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510(k) Data Aggregation

    K Number
    K112124
    Device Name
    MICROCATHETER
    Manufacturer
    NAVILYST MEDICAL, INC.
    Date Cleared
    2011-08-19

    (25 days)

    Product Code
    DQO
    Regulation Number
    870.1200
    Type
    Abbreviated
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K000177,K023861
    Predicate For
    K113638
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The NMI Microcatheter is intended for use in small vessels and supreselective anatomy during diagnostic and interventional procedures in the peripheral vasculature. Upon access of the desired region, the microcatheter can be used for the controlled and selective infusion of diagnostic, therapeutic and embolic materials. All products delivered through the microcatheter must be used in accordance with the original manufacturer's instruction for use. The catheter is not intended for use in coronary or neuro- vasculature.

    Device Description

    The proposed MC is offered in two French size configurations. The first configuration has an outside diameter of 3.0F/2.8F (tapers proximally to distally) and has a nominal inside diameter of 0.027" along the entire catheter length. The second configuration has an outside diameter of 3.0F/2.4F (tapers proximally to distally) and has a nominal insider diameter of 0.021" along the entire catheter length.

    Both MC configurations consist of a shaft and proximal hub assembly. The radiopaque shaft transitions from a stiffer proximal region to a flexible 30cm distal end. A radiopaque marker is located 1mm from the catheter's distal end to identify the location of the distal tip under fluoroscopic visualization. The distal end of the catheter's outer surface is hydrophilic coated. The microcatheter is provided with a shaping mandrel and a rotating hemostatic valve. The microcatheter kit additionally includes a guidewire, a guidewire insertion tool and a torque device.

    AI/ML Overview

    The provided document does not describe a study involving AI or machine learning. It pertains to a 510(k) premarket notification for a medical device called the "NMI Microcatheter" and focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing. Therefore, I cannot extract information related to AI acceptance criteria, sample sizes for training/test sets, expert adjudication, MRMC studies, or standalone algorithm performance.

    However, I can provide the acceptance criteria and performance data for the physical device as described in the document.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Test/Performance CharacteristicReported Device Performance (Summary from Document)
    Physical PerformanceCoating performanceDemonstrated substantial equivalence through non-clinical tests.
    TrackabilityDemonstrated substantial equivalence through non-clinical tests.
    Pressure testingDemonstrated substantial equivalence through non-clinical tests.
    Dimensional verificationDemonstrated substantial equivalence through non-clinical tests.
    RadiopacityDemonstrated substantial equivalence through non-clinical tests.
    Kink resistanceDemonstrated substantial equivalence through non-clinical tests.
    Flow rateDemonstrated substantial equivalence through non-clinical tests.
    Tip shapabilityDemonstrated substantial equivalence through non-clinical tests.
    Compatibility testsDemonstrated substantial equivalence through non-clinical tests.
    Particulate generationDemonstrated substantial equivalence through non-clinical tests.
    Luer performanceDemonstrated substantial equivalence through non-clinical tests.
    BiocompatibilityBiocompatibility per ISO 10993-1Demonstrated substantial equivalence through non-clinical tests.

    Study Proving Device Meets Acceptance Criteria:

    The document describes a series of non-clinical tests conducted to demonstrate that the NMI Microcatheter is "substantially equivalent" to specified predicate devices (Boston Scientific Renegade Hi-Flo Microcatheter K000177 and Boston Scientific Renegade STC Microcatheter K023861). The study's conclusion is based on "comparison of technological characteristics and the results of non-clinical tests."

    Missing Information (Not applicable to this document as it's not an AI/ML study):

    1. Sample size used for the test set and the data provenance.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
    3. Adjudication method for the test set.
    4. Multi-reader multi-case (MRMC) comparative effectiveness study.
    5. Standalone (i.e., algorithm only without human-in-the-loop performance) study.
    6. Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML study.
    7. Sample size for the training set.
    8. How the ground truth for the training set was established.
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