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The Model 9160 VitaloQUB is a whole-body plethysmograph device, when used with the Vitalograph Model 9100, is designed for lung function testing on adults and pediatrics, 6 years and older, by trained medical healthcare professionals in a variety of professional healthcare environments e.g., primary care, hospitals, and pharmaceutical research centers.

The proposed Model 9160 VitaloQUB incorporates the cleared Model 9100 (K221030) with integrated LCD display and ComPAS2 software (K213872). The ComPAS2 software controls valves and reads unprocessed data from the sensors in the Model 9100 and from Model 9160. The ComPAS2 software then determines respiratory parameters including the 2 new parameters. The ComPAS2 software is unchanged from K213872. The Model 9160 and Model 9100 firmware does not determine any respiratory parameters. The Model 9160 is adding 2 additional parameters: - TVG – Thoracic Gas Volume - Raw Airway resistance

The Model 9100 PFT/DICO is a pulmonary function testing device which uses Morgan Scientific's ComPAS2 software to measure subject respiratory parameters including FVC, SVC, MVV, CPF, RMS, SNIP, DLCO, MBN2 and SBN2. The device is PC-based and designed for lung function testing on adults and pediatrics, 6 years and older, in a variety of professional healthcare environments e.g., primary care, hospitals, pharmaceutical research centers and physicians' offices. The Model 9100 PFT/DICO is intended for the assessment of respiratory function through the measurement of dynamic lung volumes i.e., spirometry and other lung functions i.e., diffusing capacity.

The Model 9100 PFT/DICO is composed of various sensors and valves with associated low level firmware. The firmware interfaces with the Morgan Scientific's ComPAS2 software (K213872) that resides on an on-board computer. The Model 9100 also provides for user input and present resulting data on an integral display. The ComPAS2 software controls valves and reads unprocessed data from the sensors in the Model 9100then determines respiratory parameters including FVC, SVC, MVV, CPF, RMS (MIP and MEP), SNIP, DLCO, MBN2 and SBN2. The Model 9100 PFT/DICO firmware does not determine any respiratory parameters. The ComPAS2 software uses flow and volume from the Vitalograph pneumotachograph spirometer to display the flow and volume information measured directly from patient effort. ComPAS2 also utilizes gas analyzer readings from the Model 9100 patient test benchmark to display dilution lung volume data and single / multi breath diffusion data measured directly from patient effort. This information is then provided in a report format.

The intended use of the Vitalograph Model 6000 Alpha is the simple assessment of respiratory function through the measurement of dynamic lung volumes i.e. spirometry. The device measures patient respiratory parameters including FVC, FEV1, FEV6, PEF, MVV and VC. The device is designed to be operated by medical professionals trained in respiratory and lung function testing on adults and pediatrics, 5 years and older, in a variety of professional healthcare environments, e.g. primary care, hospitals and occupational health centers.

The Vitalograph Alpha Model 6000 is a desktop spirometer which measures the following lung function parameters FVC, FEV1, FEV6, PEF, MVV and VC in professional healthcare environments, e.g., primary care, hospitals and occupational health centers. It is externally powered from a Class II, IEC 60601-1 compliant medical power supply. It contains a rechargeable battery powered from the external supply. The device also contains an integral 4 inch thermal printer. The device has a USB port for connection to other devices and an SD card slot for backup of stored data. The device also has wired ethernet and Wi-Fi for connection to a hospital network. Its primary functions and technology are: - Spirometry measurements using single breath and multiple-breath testing techniques, the display and recording of measured lung volumes and flow rates (including FVC, FEV1, FEV6, PEF, MVV and VC) are identical to the predicate device - Record subject data - Storage of data and test results on unit for later printing or export to Spirotrac software which was cleared under 510(k) K201562. The Flowhead utilizes a Fleisch Pneumotachograph. The operating principle is identical to the predicate K200550 - User Interface navigation via touch screen display

The Vitalograph Spirotrac Model 7000 is a PC-based software application intended to be used as a spirometer or connect to compatible Vitalograph or third party devices to acquire, view, store and print the device output. The product is designed for use on adults and pediatrics, 5 years and older, in a variety of professional healthcare environments, e.g. primary care, hospitals and occupational health centers under the supervision of a healthcare provider.

The Vitalograph Spirotrac Model 7000 provides a secure PC based medical device software application for creating, adding and recalling subjects and performing Spirometry testing on those subjects. Spirotrac will also link to compatible third party devices to read and display the output from these devices to allow the information to be retained with the subject. Spirotrac integrates and reads / displays information from compatible Pulse Oximetry devices, Blood Pressure and Weight measurements devices, and ECG test devices. Its primary functions are: Spirometry measurements using single breath and multiple-breath testing techniques, the display and recording of measured lung volumes and flow rates (including VC, FIVC, FVC) and its subdivisions. The unit also allows for the measurements of Inspiratory and Expiratory Flow rates (PEF, FEFx, etc.), indirect measures (e.g. MVV) and Pre-post testing (e.g. Challenge, work shift). Record subject demographic data as input. Interact with existing Vitalograph and compatible third party devices via standard PC communication methods for download of data for storage within the Spirotrac database. Navigation is allowed via the use of a standard PC keyboard and mouse or touchscreen.

The Vitalograph Model 2120 In2itive eDiary device is a battery-operated spirometer which measures three basic patient respiratory parameters (FVC, MVV and VC). The Vitalograph Model 2120 In2itive eDiary is a handheld spirometer designed for lung function testing in a variety of environments such as hospital wards, health centres and private homes. It is intended for Adults and pediatrics, 5 years and older. The Vitalograph Model 2120 In2itive eDiary can be configured as a stand-alone spirometer or connected to a printer.

The Vitalograph Model 2120 In2itive eDiary is a hand-held, battery-operated spirometer which measures the following lung function parameters FVC, MVV and VC in hospital, clinical and home settings. It can be configured as a standalone spirometer or connected to a printer. Its primary functions and technology are: - . Spirometry measurements using single breath and multiple-breath testing techniques, the - display and recording of measured lung volumes and flow rates (including FVC, VC, ● MVV) and other parameters which are subsets of these measured parameters. - . Record subject data. Storage of data and test results on unit for later printing or export to Spirotrac software - The Flowhead utilizes a Fleisch Pneumotachograph. - User Interface navigation via five buttons (Up, Down, Enter/Select, Cancel/Esc and . Power On/Off) or an optional touch screen.