(422 days)
Air Next is intended to be used by:
Healthcare professionals trained to perform spirometry tests on patients of age ≥ 5 years old, > 10 kg and > 110 cm.
Air Next is intended to perform basic lung function and spirometry testing. The actual diagnosis shall be done by a healthcare professional in hospital and clinical settings.
Air Next is intended to perform basic lung function and spirometry testing. It measures parameters such as the forced expiratory volume in 1 sec (FEV1) and the forced vital capacity (FVC) in a forced expiratory maneuver. These measures can be used for detection, assessment and monitoring of diseases affecting the lung function, such as bronchial Asthma, COPD and Cystic Fibrosis.
Air Next is a hand-held spirometer, weighing only 75g and it is powered by 2 AAA alkaline 1.5V batteries. lt consists of 3 main components: the Air Next device, the NuvoAir disposable turbine (delivered in one package) and the Air Next mobile application downloadable from Apple's and Google's Play Stores. The package includes one Air Next device, one NuvoAir disposable turbine through which the user can start using the Air Next, two AAA 1.5V alkaline batteries, one user manual and one cotton bag to carry the device. Dimensions of the Air Next are 98 x 62 x 26 mm, which can be seen in the engineering drawing in the attachments.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Air Next spirometer, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the Air Next spirometer meets ATS/ERS 2005 guidelines and ISO standards for spirometers. The performance of the Air Next related to specific technical specifications is compared directly to the predicate device, implying these represent the acceptance criteria derived from industry standards.
| Feature / Acceptance Criteria (per ATS/ERS 2005, ISO standards, and predicate comparison) | Reported Device Performance (Air Next) |
|---|---|
| Volume Accuracy | ±3% of reading or ±0.050 L, whichever is greater (Same as predicate) |
| Volume Range | Up to 10 L (Same as predicate) |
| Flow Range | 0-15 L/s (Similar to predicate's 0-16 L/s) |
| Flow Accuracy | ±5% or 200 mL/s (Same as predicate) |
| Flow 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).