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510(k) Data Aggregation

    K Number
    K090646
    Device Name
    CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-105
    Manufacturer
    CHEST M.I., INC.
    Date Cleared
    2009-07-23

    (134 days)

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

    CHEST M.I., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CardioTech Spirometry System, Model GT-105, is a diagnostic tool to measure the maximal volume and flow of air that can be moved in and out of a patient's lungs. The system is intended for use with pediatric (4 to 17 years) and adult (18 to 99 years) patients in hospitals, physician's offices, laboratories, and occupational health environments.
    Device Description
    The CardioTech GT-105 Spirometry System measures a wide range of physiological parameters such as SVC, FVC, MVV, and MV and consists of a spirometer and a flow sensor. The flow sensor head, which includes a flow air resistance element, is mounted on the flow sensor body. Via a disposable mouthpiece and filter, the patient breathes as instructed through the flow sensor head. The pressure transducer in the spirometer then measures the differential pressure in the flow sensor head which is digitized into 12 bit data by an A/D converter. The data can be transferred via RS-232C/USB interfaces to a PC in which Spirobank software is installed. Since the software includes a number of screens and 'buttons' that help to logically perform the function, the medical practitioner (e.g., technician) can print (reports), save and recall the data/results.
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    K Number
    K080921
    Device Name
    SPIRO-MASTER PC-10 SPIROMETRY SYSTEM
    Manufacturer
    CHEST M.I., INC.
    Date Cleared
    2009-01-21

    (295 days)

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

    CHEST M.I., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spiro-Master PC-10 Spirometry System is intended to acquire, view, store and print measures and waveforms of the exhaled breath of a person and evaluate pulmonary function These measures are used in the diagnosis and monitoring of lung diseases and interventions for the treatment of certain lung diseases The spirometer should only be used with pattents able to understand the instructions for performing the test The Spiro-Master PC-10 Spirometry System is indicated for use with people of all ages, of either gender, excluding infants and neonates, to acquire, view, store and print measures and waveforms of the exhaled breath of a person and evaluate, access, describe, measure, or monitor - Symptoms, signs, or abnormal laboratory tests 1 - Effects of disease on pulmonary function 2 - 3 Individuals at risk for pulmonary disease - 4 Preoperative risk - 5 Post-surgical prognosis - ર્ભ Pre-treatment health status - 7 Therapeutic interventions - 8 The course of disease affecting lung function - 9 Persons exposed to pollutants - Adverse reactions to drugs with known pulmonary toxicity 10 - Rehabilitation programs 11 - Risks as part of an insurance evaluation 12 - Individuals for legal reasons 13 - 14 Epidemiological surveys - Derivation of reference equations । રે
    Device Description
    The "Spiro-Master PC-10 Spirometry System" is a handheld spirometer that connects to a Personal Computer (PC) via a Universal Serial Bus (USB 11 and 20) cable Windows 10-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 converter. USB microcontroller and connection via a USB cable The electronics in the handle are powered by the 5 volts DC of the PC USB port The top of the handle has a connection for the flow sensor, which connects to the mouthpiece A Pneumotach sensor is incorporated into the Spiro-Master PC-10 Spirometry System to detect arrilow The flow sensor consists of two flow tubes that connect to each other around a sensor mesh ring which provides flow resistance A differential pressure across the mesh is generated depending on the inhalation/exhalation strength of the person being tested Inside the flow tube, the front and back of the mesh is connected to a pressure sensor through pressure outlet ports and tubes This differential pressure transducer measures the pressure difference across the flow sensor (mesh ring) as the air-stream passes through it The resulting pressure change is converted to a signal proportional to the airflow rate The patient places their mouth on the mouthpiece, which is connected to a bacterial filter (KoKo Moe White Filter) between the mouthpiece and the sensor The mouthpiece is a single-use, disposable component. The patient breathes as instructed through the mouthpiece 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 cable at 12 bit samples per second The Spiro-Master PC-10 Spirometry System application software (which requires Windows 98 or later), calculates the flow and integrates the flow to calculate volume The flows are calculated from the 12 bit data stream by applying a calıbration polynomial algorithm All flow and volume data are calculated in real tıme for the flow-volume measurements which includes Peak Flow, Forced Vital Capacity, Forced Expiratory Flows Forced Inspiratory Vital Capacity as well as FEF and FIVC The spirometer technician/operator uses the software on the PC to perform the tests The software includes a number of screens and 'buttons' that assust to logically perform the tests in the correct order The tests can be saved to the PC hard drive, printed (report format) and recalled for later review There are various parameters that are displayed to assust the technician in the quality control of the test procedure per the ATS 1994 update and the ATS 2005 standards The system calıbration procedure requires sıx (6) varyıng strokes from a three (3) liter syringe
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