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510(k) Data Aggregation

    K Number
    K150137
    Device Name
    SpiroThor
    Manufacturer
    Cohero Health LLC
    Date Cleared
    2015-05-27

    (125 days)

    Product Code
    BZG
    Regulation Number
    868.1840
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K092813,K051712
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    SpiroThor spirometer is a freestanding laboratory instrument for performing basic lung function tests in adults and children over the age of four years.

    It is intended to be used by physicians or professional medical personnel for testing in physicians' offices, industrial medical, and hospital settings.

    Device Description

    The Cohero Health SpiroThor Spirometer is a hand-held portable diagnostic spirometer for the measurement of patient breath flow and volume. The proposed device consists of a compact main unit and an ultrasonic flowmeter sensor used with a pulmonary function filter. The device uses an ultrasonic sensor that measures flow. Algorithms are used to determine values based on this flow measurement. Tabular and graphical data are displayed on the spirometer LCD display.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for the SpiroThor spirometer, asserting its substantial equivalence to a predicate device, the SDI AstraSonic Spirometer (K092813).

    Here's an analysis of the acceptance criteria and study information:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document states that the SpiroThor is identical to the predicate device, the SDI AstraSonic Spirometer (K092813), with minor differences being a name change and the use of a different bacterial filter which was shown through comparative testing to have no performance differences. Therefore, the acceptance criteria and reported device performance are assumed to be the same as the predicate device, which are explicitly listed in Table 1 – Comparison to Predicate.

    SpecificationAcceptance Criteria (Predicate K092813 / SpiroThor)Reported Device Performance (SpiroThor)
    Indications for UseBasic lung function tests in adults and children over the age of four yearsMeets (Identical)
    Environment of UsePhysicians' offices, industrial medical, and hospital settingsMeets (Identical)
    Patient PopulationAdults and children over the age of four yearsMeets (Identical)
    Temperature SensorSemiconductor (-25 °C - +85 °C)Meets (Identical)
    DisplayGraphic Quarter VGA (320x240 pixels), 262K colorsMeets (Identical)
    Keyboard20-key keyboardMeets (Identical)
    Connection TypeUSB, BlueToothMeets (Identical)
    Flow Tube DimensionsØ30 mm x 150 mmMeets (Identical)
    Power SupplyInternal 3.7 V Li-Ion battery (Rechargeable via 5V 500mA mini USB charger)Meets (Identical)
    Dimensions85x120x35 mm (Flow tube: 26 mm(ID)x150 mm)Meets (Identical)
    Weight300gMeets (Identical)
    Flow/Volume Measurement SystemBidirectional, ultrasound/Ultrasonic technology (WaveFront™ technology)Meets (Identical)
    Volume Range± 20 L (BTPS)Meets (Identical)
    Flow Range± 18 L/s (BTPS)Meets (Identical)
    Volume Accuracy± 3% or 50 mLMeets (Identical)
    Flow Accuracy± 3% or 20 mL/sMeets (Identical)
    Dynamic Resistance at 14 L/s
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