(86 days)
The AirSep Impulse Oxygen Conserving Device is to be normally used in a home or institutional environment by persons who suffer from various forms of Chronic Obstructive Pulmonary Disease (COPD). It is to be used only when a nasal oxygen cannula is prescribed.
The Impulse has been designed to work in conjunction with a portable, regulated flow bottled oxygen source. The unit can be used with any oxygen source capable of delivering gaseous oxygen at 20 to 25 psig. Oxygen is delivered in a precise amount at the optimum point in the breathing cycle through the nasal cannula. This form of delivery maximizes the beneficial effects of supplemental oxygen while eliminating unnecessary waste, thus increasing user mobility and ambulatory duration of the user.
The AirSep Impulse Oxygen Conserving Device is to be normally used in a home or institutional environment by persons who suffer from various forms of Chronic Obstructive Pulmonary Disease (COPD). It is to be used only when a nasal oxygen cannula is prescribed.
The Impulse has been designed to work in conjunction with a portable, regulated flow bottled oxygen source. The unit can be used with any oxygen source capable of delivering gaseous oxygen at 20 to 25 psig. Oxygen is delivered in a precise amount at the optimum point in the breathing cycle through the nasal cannula. This form of delivery maximizes the beneficial effects of supplemental oxygen while eliminating unnecessary waste, thus increasing user mobility and ambulatory duration of the user.
The AirSep Impulse differs from the CHAD Oxymatic in having an alarm to signal no inspiration if no breaths are detected during a 30 second time period.
The document provided is a 510(k) clearance letter from the FDA for the AirSep Impulse Oxygen Conserving Device. It does not contain a study report or detailed performance data. Therefore, I cannot extract the specific information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.
The letter acknowledges that the device is "substantially equivalent" to a legally marketed predicate device (Chad Therapeutics Oxymatic Electronic Oxygen Conserver Model 301). This substantial equivalence determination means that the FDA believes the new device is as safe and effective as the predicate device, based on the information provided in the 510(k) submission. However, the letter itself does not include the detailed performance data or study results that would have been part of that submission.
To answer your questions, I would need access to the actual 510(k) summary or the full submission for K962766, which is not provided in your input.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).