(506 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on physical processes (molecular sieve, pressure swing adsorption) and standard electrical components. The software is described as "moderate level" and the performance studies are based on standard electrical, safety, and performance testing, not AI/ML model validation.
Yes
The device is described as an "oxygen supplement device" that "provides high concentration of oxygen to persons requiring oxygen therapy," indicating its use in treating a medical condition.
No
Explanation: The document states that the oxygen concentrator is "intended for using as an oxygen supplement device" and is "to be used as an oxygen supplement." Its function is to provide high concentration of oxygen, not to diagnose medical conditions.
No
The device description explicitly lists primary electrical components including a main unit, compressor, fan, flowmeter, and circuit breaker, indicating it is a hardware device with integrated software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for providing oxygen supplement to persons requiring oxygen therapy. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details how the device produces oxygen from room air. This process is related to providing a medical gas, not analyzing biological samples.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is an oxygen concentrator, which is a medical device used for respiratory support.
N/A
Intended Use / Indications for Use
This oxygen concentrator is intended for using as an oxygen supplement device in the professional healthcare facility and home healthcare environment. It provides high concentration of oxygen to persons requiring oxygen therapy. This device is to be used as an oxygen supplement and is NOT considered life-supporting or life-sustaining.
Product codes (comma separated list FDA assigned to the subject device)
CAW
Device Description
The Yuyue Oxygen Concentrator models 8F-3A/8F-5A is a portable concentrator which could utilize a molecular sieve and pressure swing adsorption to produce the oxygen. The device could separate nitrogen by absorbing through the molecular sieve when the room air enters the device, and allows the enriched oxygen to be collected. The subject device is intended use for adult population.
The subject device contains primary electrical components including main unit, compressor, fan, flowmeter and circuit breaker, the software is moderate level according to FDA software guideline.
The patient contacting components are listed in following table, the biocompatibility test and gas pathway biocompatibility test was conducted to subject device against ISO 10993-10, ISO 18562-1, ISO 18562-2, ISO 18562-3.
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
adult population
Intended User / Care Setting
professional healthcare facility and home healthcare environment
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)
To demonstrate safety and effectiveness of Oxygen Concentrator models 8F-3A/8F-5A and to show substantial equivalence to the original device, Jiangsu Yuyue Medical Equipment& Supply Co., Ltd completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. The device passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device:
- Electrical safety testing per ES 60601-1
- Electromagnetic Disturbance (EMD) testing per IEC 60601-1-2
- . General requirements, tests and guidance for alarm systems per IEC 60601-1-8
- General requirements for basic safety and essential performance in the home healthcare environment per IEC 60601-1-11
- Particular requirements for the basic safety and essential performance of oxygen concentrator equipment per ISO 80601-2-69
- Biocompatibility in gas pathway per ISO 18562-1, ISO 18562-2, ISO 10993-5, ISO 10993-10.
- Software verification and validation per IEC 62304/FDA Guidance – results /conclusion
- . Shelf Life Testing - Supports the claimed shelf life
- . Transportation Testing per ASTM D4169 – Demonstrates package integrity maintained
- . Altitude limit 2000m device performance test
- Accessory compatibility test including connect security, accessory performance
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.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
April 28, 2023
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. % Randy Jiang Sr. consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746
Re: K213825
Trade/Device Name: Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: Class II Product Code: CAW Dated: March 27, 2023 Received: March 28, 2023
Dear Randy Jiang:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ting Song -S
For
James J. Lee, Ph.D. Director, Division of Sleep Disordered Breathing, Respiratory and Anesthesia Office of Health Technologies 1, Ophthalmic, Anesthesia, Respiratory, ENT & Dental Devices Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K213825
Device Name
Oxygen Concentrator models 8F-3A&8F-5A
Indications for Use (Describe)
This oxygen concentrator is intended for using as an oxygen supplement device in the professional healthcare facility and home healthcare environment. It provides high concentration of oxygen to persons requiring oxygen therapy. This device is to be used as an oxygen supplement and is NOT considered life-supporting or life-sustaining.
Type of Use (Select one or both, as applicable)
| ❌ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
K213825
1. Submission Sponsor
Jiangsu Yuyue Medical Equipment& Supply Co., Ltd Yunyang Industrial Park Danyang Jiangsu China Wei Yan, RD/RA Email: weiyan@yuyue.com.cn Phone number: 025-85582701-6225
2. Submission Correspondent
Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX78746 Office Phone:(512) 327-9997 Contact: Randy Jiang Title: Senior Technical Consultant
3. Date Prepared
April 24, 2023
4. Device Identification
| Trade/Proprietary Name: | Oxygen Concentrator models 8F-3A/8F-5A |
|---|---|
| Common/Usual Name: | Portable oxygen generator |
| Classification Name: | Portable oxygen generator |
| Regulation Number: | 21 CFR 868.5440 |
| Product Code: | CAW |
| Class: | II |
| Classification Panel: | Anesthesiology |
5. Legally Marketed Predicate Device
| Predicate Device: | |
|---|---|
| Trade/Proprietary Name: | L4 Oxygen Concentrator (EverFlo) |
| Common/Usual Name: | Portable oxygen generator |
4
| Classification Name: | Portable oxygen generator |
|---|---|
| Regulation Number: | 21 CFR 868.5440 |
| Product Code: | CAW |
| Class: | II |
| Classification Panel: | Anesthesiology |
| 510(k) Number: | K061261 |
| Manufacturer: | RESPIRONICS, INC. |
6. Indication for Use Statement
This oxygen concentrator is intended for using as an oxygen supplement device in the professional healthcare facility and home healthcare environment. It provides high concentration of oxygen to persons requiring oxygen therapy. This device is to be used as an oxygen supplement and is NOT considered lifesupporting or life-sustaining.
7. Device Description
The Yuyue Oxygen Concentrator models 8F-3A/8F-5A is a portable concentrator which could utilize a molecular sieve and pressure swing adsorption to produce the oxygen. The device could separate nitrogen by absorbing through the molecular sieve when the room air enters the device, and allows the enriched oxygen to be collected. The subject device is intended use for adult population.
The subject device contains primary electrical components including main unit, compressor, fan, flowmeter and circuit breaker, the software is moderate level according to FDA software guideline.
The patient contacting components are listed in following table, the biocompatibility test and gas pathway biocompatibility test was conducted to subject device against ISO 10993-10, ISO 18562-1, ISO 18562-2, ISO 18562-3.
5
| Name of Component | Type and Duration of Contact | Direct or Indirect
Contact |
|-------------------|--------------------------------------------------------|-------------------------------|
| Compressor | External communicating Device,
Long term, > 30 days | Indirect (gas pathway) |
| Combination valve | External communicating Device,
Long term, > 30 days | Indirect (gas pathway) |
| Silicone tube | External communicating Device,
Long term, > 30 days | Indirect (gas pathway) |
| Sieve bed | External communicating Device,
Long term, > 30 days | Indirect (gas pathway) |
| Oxygen tank | External communicating Device,
Long term, > 30 days | Indirect (gas pathway) |
8. Substantial Equivalence Discussion
The following table compares the Oxygen Concentrator to the predicate device with respect to indications for use, and technological characteristics, forming the basis for the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate device.
6
| Characteristics | Subject Device | Predicate Device K061261 | Comparison |
|---|---|---|---|
| Device name | oxygen concentrator models | ||
| 8F-3A/8F-5A | L4 Oxygen | ||
| Concentrator(EverFlo) | N/A | ||
| Classification | 2 | 2 | Same |
| Product Code | CAW | CAW | Same |
| Regulation | |||
| Number | 21 CFR 868.5440 | 21 CFR 868.5440 | Same |
| Intended Use | Provide supplemental oxygen | Provide supplemental oxygen | Same |
| Indication for | |||
| Use | This oxygen concentrator is | ||
| intended for using as an | |||
| oxygen supplement device in | |||
| the professional healthcare | |||
| facility and home healthcare | |||
| environment. It provides high | |||
| concentration of oxygen to | |||
| persons requiring oxygen | |||
| therapy. This device is to be | |||
| used as an oxygen supplement | |||
| and is NOT considered life- | |||
| supporting or life-sustaining. | The Respironics L4 Oxygen | ||
| Concentrator is intended to | |||
| provide supplemental oxygen | |||
| to persons requiring oxygen | |||
| therapy. The device is not | |||
| intended to be life supporting | |||
| or life sustaining. | |||
| The Respironics L4 Oxygen | |||
| Concentrator is intended for | |||
| use in the home or | |||
| hospital/institutional | |||
| environment. | Equivalent | ||
| Environment of | |||
| Use | professional healthcare facility | ||
| and home healthcare | |||
| environment. | home or hospital / | ||
| institutional environment. | Same | ||
| IP classification | IP21 | IP21 | Same |
| Patient | |||
| Interface | nasal oxygen cannula | nasal oxygen cannula | Same |
| Technology | Pressure Swing Adsorption | ||
| with molecular sieve | Pressure Swing Adsorption | ||
| with molecular sieve | Same | ||
| Oxygen | |||
| Concentration | (8F-3A): ≥90%; | ||
| (8F-5A): 95.5%-87% | 90-96% from 1 to 5 LPM | Equivalent | |
| Characteristics | Subject Device | Predicate Device K061261 | Comparison |
| Flow Rate | (8F-3A): 1-3 LPM; | ||
| (8F-5A): 1-5 LPM | from 1 to 5 LPM | Equivalent | |
| Output | |||
| Pressure | ≤70 kPa | 44.8 kPa (6.5PSIG) | Equivalent |
| User Interface | Buttons | Buttons | Same |
| LCD Display and Indicator light | LCD Display and Indicator light | ||
| Alarms | E 1 low pressure | System malfunction | Similar |
| E 2 high pressure | |||
| E 3 low current | |||
| E 4 high current | |||
| Low oxygen concentration | |||
| alarm | Low oxygen condition (opi unit only) | ||
| E 5 high temperature inside | |||
| the device | N/A | ||
| N/A | high oxygen flow condition | ||
| LL low flowrate | Low oxygen flow condition | ||
| Power interrupt alarm | Power interrupt alarm | ||
| Complies with | |||
| ISO 10993-1 | Yes | Yes | Same |
| Complies with | |||
| ISO 80601-2-69 | Yes | Yes | Same |
| Complies with | |||
| ASTM D4169-16 | Yes | Yes | Same |
| Complies with | |||
| ES 60601-1 | |||
| Electrical Safety | Yes | Yes | Same |
| Characteristics | Subject Device | Predicate Device K061261 | Comparison |
| Complies with | |||
| IEC 60601-1-2 | |||
| EMC Safety | Yes | Yes | Same |
Table 5A – Comparison of Characteristics
7
8
Comparison Discussion Summary:
The Oxygen Concentrator models 8F-3A&8F-5A has the same intended use and the same or similar technological characteristics and functionality as the predicate, the slight differences do not raise new questions of safety and effectiveness as compared to the predicate device.
9. Non-Clinical Performance Data
To demonstrate safety and effectiveness of Oxygen Concentrator models 8F-3A/8F-5A and to show substantial equivalence to the original device, Jiangsu Yuyue Medical Equipment& Supply Co., Ltd completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. The device passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device:
- Electrical safety testing per ES 60601-1
- Electromagnetic Disturbance (EMD) testing per IEC 60601-1-2
- . General requirements, tests and guidance for alarm systems per IEC 60601-1-8
- General requirements for basic safety and essential performance in the home healthcare environment per IEC 60601-1-11
- Particular requirements for the basic safety and essential performance of oxygen concentrator equipment per ISO 80601-2-69
- Biocompatibility in gas pathway per ISO 18562-1, ISO 18562-2, ISO 10993-5, ISO 10993-10.
- Software verification and validation per IEC 62304/FDA Guidance – results /conclusion
- . Shelf Life Testing - Supports the claimed shelf life
- . Transportation Testing per ASTM D4169 – Demonstrates package integrity maintained
- . Altitude limit 2000m device performance test
- Accessory compatibility test including connect security, accessory performance
10. Statement of Substantial Equivalence
The Oxygen Concentrator models 8F-3A/8F-5A has the same intended use as the predicate device, and similar technological characteristics. The differences in technological characteristics do not raise new or different questions of safety and effectiveness. Performance testing has demonstrated the Oxygen Concentrator models 8F-3A/8F-5A is as safe and effective as the predicate device. Therefore, the Oxygen Concentrator models 8F-3A/8F-5A is substantially equivalent to the predicate device.