Air Next

The Air Next is a portable spirometer utilizing an infrared sensor and disposable turbine to measure key lung function parameters like FEV1 and FVC for aiding in the diagnosis and management of respiratory diseases. It pairs with a mobile application to guide healthcare professionals and display results, aiming to provide accurate spirometry in clinical settings for patients over five years old.

The Air Next is a handheld, battery-operated diagnostic spirometer designed for basic lung function and spirometry testing. It measures key respiratory parameters such as Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC) through a forced expiratory maneuver. The device is intended for use by trained healthcare professionals in hospital and clinical settings to aid in the detection, assessment, and monitoring of lung diseases like asthma, COPD, and cystic fibrosis in patients aged 5 years and older, weighing more than 10 kg, and taller than 110 cm. The system comprises the Air Next device itself, a NuvoAir disposable turbine, and a companion mobile application for displaying results and providing coaching. The Air Next operates by having the user exhale into the disposable turbine, causing a propeller to rotate. A digital infrared interruption sensor within the device registers the propeller's speed, which is then converted into airflow data by an internal algorithm. This technology supports measurements compliant with B.T.P.S. conditions and ATS guidelines. The device connects via Bluetooth to a mobile app for data display and provides feedback on test quality. It has demonstrated adherence to safety and biocompatibility standards, with technical specifications including a volume accuracy of ±3% or ±0.050 L, a flow range of 0-15 L/s, and a flow accuracy of ±5% or 200 mL/s. No clinical testing was performed with this specific device, relying on comparison to predicate devices and performance testing.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. Given that clinical testing was not performed for this device, how significantly do the differences in physical characteristics (e.g., energy type, display, weight) compared to the predicate device (Spirobank G) potentially impact usability or data acquisition in real-world clinical settings?; The device uses a mobile application for display and coaching; what specific features within the app ensure reliable test performance and adherence to ATS guidelines, especially concerning effort and test quality feedback for the healthcare professional?; How does the algorithm converting propeller rotations to airflow account for potential variations in environmental conditions (beyond B.T.P.S. calibration) or minor inconsistencies in turbine manufacturing, if any?; What is the expected lifespan of the Air Next device itself, and what are the recommended calibration or verification procedures for healthcare professionals to ensure continued accuracy over time, beyond the use of single-use turbines?; Considering the device is intended for patients ≥ 5 years old, are there specific user interface adaptations or coaching elements within the mobile application tailored for pediatric use to maximize test quality and patient cooperation?