(714 days)
When used to monitor conditions such as asthma, this device should be used under the direction of a physician or licensed health care professional. This product will be sold as an OTC device with the appropriate FDA cautionary labeling.
The STI OneFlow is a hand held, battery operated, electronic peak flow (PEFR) and FEV1 monitoring device with internal memory capable of storing 120 sets of readings. The product is available with or without software that downloads stored readings from the device and statistically analyzes this data as per criteria set in the patient information section of the program.
Based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a device called "OneFlow Tester," indicating it has been found substantially equivalent to a legally marketed predicate device.
The letter mentions:
- The device is a handheld, battery-operated electronic peak flow (PEFR) and FEV1 monitoring device.
- It has internal memory for 120 sets of readings.
- It's available with or without software for data download and statistical analysis.
- It's to be used under the direction of a physician for monitoring conditions like asthma.
- It will be sold as an OTC device with appropriate FDA cautionary labeling.
- It has been calibrated according to the American Thoracic Society "Standardization of Spirometry, 1994 Update."
However, none of this constitutes a description of acceptance criteria for a study or details of a study conducted to demonstrate performance against such criteria. The document is primarily an FDA regulatory approval notice.
Therefore, for all the requested information categories (1-9), the answer is: Not provided in the given text.
§ 868.1860 Peak-flow meter for spirometry.
(a)
Identification. A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.(b)
Classification. Class II (performance standards).