K002572,K002704
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Aesculap's Paediscope is intended for use in endoscope-assisted microneurosurgery and pure neuroendoscopy (i.e. Ventriculosopy) for direct visualization, diagnostic and/or therapeutic neuroendoscopy (for ventriculostomies, biopsies and removal of cysts, tumors and other obstructions.

    Device Description

    Aesculap's Paediscope combines the features of both flexible and rigid scopes. The distal end is a rigid neuroendoscope with a 3.0mm diameter. The rigid part includes one operating channel and two neuroendoscopes with a prism. The flexible part ends at the standard adapters for light cables and eyepiece connection. The flexible outpatient part allows more flexibility and reduces the weight of the scope part introduced into the patient. The Paediscope can be used in adult and pediatric patients. Micro-instruments are included with the Paediscope for the cutting and grasping biopsies and the removal of cysts, tumors and other obstructions.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria.

    Instead, the document is a 510(k) summary for a medical device called "Paediscope." It describes the device, its intended use, and states that no performance data or clinical performance studies were conducted or required for this submission.

    The key section regarding performance states:

    "No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, Aesculap's Paediscope comply with the requirements of IEC60601-2-18 (Medical electrical equipment, Part 2: Particular requirements for the safety of endoscopic equipment.) The Paediscope has undergone evaluation for electrical, thermal and irrigation safety to ensure the system is safe for the intended use."

    This indicates that compliance was based on adherence to existing safety standards (IEC60601-2-18) and evaluation for electrical, thermal, and irrigation safety, rather than a study with specific acceptance criteria related to clinical performance, a test set, ground truth, or expert review.

    Therefore, I cannot provide the requested information such as a table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC study details, or standalone algorithm performance, as these were not part of this 510(k) submission.

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