(382 days)
Not Found
No
The description focuses on the physical and chemical processes of oxygen concentration and pressure sensing for triggering oxygen delivery. There is no mention of AI/ML terms, data sets, or performance metrics typically associated with AI/ML algorithms.
Yes.
The device's intended use is to deliver high concentrations of oxygen for supplemental use, which is a therapeutic intervention for patients requiring such support.
No
The device is described as an oxygen concentrator used to provide supplemental oxygen to patients. Its function is to separate gases to concentrate oxygen for therapeutic use, not to diagnose a condition.
No
The device description clearly outlines a physical oxygen concentrator that utilizes molecular sieves and pressure swing adsorption to produce oxygen. This involves hardware components and physical processes, not solely software.
Based on the provided information, the Kingon P2 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for providing supplemental oxygen to patients requiring high concentrations. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The description details how the device concentrates oxygen from ambient air and delivers it to the patient. This process is related to respiratory support, not the examination of specimens derived from the human body.
- Lack of IVD Characteristics: The document 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 those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The Kingon P2 is a medical device used for oxygen therapy, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
CAW
Device 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.
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, and travel/mobile environments.
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)
Safety and performance data of the Kingon P2 device were tested against the following standards and passed:
- IEC 60601-1 (General requirements for basic safety and essential performance)
- IEC 60601-1-11 (General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment)
- ISO 80601-2-69 (Medical electrical equipment part 2: particular requirements for the basic safety and essential performance of oxygen concentrator equipment)
- ISO 80601-2-67 (ISO 80601-2-67: medical electrical equipment, part 2-67: particular requirements for basic safety and essential performance of oxygen-conserving equipment)
- IEC 60601-1-8 (Medical electrical equipment, 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 system)
- IEC 60601-1-2 (EMC TEST)
- 47 CFR Part 15, subpart B (Radiated & Conducted emissions test (FCC))
- IEC 62133, ST/SG/AC.10/11/Rev.6/Section 38.3 (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)
- AIM standard 7351731 (Electromagnetic Immunity from RFID reader)
Biocompatibility tests of shell and accessories were performed and passed:
- ISO 10993-5:2009 Test Method MTT Method MEM with 10% FBS extract (In vitro cytotoxicity test)
- ISO 10993-10: 2010 Test Methods Guinea Pig Maximization Test 0.9% Sodium Chloride Injection Extract (Skin sensitization test)
- ISO 10993-10: 2010 Test Methods Guinea Pig Maximization Test Sesame oil extract (Skin sensitization test)
- ISO 10993-10: 2010 Test Methods 0.9% Sodium Chloride Injection Extract (Skin irritation test)
- ISO 10993-10: 2010 Test Methods Sesame oil extract (Skin irritation test)
Other tests performed and passed:
- ISO 18562-3 (Emission of VOCs and aldehydes)
- ISO 18562-2 (Emissions of particulate matter, carbon dioxide, carbon monoxide and ozone)
- ISO 10993-17, ISO 18562-1 (Biological evaluation of medical devices - part 17: establishment of allowable limits for leachable substances)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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
1
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
2
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.
.
是 在
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.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"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."
3
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 | Predicate
Device | 510(k)
number |
|--------------------------------------------------------------|---------------------------------------------|------------------|
| Philips
Respironics
SimplyGo
Oxygen
Concentrator | SimplyGo
Portable
Oxygen
Generator | K111885 |
4
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
Comparison | Predicate Device | Subject Device | Comparison |
---|---|---|---|
Device name | Philips Respironics SimplyGo | ||
Portable Oxygen Concentrator | Kingon P2 Portable | ||
Oxygen Concentrator | |||
510(k) | K111885 | N/A | |
Indication for Use | The Portable Oxygen | ||
Concentrator 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, | Same | Identical | |
institutional, and travel/mobile | |||
environments. | |||
Environment of Use | Home, institutional, and | ||
travel/mobile environments. | Same | Identical | |
Patient Population | Adult | Same | Identical |
Single Patient, multi- | |||
use | Yes | Yes | Identical |
Patient Interface | Standard Single Lumen Nasal | ||
Cannula | same | Identical | |
Technology | Pressure Swing Adsorption with | ||
molecular sieve | same | Identical | |
Dimensions | 3.6"H8.3"w9.4(Standard | ||
Battery) | |||
3.6"H8.3"W10.27"L(Extend | |||
Battery) | 6.30"H3.35"W8.70"L | Similar | |
Weight | 5.0 lbs (with standard battery | ||
installed) | |||
6.0 lbs (with extended battery | |||
installed) | 4.34lbs (±0.07Ibs with | ||
standard battery) | Similar | ||
Oxygen Concentration | At least 87% at all settings | ||
(maximum of 96%) over | |||
the rated environmental range. | Same | Similar | |
Equivalent Flow rates | 15-40 BMP increments of | ||
5BPM. | 10-40BMP increments | ||
of 5BPM. | Similar | ||
Dose at Specified | |||
Flow | 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 Hz | ||
19 VDC, 6.3 A | 100-240VAC ;50-60 | ||
Hz; | |||
19 VDC + 5% 6A MAX | Similar | ||
Acoustic Noise | 42 dBA typical at setting 2 and | ||
20 BPM | |||
48 dBA typical at setting 5 and | |||
20 BPM | |||
(when measured at 1 meter from | |||
front of the device) | 49 dBA typical at | ||
setting 2 and 20BPM | |||
56 dBA typical at | |||
setting 5 and 20 BPM | |||
(when measured at 1 | |||
meter from front of | |||
device) | Similar | ||
Alarms | High Breath Rate Alarm | same | Similar |
Low Oxygen Concentration | |||
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) | ||
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 hPa | |||
Altitude: up to 10,000 ft (3048 m) | Temperature: 41 to 104°F (5 to 40°C) | ||
Humidity: 10% to 90%, non-condensing | |||
Altitude: 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-condensing | |||
Store in a dry environment | Similar |
8. Similarities/Differences between the subject and predicate device.
5
6
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
7
| Bench Tests | Standards | Results | Report File
No. |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|---------|----------------------|
| General requirements for basic safety and
essential performance | IEC 60601-1 | Pass | GZME18010
0001801 |
| General requirements for basic safety and
essential performance - Collateral Standard:
Requirements for medical electrical
equipment and medical electrical systems
used in the home healthcare environment | IEC 60601-1-11 | Pass | GZME18010
0001802 |
| Medical electrical equipment part 2:
particular requirements for the basic safety
and essential performance of oxygen
concentrator equipment | ISO 80601-2-69 | Pass | GZME18010
0001803 |
| ISO 80601-2-67: medical electrical
equipment, part 2-67: particular requirements
for basic safety and essential performance of
oxygen-conserving equipment | ISO 80601-2-67 | Pass | GZME18010
0001804 |
| IEC 60601-1-8: Medical electrical
equipment, 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
system | IEC 60601-1-8 | Pass | GZME18010
0001805 |
| EMC TEST | IEC 60601-1-2 | Pass | GZME18010
0001901 |
| Radiated & Conducted emissions test (FCC) | 47 CFR Part 15,
subpart B | Pass | GZME18010
0001902 |
| 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 | IEC 62133,
ST/SG/AC.10/11/
Rev.6/Section
38.3 | Pass | SHES180500
540701 |
| Electromagnetic Immunity from RFID reader | AIM standard
7351731 | 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:
8
| Biocompatibility
Tests | Standards | Results | Report File name
and Number |
|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|---------|--------------------------------|
| In vitro
cytotoxicity test of
shell and
accessories | ISO 10993-5:2009 Test
Method MTT Method
MEM with 10% FBS
extract | Pass | SDWH-
M201800623-1 |
| Skin sensitization
test of shell and
accessories | ISO 10993-10: 2010 Test
Methods Guinea Pig
Maximization Test 0.9%
Sodium Chloride Injection
Extract | Pass | SDWH-
M201800623-2 |
| Skin sensitization
test of shell and
accessories | ISO 10993-10: 2010 Test
Methods Guinea Pig
Maximization Test Sesame
oil extract | Pass | SDWH-
M201800623-3 |
| Skin irritation test
of shell and
accessories | ISO 10993-10: 2010 Test
Methods 0.9% Sodium
Chloride Injection Extract | Pass | SDWH-
M201800623-4 |
| Skin irritation test
of shell and
accessories | ISO 10993-10: 2010 Test
Methods Sesame oil
extract | Pass | SDWH-
M201800623-5 |
| Tests | Standards | Results | Report File name
and Number |
| Emission of
VOCs and
aldehydes | ISO 18562-3 | Pass | 18914-N01 |
| Emissions of
particulate matter.
carbon dioxide,
carbon monoxide
and ozone | ISO 18562-2 | Pass | 18914-N02 |
| Biological
evaluation of
medical devices -
part 17:
establishment of
allowable limits | ISO 10993-17
ISO 18562-1 | Pass | 18914-N03 |
9
| for leachable
substances | ||
---|---|---|
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.