(382 days)
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.
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.
This is a 510(k) premarket notification for a medical device, specifically the Kingon Portable Oxygen Concentrator P2. The document focuses on demonstrating substantial equivalence to a predicate device (Philips Respironics SimplyGo Portable Oxygen Concentrator) rather than outlining acceptance criteria and a detailed study proving performance against those criteria.
Therefore, much of the requested information regarding detailed acceptance criteria, specific study designs (like MRMC or standalone performance), sample sizes for test and training sets, expert qualifications, and ground truth establishment, is not present in the provided text.
However, based on the information provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
The document primarily focuses on demonstrating equivalence to the predicate device and adherence to various safety standards. It doesn't explicitly list "acceptance criteria" for performance in the same way an AI/ML device might have clinical performance metrics, but rather shows the device "Pass"ed various bench tests and biocompatibility tests against established standards.
| Feature / Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Bench Tests | Adherence to relevant IEC and ISO standards for medical electrical equipment and oxygen concentrators. | Pass (for all listed standards) |
| Oxygen Concentration | At least 87% (maximum 96%) over the rated environmental range (identical to predicate). | Same (Implied to meet this, as it's directly compared to the predicate with "Similar") |
| Equivalent Flow rates | 10-40 BPM (increments of 5BPM) | 10-40BMP increments of 5BPM |
| Dose at Specified Flow | 10.5mL per setting (with 20BPM) | 10.5mL per setting (with 20BPM) |
| Electrical Safety | IEC 60601-1, IEC 60601-1-11, IEC 60601-1-8 | Pass |
| Oxygen Concentrator Safety | ISO 80601-2-69, ISO 80601-2-67 | Pass |
| EMC | IEC 60601-1-2, 47 CFR Part 15, subpart B | Pass |
| Battery Safety | IEC 62133, ST/SG/AC.10/11/Rev.6/Section 38.3 | Pass |
| RF Immunity | AIM standard 7351731 | Pass |
| Biocompatibility | Adherence to ISO 10993 and ISO 18562 standards | Pass (for all listed tests) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document refers to "Performance testing provided in this submission," but doesn't detail the number of devices or units tested for the various bench and biocompatibility tests. These are typically engineering tests on a small batch of devices, not clinical trials with human subjects.
- Data Provenance: The device manufacturer is Qingdao Kingon Medical Science and Technology Co., Ltd in China. The reports for the listed tests (e.g., GZME, SHES, SDWH, ESU) indicate that testing was likely conducted by various accredited testing laboratories, potentially in China (GZME implies Guangzhou, SHES implies Shanghai, SDWH implies Shandong Weihai) or third-party labs recognized for these standards. The tests are bench and lab-based, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable or not provided. The "ground truth" for a physical device like an oxygen concentrator is typically established by physical measurements against engineering specifications and regulatory standards using calibrated equipment, not by human expert consensus or clinical assessment of outcomes.
4. Adjudication method for the test set:
This information is not applicable or not provided. Adjudication typically refers to resolving disagreements among human readers/experts, which isn't relevant for the type of bench and biocompatibility testing described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. An MRMC study is relevant for AI/ML-driven diagnostic devices that assist human readers (e.g., radiologists interpreting images). The Kingon P2 is a physical medical device (an oxygen concentrator) and does not involve AI or human interpretation in its function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The Kingon P2 is a physical medical device, not an algorithm.
7. The type of ground truth used:
- Engineering Specifications and Standard Requirements: The "ground truth" for the performance tests (e.g., oxygen concentration, flow rates, electrical safety, acoustic noise) would be the device meeting its design specifications and adhering to the limits set by the referenced international and national standards (IEC, ISO, CFR).
- Laboratory Analysis: For biocompatibility tests, the ground truth is established through laboratory analyses (e.g., in vitro cytotoxicity, skin sensitization, irritation tests) that demonstrate the materials are safe for biological contact based on established protocols in standards like ISO 10993 and ISO 18562.
8. The sample size for the training set:
This information is not applicable. This is a physical device, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established:
This information is not applicable. This is a physical device, not an AI/ML algorithm that requires a "training set."
In summary, the provided document is a 510(k) submission focusing on substantial equivalence of a physical medical device to a predicate device, rather than a performance study report for an AI/ML product. Therefore, many of the questions are not relevant or cannot be answered from the text. The "studies" mentioned are bench tests and biocompatibility assessments to regulatory standards.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
..............................................................................................................................................................................
网_皇冠 _ba
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)
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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: 86-0532-58792324 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: 216-262-0962 Email: support@elliotmd.com
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
-
- Last Edited Date
February 28, 2020
- Last Edited Date
5. Predicate Device.
| Manufacturer | PredicateDevice | 510(k)number |
|---|---|---|
| PhilipsRespironicsSimplyGoOxygenConcentrator | SimplyGoPortableOxygenGenerator | 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 ofComparison | Predicate Device | Subject Device | Comparison |
|---|---|---|---|
| Device name | Philips Respironics SimplyGoPortable Oxygen Concentrator | Kingon P2 PortableOxygen Concentrator | |
| 510(k) | K111885 | N/A | |
| Indication for Use | The Portable OxygenConcentrator is for prescriptionuse by patients requiring highconcentrations of oxygen on asupplemental basis. It is small,portable and is capable ofcontinuous use in the home, | Same | Identical |
| institutional, and travel/mobileenvironments. | |||
| Environment of Use | Home, institutional, andtravel/mobile environments. | Same | Identical |
| Patient Population | Adult | Same | Identical |
| Single Patient, multi-use | Yes | Yes | Identical |
| Patient Interface | Standard Single Lumen NasalCannula | same | Identical |
| Technology | Pressure Swing Adsorption withmolecular sieve | same | Identical |
| Dimensions | 3.6"H8.3"w9.4(StandardBattery)3.6"H8.3"W10.27"L(ExtendBattery) | 6.30"H3.35"W8.70"L | Similar |
| Weight | 5.0 lbs (with standard batteryinstalled)6.0 lbs (with extended batteryinstalled) | 4.34lbs (±0.07Ibs withstandard battery) | Similar |
| Oxygen Concentration | At least 87% at all settings(maximum of 96%) overthe rated environmental range. | Same | Similar |
| Equivalent Flow rates | 15-40 BMP increments of5BPM. | 10-40BMP incrementsof 5BPM. | Similar |
| Dose at SpecifiedFlow | 11mL per setting | 10.5mL per setting(with 20BPM) | Identical |
| Filters | Input Filter; Patient Filter | same | Identical |
| User Interface | Buttons LCD Display | same | Identical |
| Electrical | 100-240 VAC; 50/60 Hz19 VDC, 6.3 A | 100-240VAC ;50-60Hz;19 VDC + 5% 6A MAX | Similar |
| Acoustic Noise | 42 dBA typical at setting 2 and20 BPM48 dBA typical at setting 5 and20 BPM(when measured at 1 meter fromfront of the device) | 49 dBA typical atsetting 2 and 20BPM56 dBA typical atsetting 5 and 20 BPM(when measured at 1meter from front ofdevice) | Similar |
| Alarms | High Breath Rate Alarm | same | Similar |
| Low Oxygen ConcentrationAlarm | 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)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)Relative humidity: 15% to 93%Atmospheric Pressure: 700 hPa to 1010 hPaAltitude: up to 10,000 ft (3048 m) | Temperature: 41 to 104°F (5 to 40°C)Humidity: 10% to 90%, non-condensingAltitude: 0 to 10,000 ft. (0 to 3048 meters) | Similar |
| Shipping Storage | -4° F to 140° F (-20° C to 60° C)Relative humidity: up to 93%, non-condensing | Temperature: -4 to 158°F (-20 to 70°C)Humidity: 5% to 90%, non-condensingStore 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 FileNo. |
|---|---|---|---|
| General requirements for basic safety andessential performance | IEC 60601-1 | Pass | GZME180100001801 |
| General requirements for basic safety andessential performance - Collateral Standard:Requirements for medical electricalequipment and medical electrical systemsused in the home healthcare environment | IEC 60601-1-11 | Pass | GZME180100001802 |
| Medical electrical equipment part 2:particular requirements for the basic safetyand essential performance of oxygenconcentrator equipment | ISO 80601-2-69 | Pass | GZME180100001803 |
| ISO 80601-2-67: medical electricalequipment, part 2-67: particular requirementsfor basic safety and essential performance ofoxygen-conserving equipment | ISO 80601-2-67 | Pass | GZME180100001804 |
| IEC 60601-1-8: Medical electricalequipment, General requirements for basicsafety and essential performance - collateralstandard: General requirements, tests andguidance for alarm systems in medicalelectrical equipment and medical electricalsystem | IEC 60601-1-8 | Pass | GZME180100001805 |
| EMC TEST | IEC 60601-1-2 | Pass | GZME180100001901 |
| Radiated & Conducted emissions test (FCC) | 47 CFR Part 15,subpart B | Pass | GZME180100001902 |
| Secondary cells and batteries containingalkaline or other non-acid electrolytes -safety requirements for portable sealedsecondary cells, and for batteries made fromthem, for use in portable applications | IEC 62133,ST/SG/AC.10/11/Rev.6/Section38.3 | Pass | SHES180500540701 |
| Electromagnetic Immunity from RFID reader | AIM standard7351731 | Pass | 1909ESU013-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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| BiocompatibilityTests | Standards | Results | Report File nameand Number |
|---|---|---|---|
| In vitrocytotoxicity test ofshell andaccessories | ISO 10993-5:2009 TestMethod MTT MethodMEM with 10% FBSextract | Pass | SDWH-M201800623-1 |
| Skin sensitizationtest of shell andaccessories | ISO 10993-10: 2010 TestMethods Guinea PigMaximization Test 0.9%Sodium Chloride InjectionExtract | Pass | SDWH-M201800623-2 |
| Skin sensitizationtest of shell andaccessories | ISO 10993-10: 2010 TestMethods Guinea PigMaximization Test Sesameoil extract | Pass | SDWH-M201800623-3 |
| Skin irritation testof shell andaccessories | ISO 10993-10: 2010 TestMethods 0.9% SodiumChloride Injection Extract | Pass | SDWH-M201800623-4 |
| Skin irritation testof shell andaccessories | ISO 10993-10: 2010 TestMethods Sesame oilextract | Pass | SDWH-M201800623-5 |
| Tests | Standards | Results | Report File nameand Number |
| Emission ofVOCs andaldehydes | ISO 18562-3 | Pass | 18914-N01 |
| Emissions ofparticulate matter.carbon dioxide,carbon monoxideand ozone | ISO 18562-2 | Pass | 18914-N02 |
| Biologicalevaluation ofmedical devices -part 17:establishment ofallowable limits | ISO 10993-17ISO 18562-1 | Pass | 18914-N03 |
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| for leachablesubstances | ||
|---|---|---|
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.
§ 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).