(246 days)
The Inogen One Oxygen Concentrator is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Inogen One Oxygen Concentrator may be used in a home, institution, vehicles and various mobile environments.
The Inogen One Oxygen Concentrator is used on a prescriptive basis by patients requiring supplemental oxygen. Patients may include but are not restricted to those with chronic obstructive pulmonary disease (COPD). The device is not intended to be life sustaining or to be life supporting. It is used with a nasal cannula to channel oxygen from the device to the patient. The concentrator and the nasal cannula are non-sterile.
The Inogen One Oxygen Concentrator provides approximately 90% oxygen to the patient on a demand flow basis at an "equivalent" rate of 1.0 liters per minute to 5.0 liters to minute in increments of 0.5 liters per minute.
The Inogen One Oxygen Concentrator is capable of continuous use in a home, institution, vehicles and various mobile environments. Power options include 110 -- 220 VAC, 12 -- 14 VDC or rechargeable batteries.
The Inogen One Oxygen Concentrator uses molecular sieve / pressure swing adsorption technology. Ambient air is drawn thru particle filters by a compressor and forced thru molecular sicve beds, which adsorb nitrogen and allow oxygen to pass. The airflow is then changed and nitrogen is desorbed from the molecular sieve, allowing it to adsorb again during the next cycle. Oxygen is collected in an accumulator reservoir. Waste nitrogen is exhausted back into the room. A series of sieve beds, a manifold with precision valves, sensors and embedded software to control the cycle are used to make the system function.
Oxygen is delivered to the patient on a demand flow basis in precise amounts during the inhalation part of the breathing cycle. This conserver technology eliminates waste of unused oxygen at other times in the breathing cycle when it is not needed. Inogen One Oxygen Concentrator senses the beginning of the inhalation cycle and releases a specified dose of oxygen enriched gas from the accumulator reservoir, thru a final filter, into the connected nasal cannula and onto the patient.
The design of the Inogen One Oxygen Concentrator has focused on maximizing subsystem efficiencies and miniaturizing components to enable continuous duty use and to provide minimal weight and battery operation for mobile use.
The basic technology of the Inogen One Oxygen Concentrator is equivalent to other approved oxygen concentrators. The principles of operation are equivalent to the predicate device noted in the submission.
The provided text is a 510(k) summary for the Inogen One Oxygen Concentrator. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain any information about a study proving the device meets acceptance criteria, nor does it explicitly list acceptance criteria in a table format with reported device performance.
Therefore, I cannot fulfill the request to build a table of acceptance criteria and reported device performance or provide details about a study that proves the device meets those criteria, as that information is not present in the given text.
The document only states that:
- "Benchtop performance testing has demonstrated that the Inogen One Oxygen Concentrator is equivalent to the AirSep LifeStyle Oxygen Concentrator."
This is a statement of equivalence based on testing, but the specifics of that testing, the acceptance criteria used, or the results are not detailed in this summary.
In summary, the requested information is absent from the provided text.
§ 868.5440 Portable oxygen generator.
(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).