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510(k) Data Aggregation

    K Number
    K253021

    Validate with FDA (Live)

    Device Name
    ANNE Maternal
    Manufacturer
    Date Cleared
    2026-02-26

    (160 days)

    Product Code
    Regulation Number
    884.2740
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ANNE® Maternal system is a perinatal monitoring platform intended for the continuous collection, display, and storage of physiological data and vital signs from compatible medical devices in clinical settings. The system supports data acquisition from sensors, clinician inputted data, and compatible software for maternal and fetal monitoring in singleton pregnancies. Examples of parameters include maternal vital signs (e.g. heart rate, respiratory rate, SpO2, blood pressure, temperature), fetal heart rate, and uterine contractions. The system provides both visual and audio alarms, alerts, and notifications at the bedside via a mobile device or a compatible central monitor. The ANNE® Maternal system is intended for use by qualified healthcare professionals. This device is intended for use by healthcare professionals to support clinical decision-making. All information provided by the system is intended to supplement, not replace, the judgement of medical professionals and is not intended to be the sole source of information for decision-making.

    The physiological parameters collected by the ANNE® Maternal system is inputted into the integrated electronic Modified Early Obstetric Warning System (MEOWS) tool, which provides information that can signal the need for prompt bedside evaluation by the health care provider. This information is intended as adjunctive information only and is not intended to replace or supersede the review of individual vital signs by qualified healthcare professionals.

    This information is intended to supplement, and not replace, the judgment of medical professionals and is not intended to be the sole source of information for decision-making.

    Device Description

    ANNE® Maternal software application is a perinatal monitoring platform that collects, displays, and stores physiological data from compatible devices for noninvasive blood pressure, SpO₂, pulse rate, body temperature, fetal heart rate, and uterine activity.

    Designed for use in clinical environments, including labor, delivery, and postpartum care, the platform operates with compatible software display systems such as ANNE® View and Central Hub. ANNE® Maternal integrates physiological parameters into early warning information, When connected to Wi-Fi, data is transmitted and stored to the Central Hub. The system provides both visual and audio alarms, alerts, and notifications. All vital signs are continuously displayed to the clinician, with all clinical decisions remaining the responsibility of the healthcare professional. ANNE® Maternal is intended for use exclusively by trained healthcare professionals following the Instructions for Use.

    AI/ML Overview

    N/A

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