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510(k) Data Aggregation

    K Number
    K082075
    Device Name
    HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER
    Manufacturer
    HANSEN MEDICAL, INC.
    Date Cleared
    2008-08-15

    (23 days)

    Product Code
    DRE
    Regulation Number
    870.1310
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K061070
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Dilator for Artisan™ Control Catheter is intended to introduce the Artisan Control Catheter into the atria and through the intraatrial septum from the right side of the heart to the left side.

    Device Description

    The Dilator for Artisan Control Catheter is made of a flexible tube with a tapered end on the distal outer diameter. A hemostasis valve and stopcock are attached on the proximal end. The Dilator has a through lumen for introduction over a guide wire.

    AI/ML Overview

    This 510(k) summary (K082075) describes a substantial equivalence claim for a medical device called the "Dilator for Artisan™ Control Catheter." It is NOT an AI/ML device, and as such, the typical acceptance criteria and study data associated with such devices (e.g., performance metrics, ground truth, expert consensus, MRMC studies) are not applicable or provided in this document.

    The submission focuses on demonstrating substantial equivalence to a predicate device (Hansen Medical Transseptal Needle and Dilator, K061070) based on similar intended use and technological characteristics.

    Therefore, the requested information elements related to device performance, sample sizes, ground truth establishment, expert qualifications, adjudication, and comparative effectiveness studies cannot be extracted from this document as they are not relevant to a 510(k) submission for a non-AI/ML device demonstrating substantial equivalence.

    Here's what can be extracted from the provided text, formatted as closely as possible to your request, but with recognition of its limitations:

    1. Table of Acceptance Criteria and Reported Device Performance

    No specific quantitative acceptance criteria or reported device performance metrics are provided in this document for the new device. The basis for acceptance is a claim of "substantial equivalence" to a predicate device based on similar intended use and technological characteristics.

    Acceptance CriterionReported Device PerformanceComments
    Intended Use EquivalenceThe Dilator for Artisan Control Catheter has the same general intended use as the predicate device.The intended use is "to introduce the Artisan Control Catheter into the atria and through the intraatrial septum from the right side of the heart to the left side."
    Technological Characteristics EquivalenceThe Dilator for Artisan Control Catheter has similar technological characteristics as the predicate device.The device is described as a "flexible tube with a tapered end on the distal outer diameter. A hemostasis valve and stopcock are attached on the proximal end. The Dilator has a through lumen for introduction over a guide wire." The document states "minor technological differences... raise no new issues of safety or effectiveness."
    Indications for Use EquivalenceThe indications for use are confined to the role of the dilator without the needle, similar to the predicate's dilator component."The indications for use is confined to the role of the dilator without the needle."
    Principle of Operation EquivalenceThe Dilator has similar principles of operation as its predicate device.Explicitly stated: "The Dilator has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device."

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

    • Sample Size for Test Set: Not applicable. This document does not describe a performance study with a test set of data for the new device.
    • Data Provenance: Not applicable. No data or studies are presented.

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

    • Not applicable. As no test set or performance study is described, there's no mention of experts establishing ground truth.

    4. Adjudication Method for the Test Set

    • Not applicable. No test set is described.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    • Was one done? No. This document does not describe an MRMC study.
    • Effect size of human readers improvement with AI vs. without AI assistance: Not applicable, as this is not an AI-based device and no MRMC study was conducted.

    6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

    • Was one done? No. This device is a mechanical medical instrument, not an algorithm.

    7. Type of Ground Truth Used

    • Not applicable. No ground truth is established or discussed as no performance study is detailed.

    8. Sample Size for the Training Set

    • Not applicable. This is not an AI/ML device, so there is no "training set."

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

    • Not applicable. There is no training set or ground truth in the context of this submission.
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