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    K Number
    K170185
    Device Name
    tremoFlo C-100 Airwave Oscillometry System
    Manufacturer
    THORASYS Thoracic Medical Systems, Inc.
    Date Cleared
    2017-09-12

    (232 days)

    Product Code
    PNV
    Regulation Number
    868.1840
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K111587,K152585
    Why did this record match?
    Device Name :

    tremoFlo C-100 Airwave Oscillometry System

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The tremoFlo C-100 Airwave Oscillometry System is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT). tremoFlo C-100 Airwave Oscillometry System is intended for use with pediatric and adult patients 4 years of age or older. The device is designed to be used by pulmonologists, general practitioners, nurses, respiratory therapists, laboratory technologists, medical researchers and similarly trained personnel in hospitals, clinics, and private physician offices.

    Device Description

    The tremoFlo C-100 Airwave Oscillometry System (AOS) is a portable lung function testing device that implements methods known per the Forced Oscillation Technique (FOT) to assess lung function in humans. The Forced Oscillation Technique (FOT) is a non-invasive test that requires minimal patient effort and cooperation and provides a full report of lung mechanics per the FOT. In general, the FOT usually consists of superimposing given external multi-frequency sinusoidal excitation small pressure waves (1-3 cmH2O peak to peak) onto the normal breathing of the patient through the device and then deriving the mechanical properties from the patient's mouth pressure and airflow response while breathing. The main outcome reported by FOT is the mechanical impedance of the respiratory system which is the complex ratio between pressure and airflow at the given excitation frequencies.

    The tremoFlo C-100 Unit is a lightweight handheld device connected to a cradle unit. The handheld unit contains electronics, pressure and flow sensors, and the actuator providing the forced oscillations which is connected to the cradle unit via a custom cable. The tremoFlo software is a complete stand-alone software package for patient management, testing, and result analysis and presentation.

    AI/ML Overview

    The provided text describes the Tremoflo C-100 Airwave Oscillometry System, a medical device used to measure respiratory system impedance. Here's a breakdown of the acceptance criteria and the study information:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state formal "acceptance criteria" in a table format with corresponding "reported device performance." However, it presents a Predicate Product Comparison table that lists various technical features and specifications of the Tremoflo C-100 and compares them to its predicate device, the Resmon PRO FULL. The "Comparison" column in this table effectively acts as an assessment against benchmarked performance (the predicate device) or relevant standards (ERS FOT recommendations).

    Below is a summary derived from the provided comparison, highlighting what could be interpreted as acceptance criteria based on equivalence or standards, and the TremoFlo's reported performance against these.

    Table: Derived Acceptance Criteria and Reported Device Performance

    Feature/SpecificationAcceptance Criteria (Derived or Standard)TremoFlo C-100 Reported Performance
    Indications for UseEquivalent to Predicate: Measure respiratory system impedance using FOT for pediatric and adult patients (4+ years), used by trained personnel.Identical to predicate.
    Fundamental Scientific TechnologyEquivalent to Predicate: Forced Oscillation Technique and Pneumotach per ERS FOT recommendations.Identical to predicate.
    Pneumotach Flow RangeSufficient for FOT measurements (Predicate: ± 2 L/s).± 2.5 L/s (Increased flow range compared to predicate).
    Flow ResolutionSufficient for FOT measurements (Predicate: ± 4.6 mL/s).± 1.4 ml/s (Slightly better than predicate).
    Flow LinearityWithin ranges to provide equivalent performance per bench testing (Predicate: ± 2% up to 1.5 L/s).± 2% up to 1.0 L/s (Differences are small and still within ranges to provide equivalent performances in both devices per bench testing).
    Common Mode Rejection Ratio (CMRR)Provide accurate and reproducible results equivalent to predicate (>60dB over entire range of forcing frequencies).Alternate dynamic software compensation (Provided accurate and reproducible results equivalent to those provided by the predicate based on performance testing).
    Device Load to Patient
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