PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)

The PowerCube+ Series is a pulmonary function testing device that measures lung function through cooperation-dependent tests including spirometry, body plethysmography, lung diffusion measurement, occlusive resistance, and respiratory muscle strength measurement. It is intended for use by clinicians in professional healthcare settings to test adult and pediatric patients aged 5 years and older who can cooperate in testing, providing diagnostic information.

The subject device uses ultrasound flow measurement (transit-time between two ultrasound sensors) for spirometry, whereas the predicate uses a pneumotachograph (pressure drop method); both achieve similar accuracy specifications. Body plethysmography employs the same established principles of an airtight chamber, pressure sensors, and Boyle's Law. Lung diffusion testing uses helium and carbon monoxide gas analyzers with single-breath methodology consistent with ATS/ERS standards. Occlusive resistance and respiratory muscle strength measurements use pressure sensors and shutter mechanisms identical in principle to the predicate.

ISO 23747:2015 (peak expiratory flow meters), ISO 26782:2009 (spirometers), ATS Standardization of Spirometry 2019, 2017 ERS/ATS standards for single-breath carbon monoxide uptake, ATS/ERS Statement on Respiratory Muscle Testing (2002), ERS respiratory muscle testing statement (2018), ATS/ERS Standardization of lung volumes (2023), IEC 60601-1 Edition 3.2 (electrical safety), IEC 60601-1-2 Edition 4.1 (EMC), ISO 10993-1:2020 and ISO 18562 series (biocompatibility), ISO 17664-1:2021 (cleaning validation).

Although the subject device uses ultrasound-based flow measurement instead of the predicate's pneumotachograph, both achieve substantially similar accuracy specifications and conform to the same ISO standards for spirometry. Comparative bench testing against the FDA-cleared MasterScreen Body device demonstrated that body plethysmography measurements (TGV and sRaw) fall within 5% deviation, consistent with ATS/ERS guidelines. Lung diffusion, occlusive resistance, and respiratory muscle strength measurements employ the same well-established methodologies as the predicate. All reported parameters are mathematically derived from or directly measured using validated core measurements, and the device's environmental conditions and patient population are the same or broader than the predicate, with no new safety or effectiveness concerns identified.