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510(k) Data Aggregation

    K Number
    K022689
    Device Name
    MODIFICATION TO MEDAMICUS AXIA RSN
    Manufacturer
    MEDAMICUS, INC.
    Date Cleared
    2002-08-23

    (10 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K020563
    Why did this record match?
    Device Name :

    MODIFICATION TO MEDAMICUS AXIA RSN

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

    The MedAmicus Axia RSN™ is intended to minimize needle stick injuries when used for percutaneous introduction of guidewires or other devices.

    Device Description

    The MedAmicus Axia RSN™ is a single use device for percutaneous introduction of guidewires, or similar devices, up to 0.038 inches in diameter. The device is packaged as either sterile single units or as part of a kit. The device is designed with a shield as part of the safety needle mechanism to aid in the prevention of needle stick injuries. The needle of the device is retracted into the shield by pushing the button prior to removal of the device off the guidewire, or other device, and out of the body. After retraction, the shield covers the needle tip. The device is disposed of according to routine procedure in a sharps container.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a medical device called the MedAmicus Axia RSN™, a catheter introducer designed to minimize needle stick injuries. However, the document does not contain the specific information required to complete the requested table and answer the study-related questions for an AI/device performance evaluation.

    The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (MedAmicus Axia RSN K020563) and highlights a material change in the new device. The "Summary of Studies" section only states that "Design Verification has been completed to ensure that the modified material does not affect the safety and effectiveness of the device." It refers to a Risk Analysis compliant with EN 1441, but does not provide any performance metrics, acceptance criteria, or details about patient data, experts, or ground truth that would be relevant to an AI-powered diagnostic or assistive technology.

    Therefore, I cannot generate the requested table and answers based on the provided input. The document is for a traditional medical device (catheter introducer) and not an AI/software as a medical device (SaMD) that would typically have the kind of studies and performance data you are asking for.

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