(102 days)
K0972614, K042262
K0972614, K042262
No
The description focuses on the physical process of oxygen concentration (molecular sieve, pressure swing adsorption) and does not mention any computational or data-driven processes indicative of AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is described as a "medical device that produces concentrated oxygen from room air for delivery to a patient requiring oxygen therapy," indicating its use in treating a condition.
No
Explanation: The device is an oxygen concentrator intended to provide supplemental oxygen, not to diagnose a medical condition. Its function is to produce concentrated oxygen, which is a therapeutic rather than a diagnostic action.
No
The device description clearly states it is a hardware device (Oxygen Concentrator) that produces concentrated oxygen using physical processes (molecular sieve, pressure swing adsorption).
Based on the provided information, the Millennium M10 Oxygen Concentrator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide supplemental oxygen to persons requiring oxygen therapy. This is a direct therapeutic intervention on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device description explains how it concentrates oxygen from room air and delivers it to the patient. This is a physical process for delivering a gas, not a process for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), diagnostic testing, or providing information for diagnosis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Millennium M10 Oxygen Concentrator's function is to provide a therapeutic gas directly to the patient.
N/A
Intended Use / Indications for Use
The Millennium M10 Oxygen Concentrator is intended to provide supplemental oxygen to persons requiring oxygen therapy. The device is not intended to be life support nor life sustaining.
Product codes
CAW
Device Description
The Millennium M10 Oxygen Concentrator is a medical device that produces concentrated oxygen from room air for delivery to a patient requiring oxygen therapy. It uses molecular sieve and a pressure swing adsorption process to concentrate oxygen from air. The device is capable of providing oxygen flow up to 10 LPM and is offered with an optional Oxygen Percentage Indicator.
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
Not Found
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
Performance, environmental, electrical, mechanical and electromagnetic compatibility testing was performed to prove the safety and effectiveness of the Millennium M10.
Key Metrics
Not Found
Predicate Device(s)
Respironics Millennium (K0972614), SeQual Integra (K042262)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Abbreviated 510(k)
Tab 10-510(K) Summary
FEB 11 2005
Millennium M10
TAB 10
510(K) SUMMARY
| Official Contact | Zita Yurko
Manager, Regulatory Affairs
Respironics Inc.
1001 Murry Ridge Lane
Murrysville, PA 15668
Phone: 724-387-4120
Fax: 724-387-4216
zita.yurko@respironics.com |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name | Millennium M10 Oxygen Concentrator |
| Common/Usual Name | Millennium M10 |
| Classification Name | Generator, Oxygen, Portable (CAW). |
| Predicate Devices | Respironics Millennium (K0972614) |
| | SeQual Integra (K042262) |
Device Description
The Millennium M10 Oxygen Concentrator is a medical device that produces concentrated oxygen from room air for delivery to a patient requiring oxygen therapy. It uses molecular sieve and a pressure swing adsorption process to concentrate oxygen from air. The device is capable of providing oxygen flow up to 10 LPM and is offered with an optional Oxygen Percentage Indicator.
Indications for Use
The Millennium M10 Oxygen Concentrator is intended to provide supplemental oxygen to persons requiring oxygen therapy. The device is not intended to be life support nor life sustaining.
Technological characteristics, comparison to predicate devices
The Respironics Millennium M10 has the same operating principles and same technology as the predicate devices. The Millennium M10 is capable of providing oxygen flow up to 10 LPM.
1
Performance testing
Performance, environmental, electrical, mechanical and electromagnetic compatibility testing was performed to prove the safety and effectiveness of the Millennium M10.
Conclusion
It is the conclusion of Respironics that the Millennium M10 is substantially equivalent to devices already on the market (cleared by the 510(k) process) and presents no new concerns about safety and effectiveness.
(End of Tab.)
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 2005
Respironics, Incorporated C/O Ms. Zita A. Yurko Manager, Regulatory Affairs Homecare Division 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668-8550
Re: K043006
Trade/Device Name: Millennium M10 Oxygen Concentrator Regulation Number: 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: December 22, 2004 Received: December 27, 2004
Dear Ms. Yurko:
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 cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour 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
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Elsie
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Millennium M10 Oxygen Concentrator is intended to provide supplemental oxygen to persons requiring oxygen therapy. The device is not intended to he life support nor life sustaining
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use AND/OR
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Oun Salem
Radiator Oil
Dept. Anesthesiology, General Hospital
Sector Control Dental Devices
Radiator K043006