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510(k) Data Aggregation

    K Number
    K133958
    Device Name
    FLOW-I ANESTHESIA SYSTEM C20, C30 & C40
    Manufacturer
    MAQUET CRITICAL CARE AB
    Date Cleared
    2014-03-20

    (86 days)

    Product Code
    BSZ
    Regulation Number
    868.5160
    Type
    Abbreviated
    Panel
    Anesthesiology (AN)
    Reference & Predicate Devices
    K112114
    Why did this record match?
    Device Name :

    FLOW-I ANESTHESIA SYSTEM C20, C30 & C40

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

    The indication for FLOW-i Anesthesia System is administering inhalation Anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment, by healthcare professionals trained in inhalation Anesthesia administration.

    Device Description

    The modified FLOW-i Anesthesia System version 3.0 is an Anesthesia System designed to meet the many ventilatory challenges within Anesthesia, as well as to provide inhalation Anesthesia. It is intended to serve a wide range of patients from neonatal to adult. FLOW-i Anesthesia System is a software-controlled semi-closed system for inhalation Anesthesia (Sevoffurane, Desflurane, Isofturane and/or nitrous oxide). The most important performance features of the FLOW-i Anesthesia System are: - a ventilator whose functionality is based on ICU-ventilator technology, o - the volume reflector technology, o - the electronically controlled injector vaporizers and o - the ergonomic design. o

    AI/ML Overview

    The provided 510(k) summary describes modifications to an Anesthesia System and claims substantial equivalence to a predicate device. It specifically states that no clinical investigation was needed or performed to validate the changes. Therefore, the device does not have a study with acceptance criteria in the traditional sense, as it relies on non-clinical testing and substantial equivalence.

    However, the document does list technical specifications for various parameters, which can be interpreted as the performance criteria that the device (and its modifications) must continue to meet. The "study" that proves the device meets these criteria is the non-clinical testing and performance activities.

    Here's an attempt to structure the information based on the request, interpreting the provided text accordingly:

    1. Table of Acceptance Criteria and Reported Device Performance

    Since no specific "acceptance criteria" for a study are explicitly stated, the technical specifications from the "Specifications from FLOW-i User's Manual, section 14 Technical Specifications" are used as the inherent performance criteria the device is expected to meet. The document states that "Design verification and validation has demonstrated that the FLOW-i Anesthesia System performs within its specifications."

    ParameterAcceptance Criteria (Predicate Device Specification)Reported Device Performance (Subject Device Specification)
    Fresh gas oxygen conc21 - 100 % (O2/Air); 28- 100 % (O2/N2O) Accuracy: 21-59%: ±3 % v/v; 60-100%: ±5 % v/vSame
    Isoflurane conc0-5% Accuracy: ±15% of set value or ±5% of maximum possible setting (whichever is greater)Same
    Sevoflurane conc0-8% Accuracy: ±15% of set value or ±5% of maximum possible setting (whichever is greater)Same
    Desflurane conc0-10% (FG flow
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