(247 days)
The PulmOne MiniBoxPFT™ 2.0 is intended to measure lung function in adult and pediatric patients while at rest (including spirometry and lung volumes). The PulmOne MiniBoxPFT™ 2.0 is to be used by either a physician, respiratory therapist, or technician.
The PulmOne MiniBoxPFT™ 2.0 is intended to measure lung function in adult and pediatric patients while at rest (including spirometry and lung volumes). The PulmOne MiniBoxPFT™ 2.0 is to be used by either a physician, respiratory therapist, or technician. A single-use, disposable viral-bacterial filter separates the patient from the internal components of the device.
The MiniBoxPFT™ 2.0 measures all common spirometric measurements as well as relative and absolute lung volumes, including the following (the full list is detailed in Section 11 - Device Description):
Absolute Lung Volumes:
Total lung capacity (TLC) L
Thoracic Gas Volume (TGV) L
Residual volume (RV) L
Relative Lung Volumes:
Inspiratory capacity (IC) L
Expiratory reserve volume (ERV) L
Spirometry:
Forced vital capacity (FVC) L
Forced inspiratory vital capacity (FIVC) L
Slow vital capacity (SVC) L
Slow inspiratory vital capacity (IVC) L
Forced expiratory volume in 1 second (FEV1) L
Forced inspiratory volume in 1 second (FIV1) L
Ratio of FEV1 to SVC (FEV1/SVC) %
Ratio of FEV1 to FVC (FEV1/FVC) %
Forced expiratory volume in 6 seconds (FEV6) L
Ratio of FEV1 to FEV6 (FEV1/FEV6) %
Peak expiratory flow (PEF) L/s
Peak inspiratory flow (PIF) L/s
Forced Expiratory Flow at 50% of FVC (FEF50) L/s
Maximum Voluntary Ventilation (MVV) L/min
Here's a summary of the acceptance criteria and the study details for the PulmOne MiniBoxPFT™ 2.0 device, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Spirometry Measurements | Met ATS guidelines for accuracy and repeatability. | Successfully met ATS guidelines. |
| Lung Volume Measurement Repeatability & Reproducibility | Inter-device repeatability and intra-device reproducibility within accepted known range. | Validated to be within the accepted known range. |
| Total Lung Capacity (TLC) Measurement (vs. Predicate) | Met pre-defined success criteria demonstrating substantial equivalence to predicate. | Successfully met study success criteria and demonstrated substantial equivalence. |
| Flow range | +/- 16 L/s (Predicate) | +/- 16 L/s (Proposed Device) |
| Volume accuracy | +/- 3% or 50mL (Predicate) | +/- 3% or 50mL (Proposed Device) |
| Flow accuracy | +/- 5% or 200 mL/s (Predicate) | +/- 5% or 200 mL/s (Proposed Device) |
| Dynamic resistance |
§ 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).