(183 days)
The intended use of the Gas Transfill System is to provide supplemental oxygen to patients and to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. The device is not intended to be life supporting nor life sustaining.
The Respironics Gas Transfill System is comprised of a high pressure oxygen compressor and an external oxygen concentrator. The oxygen concentrator provides up to 2LPM of gaseous oxygen to the high pressure oxygen compressor for filling medical oxygen cylinders. In addition, the external oxygen concentrator provides up to 3LPM of gaseous oxygen for patient breathing. The external oxygen concentrator can be one of the Respironics series of FDA cleared devices or other manufacturers FDA cleared oxygen concentrators. The patient cannot breathe directly from the high pressure oxygen compressor. The purpose of the high pressure oxygen compressor is to fill medical oxygen cylinders only.
This looks like a 510(k) summary for a medical device. Based on the provided text, there is no information about acceptance criteria or a study proving the device meets said criteria. The document focuses on establishing substantial equivalence to predicate devices, the intended use, and general regulatory information.
Therefore, I cannot fulfill your request as the necessary data elements are not present in 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).