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    K Number
    K171609
    Device Name
    Check-Flo Performer Introducer Micropuncture Radial Artery Access Set
    Manufacturer
    Cook Incorporated
    Date Cleared
    2018-06-04

    (368 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Type
    Traditional
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    K152044
    Why did this record match?
    Device Name :

    Check-Flo Performer Introducer Micropuncture Radial Artery Access Set

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

    The Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set is intended to introduce diagnostic and interventional devices in radial artery access procedures.

    Device Description

    The Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set is a Class II device according to 21 CFR §870.1340; product code DYB (Catheter Introducer). The Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set is composed of an introducer sheath and dilator. The subject device also includes additional procedural components such as a wire guide and a 21 gage needle with a 4 inch length. Some subject device configurations also include a luer locking syringe.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    TestAcceptance CriteriaReported Device Performance
    Biocompatibility TestingMet predetermined acceptance criteria for non-toxicity in accordance with BS EN ISO 10993-1:2009.The materials and methods used to manufacture the subject device are non-toxic and met the predetermined acceptance criteria for their intended use.
    Dimensional Stability and CompatibilityMet predetermined acceptance criteria in accordance with an approved study protocol.The predetermined acceptance criteria were met.
    Dilator and Introducer Sheath Tensile TestingPeak load values in accordance with BS EN ISO 11070:2014, Annex C.The predetermined acceptance criteria were met.
    Liquid Leakage Under PressureNo leakage under proper clinical use when tested in accordance with an approved study protocol.The predetermined acceptance criteria were met.
    Valve Leakage Testing Under PressureNo leakage past the hemostasis valve under proper clinical use when tested in accordance with ISO 11070 Annex E and an approved study protocol.The predetermined acceptance criteria for the respective testing were met.
    Rollback and Kink ResistanceNo signs of damage (rollback or cracks at tip) or kinking of the shaft under proper clinical use, in accordance with ISO 11070:2014, Annex A.The predetermined acceptance criteria for the respective testing were met.
    Age TestingMet predetermined acceptance criteria in accordance with BS EN ISO 11070:2014.The predetermined acceptance criteria for the respective testing were met.
    Acute PerformanceMet predetermined acceptance criteria in an animal model.The predetermined acceptance criteria were met.

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

    The document does not explicitly state the specific sample sizes for each test conducted on the device. It generally refers to "test articles" or "devices."

    • Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. The testing was conducted internally by Cook Incorporated.

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

    This information is not provided in the document. The tests seem to be primarily engineering and performance-based against established standards, rather than requiring expert interpretation for ground truth.

    4. Adjudication Method for the Test Set

    This information is not applicable and therefore not provided. The testing described is objective performance testing against predefined criteria, not subjective interpretation requiring adjudication.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

    No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a medical instrument (catheter introducer) and not a diagnostic imaging or AI-driven decision support system, so such a study would not be relevant. The study focuses on the device's physical and functional performance.

    6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

    No, a "standalone algorithm performance" study was not done. This device is a physical medical instrument, meaning there is no algorithm or AI component involved.

    7. The Type of Ground Truth Used

    The ground truth used for performance validation was based on established industry standards and approved study protocols. For instance:

    • Biocompatibility: BS EN ISO 10993-1:2009
    • Tensile Testing: BS EN ISO 11070:2014, Annex C
    • Valve Leakage Testing: ISO 11070 Annex E
    • Rollback and Kink Resistance: ISO 11070:2014, Annex A
    • Age Testing: BS EN ISO 11070:2014
    • Acute Performance: "animal model" (implying physiological outcomes measured against a standard or control)

    8. The Sample Size for the Training Set

    This information is not applicable as there is no mention of a "training set" for an algorithm or AI model in this device submission. The device is a physical product, not a software or AI application.

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

    This information is not applicable for the same reason as point 8.

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