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510(k) Data Aggregation

    K Number
    K230178
    Device Name
    EasyOne Sky Spirometer
    Manufacturer
    NDD Medizintechnik AG
    Date Cleared
    2023-10-19

    (269 days)

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

    NDD Medizintechnik AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EasyOne Sky spirometer is intended to conduct diagnostic spirometry testing on adults and pediatric patients starting at age 4. The EasyOne Sky spirometer is used by general practitioners, specialists and healthcare professionals. The EasyOne Sky is used in hospitals, clinical settings, and in occupational medicine.
    Device Description
    The product EasyOne Sky (EOS) is a medical electrical equipment for spirometry testing. It consists of the hand-held TrueFlow Sensor FT (SeNe) comprising an ultrasonic flow sensor that conducts air flow measurements, the application EasyOne Mobile (EOMA), and the breathing mouthpiece EasyOne FlowTube (EOFT). The EOS can be used with the optional accessories EasyOne Filter FT and a nose clip. Key functions: - . The key function of the TrueFlow Sensor FT (SeNe) is to acquire patient flow data by measuring transit-times of ultrasonic pulses and to send data wireless (via Bluetooth Low Energy) to the host system. The measurements and data transmission are performed by the firmware of the SeNe defined as MDSW with clinical functions. - . The key function of the application EasyOne Mobile (EOMA) is to trigger the start of the measurement with the TrueFlow Sensor FT, to communicate with it and to visualize the data received from it. - . The EasyOne FlowTube (EOFT) is an individually packaged, single-patient-use breathing tube and is intended to canalize patient breath through the flow sensor tube. The EOFT is an essential accessory to EOS.
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    K Number
    K221250
    Device Name
    EasyOne Filter
    Manufacturer
    NDD Medizintechnik AG
    Date Cleared
    2022-11-22

    (204 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Why did this record match?
    Applicant Name (Manufacturer) :

    NDD Medizintechnik AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EasyOne Filter is intended to be used in combination with NDD breathing mouthpieces to reduce bacteria, viruses and other particulates from the patient's exhaled air while performing flow measurements, such as spirometry tests. The EasyOne Filter is a single-use device and intended for single-patient use only.
    Device Description
    The EasyOne Filter is a viral, bacterial filter designed to be used with NDD breathing mouthpieces during flow measurements, e.g. for spirometry testing with NDD spirometers. The EasyOne Filter exists in two variants which differ in the connection interface to enable mounting on the EasyOne FlowTube. The EasyOne Filter is composed of two injection molded polymeric parts which enclose a filter medium. The EasyOne Filter is an optional accessory and reduces viruses, bacteria, and other particles that may be released by the patient and thus contaminate the test environment. The EasyOne Filter is non-sterile and for single use.
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    K Number
    K161534
    Device Name
    EasyOne Pro Respiratory Analysis System
    Manufacturer
    NDD MEDIZINTECHNIK AG
    Date Cleared
    2017-02-22

    (264 days)

    Product Code
    BTY
    Regulation Number
    868.1890
    Why did this record match?
    Applicant Name (Manufacturer) :

    NDD MEDIZINTECHNIK AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EasyOne Pro/LAB is designed for conducting lung function measurements in general or specialist practices or in hospitals. EasyOne Pro/LAB can also be used in clinical settings in occupational medicine for performing lung function screenings or measurements. EasyOne Pro/LAB is used to conduct lung function measurements on adults and children starting at age 4, except measurements of diffusing capacity of the lung based on CO (DLCO), which can be performed on adults and children starting at age 6.
    Device Description
    The EasyOne Pro Respiratory Analysis System consists of two different device models: EasyOne Pro and EasyOne Pro LAB. The EasyOne Pro Respiratory Analysis System devices are pulmonary function testing devices. Both EasyOne Pro Respiratory Analysis System device models provide Spirometry and Single Breath CO Diffusion (DLCO) tests including Lung Volume Parameters. The device model EasyOne Pro LAB additionally provides the Nitrogen Multiple Breath Washout (MBW) method. The EasyOne Pro Respiratory Analysis System devices meet the ATS recommendations for accuracy and precision for Spirometry, DLCO and MBW tests. The EasyOne Pro Respiratory Analysis System devices can be used as a stand-alone system and can be connected to a network. The EasyOne Pro Respiratory Analysis System devices use the following sensors: An ultrasonic flow sensor to measure flow velocity, volume and molar mass of the gases that the patient inhales and exhales; a molar mass sensor which determines the helium content of the respired air for the DLCO test and the nitrogen concentration for the multiple-breath washout (MBW) test; a CO sensor (EasyOne Pro) or a combined CO/CO₂ sensor (EasyOne Pro LAB) to determine CO and CO2 content in breathing gas; a temperature and humidity sensor to collect environmental data. The EasyOne Pro Respiratory Analysis System devices are used in combination with test gases (DLCO gas for DLCO tests and O2 for MBW tests). The EasyOne Pro Respiratory Analysis System devices are used in combination with the single-patient use breathing tube ndd Spirette. For DLCO and MBW tests, the additional single-patient use accessories, the ndd DLCO or FRC Barriettes, are used. The single-patient use accessories prevent cross-contamination between patients. The Spirette prevents the passage of microorganisms into the inside of the flow sensor; the Barriettes prevent the passage of microorganisms into gas supply tubing.
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    K Number
    K161536
    Device Name
    EasyOne Air Spirometer
    Manufacturer
    NDD MEDIZINTECHNIK AG
    Date Cleared
    2017-01-05

    (216 days)

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

    NDD MEDIZINTECHNIK AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EasyOne Air spirometer is intended for prescription use only to conduct diagnostic spirometry testing of adults and pediatric patients over 4 years old. The EasyOne Air spirometer is used by general practitioners, specialists, and health care professionals, in hospitals and clinical settings in occupational medicine.
    Device Description
    The ndd EasyOne Air is a diagnostic spirometer. In order to conduct simple diagnostic spirometry testing, the EasyOne Air is used in combination with a commercially available disposable breathing tube with integrated mouthpiece (EasyOne Flow Tube). The sensor is an ultrasound flow sensor that measures pulse transit-time to determine gas flow velocity and volume, as well as molar mass of the gas. The collected data is used for pulmonary function evaluation and data management. The results of the testing are stored in a database and reports can be displayed or printed.
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