Vivatmo pro-S

The Vivatmo pro-S is a portable, non-invasive device that measures fractional exhaled nitric oxide (FeNO) in human breath. It is used to assess airway inflammation in asthma patients and monitor their response to anti-inflammatory therapy. The device is intended for point-of-care healthcare settings and is suitable for children approximately 7-17 years and adults 18 years and older.

The Vivatmo pro-S uses identical measurement principles to its predicate (Vivatmo pro), based on a Chemical Field Effect Transistor (Chem-FET) sensor that detects nitrogen dioxide converted from nitric oxide via a potassium permanganate converter in a disposable mouthpiece. The handheld measurement module is identical to the predicate; the key difference is that the predicate includes a separate base station for breathing visualization and data storage, whereas the pro-S operates as a standalone handheld device.

Not stated in this summary.

The Vivatmo pro-S is substantially equivalent to the predicate Vivatmo pro because: (1) both devices use identical measurement technology and principles; (2) the sample type (exhaled human breath), test result (quantitative), sensor calibration (factory), intended use setting (point-of-care under supervision), and user age indications are identical; (3) performance data are identical; (4) the minor design difference (removal of separate base station) does not alter the diagnostic effect or safety/effectiveness; and (5) EMC and cybersecurity testing of comparable hardware confirms safety.