(200 days)
The OxyconAlpha is used as a predictive pulmonary function value calculator (Product code BTY). It is a software-driven, active medical device for investigational exercise measurements. It measures the human response to increasing workloads with emphasis on the gas exchange parameters. Measurements include ventilation, oxygen uptake, carbon dioxide production and derived parameters.
It is the intention to determine on patients a cardiopulmonary limitation and to test on sport athlets their training level. The different load levels for both groups can be generated over a bicycle ergometer or over a treadmill. The patient population is age 4 and older. The environment of use is indoor.
The OxyconAlpha interfaces to a testsubject via mouthpiece or a face mask. The OxyconAlpha interfaces to peripheral equipment and is therefore available in a variety of configurations from a standard controlled ergospirometry unit to a fully expandable laboratory system with blood pressure monitor, treadmill and ergometer. The OxyconAlpha interacts with the ECG signal (recorded by another device) only to the extent of extracting the patient's heart rate from the ECG signal. Other uses such as displaying or further analyzing the ECG waveforms are not included in the present submittal.
The device is not intended for use as a diagnostic pulmonary-function interpretation calculator.
The OxyconAlpha is a software-driven, active medical device for investigational exercise measurements. It measures the human response to increasing workloads with emphasis on the gas exchange parameters. Measurements include ventilation, oxygen uptake, carbon dioxide production and derived parameters. It interfaces to a testsubject via mouthpiece or a face mask and to peripheral equipment such as a bicycle ergometer or treadmill. It can interact with an ECG signal (recorded by another device) to extract the patient's heart rate.
I'm sorry, but this document does not contain the information requested in the prompt. The document is a clearance letter from the FDA for a medical device (OxyconAlpha), and it describes the device's indications for use and regulatory classification. It does not include details on acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).