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510(k) Data Aggregation

    K Number
    K022059
    Device Name
    MICROVASIVE PULMONARY GUIDEWIRE
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Date Cleared
    2002-11-13

    (141 days)

    Product Code
    MDM
    Regulation Number
    878.4800
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MICROVASIVE PULMONARY GUIDEWIRE

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

    The Pulmonary Guidewire is indicated for use to provide access to the tracheobronchial tree.

    Device Description

    The Pulmonary Guidewire is constructed of a core wire, outer jacket and a tip. The guidewire is designed to provide access to the tracheobronchial tree.

    AI/ML Overview

    This is a marketing document for a medical device (Pulmonary Guidewire). It is not an AI/ML device, and therefore the requested information for acceptance criteria and study data related to AI/ML device performance is not applicable.

    The document describes a medical device, the Pulmonary Guidewire, which is "constructed of a core wire, outer jacket and a tip" and "designed to provide access to the tracheobronchial tree." The document states that the device successfully met biocompatibility assessment requirements.

    Here's a breakdown of why the requested information isn't present in this document:

    1. AI/ML Device: The Pulmonary Guidewire is a physical medical instrument, not an artificial intelligence or machine learning device. Therefore, the concepts of "acceptance criteria" for algorithms, "performance metrics" like sensitivity/specificity, or "ground truth" derived from expert consensus for image analysis are not relevant to this product.

    2. Study Type: The "study" mentioned is a biocompatibility assessment, which is standard for medical devices that come into contact with the body. This is distinct from clinical trials or performance studies relevant to AI/ML diagnostic or prognostic tools.

    3. Regulatory Pathway: This device is a Class I device and went through the 510(k) premarket notification pathway based on substantial equivalence to predicate devices (Boston Scientific Corporation currently marketed Microvasive® Guidewires). This pathway generally focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring elaborate de novo clinical trials with specific performance endpoints often seen with novel AI/ML technologies.

    Therefore, I cannot provide the requested information because it does not exist within the provided document, as the device is not an AI/ML product.

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