(480 days)
Not Found
No
The description focuses on physical and electrical components for oxygen generation and delivery, with no mention of AI/ML terms or functions.
Yes
The device is described as providing "respiratory therapy" and supplying "a pulsed high concentration of oxygen" to a patient via a nasal cannula, which are therapeutic functions.
No.
The device description indicates its purpose is to release oxygen for respiratory therapy, not to diagnose a condition.
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.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide supplemental oxygen for respiratory therapy." This is a therapeutic purpose, directly treating a patient's respiratory condition.
- Device Description: The device description details how it generates and delivers oxygen to the patient through physical means (molecular sieve) and a nasal cannula. This is a direct intervention on the patient's body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
The device described is a therapeutic medical device, specifically a portable oxygen concentrator.
N/A
Intended Use / Indications for Use
The Portable Oxygen Concentrator, model: P2-E6 is intended to provide supplemental oxygen in a home, institutional, or travel environment.
Product codes (comma separated list FDA assigned to the subject device)
CAW
Device Description
Portable Oxygen Concentrator, model: P2-E6 is a portable oxygen generator that is intended to release oxygen for respiratory therapy 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 P2-E6 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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests Performed for Safety and Effectiveness:
- Electrical safety and electromagnetic compatibility (EMC) testing: 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: Performed in accordance with Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff, May 2005. The software was considered "moderate" level of concern.
- Biocompatibility testing: Validated for Cytotoxicity through testing against ISO 10993-5, for Sensitization and Irritation through testing against ISO 10993-10, for Particulate matter through testing against ISO 18562-2, and for Volatile organic Compounds through testing against ISO 18562-3. All test results are positive.
- Performance tests for Pulse mode bolus size, Breath rate, Oxygen discharge pressure, and Acoustic Noise: Tested against ISO 80601-2-69: 2014 and ISO 80601-2-67: 2014 with positive results.
- Battery duration and safety: Risks mitigated by electromagnetic compatibility, electrical safety and battery safety testing in accordance with IEC 60601-1-2, ANSI AAMI ES60601-1 and IEC 62133.
- Operating condition: Risks mitigated by testing in accordance with IEC 60601-1-11 and ANSI AAMI ES60601-1.
- Shipping Storage: Verified with a positive result from Package Verification Test Report.
Key Results: Bench testing demonstrated that differences between the subject device and the predicate device do not raise new questions of safety or effectiveness. The device performs as intended and is comparable to the predicate device.
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 & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of the Department of Health & Human Services seal. To the right of the seal is the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 3, 2022
Qingdao Kingon Medical Science and Technology Co., Ltd. % You Yijie Manager Qimmiq Medical Consulting Service Co., Ltd RM.1711, Building K, NO.101 Science Ave International Creative Valley Guangzhou, Guangdong 510663 China
Re: K210371
Trade/Device Name: Portable Oxygen Concentrator, model: P2-E6 Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: Class II Product Code: CAW Dated: May 2, 2022 Received: May 2, 2022
Dear You Yijie:
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 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 Courtnev Assistant 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210371
Device Name Portable Oxygen Concentrator, model: P2-E6
Indications for Use (Describe)
The Portable Oxygen Concentrator, model: P2-E6 is intended to provide supplemental oxygen in a home, institutional, or travel environment.
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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3
510(k) Summary
K210371
1. Submitter's Information
Establishment Registration Information
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 of applicant
Name: Zhang Benrong Address: Room 301-302, No.15 HanchengRoad, Qingdao Free Trade Zone, Shandong, China, 266555 TEL: +86 18565833539 Email: augus@kingonmed.com
Contact Person of the Submission:
Name: Yijie You Address: RM.1711, Building K, NO.101 Science Ave International Creative Valley Development Zone, Guangzhou China TEL: +86 020-8224 5821 FAX: +86 020-8224 5821 Email: Jet.you@gimmiq-med.com
Date prepared: Jan. 14, 2021
2. Device Information
Trade Name: Portable Oxygen Concentrator Model: P2-E6 Classification name: Generator, Oxygen, Portable Review panel: Anesthesiology Product code: CAW Regulation Class: = Regulation Number: 868.5440
3. Predicate Device Information
510(k) submitter/holder: Oxus Inc.
4
| 510(K) Number: | K162433 |
|---|---|
| Trade Name: | GCE Zen-O™ Portable Oxygen Concentrator |
| Model: | RS-00500 |
| Classification name: | Generator, Oxygen, Portable |
| Review panel: | Anesthesiology |
| Product code: | CAW |
| Regulation Class: | II |
| Regulation Number: | 868.5440 |
4. Device description
Portable Oxygen Concentrator, model: P2-E6 is a portable oxygen generator that is intended to release oxygen for respiratory therapy 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 P2-E6 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.
Principle of operation:
The device 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.
5. Indications for Use
The Portable Oxygen Concentrator, model: P2-E6 is intended to provide supplemental oxygen in a home, institutional, or travel environment.
6. Summary of technological characteristics of device compared to the
predicate device (K162433)
| SE | Subject device | Primary predicate device | Discussion of |
|---|---|---|---|
| Comparisons | (Portable Oxygen Concentrator, | difference | |
| model: P2-E6) | (GCE Zen-O™ Portable | ||
| Oxygen Concentrator, Model: | |||
| RS-00500) | |||
| 510K Number | / | K162433 | / |
| Classification | 21CFR 868.5440 | 21CFR 868.5440 | Same |
| Product Code | CAW | CAW | Same |
| FDA Class | II | II | Same |
| Indications for Use | The Portable Oxygen Concentrator, | ||
| model: P2-E6 is intended to provide | |||
| supplemental oxygen in a home, | |||
| institutional, or travel environment. | The Portable Oxygen | ||
| Concentrator is intended to | |||
| provide supplemental oxygen in | |||
| a home, institutional, or travel | |||
| environment. | Same | ||
| Model | P2-E6 | RS-00500 | / |
| Environment of Use | Home, institutional, or travel | ||
| environment. | Home, institutional, or travel | ||
| environment. | Same | ||
| Design | table type | table type | Same |
| Prescriptive | Yes | Yes | Same |
| Patient Population | Adult | Adult | Same |
| Material of Patient | |||
| contact components | Wiring cover: PC+ABS | ||
| Intake hood: PC+ABS | |||
| Nozzle fitting: Aluminum alloy | |||
| Button panel: PET | |||
| Main housing: PC+ABS | Device enclosure, | ||
| · Handle, | |||
| · Battery, and | |||
| · Interface panel. | Different | ||
| (Discussion is | |||
| indicated in D1) | |||
| Duration and type of | |||
| contact | Type of contact: surface device; | ||
| Duration: permanent (> 30 d); | Category: External | ||
| communicating device | |||
| Contact: Tissue | |||
| Duration: A - Limited (≤ 24 h) | Different | ||
| (Discussion is | |||
| indicated in D2) | |||
| ISO 10993- 5 tested for | |||
| Cytotoxicity; | |||
| ISO 10993-10 tested for | ISO 10993- 5 tested for | ||
| Cytotoxicity; | |||
| ISO 10993-10 tested for | |||
| Complete list of all the | |||
| biocompatibility tests | |||
| performed | Sensitization and Irritation; | ||
| ISO 18562-2 tested for Particulate | |||
| matter; | |||
| ISO 18562-3 tested for Volatile | Sensitization and Irritation; | ||
| Particulate Matter test | |||
| Inorganic gases (Ozone, CO2, | |||
| and CO) test | Different | ||
| (Discussion is | |||
| indicated in D3) | |||
| organic Compounds; | |||
| Single Patient, | |||
| multi-use | Yes | Yes | Same |
| Patient Interface | Cannula Port | Cannula Port | Same |
| Technology | Pressure Swing Adsorption with | ||
| molecular sieve | Pressure Swing Adsorption with | ||
| molecular sieve | Same | ||
| Dimensions | 6.30"H3.35"W8.70"L | 6.6"H8.3"W12.3"L | Different |
| (Discussion is | |||
| indicated in D4) | |||
| Weight | 4.34lbs±0.07lbs (with standard battery) | 10.25lbs with one 12 cell battery | Different |
| (Discussion is | |||
| indicated in D5) | |||
| Oxygen Concentration | 90%-3%/+6% at all settings | 87% - 96% at all settings | Same |
| Setting | adjustable in 1 increments from 1 to 6 | adjustable in 0.5 increments | |
| from 1.0 to 6.0 in pulse mode | Same | ||
| Equivalent Flow rates | 1.0 to 6.0 LPM from setting 1 to | ||
| setting 6 | 1-6 LPM from setting 1 to | ||
| setting 6 in pulse mode | Same | ||
| Pulse mode bolus size | 60mL per breath at setting 6 with | ||
| 20BPM | 66mL per breath at setting 6 | ||
| with 20BPM | Different | ||
| (Discussion is | |||
| indicated in D6) | |||
| Principle of operation | by means of molecular sieve | by means of molecular sieve | Same |
| Filters | Input Filter, Patient Filter | Input Filter, Patient Filter | Same |
| Breath rate | 10 - 40 Breath per minute | 15 - 40 Breath per minute | Different |
| (Discussion is | |||
| indicated in D7) | |||
| User Interface | Buttons, LCD Display | Buttons, LCD Display | Same |
| Power requirements | AC adaptor: 100-240VAC ;50-60 Hz | ||
| in, 19VDC 5.26A out | |||
| DC adaptor: 12 - 16V DC in, 19V | |||
| 6A out | AC adaptor: 100-240V AC(+/- | ||
| 10%) 50-60 Hz in, 24VDC, | |||
| 6.25A out | |||
| DC adaptor: 11.5 - 16V DC in, | |||
| 19V, 7.9A out | Different | ||
| (Discussion is | |||
| indicated in D8) | |||
| Maximum oxygen | |||
| discharge pressure | 18.3 PSI (126KPa) | 20.5 PSI | Different |
| (Discussion is | |||
| indicated in D9) | |||
| Inspiratory trigger | |||
| sensitivity | -0.12cm/H20 | -0.12cm/H20 | Same |
| Software | Embedded | Embedded | Same |
| Acoustic Noise | 49 dBA at 1.2 LPM | 42 dBA at 2 LPM | Different |
| (Discussion is | |||
| indicated in D10) | |||
| Alarms | Battery empty | Battery empty | Same |
| Low pressure | Low pressure | Same | |
| No pulse | No pulse | Same | |
| High Temp | High Temp | Same | |
| Compressor Failure | Compressor Failure | Same | |
| Fan Failure | Fan Failure | Same | |
| Low Flow | Low Flow | Same | |
| Low Battery | Low Battery | Same | |
| No Breath Detected | No Breath Detected | Same | |
| EEPROM Failure | EEPROM Failure | Same | |
| Flow rates | Flow rates | Same | |
| Status Indicator | Battery Condition | Battery Condition | Same |
| Alarms | Alarms | Same | |
| Battery Duration | Up to 4.5hours at 1. 2 LPM | Approximately 4 hours at 2 LPM | |
| (pulse) | Different | ||
| (Discussion is | |||
| indicated in D11) | |||
| Operating Environment | 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) | 5-40°C; | ||
| Altitude:0-9000 ft; | |||
| RH:5-93% | Different | ||
| (Discussion is | |||
| indicated in D12) | |||
| Shipping Storage | Temperature: -4 to 158°F (-20 to | ||
| 70°C) | |||
| Humidity: 5% to 90%, non- | |||
| condensing | |||
| Store in a dry environment | Temperature:-20 to 60°C,Keep | ||
| dry: Humidity:0-93%RH | Different | ||
| (Discussion is | |||
| indicated in D13) | |||
| Electrical Safety | AAMI ANSI ES 60601-1 | AAMI ANSI ES60601-1 | Same |
| electromagnetic | |||
| compatibility | IEC 60601-1-2 | IEC 60601-1-2 | Same |
| Biocompatibility | 4 VOC's less than ambient | 4 VOC's less than ambient | Same |
| Standards Met | ANSI AAMI ES 60601- 1: 2005 / (R) | ||
| 2012 and A1: 2012 | |||
| IEC 60601-1-2: 2014 | |||
| IEC 60601-1-11: 2015 | |||
| IEC 60601-1-8: 2006+ A1:2012 | |||
| ISO 80601-2-69: 2014 | |||
| ISO 80601-2-67: 2014 | |||
| ISO 18562-2: 2017 | |||
| ISO 18562-3: 2017 | |||
| IEC 62133: 2012 | |||
| ISO 10993-5:2009 | AAMI ANSI ES60601-1 | ||
| IEC 60601-1 | |||
| IEC 60601-1-2 | |||
| IEC 60601-1-6 | |||
| IEC 60601-1-8 | |||
| IEC 60601-1-11 | |||
| ISO 80601-2-67 | |||
| ISO 80601-2-69 | |||
| 10993 | Different | ||
| (Discussion is | |||
| indicated in D14) |
5
6
7
The discussion of differences exist between the subject and predicate devices is listed in following:
- D1: The subject device P2-E6 has been validated for Cytotoxicity though testing against ISO 10993- 5, for Sensitization and Irritation though testing against ISO 10993-10 tested, for Particulate matter though testing against ISO 18562-2, for Volatile organic Compounds though testing against ISO 18562-3 according to FDA Guidance-Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and standard ISO 18562-1 (First edition 2017-03) and all test results are positive , the difference of subject device with predicate device RS-00500 (K162433) do not raise new questions of safety and effectiveness.
8
- D2: According to FDA Guidance-Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and standard ISO 18562-1 (First edition 2017-03), and with the duration is permanent (> 30 d)) and type of contact is surface device of the subject device P2-E6, we have conducted testing for Cytotoxicity though testing against ISO 10993- 5, for Sensitization and Irritation though testing against ISO 10993-10 tested, for Particulate matter though testing against ISO 18562-2, for Volatile organic Compounds though testing against ISO 18562-3 and all test results are positive, the difference of subject device with predicate device RS-00500 (K162433) do not raise new questions of safety and effectiveness.
- D3: The subject device P2-E6 has been validated for Cytotoxicity though testing against ISO 10993- 5, for Sensitization and Irritation though testing against ISO 10993-10 tested, for Particulate matter though testing against ISO 18562-2, for Volatile organic Compounds though testing against ISO 18562-3 and all test results are positive. According to FDA Guidance-Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and standard ISO 18562-1 (First edition 2017-03), the biocompatibility endpoints should be considered for the subject device are Cytotoxicity, Sensitization, Particulate matter, Volatile organic Compounds all of which are addressed though tested against ISO 10993-5, ISO 10993-10, ISO 18562-2 and ISO 18562-3, the difference of subject device with predicate device RS-00500 (K162433) do not raise new questions of safety and effectiveness.
- D4: The dimension of subject device is different with predicate device RS-00500 (K162433) will not affect the safety and effectiveness.
- D5: The weight of subject device is different with predicate device RS-00500 (K162433) will not affect the safety and effectiveness.
- D6: The Pulse mode bolus size of subject device P2-E6 is little smaller than predicate device RS-00500 (K162433), since the predicate device are safe and effectiveness, and the subject device also been tested against ISO 80601-2-69: 2014 and ISO 80601-2-67: 2014 with positive result, which means the subject device P2-E6 is also safe and effective as predicate device when used with this setting parameter and will not raise new questions of safety and effectiveness.
- D7: The Breath rate of subject device P2-E6 is different with predicate device RS-00500 (K162433), since the subject device has been tested against ISO 80601-2-69: 2014 and ISO 80601-2-67: 2014 with positive result, therefore, the subject device P2-E6 is as safe and effective as the predicate device and the difference of subject device with predicate device RS-00500 (K162433) do not raise new questions of safety and effectiveness.
- D8: The Power of subject device are different with predicate devices, the difference introduces risks mitigated by the electromagnetic compatibility and electrical safety testing in accordance with IEC 60601-1-2 and ANSI AAMI ES60601-1 provided in this submission, therefore the difference does not raise new questions of safety and effectiveness.
- D9: The Maximum oxygen discharge pressure of subject device P2-E6 is different with predicate device RS-00500 (K162433), since the subject device has been tested against ISO 80601-2-69: 2014 and ISO 80601-2-67: 2014 with positive result, the difference of subject device with predicate device RS-00500 (K162433) do not raise new questions of safety and effectiveness.
- D10: The Acoustic Noise of subject device P2-E6 is litter bigger than predicate device RS-00500 (K162433), since the subject device P2-E6 has been tested against ISO 80601-2-69: 2014 and ANSI AAMI
9
ES60601-1 with positive results, the difference of subject device with predicate device RS-00500 (K162433) do not raise new questions of safety and effectiveness.
- D11: The subject device P2-E6 equipped with longer Battery duration than predicate device RS-00500 (K162433), the difference introduces risks mitigated by the electromagnetic compatibility, electrical safety and battery safety testing in accordance with IEC 60601-1-2, ANSI AAMI ES60601-1 and IEC 62133 provided in this submission, therefore the difference do not raise new questions of safety and effectiveness.
- D12: The operating condition of subject device are different with predicate device RS-00500 (K162433), the difference introduce risks mitigated by testing in accordance with IEC 60601-1-11 and ANSI AAMI ES60601-1 provided in this submission, therefore the difference do not raise new questions of safety and effectiveness.
- D13: The Shipping Storage of subject device P2-E6 is different with predicate device RS-00500 (K162433), since the Shipping Storage of subject device had been verified with positive result (Package Verification Test Report), therefore the difference of subject device with predicate device RS-00500 (K162433) do not raise new questions of safety and effectiveness.
- D14: The Standards Met. of subject device P2-E6 is different with predicate device RS-00500 (K162433), the difference of subject device with Primary predicate device RS-00500 (K162433) do not raise new questions of safety and effectiveness.
7. Discussion of Non-Clinical Tests Performed for Safety and
effectiveness are as follows
The recognized consensus standards for safety of medical electrical equipment: ANSI AAMI ES60601-1, IEC 60601-1-11 for safety, IEC 60601-1-2 for electromagnetic compatibility, ISO 80601-2-69: 2014 and ISO 80601-2-67: 2014 for performance and IEC 62304 for software verification are complied. See below table for details:
| 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 |
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| 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.
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 patient or 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, detect task, display task, startup task, breath task, as well as dealing with USART1-interrupt, USART2-interrupt, RTC-interrupt, WDTinterrupt, and controlling the sensor module.
A Programming language
STMicroelectronics and Texas Instruments.
- Hardware platform A
- a) Applicable Device Name: Portable Oxygen Concentrator
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- Applicable model: P2-E6 b)
- Micro-controller used: STM32F103RCT6, STM32F103C8T6, MSP430G2755 c)
- ROM Size: STM32F103RCT6 256K, STM32F103C8T6 64K, MSP430G2755 32K d)
- RAM Size: STM32F103RCT6 48K, STM32F103C8T6 20K, MSP430G2755 -4K e)
- f) Software Release Version Number: Keil uVision5 V5.25.20, IRA for 430 V7.12.1
8. Discussion of Clinical Accuracy Testing Performed
There was no clinical testing performed.
9. Conclusions
The Portable Oxygen Concentrator, model P2-E6, have the same intended use and similar characteristics as the cleared predicate device RS-00500 (K162433). Moreover, bench testing contained in this submission supplied demonstrate that the differences existed between P2-E6 and RS-00500 (K162433) do not raise any new questions of safety or effectiveness.
The non-clinical tests support the safety of the device and the hardware and software verification and validation demonstrate that the Portable Oxygen Concentrator, model P2-E6 performs as intended in the specified use conditions are same with predicate device. The performance tests demonstrate that the Portable Oxygen Concentrator, model P2-E6 performs comparably to the predicate device that is currently marketed for the same intended use. Thus, the Portable Oxygen Concentrator, model P2-E6 is Substantially Equivalent (SE) to the predicate device.