Search Results
Found 1 results
510(k) Data Aggregation
K Number
K091650Device Name
AXS-590 SERIES
Manufacturer
SWR INTERNATIONAL, LTD
Date Cleared
2009-11-24
(168 days)
Product Code
CAW
Regulation Number
868.5440Why did this record match?
Applicant Name (Manufacturer) :
SWR INTERNATIONAL, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
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.
Ask a Question
Page 1 of 1