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    K Number
    K162821
    Device Name
    Babyleo TN500
    Manufacturer
    Draegerwerk AG & Co. KGaA
    Date Cleared
    2017-06-23

    (259 days)

    Product Code
    FMZ,BAB,FMT
    Regulation Number
    880.5400
    Type
    Traditional
    Panel
    Hematology (HO)
    Reference & Predicate Devices
    K003067,K971198,K010222
    Why did this record match?
    Reference Devices :

    K003067, K971198

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

    Babyleo TN500 is intended for use with premature babies and can be used as both an incubator and a radiant warmer. When the product is switched between incubator and radiant warmer operation, patients continue to be kept warm during the transition. The device provides a thermally regulated environment for patients with a body weight of up to 5 kg (11 lbs) and a height of up to 55 cm (22 in). The device can be operated as either a closed care unit or an open care unit. As a closed care unit, Babyleo TN500 is an incubator.Neonates are kept warm in the patient with humidifiable air, which can be enriched with oxygen (option). As an open care unit, Babyleo TN500 is a radiant warmer. Babyleo TN500 provides controlled ambient conditions for premature babies and neonates. The following parameters are regulated, according to the intended use: - Temperature - Humidity - Oxygen (option)

    Device Description

    The device Babyleo TN500 is a medical device used to maintain environmental conditions suitable for preterm babies and neonates. The important features are temperature and humidity. The operational principle is a combination of a neonatal incubator and an open warmer.

    Babyleo TN500 can be operated in closed care therapy as an incubator according to IEC60601-2-19 or in open care therapy as a warmer according to IEC60601-2-21. Additionally, an optional x-ray translucent heated mattress is intended to provide sensible heat to the preterm babies and neonates.

    The device consists of the following components: Incubator (=bassinet) with a convection heater and closed humidification system for the patient, trolley, radiant warmer, display, mattress, x-ray and height adjustment. Optional components are scale, heated mattress, drawer, oxygen regulation with cylinder holder and Auto Thermo package and Developmental Care package.

    AI/ML Overview

    This document is a 510(k) Premarket Notification for the Babyleo TN500, a neonatal incubator and radiant warmer. It aims to demonstrate substantial equivalence to legally marketed predicate devices. The information provided heavily focuses on design verification and validation testing, and therefore, does not contain the details on acceptance criteria and study proving performance in the context of an AI/ML medical device that would typically involve clinical studies, multi-reader multi-case studies, and explicit ground truth establishment with expert consensus.

    Given the document talks about a physical medical device (neonatal incubator/radiant warmer) and not an AI/ML diagnostic or prognostic tool, the questions posed about "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, or AUC, multi-reader multi-case studies, expert consensus for ground truth, effect size for human reader improvement with AI assistance, and training/test set sample sizes and provenance for AI/ML models are not applicable to this submission.

    The "acceptance criteria" and "study that proves the device meets the acceptance criteria" for this conventional medical device primarily revolve around safety and performance standards, electrical safety, EMC, software verification, biocompatibility, human factors, and reprocessing validation.

    Here's how to address the prompt based on the provided document:

    1. A table of acceptance criteria and the reported device performance:

    The document lists compliance with various standards and provides specifications that serve as performance criteria.

    Acceptance Criteria (Standard Compliance / Performance Spec)Reported Device Performance (Compliance / Value)
    Electrical Safety: IEC 60601-1, IEC 60601-2-19, IEC 60601-2-21, IEC 60601-2-35Device complies with all listed standards.
    Electromagnetic Compatibility (EMC): IEC 60601-1-2Device complies with the standard.
    Software Verification and Validation: FDA Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (2005)Software verification and validation testing conducted; documentation provided; considered "major" level of concern.
    Biocompatibility: ISO 10993, ISO 10993-1, ISO 10993-17, ISO 10993-18Evaluation conducted in accordance with FDA guidance; battery of testing included: Integral Test for volatile organic compounds, Photogenic bacteria test, Emission of particles, Material characterization, Toxicological Evaluation, Cytotoxicity, Irritation, Sensitization.
    Human Factors: FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices Guidance for Industry and Food and Drug Administration Staff, 2016Usability evaluation conducted in accordance with FDA guidance.
    Reprocessing: FDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling; Guidance for Industry and Food and Drug Administration Staff, 2015Reprocessing validation conducted in accordance with FDA guidance.
    Operating Noise Volume in Patient CompartmentTypically 40 dB(A) (Measured without oxygen application) - _(Compared to predicate
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