Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K240706
    Device Name
    PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)
    Manufacturer
    GANSHORN Medizin Electronic GmbH
    Date Cleared
    2024-12-09

    (270 days)

    Product Code
    JEH, BZG, CAH
    Regulation Number
    868.1760
    Why did this record match?
    Applicant Name (Manufacturer) :

    GANSHORN Medizin Electronic GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PowerCube+ Series is indicated for use in the measurement and data collection of lung function parameters. The system performs cooperation-dependent pulmonary function tests which include Spirometry/Flow-Volume measurement, Body Plethysmography measurement, Lung Diffusion measurement, Occlusive Resistance measurement and Respiratory Muscle Strength measurement. The device provides information that aids in a diagnosis by a clinician. The PowerCube+ Series is indicated for use by a clinician in a professional healthcare setting on adult and pediatric patients who are 5 years and older that can cooperate in the testing.
    Device Description
    The GANSHORN PowerCube+ Series is a device that performs cooperation-dependent pulmonary function tests, including Spirometry, Body Plethysmography, Lung Diffusion measurement, Occlusive Resistance measurement and Respiratory Muscle Strength measurement. The device provides information that aids in a diagnosis by a clinician. Spirometry is a set of non-invasive pulmonary function tests where the flow of inhaled/exhaled air is measured to determine physiological parameters such as Peak Expiratory Flow and Forced Vital Capacity. The patient's breathing flow is measured with ultrasound technology inside a breathing insert. Two ultrasound transducers measure the difference in ultrasound wave transit time to calculate breathing flow direction, speed, and volume. Body Plethysmography provides for the measurement of physiological parameters such as Functional Residual Capacity and Specific Airway Resistance. The patient is seated in an air-tight chamber which has a fixed shape and volume. Pressure sensors measure the chamber pressure and the pressure close to the mouth, which is used as a proxy for alveolar pressure when measured under a zero-flow condition. Boyle's Law is used to infer the volume in the lungs from changes in chamber pressure. Lung Diffusion testing is a non-invasive process for measuring diffusion capacity and lung volume. The patient inhales a test gas with known concentrations of helium and carbon monoxide. The patient's breath is held for 10 seconds during which time the helium dilutes into the lungs and the carbon monoxide diffuses through the alveoli into the blood. After 10 seconds of breath-hold time, the patient exhales and the difference between inhaled and exhaled gas concentrations is measured with a gas analyzer. The differences in gas concentration are used to determine physiological parameters such as DLCO (diffusing capacity of the lungs for carbon monoxide) and Alveolar Volume. Occlusive Resistance measurement is an established method for measuring airway resistance during tidal breathing, using a shutter and mouth pressure sensor. Respiratory Muscle Strength measurement is an established method for measuring the maximal strength of respiratory muscles, using a shutter and mouth pressure sensor. The PowerCube+ Series has the following product model configurations: - . PowerCube Body+ includes Spirometry and Body Plethysmography measurement - . PowerCube Diffusion+ includes Spirometry and Lung Diffusion measurement - . PowerCube Body+ / Diffusion+ includes Spirometry, Body Plethysmography, and Lung Diffusion measurement All product model configurations support Occlusive Resistance measurement and Respiratory Muscle Strength measurement. The PowerCube+ Series is mains-powered and not intended for mobile/transportable use.
    Ask a Question
    K Number
    K160116
    Device Name
    SpiroScout
    Manufacturer
    GANSHORN MEDIZIN ELECTRONIC GMBH
    Date Cleared
    2016-10-07

    (262 days)

    Product Code
    BZG
    Regulation Number
    868.1840
    Why did this record match?
    Applicant Name (Manufacturer) :

    GANSHORN MEDIZIN ELECTRONIC GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ganshorn SpiroScout is intended for prescription use only to conduct simple diagnostic spirometry testing of adults and pediatric patients over 5 years old, in general practice and specialty physician, industrial and hospital settings.
    Device Description
    The SpiroScout is an electronic measurement device intended to be used for measurement of lung function (determination of the respiratory flows and volume) parameters. It enables the determination of the following parameters. Spirometry Inspiratory and expiratory vital capacity (VC) Inspiratory and expiratory subdivisions Flow/Volume The measurement of the flow/volume curve enables the determination of the dynamic lung volumes. FEV1 value (forced expiratory volume within the first second of exhalation). Maximum Voluntary Ventilation MVV The respiratory limit value indicates the respired volume per minute during maximally forced respiration. The respiratory limit value is also referred to as "Maximum Voluntary Ventilation". The SpiroScout sensor operates using two diagonally opposing ultrasound transducers that alternately send and receive ultrasonic waves. The ultrasound technology simultaneously measures the flow, temperature and humidity. The SpiroScout is a PC-based system running the Ganshorn LFX software program. The system comprises: - the hand-held ScoutSensor - Base station where the sensor is stored. - Spirette, a single use, disposable mouthpiece and flow tube
    Ask a Question

    Page 1 of 1