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510(k) Data Aggregation

    K Number
    K964281
    Device Name
    AESCULAP ANGLED NEUROENDOSCOPES
    Manufacturer
    AESCULAP, INC.
    Date Cleared
    1997-04-21

    (175 days)

    Product Code
    GWG
    Regulation Number
    882.1480
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AESCULAP ANGLED NEUROENDOSCOPES

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

    Aesculap's Angled Neuroendoscopes are intended for use in visualization of ventricles and structures within the brain.

    Device Description

    These rigid, rod-lens neuroendoscopes are 4.0mm in diameter, 160mm in working length, with either 0°, 30° or 70° direction of view. The lens eyepiece is angled at 90° to allow an unobstructed view when used in conjunction with a surgical microscope. The angled neuroendoscopes are reusable devices composed primarily of stainless steel. An optional holding device, Aescular's Flexible Titanium Support Arm (FF169R), can be used to position and hold the neuroendoscope.

    AI/ML Overview

    This document describes a 510(k) premarket notification for Aesculap Angled Neuroendoscopes from 1997. It outlines the intended use, technological characteristics, and conformance to safety standards. However, it does not contain any information about a study with acceptance criteria and reported device performance related to AI/ML or comparative effectiveness studies.

    The provided text describes a medical device clearance process for traditional hardware, specifically neuroendoscopes. It focuses on:

    • Intended Use: Visualization of ventricles and structures within the brain.
    • Technological Characteristics: Rigid, rod-lens neuroendoscopes (4.0mm diameter, 160mm working length, various angles of view).
    • Performance Standards: Conformance to IEC 601-1 and IEC 601-2-18, and Thermal Safety testing.
    • Sterilization: Non-sterile, to be steam sterilized before use.
    • Substantial Equivalence: Comparison to other commercially available neuroendoscopes.

    Therefore, I cannot provide the requested information regarding acceptance criteria, device performance from a study, sample sizes, ground truth, expert qualifications, adjudication methods, or AI/MRMC studies because this information is not present in the provided text.

    This document predates modern AI/ML medical device regulations and evaluation methodologies, and the device itself is a purely mechanical optical instrument, not an AI-powered diagnostic or therapeutic tool.

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