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510(k) Data Aggregation

    K Number
    K973814
    Device Name
    TRUMP-IT II AND MAGNUM 250
    Manufacturer
    VALLEY WEST, INC.
    Date Cleared
    1998-01-30

    (115 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K951086
    Why did this record match?
    Reference Devices :

    K951086

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

    The device is indicated for use in patients eligible for treatment via general laparoscopic surgical procedures.

    Device Description

    The Candidate Device consists of a hand-held trumpet valve suction-irrigator designed to provide pinpoint suction and irrigation to the surgical site during general laparoscopic procedures. This device is designed for use with legally-marketed irrigation pumps, irrigant bags and bottles, and legallymarketed suction sources.

    AI/ML Overview

    The provided document is a 510(k) summary for the Trump-It II™ and Magnum 250 Trumpet Valve Suction-Irrigation Handpieces. This document focuses on establishing substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria or a study proving that the device meets those criteria.

    Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details from the provided text.

    The document primarily covers:

    • Submitter's Name and Contact
    • Device Name and Classification
    • Predicate Device identification (Nezhat-Dorsey Hydro-Dissection System & Accessories, K951086)
    • Device Description (function, scientific basis, physical/performance characteristics like sterile, disposable, single-use, and materials are proprietary)
    • Intended Use Statement (general laparoscopic surgical procedures for eligible patient populations)
    • Technological Characteristics Summary
    • FDA's 510(k) clearance letter confirming substantial equivalence.
    • Indications For Use statement.

    It specifically states that the device provides "pinpoint suction and irrigation to the surgical site during general laparoscopic procedures" by combining a hand-held trumpet valve suction-irrigator and a laparoscopic probe. The basis of the 510(k) is substantial equivalence to an existing device, rather than explicit performance criteria described by a detailed study in this document.

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