(168 days)
The intended function and use of the SWR International AXS-590Hi and AXS-590i oxygen concentrators is to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. It is not intended to sustain or support life.
The AXS-590Hi and AXS-590i oxygen concentrators are designed to provide an inexpensive supply of supplemental oxygen in a home or institution without a continuous source of purified oxygen. They are not life-supporting or lifesustaining devices. Both the SWR AXS-590Hi and AXS-590i oxygen concentrators and the predicate Invacare Platinum oxygen concentrators are of the pressure-swing-adsorber (PSA) variety. In PSA type oxygen concentrator devices, the molecular sieve material operates as a catalyst that binds with the water and nitrogen in filtered room air to leave a gas that is typically not less than 85% oxygen when delivered to the patient. Air is exposed, at a certain pressure, to molecular sieve material that selectively retains nitrogen and other components until they are subsequently released when the pressure is reduced, thus the term pressure-swing. The compressor creates a vacuum to suck room air through a pre-filter into a holding tank. At the same time, downstream of the compressor, the air from the previous cycle is pressurized into one of the two aluminum molecular sieve tanks. As the oxygen is forced out of the end of the tank, it enters a "T" fitting that directs most of the gas to flush the nitrogen out of the second molecular sieve tank into the ambient air. The remaining oxygen is delivered to the patient. On the next cycle, the air is directed into the second molecular sieve tank with the oxygen generated flushing the first tank and continuing the supply to the patient. This repetitive cycle generates the oxygen necessary to flush and prepare the saturated sieve tank while supplying the patient with a continuous flow of high concentration oxygen.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the format you requested.
The document is a 510(k) summary for the SWR International AXS-590Hi and AXS-590i oxygen concentrators. It describes:
- Device Description and Intended Use: Portable oxygen generators that provide supplemental oxygen for respiratory disorders, using a pressure-swing-adsorber (PSA) methodology with molecular sieves. They are not life-supporting.
- Predicate Device: Invacare Platinum 510(k) K02038-.
- Discussion of Non-clinical Studies: States that "extensive bench testing was performed" to ensure compliance with identified standards and to show that the devices meet requirements and have effective hazard mitigations.
- Conclusion: Claims the devices are "as safe and effective as the predicate device."
- FDA Letter: A letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.
However, the document does not contain:
- A table of specific acceptance criteria.
- Reported device performance against numerical acceptance criteria.
- Details about sample sizes for test sets, data provenance, or ground truth establishment for any study.
- Information about expert involvement, adjudication methods, or MRMC studies.
- Any discussion of standalone algorithm performance.
- Sample size or ground truth details for a training set.
The submission focuses on establishing substantial equivalence to a predicate device through shared functionality and bench testing, rather than presenting a detailed clinical or performance study with defined acceptance criteria and statistical outcomes.
§ 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).