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510(k) Data Aggregation

    K Number
    K240039
    Device Name
    Enteral Feeding Sets
    Manufacturer
    Hangzhou Primecare Medical Co., Ltd.
    Date Cleared
    2024-04-17

    (103 days)

    Product Code
    KNT,DAT,PIF
    Regulation Number
    876.5980
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K181276
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Enteral Feeding Sets are intended to dispense liquid nutrition (feeding solutions) at a user controlled rate. These enteral feeding sets interface with a patient's feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The enteral feeding sets include a bag to contain the feeding solution and/or a EnPlus spike to connect to a pre-filled container. The device is used for infants, children, adolescents and adults.

    Device Description

    The Enteral Feeding Sets have four models, Enteral Feeding Pump bag Set, Enteral Feeding Pump EnPlus spike Set, Enteral Feeding Gravity bag Set, Enteral Feeding Gravity EnPlus spike Set. The Enteral Feeding Pump bag Set and Enteral Feeding Gravity bag Set both have a structure of a formula bag with 100ml graduations and a protective closure cap. The difference is the former is droved by pump and the latter is droved by gravity. Enteral Feeding Pump EnPlus spike Set and Enteral Feeding Gravity EnPlus spike Set feature a piercing spike (with or without screw cap) used to connect the set to a prefilled container of enteral feeding solution. It is a single-use, non-sterile device.

    AI/ML Overview

    The provided document is a 510(k) Premarket Notification from the FDA for "Enteral Feeding Sets." It describes the device, its intended use, and a comparison to a predicate device, along with a summary of non-clinical testing.

    However, the document does not contain any information about a study that proves the device meets the acceptance criteria for an AI/ML powered medical device. The acceptance criteria and testing detailed in the document are for traditional medical device performance, such as dimensions, material properties, leakage, tensile strength, and biocompatibility. There is no mention of AI models, test sets for AI performance, expert ground truth establishment, or MRMC studies.

    Therefore, I cannot fulfill your request for information regarding AI/ML acceptance criteria and study details based on the provided text.

    If you are looking for an example of how such a request would be answered for an AI/ML device, please provide a document that discusses an AI/ML powered medical device and its validation.

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