(440 days)
The tremoflo C2 Airwave Oscillometry System is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT). The tremoflo C2 Airwave Oscillometry System is intended for use with pediativ 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.
The tremoflo C2 Airwave Oscillometry System (tremoflo C2) is a portable lung function testing device that implements methods known per the Forced Oscillation Technique (FOT), or oscillometry, to assess lung function in humans. The Forced Oscillation Technique (FOT) is a non-invasive test that 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) 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 main tremoflo C2 Unit is a lightweight handheld device. It contains electronics, pressure and flow sensors, and the actuator providing the forced oscillations. The tremoflo software is a complete standalone software package for patient management, testing, result analysis, and presentation.
During use the operator holds the handheld device using the ergonomic handle while the patient is seated, wearing a standard nose clip and with hands on cheeks. To perform the test, the patient then breathes quietly through the device into a standard single use Pulmonary Function Testing (PFT) filter connected at the front of the C2 Unit via the PFT filter interface. The tremoflo C2 is not intended to be used as a stand-alone diagnostic device.
The provided text describes the Thorsys tremoflo C2 Airwave Oscillometry System and its substantial equivalence to a predicate device (tremoFlo C100 Airwave Oscillometry System) as determined by the FDA. The document outlines changes made to the device and provides performance data to support its claims.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present a formal table of "acceptance criteria" against "reported device performance" in the typical sense of numerical thresholds for clinical endpoints. Instead, it focuses on demonstrating equivalence to a predicate device, primarily through technical specifications and verification/validation testing against established standards and recommendations.
However, based on the "Performance Data" section and the comparison table, we can infer some criteria and reported performance:
| Acceptance Criterion (Inferred from testing) | Reported Device Performance (tremoflo C2) |
|---|---|
| Fundamental Scientific Technology | Identical to C100 (Forced Oscillation Technique and Pneumotach per ERS FOT recommendations) |
| Pneumotach Flow Range | Identical to C100 (± 2.5 L/s) |
| Flow Resolution | Identical to C100 (±1.4 ml/s) |
| Flow Linearity | Identical to C100 (± 2% up to 1.0 L/s) |
| Common Mode Rejection Ratio (CMRR) | Identical to C100 (Dynamic software compensation signal processing) |
| Device Load to Patient | Modified: 1.1 ± 5% cmH2O.s/L at 1 L/s (C100: 1.0 ± 5% cmH2O.s/L at 1 L/s). Discussion: Small difference, within potential variation of bacterial/viral filters, does not raise different questions of safety and effectiveness. |
| Volume Range | Identical to C100 (+3 Liters) |
| Volume Accuracy | Identical to C100 ( |
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).