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510(k) Data Aggregation

    K Number
    K220165
    Device Name
    Enteral Transition Adaptor
    Manufacturer
    GBUK Group Ltd
    Date Cleared
    2022-10-21

    (274 days)

    Product Code
    PIO
    Regulation Number
    876.5980
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Enteral Transition Adaptor

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

    The enteral specific transition connectors are intended to facilitate enteral specific connections between ISO 80369-3 compliant connectors and non-ISO 80369-3 compliant legacy enteral connectors.

    Device Description

    Not Found

    AI/ML Overview

    The provided FDA document, K220165, describes a premarket notification for an Enteral Transition Adaptor. This device is a component of a medical system and not an AI/ML powered device. As such, the concept of "acceptance criteria" and "study proving device meets acceptance criteria" as it relates to performance metrics for AI/ML algorithms, ground truth establishment, training/test sets, expert adjudication, or comparative effectiveness studies with human readers, does not apply to this regulatory submission.

    The FDA 510(k) clearance process for devices like the Enteral Transition Adaptor focuses on establishing substantial equivalence to a predicate device. This typically involves demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, or if there are different technological characteristics, that they do not raise different questions of safety and effectiveness.

    The document states:

    • Trade/Device Name: Enteral Transition Adaptor
    • Regulation Number: 21 CFR 876.5980
    • Regulation Name: Gastrointestinal tube and accessories
    • Regulatory Class: Class II
    • Product Code: PIO
    • Indications for Use: The enteral specific transition connectors are intended to facilitate enteral specific connections between ISO 80369-3 compliant connectors and non-ISO 80369-3 compliant legacy enteral connectors.

    Therefore, the standard questions related to acceptance criteria and studies for AI/ML performance (such as those outlined in your prompt) are not applicable here. The "study" proving the device meets acceptance criteria would be a demonstration of its compatibility and fit with the specified connectors, and its adherence to relevant standards for medical device accessories, rather than a performance study involving diagnostic accuracy.

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