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510(k) Data Aggregation

    K Number
    K020102
    Device Name
    IQTEQ SPIROMETER
    Manufacturer
    IQTEQ DEVELOPMENT
    Date Cleared
    2003-03-21

    (434 days)

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

    IQTEQ DEVELOPMENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IQTeQ Spirometer is intended for use as a prescription-use-only clinical diagnostic spirometer for pulmonary function evaluation and data management. The IQTeQ Spirometer is for use in hospitals, clinics and physician/clinician offices by individuals that have received minimal instruction or training in the administration of spirometry tests. The IQTeQ Spirometer operates with an IBM or compatible computer using a USB port (Universal serial bus) connection and the PC's installed IQTeQ Spirometer Windows™ compatible software. Minimum PC and operating system requirements are specified in the IQTeQ Spirometer Manual. The IOTeO Spirometer is indicated for use with male/female adult patients and male/female pediatric patients to evaluate, access, describe, measure, or monitor. - Symptoms, signs, or abnormal laboratory tests 】. - Effects of disease on pulmonary function 2. - Individuals at risk for pulmonary disease 3. - 4. Preoperative risk - 5. Post-surgical prognosis - 6. Pre-treatment health status - 7. Therapeutic interventions - The course of disease affecting lung function 8. - Persons exposed to pollutants 9. - 10. Adverse reactions to drugs with known pulmonary toxicity - 11. Rehabilitation programs - 12. Risks as part of an insurance evaluation - 13. Individuals for legal reasons - 14. Epidemiological surveys - 15. Derivation of reference equations
    Device Description
    The IQTeQ Spirometer2001 is a handheld spirometer that connects to a Personal Computer (PC) via a Universal Serial Bus (USB) port cable connection. Windows based software on the PC runs the diagnostic spirometer application. The device consists of a plastic handle which houses the amplified pressure transducer, analog to digital conversion, USB microcontroller and connection to the USB cable. The electronic component is screened and connects to the USB cable screen. The entire electronic component is sealed in epoxy (Eli-Cast FR 453) and permanently fixed into the handle with epoxy. The electronics in the handle is powered by the 0 and 5volt power supply, which is provided with all USB ports. The top of the handle has a circular tube for connection to the flow tube, which is inserted into the handle tube. The flow tube, which includes a laminar flow air resistance element, is inserted into the handle tube. Porting of the flow tube and the handle tube allows air pressure to connect to the pressure transducer in the handle. Two 'O' rings maintain an airtight seal between the tubes. The flow tube includes an inert ceramic (CORDIERITE) laminar flow air resistance element. The patient is connected by mouth to a bacterial filter, which is fitted to the flow tube. The patient breathes as instructed through the flow tube. The pressure transducer in the handle continuously transmits the differential pressure in the flow tube to the analog to digital converter. The digitized 12 bit data is sent to the PC via the USB port at 335, 12bit samples per second. The IQTeQ application software which requires Windows 98 SE or later calculates the flow and integrates flow to calculate volume. The flows are calculated from the 12 bit data by applying the calibration polynomial algorithm. Therefor all flow and volume data is calculated in real time for the flow-volume measurements which includes: Peak Flow, Forced Vital Capacity, Forced Expiratory Flows Forced Inspiratory Vital Capacity as well as MVV and SVC.
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