(254 days)
Not Found
No
The summary describes a standard oxygen concentrator using physical processes (molecular sieve, pressure swing adsorption) and does not mention any AI/ML components or related data processing/analysis.
Yes
The device is described as providing "supplemental oxygen to patients who require supplemental O2," which is a treatment for a medical condition. It also explicitly states that it is not intended to sustain or support life, implying a therapeutic rather than life-sustaining role.
No
Explanation: The device is an Oxygen Concentrator that provides supplemental oxygen by separating nitrogen from room air. Its purpose is therapeutic (providing oxygen), not diagnostic (identifying or measuring a medical condition).
No
The device description clearly outlines a physical hardware device (Oxygen Concentrator) that utilizes a molecular sieve and pressure swing adsorption to produce oxygen. While it contains software, 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 who require supplemental O2". This is a therapeutic purpose, delivering a substance to the body.
- Device Description: The description details how the device physically separates oxygen from air and delivers it to the patient. This is a mechanical/physical process, not a diagnostic test performed on a sample from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing information for diagnosis, monitoring, or screening.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This oxygen concentrator does not fit that definition.
N/A
Intended Use / Indications for Use
The Oxygen Concentrator provide supplemental oxygen to patients who require supplemental O2, 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 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 device could provide approximately 90~96% of oxygen to patients on a continuous flow basis at a rate of 1L/min to 10L/min. The nasal cannula are not sold with the device, users need to purchase the accessories by themselves that are legally marketed. The products have not undergone biocompatibility assessment of condensate precipitates according to ISO18562-4, and it is not recommended to use humidification bottles.
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
Adult, above 18 years old
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)
Non-Clinical Tests Performed:
- Electrical safety, and electromagnetic compatibility Test: The device was shown to comply with IEC 60601-1-2:2020 and IEC TR 60601-4-2:2016 for electromagnetic compatibility, IEC 60601-1:2020, IEC 60601-1-8:2012, IEC 60601-1-11:2020 and ISO 80601-2-69:2020 for electrical safety.
- Biocompatibility Test: The device was shown to comply with ISO 18562-2 and ISO 18562-3.
- Software verification and validation: Documentation was provided as recommended by FDA'S Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level concern.
- Usability validation: The result of the usability demonstrated all the users in testing did not show any critical errors and represented the performance of using can be smoother by extra practices without specific usability problems. The device has been found to be reasonably safe and effective for the intended users, uses and uses environments.
- Cybersecurity: Not needed as the device has no external interfaces.
Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 contains 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.
December 6, 2024
Foshan Care Medical Technology Co., Ltd. % Cassie Lee Official Correspondent Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road Huangpu District Guangzhou, Guangdong 510530 China
Re: K240840
Trade/Device Name: Oxygen Concentrator (ZY-10AB/115) Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: Class II Product Code: CAW Dated: November 4, 2024 Received: November 4, 2024
Dear Cassie Lee:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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,
FDA
Linta Farooq -S 2024.12.06 11:40:07 -05'00'
For
Bradley Quinn Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K240840
Device Name Oxygen Concentrator (ZY-10AB/115)
Indications for Use (Describe)
The Oxygen Concentrator provide supplemental oxygen to patients who require supplemental 02, 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) |
|---|---|
| ----------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------- |
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510(k) Summary of K240840
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
Company Name: FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD. Establishment Registration Number: 3008220943 Address: #2 Haitang Rd, National Ecological Industrial Park Danzao, Town, Nanhai District Foshan Guangdong, China Contact Person (including title): Leona Zhou (Regulatory Affair Manager) Tel: 086 18666388285 Fax: / Post code: 528000 E-mail: zhouliming@caremedical.com.cn
Application Correspondent:
Contact Person: Ms. Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minije Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel : +86 20 8266 2446 Email : 382198657@gg.com
Subject Device Information: 2.
Type of 510(k): Traditional Common Name: Portable Oxygen Concentrator Classification Name: Generator, Oxygen, Portable Trade Name: Oxygen Concentrator Model Name: ZY-10AB/115 Review Panel: Anesthesiology Product Code: CAW Regulation Number: 868.5440 Requlatory Class: II
Predicate Device Information 3.
Sponsor: Zhengzhou Olive Electronic Technology Co., Ltd. Trade Name: Oxygen concentrator Model: OLV-5S, OLV-10S Common Name: Portable Oxygen Concentrator Classification Name: Generator, Oxygen, Portable 510(K) Number: K222920 Review Panel: Anesthesiology Product Code: CAW Regulation Number: 868.5440 Requlation Class: .
Device Description 4.
The Oxygen Concentrator 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 device could provide approximately 90~96% of oxygen to patients on a continuous flow basis at a rate of 1L/min to 10L/min. The nasal cannula are not sold with the device, users need to purchase the accessories by themselves that are legally marketed. The products have not undergone biocompatibility
5
assessment of condensate precipitates according to ISO18562-4, and it is not recommended to use humidification bottles.
The maximum altitude the subject device can operate without degradation of concentration is 2000m.
5. Intended Use / Indications for Use
The Oxygen Concentrator provide supplemental oxygen to patients who require supplemental O2, 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. Intended patient population
- Population: adult
- Age: above 18 years old •
- . Health status: adult patients requiring supplemental oxygen.
| 7. Comparison to predicate devices
Elements of
| Comparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Company | FOSHAN CARE MEDICAL | ||
| TECHNOLOGY CO., LTD. | Zhengzhou Olive Electronic | ||
| Technology Co., Ltd. | -- | ||
| Trade Name | Oxygen Concentrator | Oxygen Concentrator | -- |
| Model | ZY-10AB/115 | OLV-5S, OLV-10S | -- |
| Classification Name | Generator, Oxygen, Portable | Generator, Oxygen, Portable | Same |
| 510(k) Number | K240840 | K222920 | -- |
| Product Code | CAW | CAW | Same |
| Intended Use / | |||
| Indications for Use | The Oxygen Concentrator | ||
| provide supplemental oxygen to | |||
| patients who require | |||
| supplemental O2, 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 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. | Same | ||
| Work principle | Pressure swing adsorption | ||
| principle, filtering by molecular | |||
| sieve | Pressure swing adsorption | ||
| principle, filtering by molecular | |||
| sieve | Same | ||
| Working mode | Continuous | Continuous | Same |
| Environments of Use | Home or health care facility | Home or health care facility | Same |
| Intended patient | |||
| population | Population: adult | ||
| Age: above 18 years old | |||
| Health status: adult patients | |||
| requiring supplemental | |||
| oxygen. | Patients with respiratory | ||
| disorders | Similar | ||
| Note 6 | |||
| Performance Comparison | |||
| Power supply | AC 100-120V, 60Hz | AC 120V±11V, 60Hz±1Hz | Same |
| Max.Input power | 550VA | OLV-5S: 500VA | |
| OLV-10S: 800VA | Similar | ||
| Note 1 | |||
| Elements of | |||
| Comparison | Subject Device | Predicate Device | Verdict |
| Oxygen | |||
| concentration | 93% ± 3% | 93% ± 3% | Same |
| Oxygen flow | 1-10L/min | OLV-5S: 0-5L/min | |
| OLV-10S: 0-10L/min | Similar | ||
| Note 2 | |||
| Outlet pressure | 40kPa-80kPa | 20kPa-60kPa | Similar |
| Note 2 | |||
| Noise | ≤60dB (A) under max. flowrate | ≤70dB (A) under max. flowrate | Similar |
| Note 1 | |||
| Electrical | |||
| classification | Class II Type BF | Class II Type B | Similar |
| Note 1 | |||
| Alarm | Low Oxygen purity; | ||
| Low & high pressure; | |||
| Power loss alarm; | |||
| Oxygen Sensor failure; | |||
| Flow rate less than 0.4L/Min; | |||
| Display Circuit Board failure | Low Oxygen purity; | ||
| Low & high pressure; | |||
| Overheating; | |||
| Compressor failure; | |||
| Obstruction of gas pathway; | |||
| Pressure failure | Different | ||
| Note 3 | |||
| Oxygen concentration | |||
| warning |