(297 days)
Not Found
No
The description focuses on the physical process of oxygen concentration using pressure swing adsorption and does not mention any AI or ML components.
Yes
The device is described as providing "supplemental oxygen to patients with respiratory disorders," which indicates a therapeutic purpose.
No
This device is an oxygen concentrator, which provides supplemental oxygen to patients. Its function is to generate and supply oxygen, not to diagnose medical conditions.
No
The device description clearly outlines a physical oxygen concentrator that uses mechanical and electrical components (compressor, cooler, absorption tower, valves, flow meter, humidifier) to produce oxygen. It is not solely software.
Based on the provided information, 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 physical process of separating gases from air to produce oxygen for breathing. It does not involve analyzing biological samples (like blood, urine, or tissue) to diagnose a condition.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Providing information for diagnosis, monitoring, or prognosis of a disease.
- Using reagents or assays.
The device is clearly described as a medical device used for providing respiratory support, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Oxygen concentrator provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve, it can be used in the home or health care facility. It is not intended to sustain or support life.
Product codes
CAW
Device Description
The oxygen concentrator adopts pressure swing adsorption principle, which can separate oxygen, nitrogen and other gas from the air, at constant temperature. As soon as power is connected, the air is taken in and compressed by oilless air compressor through filtering, then the compressed air goes through the cooler and it is cooled. After that, the air is taken into absorption tower by control valve and the oxygen can be separated in the absorption tower. At the same time, the high purity oxygen is collected into the oxygen tank, and it goes through the flow meter and humidifier, finally the oxygen that meets medical standards can be supplied. Oxygen is generated by pure physical method.
The maximum altitude the subject device can operate without degradation of concentration is 2000m.
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 health care facility
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 device has been tested and verified in various phases, internal testing, verification and validation as well as external testing and validation. The design was verified throughout the design process. Risk analysis was done, appropriate measures were implemented and their effectiveness verified. External test house was used to confirm compliance to EMC requirements and standards for electrical safety. The testing confirms the Oxygen concentrator (OLV-5S, OLV-10S) meets the ISO 80601-2-69 standards for Oxygen Concentrator devices. Testing demonstrates that the product is in compliance to: IEC 60601-1 Medical electrical equipment-Part 1: General requirements for basic safety, and essential performance. IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests. The oxygen flow rate and purity at the operating pressure was tested and verified in the Performance Bench Testing section of this submission, the instruction manual and in accordance with: ISO 80601-2-69 Medical Electrical Equipment, Part 2-69; IEC 60601-1 Safety Requirements (Medical Electrical Equipment Part 1: General Requirements); IEC 60601-1-2 EMC (Electro Magnetic Compatibility Testing); IEC 62304 Medical Device Software-Software Life-Cycle Processes, Class B. Moderate Level of Concern, as per FDA software guidance; ISO 10993-1 Biological Evaluation of Medical Devices - Cytotoxicity - Sensitization - Irritation; ISO 18562-1 Biological Evaluation of Breathing Gas pathway -Emission of particle matter -Volatile organic compounds (VOCs); Compliance with USP 93% +/-3%.
No clinical study implemented for the oxygen concentrator.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Oxygen concentration: 93% ± 3% (OLV-5S, OLV-10S)
Oxygen flow: 0-5L/min (OLV-5S), 0-10L/min (OLV-10S)
Noise: ≤70dB (A) under max. flowrate
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 20, 2023
Zhengzhou Olive Electronic Technology Co., Ltd. % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. RM. 1801, No. 161, East Lujiazui Rd., Pudong Shanghai, Shanghai 200120 China
Re: K222920
Trade/Device Name: Oxygen concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: Class II Product Code: CAW Dated: June 16, 2023 Received: June 16, 2023
Dear Boyle Wang:
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.
James J. Lee -S
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
Enclosure
2
Indications for Use
510(k) Number (if known) K222920
Device Name Oxygen concentrator
Indications for Use (Describe)
The Oxygen concentrator provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve, it can be used in the home or health care facility. It is not intended to sustain or support life.
| 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
510(k) number: K222920
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
1.0 Submitter's information
Name: Zhengzhou Olive Electronic Technology Co., Ltd. Address: 5th Floor, Block D, Building 18, Henan International University Science Park (East District) 450001 Zhengzhou, Henan, PEOPLE'S REPUBLIC OF CHINA Contact: Ms. Yunping Qu Phone Number: +86-371-86097307 E-mail: selina@zzolive.com Date of Preparation: Sep.22, 2022
Prior submissions
This is the first submission, there is no prior submission.
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM. 1801, No. 161, East Lujiazui Rd., Pudong, Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device information
| Trade name: | Oxygen concentrator |
|---|---|
| Common name: | Oxygen concentrator |
| Regulation name: | Oxygen concentrator, Portable |
| Model(s): | OLV-5S, OLV-10S. |
3.0 Classification
Production code: CAW Regulation number: 21 CFR 868.5440 Classification: Class II Anesthesiology Panel:
4.0 Predicate device information
Manufacturer: AirSep Corporation
4
Device: Deployable Oxygen Generator System - Small (DOGS-S) 510(k) number: K150930
5.0 Indication for Use Statement
The Oxygen concentrator provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve, it can be used in the home or health care facility. It is not intended to sustain or support life.
6.0 Device description
The oxygen concentrator adopts pressure swing adsorption principle, which can separate oxygen, nitrogen and other gas from the air, at constant temperature. As soon as power is connected, the air is taken in and compressed by oilless air compressor through filtering, then the compressed air goes through the cooler and it is cooled. After that, the air is taken into absorption tower by control valve and the oxygen can be separated in the absorption tower. At the same time, the high purity oxygen is collected into the oxygen tank, and it goes through the flow meter and humidifier, finally the oxygen that meets medical standards can be supplied. Oxygen is generated by pure physical method.
The maximum altitude the subject device can operate without degradation of concentration is 2000m.
7.0 Non-Clinical Test Conclusion
The device has been tested and verified in various phases, internal testing, verification and validation as well as external testing and validation. The design was verified throughout the design process. Risk analysis was done, appropriate measures were implemented and their effectiveness verified. External test house was used to confirm compliance to EMC requirements and standards for electrical safety.
The testing confirms the Oxygen concentrator (OLV-5S, OLV-10S) meets the ISO 80601-2-69 standards for Oxygen Concentrator devices. Testing demonstrates that the product is in compliance to:
IEC 60601-1 Medical electrical equipment-Part 1: General requirements for basic safety, and essential performance.
IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
The oxygen flow rate and purity at the operating pressure was tested and verified in the Performance Bench Testing section of this submission, the instruction manual and in accordance with:
| ISO 80601-2-69 | Medical Electrical Equipment, Part 2-69 |
|---|---|
| IEC 60601-1 | Safety Requirements (Medical Electrical Equipment Part 1: |
| General Requirements) |
5
| IEC 60601-1-2 | EMC (Electro Magnetic Compatibility Testing) |
|---|---|
| IEC 62304 | Medical Device Software-Software Life-Cycle Processes, Class |
| B. | |
| Moderate Level of Concern, as per FDA software guidance | |
| ISO 10993-1 | Biological Evaluation of Medical Devices |
| - Cytotoxicity | |
| - Sensitization | |
| - Irritation | |
| ISO 18562-1 | Biological Evaluation of Breathing Gas pathway |
| -Emission of particle matter | |
| -Volatile organic compounds (VOCs) | |
| Compliance with | USP 93% +/-3% |
The test platform ensures compliance to recognized consensus standards and therefore does not raise new questions of safety and effectiveness.
8.0 _Clinical Test Conclusion
No clinical study implemented for the oxygen concentrator.
9.0 Technological Characteristic Comparison Table
| Item | Proposed device | Predicated device | Remark |
|---|---|---|---|
| Product Code | CAW | CAW | Same |
| Regulation No. | 21 CFR 868.5440 | 21 CFR 868.5440 | Same |
| Class | II | II | Same |
| Product name | Oxygen concentrator | Deployable Oxygen Generator System - Small (DOGS-S) | - |
| Common Name | Oxygen concentrator | Oxygen concentrator | Same |
| Classification Name | Oxygen concentrator, Portable | Oxygen concentrator, Portable | Same |
| 510(k) No. | - | K150930 | - |
| Models | OLV-5S, OLV-10S | - | - |
| Intended Use | The Oxygen concentrator provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve, it can be used in the home or health care facility. It is not intended to sustain or support life. | The Deployable Oxygen Generator System – Small (DOGS-S) is intended for the administration of supplemental oxygen. This device is not intended for life support nor does it provide any patient monitoring capabilities. The system will be operated by trained personnel | Same |
| Work principle | Pressure swing adsorption | Pressure swing adsorption | Same |
Table 3- General Comparison
6
| | principle, filtering by molecular
sieve | principle, filtering by molecular
sieve | |
|--------------|--------------------------------------------|--------------------------------------------|------|
| Working mode | Continuous | Continuous | Same |
Table 4- Performance Comparison
| Item | Proposed Device | Predicate Device | Remark | |
|---|---|---|---|---|
| Models | OLV-5S | OLV-10S | Jay-5 | - |
| Power supply | AC 120V±11V, 60Hz±1Hz | AC 100V/240, 50/60Hz | * Gap 1 | |
| Max.Input power | 500VA | 800VA | 550W | * Gap 2 |
| Oxygen | ||||
| concentration | 93% ± 3% | 93% ± 3% | Same | |
| Oxygen flow | 0-5L/min | 0- 10L/min | 0.5~15L/min | * Gap 3 |
| Outlet pressure | 20kPa-60kPa | 10psig (68kpa) | * Gap 4 | |
| Noise | ≤70dB (A) under max. flowrate | ≤70dB (A) | Same | |
| Electrical | ||||
| classification | Class II Type B | Class II Type B | Same | |
| Alarm | Low Oxygen purity; | |||
| Low & high pressure; | ||||
| Overheating; | ||||
| Compressor failure; | ||||
| Obstruction of gas pathway; | ||||
| Pressure failure; | Low Oxygen purity | |||
| O2 Flow High or Low | ||||
| Low power indicator (Battery) | ||||
| Unit malfunction | * Gap 5 | |||
| Oxygen | ||||
| concentration | ||||
| warning |