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510(k) Data Aggregation

    K Number
    K972958
    Device Name
    LYSONIX TTD DELTA SCAVENGER SUCTION/ASPIRATION CANNULAS LYSONIX INFUSION DIAMOND CANNULAS
    Manufacturer
    LYSONIX, INC.
    Date Cleared
    1997-09-19

    (39 days)

    Product Code
    GCJ,FGY
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K962525,K832520,K914526,K862936,K861878
    Why did this record match?
    Device Name :

    LYSONIX TTD DELTA SCAVENGER SUCTION/ASPIRATION CANNULAS LYSONIX INFUSION DIAMOND CANNULAS

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

    The LySonix Cannulas are instruments used for suction of fluids and tissue and for infusion of fluids during a variety of surgical procedures.

    Device Description

    The LySonix Suction/Aspiration and Infusion Cannulas are hollow stainless steel tubes, with a blunt, bullet, or spatula-shaped tip. The cannulas are provided with an attached handle. The Suction and Infusion Cannulas are each available in three cannula lengths and four diameters. The LySonix Suction/Aspiration and Infusion Cannulas will be provided non-sterile.

    AI/ML Overview

    The provided document is a 510(k) summary for the LySonix Suction/Aspiration and Infusion Cannulas. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and performance data for the device itself.

    Therefore, many of the requested sections (e.g., acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of submission.

    The core of this 510(k) is to show that the new device has the same technological characteristics and intended use as legally marketed predicate devices, implying that it would perform similarly and thus be as safe and effective. It does not contain a study designed to quantify the performance of the device against predefined acceptance criteria in the way one might find for a diagnostic or AI device.

    Here's a breakdown based on the information available:

    1. Table of Acceptance Criteria and Reported Device Performance

    CriterionAcceptance CriteriaReported Device Performance
    Material CompositionNot explicitly stated but implied to be "biocompatible metal" (stainless steel) for cannulas and aluminum for handles, matching predicates.LySonix cannulas are stainless steel, handles are aluminum.
    Technological CharacteristicsImplied to be "same technological characteristics" as predicate devices."No new technology is being introduced... design is similar to the predicate Suction Aspiration Cannulas already on the market." This includes lengths, diameters, and tip shapes/styles within the same ranges.
    Intended UseSame as predicate devices: for suction of fluids/tissue and infusion of fluids during surgical procedures."instruments used for suction of fluids and tissue and for infusion of fluids during a variety of surgical procedures."
    SterilityNon-sterile, with predicate devices also offered non-sterile (and some as sterile options).Provided non-sterile.

    Note: The 510(k) process for this type of device relies heavily on substantial equivalence to existing devices, rather than establishing new performance metrics. Performance is assumed to be acceptable if it matches that of the legally marketed predicate devices.

    2. Sample Size Used for the Test Set and Data Provenance

    • Not Applicable / Not Provided: This 510(k) summary does not describe a performance study with a test set of data in the context of diagnostic or AI device evaluation. The assessment is based on a comparison of design, materials, and intended use to predicate devices. There is no "test set" of patient data in this submission.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

    • Not Applicable / Not Provided: There was no "ground truth" derived from expert review of a test set, as this device submission does not involve a diagnostic or AI algorithm requiring such validation.

    4. Adjudication Method for the Test Set

    • Not Applicable / Not Provided: No test set or expert adjudication was performed for this 510(k) submission.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

    • No: This document does not describe an MRMC study. This type of study is typically conducted for diagnostic devices (especially imaging-based AI) to assess the impact of the device on human reader performance. This product is a surgical tool, not a diagnostic device.

    6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

    • Not Applicable: This product is a physical surgical instrument (cannulas), not an algorithm or AI. Therefore, the concept of "standalone performance" for an algorithm is not relevant.

    7. The Type of Ground Truth Used

    • Not Applicable: For this type of medical tool that is claiming substantial equivalence, the "ground truth" is effectively the established safety and effectiveness profile of the predicate devices. There is no specific outcome data, pathology, or expert consensus used as ground truth for a new performance claim, as no new performance claim is being made.

    8. The Sample Size for the Training Set

    • Not Applicable / Not Provided: This submission does not involve a machine learning or AI model, so there is no "training set."

    9. How the Ground Truth for the Training Set was Established

    • Not Applicable / Not Provided: As there is no training set, this question is not relevant.
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