MESI mTABLET SPIRO

The MESI mTABLET SPIRO is an automated wireless spirometer for assessing respiratory function through measurement of dynamic lung volumes in adults and pediatric patients ages 5 and older. It measures spirometry parameters including FVC, FEV1, FEV6, and VC, and is intended to be operated by medical professionals in clinical settings such as primary care facilities, hospitals, and health centers.

The device uses a Fleisch pneumotachograph measurement principle with flow integration sampling at 800 Hz (versus 100 Hz for predicate), supports a maximum displaced volume of 14 L (versus 10 L), and employs a wireless tablet-based architecture with Bluetooth and Wi-Fi connectivity. It measures a more limited set of parameters (FVC, FEV1, FEV6, VC) compared to the predicate which also reports PEF and MVV. The system uses a rechargeable lithium-polymer battery and has an IP30 rating.

ATS/ERS (2019), ISO 23747:2007, ISO 26782:2009, AAMI ANSI ES 60601-1:2005 + A1:2012, IEC 60601-1-2:2014, ISO 10993-5 (2009), ISO 10993-10 (2010), ISO 10993-18 (2020), ISO 18562-2 (2017), ISO 18562-3 (2017), ANSI/IEEE C63.27:2017, and AAMI ST98.

The MESI mTABLET SPIRO is substantially equivalent to the Vitalograph Model 6000 Alpha predicate (K212938) because both devices have the same intended use, similar indications for use, and utilize the Fleisch pneumotachograph measurement principle for assessment of dynamic lung volumes. Technological differences in wireless architecture, sampling rate, maximum volume, and parameter set relate to hardware design rather than the fundamental measurement principle and do not raise new safety or effectiveness questions. Performance testing demonstrated the subject device meets applicable standard performance requirements.