(184 days)
The SpiroPro SpO2 is a portable, battery operated device and can be used by physicians in the office or hospital, in occupational medicine or by patients in the home. The SpiroPro SpO2 measures inspiratory and expiratory lung function parameters in adults and children 4 years and older. In addition to the pulmonary function measurements, oxygen saturation and heart rate can be recorded.
The pocket spirometer SpiroPro® SpO2 is a portable, electronic measuring device for the determination of expiratory and inspiratory parameters (Vcin, FVC, FEV1, MEF50 etc.) including Pre/Post testing, date and time stamps as well as the complete registration of spirogram and flowvolume curves by a very precise pressure transducer (pneumotachograph). The built-in interpretation module enables an easy quality check and an automatic selection of the best measuring result. The unique SpO2 option completes the range of functions of the versatile spirometer. SpO--spot and trend measurements can be performed also oxygen saturation and heart rate can be recorded over a period of 60 minutes. Equipped with a graphical LCD display, an innovative touch-screen technology and a user-friendly graphical user interface, the SpiroPro® SpO2 provides the latest developments in technology. The input of patient data and the selection of the menu functions is realised by just touching the corresponding icon with your finger tips. The SpiroPro® SpO2 can store up to 600 measurements in its non-volatile memory. If required also versions with higher capacity are available. The rechargeable battery allows an operation time of approximately 2 weeks. A charger that recharges the battery within 2 hours is supplied with the unit. With the built-in communication module a direct printout of results and graphs to a PCL-compatible printer is possible. Of course, data transmission to and from a PC by a serial port is an integral part of the innovative concept. The optional software package "SpiroPro® SpO2 for Windows" receives the data all-automatically and stores them on the PC. The unit can work stand alone or in combination with a PC for measurements with real-time display, questionnaire functionality, data analysis and long term storage. Combining the two diagnostic devices into one device is very cost effective for the user. A pulmonary function calculator and a pulse oximeter are two devices that a physician will use on a regular basis for patient care. The handy, modular design allows the use of the SpiroPro® SpO2 in many fields of primary care.
The provided text is a 510(k) summary for the SpiroPro® SpO2 device. It describes the device, its intended use, and compares it to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving that the device meets such criteria.
The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with detailed acceptance criteria. Performance data related to the accuracy of the spirometry and pulse oximetry functions would typically be found in engineering or validation reports, which are usually not included in the public-facing 510(k) summary.
Therefore, I cannot fulfill your request for the tables and details about the study because the necessary information is not present in the provided document.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).