(232 days)
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.
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.
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/Specification | Acceptance Criteria (Derived or Standard) | TremoFlo C-100 Reported Performance |
|---|---|---|
| Indications for Use | Equivalent to Predicate: Measure respiratory system impedance using FOT for pediatric and adult patients (4+ years), used by trained personnel. | Identical to predicate. |
| Fundamental Scientific Technology | Equivalent to Predicate: Forced Oscillation Technique and Pneumotach per ERS FOT recommendations. | Identical to predicate. |
| Pneumotach Flow Range | Sufficient for FOT measurements (Predicate: ± 2 L/s). | ± 2.5 L/s (Increased flow range compared to predicate). |
| Flow Resolution | Sufficient for FOT measurements (Predicate: ± 4.6 mL/s). | ± 1.4 ml/s (Slightly better than predicate). |
| Flow Linearity | Within 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 |
§ 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).