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510(k) Data Aggregation

    K Number
    K242588
    Device Name
    COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)
    Manufacturer
    OrbusNeich Medical (Shenzhen) Co., Ltd.
    Date Cleared
    2025-01-07

    (130 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K182360,K191560,K231608
    Why did this record match?
    Reference Devices :

    K182360, K191560

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

    The COREPASS FLEX/CONTROL microcatheters are indicated for:
    · supporting and facilitating the placement of guidewires in the coronary and peripheral vasculature (not intended for neurovasculature).
    · exchanging guidewires in the coronary and peripheral vasculature.
    · the delivery of contrast media into the coronary, peripheral, and abdominal vasculature.

    Device Description

    The COREPASS FLEX/ CONTROL microcatheters are singe lumen catheters, offered in two shaft sizes (2.2F and 2.5F) with working lengths of 135cm or 150cm, designed for use in coronary, peripheral, and abdominal vasculature. The COREPASS FLEX/CONTROL share identical shaft profile 2.5F (0.032'') but different distal profile, including 2.2F (0.028'') for the 2.2F configuration (COREPASS FLEX) and 2.5F (0.032'') for the 2.5F configuration (COREPASS CONTROL). The catheter consists of five sections: hub with a female luer connector, catheter body shaft, proximal section, distal section, and tip. The distal most 60cm of the outer surface is coated with a hydrophilic polymer to increase lubricity and the lumen of catheter is lined with a fluoropolymer to facilitate movement of the guidewire. The catheter is compatible with a standard 0.014 inch (0.36mm) guidewire.

    AI/ML Overview

    The provided text is a summary of a 510(k) premarket notification for a medical device (COREPASS Modular Microcatheter) and does not contain information about a study that proves the device meets specific acceptance criteria in the context of an AI-powered diagnostic tool. The document focuses on the regulatory clearance process for a physical medical catheter device.

    Therefore, I cannot extract the requested information regarding:

    1. A table of acceptance criteria and the reported device performance (in the context of an AI device)
    2. Sample size used for the test set and the data provenance
    3. Number of experts used to establish the ground truth
    4. Adjudication method
    5. Multi-reader multi-case (MRMC) comparative effectiveness study
    6. Standalone performance
    7. Type of ground truth used
    8. Sample size for the training set
    9. How the ground truth for the training set was established

    The "Performance Data" section in the document lists various physical and material-related tests conducted on the microcatheter (e.g., Sterilization, Shelf-Life Performance, Particulate Evaluation, Dimension Inspection, Media Flow Rate, Shaft Burst Pressure, Guidewire Compatibility, Coating Integrity, Flexibility and Kinking, Corrosion Resistance, Torque Strength, Tensile Strength, Radiopacity, and a range of Biocompatibility tests). It simply states:

    "The test results of COREPASS Modular Microcatheter met all acceptance criteria, which are same or similar to the predicate device and reference device. It ensures that the design and construction of COREPASS Modular Microcatheter are suitable for its intended use."

    This confirms that acceptance criteria exist for these physical properties and that the device met them, but the document does not elaborate on what those specific criteria are nor does it describe a study design in the way one would for an AI/software as a medical device (SaMD).

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