Kingon P2 Oxygen Concentrator

K190304 · Qingdao Kingon Medical Science and Technology Co. · CAW · Feb 29, 2020 · Anesthesiology

Device Facts

• Record ID: K190304
• Device Name: Kingon P2 Oxygen Concentrator
• Applicant: Qingdao Kingon Medical Science and Technology Co.
• Product Code: CAW · Anesthesiology
• Decision Date: Feb 29, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Kingon P2 is for prescription use by patients requiring high concentrations of oxygen on a supplemental basis. It is small, portable, and is capable of continuous use in the home, institutional, and travel / mobile environments.

Device Story

Kingon P2 is a portable oxygen concentrator for patients requiring supplemental oxygen. Device uses molecular sieve and pressure swing adsorption to extract oxygen from ambient air; nitrogen is adsorbed while oxygen is collected and delivered via nasal cannula. Device features pressure-sensing technology to trigger oxygen pulse delivery upon patient inhalation; regenerates oxygen pulse between breaths. Operates in home, institutional, and mobile environments; intended for prescription use. Output is pulse of oxygen (87-96% purity). Healthcare providers use device to provide supplemental oxygen therapy, potentially improving patient mobility and oxygenation. Device includes carry bag, AC power supply, and battery.

Clinical Evidence

Bench testing only. Device passed testing for electrical safety (IEC 60601-1, IEC 60601-1-11), oxygen concentrator performance (ISO 80601-2-69), oxygen-conserving equipment (ISO 80601-2-67), alarm systems (IEC 60601-1-8), EMC (IEC 60601-1-2, FCC Part 15), and battery safety (IEC 62133). Biocompatibility testing (ISO 10993) and gas pathway emissions testing (ISO 18562) also passed.

Technological Characteristics

Portable oxygen concentrator using pressure swing adsorption with molecular sieve. Dimensions: 6.30"H x 3.35"W x 8.70"L; Weight: 4.34 lbs. Power: 100-240 VAC, 50/60 Hz or 19 VDC. Connectivity: Standalone. Standards: IEC 60601-1, IEC 60601-1-11, ISO 80601-2-69, ISO 80601-2-67, IEC 60601-1-8, ISO 10993, ISO 18562.

Indications for Use

Indicated for adult patients requiring supplemental high-concentration oxygen. Suitable for home, institutional, and mobile/travel use.

Regulatory Classification

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).

Predicate Devices

• SimplyGo Portable Oxygen Generator (K111885)

Submission Summary (Full Text)

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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.

Qingdao Kingon Medical Science and Technology Co. % Roman Huang General Manager Elliot Medical Solutions Parkland Drive Cleveland Heights, Ohio 44106

Re: K190304

Trade/Device Name: Kingon Portable Oxygen Concentrator P2 Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: Class II Product Code: CAW Dated: January 15, 2020 Received: January 24, 2020

### Dear Roman Huang:

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 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

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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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia 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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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

..............................................................................................................................................................................

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510(k) Number (if known)

#### K190304

#### Device Name

Kingon Portable Oxygen Concentrator P2

Indications for Use (Describe)

The Kingon P2 is for prescription use by patients requiring high concentrations of oxygen on a supplemental basis. It is small, portable, and is capable of continuous use in the home, institutional, and travel / mobile environments.

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| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X 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.

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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:

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"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."

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# Section 4

# 510(k) Summary

# 1. Company making the submission:

Company Name - Qingdao Kingon Medical Science and Technology Co., Ltd Company Address - 24th East Building, No. 252 Yanhe Road, Tianhe Industrial Park, Huangdao, Qingdao, Shangdong, China Tel: [phone] Contact - Wu Xiao CEO and Chief Manager

# 2. U.S. Correspondent and Contact

Name: Elliot Medical Solutions Address: Cleveland Heights, Cleveland, Ohio Contact: Roman Huang General Manager Tel: [phone] Email: [e-mail]

## 3. Submitted device

Device Name: Portable Oxygen Concentrator Trade name: Kingon Portable Oxygen Concentrator Models: P2 Common Name: Oxygen Concentrator Classification Name: Oxygen Concentrator, Portable Regulation Number: 868.5440 Regulatory Class: II Product Code: CAW Type of 510(k) submission: Traditional

- 4. Last Edited Date
February 28, 2020

# 5. Predicate Device.

| Manufacturer | Predicate<br>Device | 510(k)<br>number |
|--------------------------------------------------------------|---------------------------------------------|------------------|
| Philips<br>Respironics<br>SimplyGo<br>Oxygen<br>Concentrator | SimplyGo<br>Portable<br>Oxygen<br>Generator | K111885 |

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### 6. Description.

The Kingon P2 oxygen concentrator includes the following items:

- One Kingon P2 oxygen concentrator ●
- One Carry bag ●
- One Nasal cannula ●
- One AC power supply ●
- Five Intake filters
- One Battery ●
- . One User manual

The Kingon P2 oxygen concentrator utilizes a molecular sieve and differential pressure swing adsorption to separate the gases in ambient air. In brief, after the device takes the room air, the molecular sieve packed in a sealed container can absorb nitrogen in the air, and the oxygen still exists in gaseous form that can be collected by specially designed pipelines and deliver to patients. When the environmental air pressure decreases, exhaust of the vacuum container occurs and nitrogen will be released from the molecular sieve. When the patient inhales, the device senses the pressure change and is triggered to release the oxygen pulse. In between breaths, the device regenerates an oxygen pulse and waits for the next inhalation breath before dispensing it. In this way, Kingon P2 device can concentrate the oxygen in the air to produce a pulse of oxygen between 87-96% in purity.

## 7. Indication for use.

The Kingon P2 is for prescription use by patients requiring high concentrations of oxygen on a supplemental basis. It is small, portable, and is capable of continuous use in the home, institutional, and travel / mobile environments.

| Element of<br>Comparison | Predicate Device | Subject Device | Comparison |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Device name | Philips Respironics SimplyGo<br>Portable Oxygen Concentrator | Kingon P2 Portable<br>Oxygen Concentrator | |
| 510(k) | K111885 | N/A | |
| Indication for Use | The Portable Oxygen<br>Concentrator is for prescription<br>use by patients requiring high<br>concentrations of oxygen on a<br>supplemental basis. It is small,<br>portable and is capable of<br>continuous use in the home, | Same | Identical |
| | institutional, and travel/mobile<br>environments. | | |
| Environment of Use | Home, institutional, and<br>travel/mobile environments. | Same | Identical |
| Patient Population | Adult | Same | Identical |
| Single Patient, multi-<br>use | Yes | Yes | Identical |
| Patient Interface | Standard Single Lumen Nasal<br>Cannula | same | Identical |
| Technology | Pressure Swing Adsorption with<br>molecular sieve | same | Identical |
| Dimensions | 3.6"H*8.3"w*9.4(Standard<br>Battery)<br>3.6"H*8.3"W*10.27"L(Extend<br>Battery) | 6.30"H*3.35"W*8.70"L | Similar |
| Weight | 5.0 lbs (with standard battery<br>installed)<br>6.0 lbs (with extended battery<br>installed) | 4.34lbs (±0.07Ibs with<br>standard battery) | Similar |
| Oxygen Concentration | At least 87% at all settings<br>(maximum of 96%) over<br>the rated environmental range. | Same | Similar |
| Equivalent Flow rates | 15-40 BMP increments of<br>5BPM. | 10-40BMP increments<br>of 5BPM. | Similar |
| Dose at Specified<br>Flow | 11mL per setting | 10.5mL per setting<br>(with 20BPM) | Identical |
| Filters | Input Filter; Patient Filter | same | Identical |
| User Interface | Buttons LCD Display | same | Identical |
| Electrical | 100-240 VAC; 50/60 Hz<br>19 VDC, 6.3 A | 100-240VAC ;50-60<br>Hz;<br>19 VDC + 5% 6A MAX | Similar |
| Acoustic Noise | 42 dBA typical at setting 2 and<br>20 BPM<br>48 dBA typical at setting 5 and<br>20 BPM<br>(when measured at 1 meter from<br>front of the device) | 49 dBA typical at<br>setting 2 and 20BPM<br>56 dBA typical at<br>setting 5 and 20 BPM<br>(when measured at 1<br>meter from front of<br>device) | Similar |
| Alarms | High Breath Rate Alarm | same | Similar |
| | Low Oxygen Concentration<br>Alarm | same | Similar |
| | Technical Fault Alarm | same | Similar |
| | Low Battery Alarm | same | Similar |
| Warm Up Indicator | same | | |
| No Flow Alarm | same | | |
| External Power Failure Alarm | same | | |
| Depleted Battery Alarm | same | | |
| Status Indicator | Tool icon | same | Similar |
| | Flow Setting | same | |
| | Battery Charge Level | same | |
| | Alarm Silence Symbol | same | |
| | Attention | same | |
| | Flow Control Setting | same | |
| Battery Duration | Up to 4.5 hours (Pulse setting of 2 at 20 BPM with Standard battery)<br>Up to 9 hours (Pulse setting of 2 at 20 BPM with Extended battery) | Up to 3.8 hours (Pulse setting of 1 at 20 BPM with Standard battery) | Similar |
| Operating Environment | Temperature: 41° F to 95° F (5° C to 35° C)<br>Relative humidity: 15% to 93%<br>Atmospheric Pressure: 700 hPa to 1010 hPa<br>Altitude: up to 10,000 ft (3048 m) | Temperature: 41 to 104°F (5 to 40°C)<br>Humidity: 10% to 90%, non-condensing<br>Altitude: 0 to 10,000 ft. (0 to 3048 meters) | Similar |
| Shipping Storage | -4° F to 140° F (-20° C to 60° C)<br>Relative humidity: up to 93%, non-condensing | Temperature: -4 to 158°F (-20 to 70°C)<br>Humidity: 5% to 90%, non-condensing<br>Store in a dry environment | Similar |

## 8. Similarities/Differences between the subject and predicate device.

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## 9. Comparison of Technological Characteristics with Predicate Device.

Both the Kingon P2 oxygen concentrator and the predicate device (SimplyGo) have the same indication of use. Both of them have incorporated the same basic design and the same technological characteristics, and utilize the same operating principle. Both of them have been tested to the same electrical and electromagnetic safety standards for medical electrical equipment. And both of them are manufactured under a quality system. The differences between the subject device and predicate such as size, storage condition, operating condition, battery duration, alarm setting and panel indicator introduce risks mitigated by the performance testing provided in this submission.

#### 10. Safety and Performance Data, Biocompatibility Data

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| Bench Tests | Standards | Results | Report File<br>No. |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|---------|----------------------|
| General requirements for basic safety and<br>essential performance | IEC 60601-1 | Pass | GZME18010<br>0001801 |
| General requirements for basic safety and<br>essential performance - Collateral Standard:<br>Requirements for medical electrical<br>equipment and medical electrical systems<br>used in the home healthcare environment | IEC 60601-1-11 | Pass | GZME18010<br>0001802 |
| Medical electrical equipment part 2:<br>particular requirements for the basic safety<br>and essential performance of oxygen<br>concentrator equipment | ISO 80601-2-69 | Pass | GZME18010<br>0001803 |
| ISO 80601-2-67: medical electrical<br>equipment, part 2-67: particular requirements<br>for basic safety and essential performance of<br>oxygen-conserving equipment | ISO 80601-2-67 | Pass | GZME18010<br>0001804 |
| IEC 60601-1-8: Medical electrical<br>equipment, General requirements for basic<br>safety and essential performance - collateral<br>standard: General requirements, tests and<br>guidance for alarm systems in medical<br>electrical equipment and medical electrical<br>system | IEC 60601-1-8 | Pass | GZME18010<br>0001805 |
| EMC TEST | IEC 60601-1-2 | Pass | GZME18010<br>0001901 |
| Radiated & Conducted emissions test (FCC) | 47 CFR Part 15,<br>subpart B | Pass | GZME18010<br>0001902 |
| Secondary cells and batteries containing<br>alkaline or other non-acid electrolytes -<br>safety requirements for portable sealed<br>secondary cells, and for batteries made from<br>them, for use in portable applications | IEC 62133,<br>ST/SG/AC.10/11/<br>Rev.6/Section<br>38.3 | Pass | SHES180500<br>540701 |
| Electromagnetic Immunity from RFID reader | AIM standard<br>7351731 | Pass | 1909ESU013<br>-U1 |

Safety and performance data of the Kingon P2 device are listed in Table as below.

Biocompatibility data are listed in Table as below:

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| Biocompatibility<br>Tests | Standards | Results | Report File name<br>and Number |
|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|---------|--------------------------------|
| In vitro<br>cytotoxicity test of<br>shell and<br>accessories | ISO 10993-5:2009 Test<br>Method MTT Method<br>MEM with 10% FBS<br>extract | Pass | SDWH-<br>M201800623-1 |
| Skin sensitization<br>test of shell and<br>accessories | ISO 10993-10: 2010 Test<br>Methods Guinea Pig<br>Maximization Test 0.9%<br>Sodium Chloride Injection<br>Extract | Pass | SDWH-<br>M201800623-2 |
| Skin sensitization<br>test of shell and<br>accessories | ISO 10993-10: 2010 Test<br>Methods Guinea Pig<br>Maximization Test Sesame<br>oil extract | Pass | SDWH-<br>M201800623-3 |
| Skin irritation test<br>of shell and<br>accessories | ISO 10993-10: 2010 Test<br>Methods 0.9% Sodium<br>Chloride Injection Extract | Pass | SDWH-<br>M201800623-4 |
| Skin irritation test<br>of shell and<br>accessories | ISO 10993-10: 2010 Test<br>Methods Sesame oil<br>extract | Pass | SDWH-<br>M201800623-5 |
| Tests | Standards | Results | Report File name<br>and Number |
| Emission of<br>VOCs and<br>aldehydes | ISO 18562-3 | Pass | 18914-N01 |
| Emissions of<br>particulate matter.<br>carbon dioxide,<br>carbon monoxide<br>and ozone | ISO 18562-2 | Pass | 18914-N02 |
| Biological<br>evaluation of<br>medical devices -<br>part 17:<br>establishment of<br>allowable limits | ISO 10993-17<br>ISO 18562-1 | Pass | 18914-N03 |

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| for leachable<br>substances | | |
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#### 10. Conclusion.

The Kingon P2 oxygen concentrator has similar intended use, principle of operation, and similar technological characteristics as the predicate device identified. Performance testing contained in this submission demonstrates the minor differences in technological characteristics between the subject device and the predicate do not raise different questions of safety and effectiveness. Thus, in accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part807 and based on the information provided in this premarket notification, we conclude that Kingon P2 oxygen concentrator is substantially equivalent to predicate device.

End.