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510(k) Data Aggregation

    K Number
    K964585
    Device Name
    RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS (MULTIPLE)
    Manufacturer
    TRIMEDYNE, INC.
    Date Cleared
    1997-04-17

    (153 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    These devices are intended for use with any holmium laser (with a compatible connector) for its cleared applications.

    Device Description

    The Multiuse Switchable Tip is a fiber optic energy delivery device consisting of a nearcontact fixed laser fiber contained in a stainless steel shaft; it attaches to the Omni'10 Multiuse Handpiece through a quick-connect mechanism.

    AI/ML Overview

    This document is a 510(k) summary for a medical device (Trimedyne Multiuse Switchable Tips). It explicitly states that "No clinical tests were submitted in this Premarket Notification." This means there is no study described within this document that proves the device meets specific acceptance criteria based on clinical performance.

    Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies cannot be provided from the given text.

    The only "tests" mentioned are "Nonclinical Tests" which included sterilization, mechanical, biological, and performance studies. However, the document does not elaborate on specific acceptance criteria for these nonclinical tests, nor does it provide detailed results or methodologies for these tests beyond their general categories.

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