(168 days)
K02038
Not Found
No
The description details a mechanical process (pressure-swing adsorption) for oxygen concentration and does not mention any AI/ML components or functions.
Yes
The device is intended to provide supplemental oxygen to patients with respiratory disorders, which is a therapeutic function.
No
This device is an oxygen concentrator, which provides supplemental oxygen to patients. It does not perform any diagnostic functions like detecting, diagnosing, or monitoring a disease or condition. Its purpose is therapeutic, not diagnostic.
No
The device description clearly details hardware components like compressors, molecular sieve tanks, and filters, indicating it is a physical medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide supplemental oxygen to patients with respiratory disorders by separating nitrogen from room air. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details a mechanical process of air filtration and oxygen concentration. It does not involve analyzing biological samples (blood, urine, tissue, etc.) which is the hallmark of an in vitro diagnostic device.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device is clearly described as a medical device used for delivering oxygen to a patient, which falls under a different regulatory category than in vitro diagnostics.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
CAW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home or institution
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The AXS-590Hi and AXS-590i oxygen concentrators have had extensive bench testing performed. This testing was designed to insure compliance with the standards identified in sections 9 and 18 of this submission. The testing was also performed to show that the devices meet the requirements specifications and that hazard mitigations are effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Invacare Platinum 510(k) K02038
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Traditional 510(k) 510(k) Summary Section 5:
SWR International - AXS-590Hi and AXS-590i
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990, 21 CFR 807.87, 21 CFR 807.92, Format for Traditional and Abbreviated 510(k)s.
1. Name of Submitter, Contact Person and Date Summary Prepared:
| Applicant: | SWR International, Ltd |
|---|---|
| Room 2706 27th Floor, South Tower | |
| Guangzhou World Trade Center Complex | |
| 37 Huanshi Road East, Guangzhou | |
| China |
Contact: Ms. J. Deng Phone: +86.20.2884.8651 +86.20.8762.4275 Fax:
Date of Preparation: November 24, 2009
- Device Trade Name and Common Name:
| Trade Name: | AXS-590Hi and AXS-590i |
|---|---|
| Common/Usual Name: | Portable oxygen generator |
| Classification Name: | generator, oxygen, portable |
| Regulation Number: | 21 CFR 868.5440 |
| Product Code: | CAW |
| Device Class: | Class 2 |
| Predicate Device: | Invacare Platinum 510(k) K02038- |
5. Description of the Device:
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.
Section 5- Page 2 of 3
1
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. Also see section 11.1 of this submission.
6. Intended Use of the Device:
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.
- Comparison of technological characteristics with Predicate Device: 7. The AXS-590Hi and AXS-590i oxygen concentrators perform the same function as the Invacare Platinum oxygen concentrator and performs this function by the same methodology (molecular sieve).
8. Discussion of Non-clinical Studies:
The AXS-590Hi and AXS-590i oxygen concentrators have had extensive bench testing performed. This testing was designed to insure compliance with the standards identified in sections 9 and 18 of this submission. The testing was also performed to show that the devices meet the requirements specifications and that hazard mitigations are effective.
9. Conclusion:
The AXS-590Hi and AXS-590i oxygen concentrators are as safe and effective as the predicate device and provide an inexpensive supply of supplemental oxygen in a home or institution without a continuous source of purified oxygen.
SWR International Ltd. 37 Huanshi Rd East Guangzhou, China
Section 5- Page 3 of 3
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle. The eagle is black, and the text is also black.
Public Health Service
NOV 2 4 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
SWR International, Limited C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, L.L.C. 1394 25th Street Northwest Buffalo, Minnesota 55313
Rc: K091650
Trade/Device Name: AXS-590Hi and AXS-590i Oxygen Concentrators Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: November 11, 2009 Received: November 12, 2009
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2- Mr. Job
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
th far
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Traditional 510(k)
Section 4 Indications for Use
510(k) Number (if known): K091650
Device Name: AXS-590Hi and AXS-590i Oxygen Concentrators
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.
Prescription Use X (Per 21 CFR 801.109) OR
Over-The-Counter Use_
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schultheis
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
KO91650 510(k) Number:
SWR International Ltd. 37 Huanshi Rd East Guangzhou, China
Section 4- Page 2 of 2