LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K220230
    Device Name
    AMSure Enteral Feeding Pump
    Manufacturer
    Amsino International Inc.
    Date Cleared
    2022-11-10

    (287 days)

    Product Code
    LZH
    Regulation Number
    880.5725
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K011587
    Why did this record match?
    Device Name :

    AMSure Enteral Feeding Pump

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

    The AMSure® Enteral Feeding Pump is intended to work with the disposable enteral feeding sets to deliver nutritional formula to the gastrointestinal system of adult patients who are physically unable to eat and swallow or who are unable to get sufficient nutrition through eating and swallowing.

    Only intended for adult patients, not for pediatric use.

    The AMSure® Enteral feeding pump is intended to be used in healthcare facilities by licensed healthcare professional users only.

    The AMSure® Enteral feeding pump is for use only with Amsino AMSure® feeding sets.

    Device Description

    The AMSure® enteral feeding pump is intended to work with the disposable enteral feeding sets that deliver formula via rotary peristaltic pumping system to provide nutrition for those who do not have the ability to orally ingest food

    AI/ML Overview

    The provided text does not contain information about an AI/ML-driven medical device, an acceptance criteria table with reported device performance for such a device, or a study that proves a device meets specific acceptance criteria using AI/ML technology.

    The document is a 510(k) Premarket Notification for a non-AI/ML medical device, specifically an AMSure® Enteral Feeding Pump and Feeding Set. It details the device's indications for use, technological characteristics, and compares it to a predicate device (SENTINEL Enteral Feeding pump K011587) to demonstrate substantial equivalence.

    While the document mentions "custom software designed to allow the user to set feed rates and volumes as well as other feeding options" and "2 separate MCUs, and each MCU embeds a specific software in order to secure the pump's running," this refers to basic embedded software for controlling the pump's mechanical functions and not an AI/ML algorithm that requires a test set, ground truth experts, or MRMC studies.

    Therefore, I cannot extract the requested information (table of acceptance criteria and reported device performance for an AI/ML device, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, training set details, or ground truth establishment) because the document describes a traditional medical device without AI/ML components.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1