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    K Number
    K230501
    Device Name
    Spirobank Oxi
    Manufacturer
    MIR Medical International Research USA
    Date Cleared
    2023-12-15

    (294 days)

    Product Code
    BZG,DQA
    Regulation Number
    868.1840
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K103530
    Why did this record match?
    Applicant Name (Manufacturer) :

    MIR Medical International Research USA

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

    The Spirobank Oxi Spirometer and Pulse Oximeter is intended to be used by a physician or by a patient under the prescribed use of a physician. The equipment is intended to test lung function and can perform tests in adult and pediatric patients greater than 5 years. When used as Oximeter, the Spirobank Oxi is intended for spot-checking of functional oxygen saturation of arterial haemoglobin (SpO2) and Pulse Rate (PR) from the patient finger. The Spirobank Oxi has been designed for use in the physician's office, in hospital, or directly by the patient to monitor her/his physical conditions at home.

    Device Description

    Spirobank Oxi is a pocket-size spirometer and oximeter. The device is made up of:

    • a central unit which measures and collects information related to the state of health of the patient, using a microprocessor based system. It operates via a Bluetooth connection
    • a removable sensor for the measurement of respiratory air flow and volume,
    • a pulse oximetry sensor using reflective technology. -
      The device is powered by two AAA alkaline batteries.

    Spirometry: the device is equipped with a plastic mouthpiece connected to a turbine flow meter based on the infrared interruption principle. The device detects the signals generated by the turbine, and measures flow and volume. At the end of the expiration, the device calculates the respiratory parameters.

    Oximetry: the device measures functional oxygen saturation of arterial haemoglobin (SpO2) and pulse rate (PR) by means of a reflective light sensor. Specifically, it uses a two-wavelength sensor to measure the indicated parameters based on light reflection principles of oxygenated blood and deoxygenated blood, which generates a photoplethysmogram. From the photoplethysmogram the device calculates SpO2 and PR

    Spirobank Oxi connects via Bluetooth to a device (PC, tablet or smartphone) which allows to insert patient data, perform spirometry manoeuvres and oximetry tests, as well as display the results, including the relative graphs.

    AI/ML Overview

    Acceptance Criteria and Study for Spirobank Oxi

    This document describes the acceptance criteria and a detailed study supporting the substantial equivalence of the Spirobank Oxi device.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific CriteriaReported Device Performance (Spirobank Oxi)Complies?
    Spirometry
    Volume AccuracyAmerican Thoracic Society (ATS) 2019 guidelines± 2.5%Yes
    LinearityATS 2019 guidelines± 2.5%Yes
    RepeatabilityATS 2019 guidelines± 2.5%Yes
    Expiratory ImpedanceATS 2019 guidelines:
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