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510(k) Data Aggregation

    K Number
    K210516
    Device Name
    Clicky Cross
    Date Cleared
    2022-05-16

    (447 days)

    Product Code
    Regulation Number
    880.5440
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    Clicky Cross

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

    Clicky Cros™ is indicated for fluid flow control and for providing access port(s) for administration of solutions in a limited contact duration (24 hours or less). Typical uses include pressure monitoring, intravenous fluid administration, transfusion and infusion of nutritive or medicinal fluids.

    Device Description

    Clicky Cross™ is indicated for fluid flow control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration, transfusion and infusion of nutritive or medicinal fluids. Yomura Clicky Cross™ is a new medical device using as flow control switch and is developed by Yomura Technologies Inc. Click-release process via one-handed operation Less leakage issue than currently commercial products Stopcock system for I.V. set and other application Suitable for all current pressure infusion system There are two types of fitting end (Barb /Luer) for normal I.V. infusion sets. In order to meet the requirement of I.V. infusion set, here we provide two different types of fitting end (Barb/Luer).

    AI/ML Overview

    The provided FDA 510(k) summary for the Clicky Cross™ device details its substantial equivalence to a predicate device, the Safeport Manifold™ (K111016). It primarily focuses on demonstrating that the new device is as safe and effective as the predicate.

    Here's an analysis of the acceptance criteria and study information based on the provided text:

    1. A table of acceptance criteria and the reported device performance:

    The document doesn't explicitly present a table of "acceptance criteria" in a typical quantitative format for algorithmic performance metrics (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating equivalence to a predicate device by meeting established performance and safety standards for medical devices of this type.

    The reported device performance is indicated by its compliance with various ISO and ASTM standards relevant to infusion equipment and biocompatibility.

    Acceptance Criteria CategorySpecific Criteria / Standard MetReported Device Performance
    Functional PerformanceISO 8536-4:2019Meets standard for Infusion equipment for medical use -- Part 4: Infusion sets for single use, gravity feed
    ISO 80369-7:2016Meets standard for Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
    BiocompatibilityISO 10993-3Meets standard for genotoxicity, carcinogenicity, and reproductive toxicity
    ISO 10993-5Meets standard for irritation and skin sensitization
    ISO 10993-11Meets standard for systemic toxicity
    ISO 10993-12Meets standard for sample preparation and reference materials
    USPMeets standard for Particulate Matter in Injection (Particulate testing)
    SterilityISO 11135:2014Meets standard for Sterilization of healthcare products - Ethylene Oxide (Overkill Approach (Half-cycle) validation method; residuals EO
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