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510(k) Data Aggregation

    K Number
    K231531
    Device Name
    Pediarity™
    Manufacturer
    Gabi SmartCare SA
    Date Cleared
    2023-12-21

    (209 days)

    Product Code
    DQA,DRG
    Regulation Number
    870.2700
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K213515,K190399,K231506,K201770
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Pediarity™ system is intended for use in the home setting and/or continuous recording of pulse rate (PR) and functional oxygen saturation of arterial hemoglobin (SpO2) of well-perfused infants and children in non-notion conditions.

    The Pediarity™ system is not a monitoring device and does not provide physiological alarms during use.

    Measurements are sent to a web server for remote review by a physician.

    Device Description

    The Pediarity™ system is a non-invasive, innovative, and advanced solution that allows to measure wirelessly several physiological parameters (SpO2, Pulse Rate) of infants and children up to 12 years old in non-motion conditions.

    The Pediarity™ system is composed of:

    • a) Gabi™ Band, a non-invasive, wearable, wireless measuring device positioned around the patient's upper arm.
    • b) Gabi™ Monitor, made of:
      • Gabi Monitor App: a mobile application dedicated to caregivers, allowing to o start and stop a recording of physiological parameters measured by the Gabi Band, displays measuring information and transfers collected data to the Gabi Cloud via Wi-Fi.
      • Gabi Monitor Tablet: a tablet provided to the caregiver inside the solution o package, on which the Gabi Monitor App is pre-installed.
    • c) A Gabi™ Cloud, an online service that stores and manages the collected data and shares them with Gabi Analytics.
    • d) Gabi™ Analytics, a web interface allowing the Healthcare Professionals (HCP) to access and review remotely the physiological parameters of the patient.
    AI/ML Overview

    Here's an analysis of the acceptance criteria and the study proving the device meets those criteria, based on the provided document:

    1. Table of acceptance criteria and reported device performance:

    FeatureAcceptance Criteria (from ISO 80601-2-61:2017 & FDA Guidance)Reported Device Performance (Pediarity™)
    SpO2 Accuracy (Arms), non-motion, 70-100%≤ 3.5%2.95%
    Pulse Rate Accuracy (non-motion)3 bpm (implied by predicate, as it's the same)3 bpm

    Note: The document explicitly states the SpO2 accuracy requirement of less than or equal to 3.5%. The pulse rate accuracy of 3 bpm is stated as "Same" as the predicate, implying it meets the same standard.

    2. Sample size used for the test set and the data provenance:

    • Sample Size (Clinical Study): 12 healthy adult male and female volunteers.
    • Data Provenance: The clinical studies were conducted in the United States. They appear to be prospective, as hypoxia was induced to different and stable levels of oxyhemoglobin saturation.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    The document does not explicitly state the number of experts used to establish ground truth or their qualifications. However, for the SpO2 accuracy clinical study, ground truth was established by:

    • Blood gas analysis using an ABL-90 multi-wavelength oximeter. This is a highly accurate method for determining oxyhemoglobin saturation and is considered the gold standard for ground truth in SpO2 accuracy studies. The operation and interpretation of this equipment would typically be performed by trained medical professionals (e.g., laboratory technicians, physicians) who are experts in blood gas analysis, but their specific number and qualifications are not provided.

    4. Adjudication method for the test set:

    Not applicable. The ground truth for SpO2 accuracy was established through direct measurement by a reference device (ABL-90 multi-wavelength oximeter) rather than expert consensus requiring adjudication.

    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

    Not conducted. This type of study (MRMC for AI assistance) is not relevant to this device, which is a standalone oximeter measuring physiological parameters.

    6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

    Yes, a standalone clinical study was performed to demonstrate the SpO2 accuracy of the Pediarity™ system. The device itself performs the measurement and calculation of SpO2 and Pulse Rate.

    7. The type of ground truth used:

    For the SpO2 accuracy clinical study, the ground truth was blood gas analysis performed using an ABL-90 multi-wavelength oximeter.

    8. The sample size for the training set:

    The document does not specify the sample size for any training set. It describes a clinical study for performance validation (testing) and refers to software verification and validation, but not a specific training set size for an AI/ML algorithm (though it does mention "the signals obtained by the photodetector are then processed," which could imply an algorithm).

    9. How the ground truth for the training set was established:

    The document does not provide information on a training set or how its ground truth was established.

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