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510(k) Data Aggregation

    K Number
    K120130
    Device Name
    FALLER TROCAR
    Manufacturer
    MEDIGROUP, INC.
    Date Cleared
    2012-05-21

    (125 days)

    Product Code
    FJS,CLA
    Regulation Number
    876.5630
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K910786,K823331
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Faller Trocar is used to create an ante-grade subcutaneous tunnel for a peritoneal dialysis catheter from the initial implantation site to the preferred exit-site. It separates the tissue as it leads the catheter through to the skin exit-site.

    Device Description

    The Faller Trocar is a surgical tool, made of either stainless steel or approved plastic, with a barbed section on one end and a sharp tip on the other end. The device is curved so that the physician using it can follow a tunnel path to lead the catheter from the initial catheter implantation site to the exit-site in an ante-grade manner.

    AI/ML Overview

    This document describes a 510(k) premarket notification for the Faller Trocar Catheter Tunneling Device. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and detailed performance metrics. Therefore, many of the requested data points (like sample sizes, ground truth establishment, MRMC studies, or standalone algorithm performance) are not applicable or not provided in the document for this type of medical device submission.

    Here's an analysis of the provided information in relation to your request:

    1. Table of acceptance criteria and the reported device performance:

    Specific numerical acceptance criteria and reported performance metrics (e.g., sensitivity, specificity, AUC) are not provided in this 510(k) summary. The submission focuses on demonstrating substantial equivalence through material, design, and functional comparisons, along with a historical safety record of predicate devices.

    Acceptance Criteria (Not Explicitly Stated as Numerical)Reported Device Performance (as demonstrated by comparison to predicates)
    Ability to create an ante-grade subcutaneous tunnel for a peritoneal dialysis catheter from the initial implantation site to the preferred exit-site.Functions as designed and intended, similar to predicate devices.
    Separation of tissue as it leads the catheter through to the skin exit-site.Functions as designed and intended, similar to predicate devices.
    Safe and effective operation during indicated use.As safe and effective as predicate devices with a proven record of more than twenty years of successful use.
    Barbed ends for catheter attachment function correctly.Barbed ends were tested in-house with acceptable comparisons to predicate devices.
    Sharp tip for opening tunnel path functions correctly.Cutting tip was tested in-house with acceptable comparisons to predicate devices.
    Material compatibility and durability.Made of the same materials (stainless steel or approved plastic) as predicate devices.
    Similar shape and bend (for stainless steel version).Similar to predicate Covidien's Trocar (Faller Stylet).
    Similar curvature (for plastic version).Similar to predicate Medigroup's Tunnelor® Tool.

    2. Sample size used for the test set and the data provenance:

    • Test set sample size: Not applicable. The submission does not describe a clinical study with a "test set" in the context of an AI/ML device. Instead, "in-house testing" and "historical data of the predicate devices" are mentioned.
    • Data provenance: "In-house" testing for barbed ends and cutting tip. "Journal articles and historical data of the predicate devices" for overall safety and effectiveness. The country of origin for the historical data is not specified, but the predicate devices have been on the market for 20+ years. This would be considered retrospective data.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • Not applicable. There is no mention of experts establishing ground truth for a test set in the context of an AI/ML device. The evaluation relies on comparisons to predicate devices and historical performance.

    4. Adjudication method for the test set:

    • Not applicable. No test set or adjudication method is described.

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

    • Not applicable. This is not an AI/ML device, and no MRMC study was conducted or described.

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

    • Not applicable. This is not an AI/ML device.

    7. The type of ground truth used:

    • The "ground truth" for this device's performance relies on:
      • Functional comparison: Direct comparison of the new device's components (barbed ends, cutting tip) with those of the predicate devices through "in-house testing."
      • Historical outcomes data: The safety and effectiveness of the predicate devices are based on their long history of use (more than twenty years) and cited "Journal articles and historical data." The new device is deemed safe and effective due to its "substantial equivalence" to these predicates.

    8. The sample size for the training set:

    • Not applicable. This is not an AI/ML device, and no training set is described.

    9. How the ground truth for the training set was established:

    • Not applicable. This is not an AI/ML device.
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