Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on physical means of oxygen generation and standard electronic components, with no mention of AI/ML terms or functionalities.

Therapeutic

Yes
The device is intended to provide supplemental oxygen for respiratory use, which directly addresses a physiological need and is used to treat conditions requiring oxygen support.

Diagnostic

No

The device is described as an oxygen concentrator intended to provide supplemental oxygen, not to diagnose a medical condition.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components such as a compressor, battery, solenoid valve, molecular sieve, and circuit control system, indicating it is a physical device with integrated software, not a software-only medical device.

IVD (In Vitro Diagnostic)

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 in a home, institutional, or travel environment." This is a therapeutic purpose, providing a substance to the patient for treatment or support.
Device Description: The device description clearly states it's an "oxygen generator" that "release[s] oxygen for respiratory by means of physical means (a molecular sieve)." It delivers oxygen to the patient via a nasal cannula.
Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a physiological state, health, or disease. This device does not interact with or analyze any biological specimens.

The device is a medical device, specifically a therapeutic device for respiratory support, but it does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Portable Oxygen Concentrator (Model: P2-E7, P2-E) is intended to provide supplemental oxygen in a home, institutional, or travel environment.

Product codes

CAW

Device Description

Portable Oxygen Concentrator (Model: P2-E7, P2-E) is a portable oxygen generator that is intended to release oxygen for respiratory by means of physical means (a molecular sieve). It supplies a pulsed high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Portable Oxygen Concentrator is small, portable and may be used in home, institutional, or travel environment.

The portable oxygen concentrator consists of two parts: an oxygen concentrator and accessories. The oxygen concentrator is composed of compressor, battery, solenoid valve, molecular sieve, circuit control system, heat dissipation system, and a flow control device. Accessories include power adapters.

Model difference: The only different between model P2-E7 and P2-E is that P2-E7 has biggest output oxygen flow of 1.4L/min (at 7 gears) and P2-E has biggest output oxygen flow of 1.0L/min (at 5 gears).

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, institutional, or travel 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

There was no clinical testing performed.

Key Metrics

Not Found

Predicate Device(s)

K210371

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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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.

June 22, 2023

Qingdao Kingon Medical Science and Technology Co., Ltd. Zhang Benrong Technical Supervisor RM.1711, Building K, NO.101 Science Ave International Creative Valley Qingdao Free Trade Zone, Shandong 266555 China

Re: K223379

Trade/Device Name: Portable Oxygen Concentrator (Model: P2-E7, P2-E) Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: Class II Product Code: CAW Dated: May 24, 2023 Received: May 24, 2023

Dear Zhang Benrong:

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.

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

1

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 and Part 809); 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 medical devices and radiation-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 DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure

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Indications for Use

510(k) Number (if known) K223379

Device Name

Portable Oxygen Concentrator (Model: P2-E7, P2-E)

Indications for Use (Describe)

The Portable Oxygen Concentrator (Model: P2-E7, P2-E) is intended to provide supplemental oxygen in a home, institutional, or travel environment.

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)

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)

Date of the summary prepared: 10/30/2022 l.

Administrative Information ll.

| 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 HanchengRoad, Qingdao Free Trade Zone,
Shandong, China, 266555 |
| | Contact Person | Name: Benrong Zhang
Address: Room 301-302, No.15 HanchengRoad, Qingdao Free Trade Zone, Shandong, China, 266555
TEL: +86-18565833539
FAX: +86 532 58792324
Email: augus@kingonmed.com |
| Submission
Correspondent | Contact Person | Name: Tracy Nanan
Address: Room 301-302, No.15 HanchengRoad, Qingdao Free Trade Zone, Shandong, China, 266555
TEL: +86-18565833539
FAX: +86 532 58792324
Email: ptg2022ptg@163.com |

III. Device Information

Type of 510(k)	Special 510(k): Device Modification
Prior submission	No prior submission
Common Name	Generator, Oxygen, Portable
Classification name	Portable oxygen generator
Trade Name	Portable Oxygen Concentrator (Model: P2-E7, P2-E)
Review panel	Anesthesiology

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Product code	CAW
Regulation Number	868.5540
Regulation Class	2

IV. Predicate Device Information

Common Name	Generator, Oxygen, Portable
Classification name	Portable oxygen generator
Trade Name	Portable Oxygen Concentrator, model: P2-E6
Review panel	Anesthesiology
Product code	CAW
Regulation Number	868.5540
Regulation Class	2

V. Device description

Portable Oxygen Concentrator (Model: P2-E7, P2-E) is a portable oxygen generator that is intended to release oxygen for respiratory by means of physical means (a molecular sieve). It supplies a pulsed high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Portable Oxygen Concentrator is small, portable and may be used in home, institutional, or travel environment.

The portable oxygen concentrator consists of two parts: an oxygen concentrator and accessories. The oxygen concentrator is composed of compressor, battery, solenoid valve, molecular sieve, circuit control system, heat dissipation system, and a flow control device. Accessories include power adapters.

Model difference: The only different between model P2-E7 and P2-E is that P2-E7 has biggest output oxygen flow of 1.4L/min (at 7 gears) and P2-E has biggest output oxygen flow of 1.0L/min (at 5 gears).

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VI. Principle of operation

Both model P2-E7 and P2-E has the same principle of operation. The portable oxygen concentrator 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 increasing of ambient pressure, while the oxygen in the air is still existed in gaseous form, then the oxygen are collected through some pipelines. 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.

VII. Indications for Use

The Portable Oxygen Concentrator (Model: P2-E7, P2-E) is intended to provide supplemental oxygen in a home, institutional, or travel environment.

| ID | Comparison
Items | Subject device | Predicate device | Comparison |
|-----|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| 1. | 510K Number | / | K210371 | / |
| 2. | Manufacturer | Qingdao Kingon Medical Science and
Technology Co., Ltd. | Qingdao Kingon Medical Science and
Technology Co., Ltd. | Same |
| 3. | Device name | Portable Oxygen Concentrator | Portable Oxygen Concentrator | / |
| 4. | Model | P2-E7, P2-E | P2-E6 | / |
| 5. | Classification | 21CFR 868.5440 | 21CFR 868.5440 | Same |
| 6. | Product Code | CAW | CAW | Same |
| 7. | FDA Class | II | II | Same |
| 8. | Indications for
Use | The Portable Oxygen Concentrator
(Model: P2-E7, P2-E) is intended to
provide supplemental oxygen in a
home, institutional, or travel
environment. | The Portable Oxygen Concentrator,
model: P2-E6 is intended to provide
supplemental oxygen in a home,
institutional, or travel environment. | Same |
| 9. | Environment of
Use | Home, institutional, or travel
environment. | Home, institutional, or travel
environment. | Same |
| 10. | Design | table type | table type | Same |
| 11. | Prescriptive | Yes | Yes | Same |
| 12. | Patient
Population | Adult | Adult | Same |
| | | | | |
| 13. | Material of
Patient contact
components | Wiring cover: PC+ABS
Intake hood: PC+ABS
Nozzle fitting: Aluminum alloy
Button panel: PET
Main housing: PC+ABS | Wiring cover: PC+ABS
Intake hood: PC+ABS
Nozzle fitting: Aluminum alloy
Button panel: PET
Main housing: PC+ABS | Same |
| 14. | Duration and
type of contact | Type of contact: surface device;
Duration: permanent (> 30 d); | Type of contact: surface device;
Duration: permanent (> 30 d); | Same |
| 15. | Complete list of
all the
biocompatibility
tests performed | ISO 10993- 5 tested for Cytotoxicity;

ISO 10993-10 tested for Sensitization
and Irritation;

ISO 18562-2 tested for Particulate
matter;

ISO 18562-3 tested for Volatile
organic Compounds; | ISO 10993- 5 tested for Cytotoxicity;

ISO 10993-10 tested for Sensitization
and Irritation;

ISO 18562-2 tested for Particulate
matter;

VIII. Comparison with predicate device

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kıngon

7

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8

Image /page/8/Picture/0 description: The image shows the word "kingon" in a dark blue sans-serif font. The letters are all lowercase, and there is a small circle above the "o" in "kingon". The word is centered and takes up most of the frame. The background is white.

Note:

ID 22: The max setting of subject device P2-E7 is 7 and of subject device P2-E is 5 while the predicate device is 6, the extra setting 7 of P2-E7 introduce risks of increased output flow and increased Emission of particulate matter of gas pass way, those risks are mitigated by tests tested according to ISO 80601-2-69: 2014, ISO 80601-2-67: 2014 and ISO 18562-2: 2017, therefore the difference does not raise new questions of safety and effectiveness.
ID_29: The Maximum oxygen discharge pressure of subject device P2-E is different with predicate device P2-E6 (K210371), since the subject device has been tested against ISO 80601-2-69: 2014 with positive result, the difference of subject device with predicate device RS-00500 (K162433) do not raise new questions of safety and effectiveness.
ID 32: The Acoustic Noise of subject device P2-E7 is litter bigger than predicate device P2-E6 (K210371) and subject device P2-E is litter smaller than predicate device P2-E6 (K210371), since the subject device P2-E7 has been tested against ISO 80601-2-69: 2014 and ANSI AAMI ES60601-1 with positive results, the difference of subject device with predicate device P2-E6 (K210371) do not raise new questions of safety and effectiveness.

IX. Discussion of Non-Clinical Tests Performed for Safety and effectiveness are as

follows

The recognized consensus standards for safety of medical equipment: ANSI AAMI ES60601 -1, IEC 60601 - 1 - 1 for safety, IEC 60601 - 1 -2 for electromagnetic compatibility, ISO 80601 - 2 - 69: 2014 and ISO 80601-2-67: 2014 for performance and IEC 62304 for software verification are complied. See below table for details:

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kıngo'n

Standards	Standards Name
ANSI AAMI ES60601-
1:2005/(R)2012 and A1:2012	Medical Electrical Equipment - Part 1: General Requirements For
Basic Safety And Essential Performance
IEC 60601-1-2: 2014	Medical Electrical Equipment - Part 1-2: General Requirements For
Basic Safety And Essential Performance - Collateral Standard:
Electromagnetic Disturbances - Requirements And Tests
IEC 60601-1-11: 2015	Medical Electrical Equipment - Part 1-2: General Requirements For
Basic Safety And Essential Performance - Collateral Standard:
Electromagnetic Disturbances - Requirements And Tests
IEC 60601-1-8: 2006+ A1:2012	Medical electrical equipment - Part 1-8: General requirements for
basic safety and essential performance - Collateral Standard:
General requirements, tests and guidance for alarm systems in
medical electrical equipment and medical electrical systems
ISO 80601-2-69: 2014	Medical electrical equipment. Particular requirements for the basic
safety and essential performance of oxygen concentrator
equipment
ISO 80601-2-67: 2014	Medical electrical equipment. Particular requirements for basic
safety and essential performance of oxygen-conserving equipment
ISO 18562-2: 2017	Biocompatibility evaluation of breathing gas pathways in healthcare
applications - Part 3: Tests for emissions of volatile organic
compounds
ISO 18562-3: 2017	Biocompatibility evaluation of breathing gas pathways in healthcare
applications. Tests for emissions of volatile organic compounds
(VOCs)
IEC 62133: 2012	Secondary cells and batteries containing alkaline or other non-acid
electrolytes - Safety requirements for portable sealed secondary
cells, and for batteries made from them, for use in portable
applications
ISO 10993-5:2009	Biological evaluation of medical devices - Part 5: Tests for in vitro
cytotoxicity
ISO 10993-10:2010	Biological evaluation of medical devices - Part 10: Tests for irritation
and skin sensitization
IEC 62304:2006+A1:2015	Medical device software - Software life cycle processes

● Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the subject device P2-E6. The system complies with the AAMI ANSI ES60601-1, IEC 60601-1, IEC 60601-1-8, IEC 60601-1-11, ISO 80601-2-67, and ISO 80601-2-69 standards for electrical safety and the IEC 60601-1-2 standard for EMC.

● 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, May 2005.

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Software Description:

The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software could result in Minor Injury, either to a user of the device. The software of the system, on the whole, is accountable for the system scheduler of the device, including fulfilling alarm task, beep task, display task, monitor task, startup task, breath task, as well as dealing with USART1-interrupt, USART2-interrupt, WDT-interrupt, and controlling the sensor module.

A Programming language
STMicroelectronics and Texas Instruments.
Hardware platform
a) Applicable Device Name: Portable Oxygen Concentrator
b) Applicable model: P2-E7, P2-E
Micro-controller used: STM32F103RCT6, STM32F103C8T6, MSP430G2755 C)
ROM Size: STM32F103RCT6 256K, STM32F103C8T6 64K, MSP430G2755 32K ರು)
RAM Size: STM32F103RCT6 48K, STM32F103C8T6 20K, MSP430G2755 -4K e)
Software Release Version Number: Keil uVision5 V5.25.20, IRA for 430 V7.12.1 f)

X. Discussion of Clinical Accuracy Testing Performed

There was no clinical testing performed.

XI. Conclusions

The Portable Oxygen Concentrator (Model: P2-E7, P2-E) have the same intended use and similar characteristics as the cleared predicate device Portable Oxygen Concentrator, model: P2-E6. Moreover, bench testing contained in this submission supplied demonstrate that the differences existed between Portable Oxygen Concentrator (Model: P2-E7, P2-E) and Portable Oxygen Concentrator, model: P2-E6 (K210371) do not raise any new questions of safety or effectiveness.

The non-clinical tests support the safety of the device and software verification and validation demonstrate that the Portable Oxygen Concentrator (Model: P2-E7, P2-E) performs as intended in the specified use conditions are same with predicate device. The performance tests demonstrate that the Portable Oxygen Concentrator (Model: P2-E7, P2-E) performs comparably to the predicate device that is currently marketed for the same intended use. Thus, Portable Oxygen Concentrator (Model: P2-E7, P2-E) is Substantially Equivalent (SE) to the predicate device.