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.

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.

AI/ML Overview

This submission focuses on the substantial equivalence of the Millennium M10 Oxygen Concentrator to existing predicate devices rather than providing a detailed performance study with specific acceptance criteria and ground truth analysis. Therefore, much of the requested information regarding sample sizes, expert qualifications, and specific statistical performance metrics is not available in the provided text.

Here's an analysis based on the available information:

Acceptance Criteria and Reported Device Performance

The document states that "Performance, environmental, electrical, mechanical and electromagnetic compatibility testing was performed to prove the safety and effectiveness of the Millennium M10." However, it does not explicitly list specific numerical acceptance criteria or the reported performance data against those criteria. The conclusion is a general statement of substantial equivalence.

Acceptance Criteria	Reported Device Performance
Safety and Effectiveness: Implied to be equivalent to predicate devices based on technological characteristics and testing performed. Specific criteria are not detailed.	Based on "Performance, environmental, electrical, mechanical and electromagnetic compatibility testing," the device was deemed safe and effective and "substantially equivalent to devices already on the market."
Oxygen Flow: Capable of providing oxygen flow up to 10 LPM.	The device's description states it "is capable of providing oxygen flow up to 10 LPM."
Technological Equivalence: Same operating principles and technology as predicate devices.	Stated that the device "has the same operating principles and same technology as the predicate devices."

Study Information

Due to the nature of this 510(k) summary, which focuses on substantial equivalence to predicate devices, comprehensive study details typically found in a clinical trial report are not present.

Sample size used for the test set and the data provenance: Not explicitly stated. The testing mentioned ("Performance, environmental, electrical, mechanical and electromagnetic compatibility testing") likely involved a series of engineering and bench tests rather than a patient-based test set with a defined sample size for performance evaluation in the context of diagnostic accuracy.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not stated. As this is not a diagnostic device with "ground truth" established by human interpretation, there's no mention of experts for ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable or not stated.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is an oxygen concentrator, not an AI-assisted diagnostic device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not a standalone AI algorithm. The performance evaluation would be of the device itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly defined as "ground truth" in the diagnostic sense. The "ground truth" for an oxygen concentrator would be its physical output and functional parameters measured against engineering specifications and industry standards for safety and performance (e.g., oxygen concentration, flow rate, purity, noise levels, power consumption, etc.).
The sample size for the training set: Not applicable. This is a hardware device, not a machine learning model requiring a training set.
How the ground truth for the training set was established: Not applicable.

In conclusion, the provided document is an Abbreviated 510(k) summary for an oxygen concentrator, primarily demonstrating substantial equivalence to existing devices. It outlines that various engineering and performance tests were conducted to confirm safety and effectiveness, but it does not detail specific acceptance criteria or results in the way a diagnostic device study would.

Summary

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Abbreviated 510(k)
Tab 10-510(K) Summary

FEB 11 2005

K043006

Millennium M10

TAB 10

510(K) SUMMARY

Official Contact	Zita YurkoManager, Regulatory AffairsRespironics Inc.1001 Murry Ridge LaneMurrysville, PA 15668Phone: 724-387-4120Fax: 724-387-4216zita.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

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.

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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.)

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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.

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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

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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

Regulation Number and Section

§ 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).