The YuYue OxygenMax™ 7F-5 Oxygen Concentrator is intended solely for medical use in oxygen therapy programs under the supervision of a physician. It is intended to provide supplemental oxygen to patients with respiratory disorders for use in the home or health care facility. This device is available by prescription only and is not intended to support or sustain life.

Device Description

The Yuyue OxygenMax™ 7F-5 oxygen concentrator (" the Yuyue 7F-5") is used by patients with respiratory disorders who require supplemental oxygen. The device can be used in the home or an institutional environment. The device is not intended to sustain or support life. The device is used with a nasal cannula to direct oxygen from the device to the patient. The Yuyue 7F-5 provides oxygen in pulsed demand flow dosages at settings of 1 through 5. The oxygen concentration level of the output gas ranges from 90% to 94%. The Yuyue 7F-5 uses a standard AC power of 120 V/60 Hertz. The Yuyue 7F-5 uses a molecular sieve and pressure swing adsorption methodology to produce the oxygen gas output. Ambient air enters the device, is filtered and then compressed. This compressed air is then directed toward one of two nitrogen adsorbing sieve beds. Concentrated oxygen exits the opposite end of the active sieve bed and is directed into an oxygen reservoir where it is delivered to the patient in specific volumes during the inhalation portion of a detected breath The basic technology of The Yuyue 7F-5 is commonly used and equivalent to other FDA approved oxygen concentrators under the same Product Code of CAW. The principles of operation are equivalent to the predicate device.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Yuyue OxygenMax™ 7F-5 oxygen concentrator. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a de novo study with acceptance criteria and novel performance data. Therefore, many of the requested elements for a study proving acceptance criteria will not be present in this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide specific acceptance criteria in the format of a table with numerical thresholds for performance metrics. Instead, it relies on demonstrating conformity to recognized standards and substantial equivalence to a predicate device.

Performance Metric / Standard	Acceptance Criteria (Implicit)	Reported Device Performance
Oxygen Concentration Level	Within specified range (90-94%) (Implicit from device description)	Ranges from 90% to 94% (Stated in Device Description)
Safety Requirements	Conformity to ISO 8359:1996	Yuyue 7F-5 conforms to ISO 8359:1996
Standard Specification for Domiciliary Use	Conformity to ASTM F1464-93 (2005)	Yuyue 7F-5 conforms to ASTM F1464-93 (2005)
Electromagnetic Compatibility (EMC)	Conformity to IEC 60601-1-2:2001	Yuyue 7F-5 conforms to IEC 60601-1-2:2001
EMI (Electromagnetic Interference)	Conformity to FDA Reviewer Guidance document "Excerpts Related to EMI from November 1993" as appropriate	Yuyue 7F-5 conforms to FDA Reviewer Guidance for EMI
Overall Safety and Effectiveness	Substantially equivalent to predicate device	Shown to be safe and effective for intended use and substantially equivalent to predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a test set or data provenance in the context of a clinical study or new performance data. The evaluation is based on bench testing against established standards and comparison to a predicate device. Therefore, there is no "test set" in the traditional sense for evaluating AI or diagnostic performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is a 510(k) submission for an oxygen concentrator, not an AI or diagnostic device that relies on expert ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable. There is no test set requiring adjudication in this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is an oxygen concentrator, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is an oxygen concentrator, not an algorithm. Bench tests were performed to demonstrate compliance with standards and equivalence to the predicate device.

7. The Type of Ground Truth Used

The "ground truth" in this context is the conformity to established engineering and medical device standards (ISO 8359, ASTM F1464-93, IEC 60601-1-2) and the demonstrated equivalence to a legally marketed predicate device (John Bunn® O2 Premier oxygen concentrator, K844223). This is primarily based on technical specifications, functional testing, and regulatory compliance, rather than clinical outcomes or pathology data for a new diagnostic claim.

8. The Sample Size for the Training Set

Not applicable. This device is an oxygen concentrator, not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This device is an oxygen concentrator.

Summary of the Study and Device Proof:

The study proving the device meets the acceptance criteria is primarily a non-clinical performance evaluation based on bench testing and a substantial equivalence comparison to a predicate device.

Bench Tests: The Yuyue 7F-5 underwent bench tests to conform to the following recognized standards:
- ISO 8359:1996 for oxygen concentrators for medical use - safety requirements.
- ASTM F1464-93 (2005) for oxygen concentrators for domiciliary use.
- IEC 60601-1-2:2001 for medical electrical equipment - electromagnetic compatibility.
- FDA Reviewer Guidance document "Excerpts Related to EMI from November 1993" as appropriate.
Substantial Equivalence: The Yuyue 7F-5 was determined to be substantially equivalent to the John Bunn® O2 Premier oxygen concentrator (K844223). The submission states that, "Except using different trade name and model name, the subjective device and the predicate device is identical in the intended use, specification and other key characteristics." Minor power supply differences between models were noted but the counterpart models (Yuyue 7F-5 and John Bunn O2 Premier, JB0160-010/015) use identical power supply.

The results of these tests and the successful demonstration of substantial equivalence were deemed sufficient by the FDA to determine that the Yuyue 7F-5 oxygen concentrator is safe and effective for its intended use.

Summary

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1083559

SEP - 4 2009

SEP - 4 200

江苏鱼跃医疗设备有限公司 JIANGSU YUYUE MEDICAL SUPPLY & EQUIPMENT CO., LTD Yun Yang Industrial Park Dan Yang City, Jiangsu, CHINA 212300 Tel: (86)511-86900809 Fax: (86)511-86900800

4.2.3. Common Name:	Oxygen concentrator
4.2.4. Calcification Name:	Oxygen concentrator, Portable
4.2.5. Regulation Number:	21 CFR 868.5440
4.2.6. Proposed Regulation Class:	Class II
4.2.7. Device Product Code:	CAW
4.2.8. Medical Specialties:	Anesthesiology

4.3. DEVICE DESCRIPTION

The Yuyue 7F-5 uses a molecular sieve and pressure swing adsorption methodology to produce the oxygen gas output. Ambient air enters the device, is filtered and then compressed. This compressed air is then directed toward one of two nitrogen adsorbing sieve beds. Concentrated oxygen exits the opposite end of the active sieve bed and is directed into an oxygen reservoir where it is delivered to the patient in specific volumes during the inhalation portion of a detected breath The basic technology of The Yuyue 7F-5 is commonly used and equivalent to other FDA approved oxygen concentrators under the same Product Code of CAW. The principles of operation are equivalent to the predicate device.

4-4. INDICATIONS FOR USE

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Image /page/1/Picture/0 description: The image shows a logo with two distinct parts. On the left, there is a circular graphic composed of several concentric dotted lines, creating a layered effect. To the right of the graphic, the text "YUYUE" is displayed in bold, block letters above three Chinese characters, which are stacked vertically.

江苏鱼跃医疗设备有限公司 JIANGSU YUYUE MEDICAL SUPPLY & EQUIPMENT CO., LTD Yun Yang Industrial Park Dan Yang City, Jiangsu, CHINA 212300 Tel: (86)511-86900809 Fax: (86)511-86900800

life.

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PREDICATE DEVICE ............................................................................................................................................................. 4.5.

4.5.1. Predicate Device Name: John Bunn® O2 Premier oxygen concentrator

4.5.2. Device FDA 510 (k) Number: K844223

4.6. SUBSTENTIAL EQUIVALENCE CONSULTION

The Yuyue 7F-5 (the subjective device) is determined to be substantially equivalent to the predicate device, John Bunn O2 Premier oxygen concentrator. Both the predicate device and the subject device are designed and manufactured by Yuyue Medical. Except using different trade name and model name, the subjective device and the predicate device is identical in the intended use, specification and other key characteristics. In addition. The subject device uses 120 V/60Hz AC power only, and the predicate device has two models, using 120V/60Hz and 220V/50 Hz respectively. But the counterpart model of the two devices, Yuyue 7F-5 and John Bunn O2 Premier, JB0160-010/015, uses the identical power supply, 120 V/60 Hz. .........................................................................................................................................................

NON-CLINICAL PERFORMANCE 4.7 . . . . . .

The bench tests of Yuyue 7F-5 conform the following recognized sfandards:

ISO 8359:1996: Oxygen concentrators for medical sue - Safety requirements
ASTM F1464-93 (2005): Standard Specification for Oxygen Concentrators for Domiciliary Use
IEC 60601-1-2:2001: Medical Electrical Equipment - Sec 1.2 -Collateral standard: Electromagnetic compatibility
FDA Reviewer Guidance document "Excerpts Related to EMI from November 1993" as appropriate to the area of usage.

The results of the testing have shown that the Yuyue 7F-5 oxygen concentrator is safe and effective for its intended use and substantially equivalent to its predicate device.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure. The symbol is composed of three curved lines that form the body and wings of the bird.

SEP - 4 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Jiangsu Yuyue Medical Supply & Equipment Company, Limited C/O Norman F. Estrin, Ph.D. President Estrin Consulting Group, Incorporated 9109 Copenhaver Drive Potomac, Maryland 20854

Re: K083559

Trade/Device Name: Yuyue OxygenMax™ 7F-5 Oxygen Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: August 26, 2009 Received: August 28, 2009

Dear Dr. Estrin:

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.

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Page 2 - Dr. Estrin

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 (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Runner, D.D.S., M.A. Acting Division 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

5 10(k) Number (if known):

Device Name: Yuyue OxygenMax™ 7F-5 oxygen concentrator J

Indications for Use:

Page 1 of 1

Prescription Use Yes (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K083559

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).