(165 days)
The PulmOne MiniBox+ is intended to measure lung function in adult and pediatric patients, 5 years and older, while at rest (including spirometry, lung volumes and diffusing capacity). The PulmOne MiniBox+ is to be used by a physician, respiratory therapist, or technician in a hospital or clinic setting
The PulmOne MiniBox+ is intended to measure lung function in adult and pediatric patients while at rest (including spirometry, lung volumes and diffusing capacity). The PulmOne MiniBox+ is to be used by either a physician, respiratory therapist, or technician. A cleared single-use, disposable viral-bacterial filter separates the patient from the internal components of the device.
The MiniBox+ measures all common spirometric measurements as well as relative and absolute lung volumes and diffusing capacity.
The MiniBox+ is equipped with a diffusing capacity module which is embedded into the MiniBox+ enclosure and located in the upper end of the device. This feature allows easy measurement of the volumes and concentrations (CO and CH4) of inspired and expired breath, of the test gas mixture and patient sample respectively, making possible the calculation of the diffusion capacity [DLco]. MiniBox + DLco [diffusing capacity factor of the lung for carbon monoxide (CO)] module uses the single breath concept and enables the measurements by setting and controlling the maneuver stages as defined in ATS/ETS DLco guidelines.
Here's a breakdown of the acceptance criteria and study information for the PulmOne MiniBox+ device, based on the provided document:
Acceptance Criteria and Device Performance
The document describes the performance and technical specifications of the MiniBox+ and compares them to predicate devices. The MiniBox+ is a pulmonary function data calculator, and its performance is evaluated against established standards for spirometry, lung volumes, and diffusing capacity measurements.
Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from Predicate/Standards) | Reported Device Performance (MiniBox+) | Notes |
|---|---|---|---|
| Spirometry | Identical to MiniBoxPFT™ 2.0 (K141793) | ||
| Flow range | +/- 16 L/s (MiniBoxPFT™ 2.0) | +/- 16 L/s | Same as predicate. |
| Volume accuracy | +/- 3% or 50mL (MiniBoxPFT™ 2.0) | +/- 3% or 50mL | Same as predicate. |
| Flow accuracy | +/- 5% or 200mL/s (MiniBoxPFT™ 2.0) | +/- 5% or 200mL/s | Same as predicate. |
| Dynamic resistance at 14 L/s |
§ 868.1880 Pulmonary-function data calculator.
(a)
Identification. A pulmonary-function data calculator is a device used to calculate pulmonary-function values based on actual physical data obtained during pulmonary-function testing.(b)
Classification. Class II (performance standards).