(171 days)
No
The description focuses on standard oxygen concentration technology (pressure swing adsorption) and basic respiratory rate detection for pulse mode, with no mention of AI/ML terms or capabilities.
Yes
The device is intended to provide supplemental low flow oxygen, which is a therapeutic intervention for individuals who require additional oxygen.
No
The device is an oxygen concentrator intended to provide supplemental low flow oxygen, not to diagnose a medical condition. The description explicitly states it does not provide any patient monitoring capabilities.
No
The device description clearly outlines a hardware device (Portable Oxygen Concentrator) that uses physical principles (molecular sieve pressure swing adsorption) to produce oxygen. While it includes software (Software Verification and Validation Testing is mentioned), it is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide supplemental low flow oxygen." This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details how the device generates oxygen and delivers it to the user via a nasal cannula. This is a medical device for direct patient use, not for analyzing biological samples.
- Lack of IVD Characteristics: 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 samples
- Providing information for diagnosis, monitoring, or screening of diseases
The device is clearly a medical device intended for respiratory support.
N/A
Intended Use / Indications for Use
The Portable Oxygen Concentrator P2-TOC is intended to provide supplemental low flow oxygen. The device is not intended for life support, nor does it provide any patient monitoring capabilities. This device is for adults only.
Product codes
CAW
Device Description
The Portable Oxygen Concentrator P2-TOC is a device that uses the principle of molecular sieve pressure swing adsorption to increase oxygen concentration by adsorption of nitrogen and other gas components. The device needs to be used with a nasal oxygen cannula, which can provide oxygen supplementation to the user.
The Portable Oxygen Concentrator P2-TOC has two oxygen supply modes, namely continuous oxygen supply mode and pulse oxygen supply mode. Hereinafter referred to as "continuous mode" and "pulse mode".
In the continuous mode, the Portable Oxygen Concentrator P2-TOC can continuously deliver oxygen at a fixed flow rate. In the pulse mode, the Portable Oxygen Concentrator P2-TOC is able to deliver oxygen only when the user inhales by detecting the human respiratory rate.
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
Intended User / Care Setting
Home, outside the home
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 for Safety and effectiveness:
The recognized consensus standards for safety of medical electrical equipment: ANSI AAMI ES60601- 1, IEC 60601-1-11 for safety, IEC 60601-1-2 for electromagnetic compatibility, ISO 80601-2-69 and ISO 80601-2-67 for performance and IEC 62304 for software verification are complied.
Software Verification and Validation Testing:
Software verification and validation was performed for the subject device in accordance with Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff.
Biocompatibility Testing:
Biocompatibility testing were conducted on the subject device model P2-TOC. The system complies with the ISO 18562-2, ISO 18562-3, ISO 18562-1, ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-23 for biocompatibility safety.
Clinical Accuracy Testing:
There was no clinical testing performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K230702, K223379, K210371, K190304
Reference Device(s)
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).
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February 28, 2025
Qingdao Kingon Medical Science and Technology Co., Ltd Benrong Zhang Official Correspondent Room 301-302(B), No.15 Hancheng Road,Qingdao Free Trade Zone 24th Building, NO. 252 Yanhe Road, Huangdao Qingdao, Shandong 266510 China
Re: K242718
Trade/Device Name: Portable Oxygen Concentrator (P2-TOC) Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: Class II Product Code: CAW Dated: January 27, 2025 Received: January 27, 2025
Dear Benrong Zhang:
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.
1
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.
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 Rue"). 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.
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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical
2
devices/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,
Bradley Q. Quinn -S
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
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Indications for Use
510(k) Number (if known) K242718
Device Name Portable Oxygen Concentrator (P2-TOC)
Indications for Use (Describe)
The Portable Oxygen Concentrator P2-TOC is intended to provide supplemental low flow oxygen.
The device is not intended for life support, nor does it provide any patient monitoring capabilities. This device is for adults only.
| 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 as required by section 807.92(c)
I. Date of the summary prepared: 20/01/2025
II. Administrative Information
| Manufacturer
| information | Establishment registration number | 3014777423 |
|---|---|---|
| Owner/Operator Number | 10061814 | |
| Name | Qingdao Kingon Medical Science and | |
| Technology Co., Ltd. | ||
| Address | Room 301-302, No.15 Hancheng Road, | |
| Qingdao Free Trade Zone, | ||
| Shandong, China, 266555 | ||
| Contact Person | Name: Benrong Zhang | |
| Address: Room 301-302, No.15 | ||
| Hancheng Road, Qingdao Free | ||
| Trade Zone, Shandong, China, 266555 | ||
| TEL: +86-18565833539 | ||
| FAX: +86 532 58792324 | ||
| Email: augus@kingonmed.com |
III. Device Information
| Type of 510(k) | Traditional 510K |
|---|---|
| Prior submission | K240354 |
| Common Name | Generator, Oxygen, Portable |
| Classification name | Portable oxygen generator |
| Trade Name | Portable Oxygen Concentrator (Model:P2-TOC) |
| Review panel | Anesthesiology |
| Product code | CAW |
| Regulation Number | 868.5440 |
| Regulation Class | 2 |
IV. Predicate Device Information
| 1 Product name | Portable Oxygen Concentrator. Model:
P2-S4,P2-S3,P2-K4,P2-K3 |
|----------------|-----------------------------------------------------------------|
| 510(k) number | K230702 |
| 2 Product name | Portable Oxygen Concentrator. Model: P2-E7,P2-E |
5
| 510(k) number | K223379 | |
|---|---|---|
| 3 | Product name | Portable Oxygen Concentrator. Model: P2-E6 |
| 510(k) number | K210371 | |
| 4 | Product name | Kingon P2 Oxygen Concentrator |
| 510(k) number | K190304 |
V. Device description and Indications for Use
Device description: The Portable Oxygen Concentrator P2-TOC is a device that uses the principle of molecular sieve pressure swing adsorption to increase oxygen concentration by adsorption of nitrogen and other gas components. The device needs to be used with a nasal oxygen cannula, which can provide oxygen supplementation to the user.
The Portable Oxygen Concentrator P2-TOC has two oxygen supply modes, namely continuous oxygen supply mode and pulse oxygen supply mode. Hereinafter referred to as "continuous mode" and "pulse mode" .
In the continuous mode, the Portable Oxygen Concentrator P2-TOC can continuously deliver oxygen at a fixed flow rate. In the pulse mode, the Portable Oxygen Concentrator P2-TOC is able to deliver oxygen only when the user inhales by detecting the human respiratory rate.
Indications for Use: The Portable Oxygen Concentrator P2-TOC is intended to provide supplemental low flow oxygen.
The device is not intended for life support, nor does it provide any patient monitoring capabilities. This device is for adult only.
VI. Principle of operation
The Portable Oxygen Concentrator P2-TOC works by getting use of the molecular sieves character that the internal pressure of a sealed container containing of molecular sieve will increase when injecting air into it. At this time, the molecular sieve will absorb a lot of nitrogen in the air with the increasing of ambient pressure, while the oxygen in the air is still existed in gaseous form, then the oxygen are collected in the Air receiver. When the nitrogen absorption process in the container reaches a certain level, then exhaust of the vacuum container and nitrogen will be released from molecular sieve with the ambient pressure decreases. It will detect when the user begins to take a breath and then delivers a pulsed volume of oxygen during the inhalation period. The volume of the oxygen pulse is dependent on the setting value.
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VII. Comparison with predicate device
Model 1000 Portable Oxygen Concentrator and Model 4000 that manufactured by CAIRE was selected for comparison. See the following table for details of comparison:
| ID | Items | Predicate Device (K013931) | Reference Device (K120785) | Device to be submitted for 501K | Comparison |
|---|---|---|---|---|---|
| 1 | Device Name | Omni Portable Oxygen Concentrator | eQuinox Oxygen System | Portable Oxygen Concentrator | Similar |
| 2 | Model | Model 1000 | Model 4000 | P2-TOC | Different mode |
| names | |||||
| 3 | Indication for | ||||
| Use | The Omni portable oxygen concentrator | ||||
| is intended for the administration of | |||||
| supplemental oxygen. The device is not | |||||
| intended for life support nor does it | |||||
| provide any patient monitoring | |||||
| capabilities. | The eQuinox is intended for the | ||||
| administration of supplemental oxygen. The | |||||
| device is not intended for life support, nor | |||||
| does it provide any patient monitoring | |||||
| capabilities. | The Portable Oxygen Concentrator P2-TOC is | ||||
| intended to provide supplemental low flow | |||||
| oxygen.. | |||||
| The device is not intended for life support, nor | |||||
| does it provide any patient monitoring | |||||
| capabilities. | Similar | ||||
| (See below note | |||||
| ID_3) | |||||
| 4 | Environment of | ||||
| Use | Home, outside the home and institutions | Home, outside the home | Home, outside the home | Similar | |
| (See below note | |||||
| ID_4) | |||||
| 5 | Prescriptive | Yes | Yes | Yes | Same |
| 6 | Patient Interface | Nasal Cannula | Nasal Cannula | Nasal Cannula | Same |
| 7 | Technology | Pressure Swing Adsorption with | |||
| molecular sieve | Pressure Swing Adsorption with molecular | ||||
| sieve | Pressure Swing Adsorption with molecular | ||||
| sieve | Same | ||||
| 8 | Dimensions | 19.3 high x 12.3 wide x 7.1 deep | |||
| (inches) | |||||
| 49.0 height x 31.2 wide x 18.0 deep | 15.5 high x10.8 wide x 7.3 deep (inches) | 11.1 length x 6.7 width x15 height (inch) | |||
| 28.2 length x 17.1 width x 38.2 height (cm) | Different (See below | ||||
| note ID_8) | |||||
| (cm) | |||||
| 9 | Weight | 17.9 pounds (8.1 kg) with Power | |||
| Cartridge | 12lbs | 18.8 lbs / 8.5kg ( with battery) | Different (See below | ||
| note ID_9) | |||||
| 10 | Oxygen | ||||
| Concentration | 90% +/- 3% for all flow settings | 90%+3%/-3% at all settings | 90%-3%/+6% at all settings | Different (See below | |
| note | |||||
| ID_10) | |||||
| 11 | Equivalent Flow | ||||
| Rates | Continuous Flow Mode: 1.0-3.0 LPM | Continuous Flow Mode: 1.0-3.0 LPM | Continuous Flow Mode: 1.0-3.0 LPM | Different (See below | |
| note | |||||
| ID_11) | |||||
| Pulse Dose Mode: 16-96 ml Pulse | |||||
| Volumes | Pulse Dose Mode: 16-192 ml Pulse Volumes | Pulse Dose Mode: 5-133 ml Pulse Volumes | |||
| Breathing rate is 15 times a minute | |||||
| 6 to 25 breaths per minute average, | |||||
| sustainable | Breathing rate is 15 times a minute | Pulse Dose Mode: 5-200 ml Pulse Volumes | |||
| Breathing rate is 10 times a minute | |||||
| 12 | Filters | Air Inlet Filter | Air Inlet Filter | Air Inlet Filter | Same |
| 13 | User Interface | Buttons, LCD Display | Buttons, LCD Display | Buttons, LCD Display | Same |
| 14 | Power Supply | AC Power (100-240 VAC, 50-60 Hz) | AC Power (100VAC, 50-60 Hz) | AC Adaptor (Input: 100-240 VAC, 50-60 Hz) | Similar (See below |
| note | |||||
| ID_14) | |||||
| DC Power (12V nominal) | DC Power (12V nominal) | DC Adaptor (Input: 11-16 VDC Output: 19V) | |||
| Battery (Lithium Ion) | Battery (Lithium Ion) | Battery (Lithium Ion) | |||
| 15 | Software | Embedded | Embedded | Embedded | Same |
| 16 | Acoustic Noise | 48 dBA at 3.0 LPM in Continuous Flow | |||
| Mode |