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510(k) Data Aggregation

    K Number
    K991426
    Device Name
    MAHE INSTRUMENTS
    Manufacturer
    MAHE INTL., INC.
    Date Cleared
    1999-08-05

    (104 days)

    Product Code
    FDC,FAS,FJL
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MAHE INSTRUMENTS

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

    THE INTENDED USE FOR THE RESECTOSCOPE AND WORKING ELEMENTS IS IN UROLOGICAL PROCEDURES TO ENDOSCOPICALLY REMOVE, CUT, COAGULATE, AND OR TRANSECT TISSUE IN THE BLADDER, PROSTRATE, AND URETHRA. THE SURGEON PERFORMS THE EXAMINATION THROUGH THE URETHRA. THE DOCTOR CONTROLS THE BACK AND FORTH MOVEMENT OF THE ELECTRODE USING FINGER CONTROLS. THE WORKING ELEMENTS ALSO HOUSE A CYSTOSCOPE FOR VISALIZATION. THE HIGH FREQUENCY CABLE TRANSMITS ELECTRICAL CURRENT

    Device Description

    The Resectoscope is a reuasble non sterile urological instrument used with disposable sterile, single use electrodes for electro-cautery. The sheath and electrodes will be marketed in 24-27 French sizes.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study, sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth.

    The document describes a 510(k) premarket notification for a medical device called the MAHE Resectoscope. It details:

    • Device Description: A reusable, non-sterile urological instrument used with disposable, sterile, single-use electrodes for electro-cautery.
    • Intended Use: Endoscopic removal, cutting, coagulation, and/or transection of tissue in the bladder, prostate, and urethra during urological procedures.
    • Technological Characteristics: Claims substantial equivalence to a predicate device (Karl Storz and Wolf) based on similar materials, function, indications for use, and overall design.
    • Regulatory Information: The FDA's review and determination of substantial equivalence to a legally marketed predicate device, allowing the device to be marketed.

    The content focuses on regulatory approval based on substantial equivalence, rather than a detailed performance study with acceptance criteria.

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