(218 days)
The Portable Oxygen Concentrator (Model: P2-K4.P2-S4. P2-S3) is intended to provide supplemental oxygen in a home, institutional, or travel environment. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Portable Oxygen Concentrator(Model:P2-K4,P2-K3,P2-S4,P2-S3) is small, portable and may be used in home, institution and various mobile environments. However, there is not any type of humidifier that is suitable for use with this device because of its pulse dose delivery mode.
Portable Oxygen Concentrator (Model:P2-K4,P2-K3,P2-S4,P2-S3) 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 Portable Oxygen Concentrator is small, portable and may be used in home, institutional, or travel environment. The portable oxygen concentrator consists of two parts: an oxygen concentrator and accessories. The oxygen concentrator is composed of compressor, battery, solenoid valve, molecular sieve, circuit control system, heat dissipation system, and a flow control device. Accessories include power adapters.
This document describes acceptance criteria and testing for a Portable Oxygen Concentrator (Models: P2-K4, P2-K3, P2-S4, P2-S3).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established by compliance with various international and national standards for medical electrical equipment, biocompatibility, and specific oxygen concentrator requirements. The reported device performance is demonstrated by the successful completion of tests against these standards.
| Acceptance Criteria (Standard Compliance) | Reported Device Performance (Compliance Status) |
|---|---|
| Electrical Safety (AAMI ANSI ES 60601-1, IEC 60601-1, IEC 60601-1-8, IEC 60601-1-6, IEC 60601-1-11) | Complies |
| Electromagnetic Compatibility (IEC 60601-1-2) | Complies |
| Oxygen Concentrator Specific Safety & Performance (ISO 80601-2-69) | Complies |
| Oxygen-Conserving Equipment Specific Safety & Performance (ISO 80601-2-67) | Complies |
| Biocompatibility - Cytotoxicity (ISO 10993-5) | Complies |
| Biocompatibility - Skin Sensitization (ISO 10993-10) | Complies |
| Biocompatibility - Irritation (ISO 10993-23) | Complies |
| Biocompatibility - Particulate matter (ISO 18562-2) | Complies |
| Biocompatibility - Volatile organic Compounds (ISO 18562-3) | Complies (VOC's less than ambient) |
| Battery Safety (IEC 62133) | Complies |
| Software Verification and Validation (FDA Guidance for Software in Medical Devices) | Ensures compliance to recognized consensus standards |
Differences Noted in Comparison to Predicate Device and their Mitigation:
| Difference ID | Description of Difference | Mitigation (Tests Performed) |
|---|---|---|
| ID_22 & ID_23 | Smaller number of gear settings and smaller pulse mode bolus size compared to predicate. | Verified by tests according to ISO 80601-2-69: 2020, ISO 80601-2-67: 2020, ISO 18562-2: 2017, ISO 18562-3: 2017, ISO 10993-5:2009, ISO10993-10:2021, and ISO10993-23:2021. |
| ID_29 | Different maximum oxygen discharge pressure. | Verified by tests against ISO 80601-2-69: 2020 with positive result. |
| ID_32 | Slightly lower acoustic noise. | Verified by tests against ISO 80601-2-69: 2020 and ANSI AAMI ES 60601-1: 2005 /A1:2012 and A2:2020 with positive result. |
| ID_46 | Different battery durations and multiple battery types. | Verified by tests according to IEC 62133: 2017. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical trials or AI model validation with a specific number of cases. Instead, it refers to conformity testing against established standards. For such conformity testing, the "sample size" typically refers to the number of devices or components tested to ensure consistent performance across the production. This information (specific number of devices tested for each standard) is not provided in this summary.
Data provenance: The testing appears to be primarily non-clinical bench testing and verification, likely conducted at the manufacturer's facility or by a certified testing laboratory. There is no mention of country of origin of data for a "test set" as understood in a clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is not an AI/ML-driven diagnostic device that requires expert-established ground truth on a test set of medical images or patient data. The device's performance is validated against engineering and medical device standards.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is not a diagnostic device requiring adjudication of expert interpretations for ground truth.
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
No. This is a medical device for oxygen delivery, not a diagnostic AI system, therefore, an MRMC comparative effectiveness study is not relevant or mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a hardware-based oxygen concentrator with embedded software; it is not a standalone AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is defined by compliance with a comprehensive set of international and national standards for medical devices, electrical safety, EMC, biocompatibility, and specific oxygen concentrator requirements (e.g., ISO 80601-2-69, ISO 80601-2-67). This is a technical and performance-based "ground truth" rather than clinical diagnostic ground truth.
8. The Sample Size for the Training Set
Not applicable. As this is not an AI/ML device trained on data, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no "training set" or associated ground truth for this device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
October 18, 2023
Qingdao Kingon Medical Science and Technology Co., Ltd. Yanmei Jiao Certification Engineer 24th Building, NO. 252 Yanhe Road Huangdao, Qingdao, Shandong 266555 China
Re: K230702
Trade/Device Name: Portable Oxygen Concentrator (Model: P2-S4, P2-S3.P2-K4.P2-K3) Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: Class II Product Code: CAW Dated: May 31, 2023 Received: May 31, 2023
Dear Yanmei Jiao:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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, Bradley Q. Quinn -S
Bradley Quinn 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
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Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Portable Oxygen Concentrator (Model: P2-K3, P2-K4,P2-S3,P2-S4)
Indications for Use (Describe)
The Portable Oxygen Concentrator (Model: P2-K4.P2-S4. P2-S3) is intended to provide supplemental oxygen in a home, institutional, or travel environment.
It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Portable Oxygen Concentrator(Model:P2-K4,P2-K3,P2-S4,P2-S3) is small, portable and may be used in home, institution and various mobile environments. However, there is not any type of humidifier that is suitable for use with this device because of its pulse dose delivery mode.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ❌ Prescription Use (Part 21 CFR 801 Subpart D) | ❍ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary as required by section 807.92(c)
I. Date of the summary prepared: 15/08/2023
II. Administrative Information
| Manufacturerinformation | Establishment registrationnumber | 3014777423 |
|---|---|---|
| Owner/OperatorNumber | 10061814 | |
| Name | Qingdao Kingon Medical Scienceand Technology Co., Ltd. | |
| Address | Room 301-302, No.15 HanchengRoad,Qingdao Free Trade Zone,Shandong, China, 266555 | |
| Contact Person | Name: Benrong ZhangAddress: Room 301-302, No.15HanchengRoad, Qingdao FreeTrade Zone, Shandong, China, 266555TEL: +86-18565833539FAX: +86 532 58792324Email: augus@kingonmed.com | |
| SubmissionCorrespondent | Contact Person |
III. Device Information
| Type of 510(k) | Traditional 510K |
|---|---|
| Prior submission | No prior submission |
| Common Name | Generator, Oxygen, Portable |
| Classification | Portable oxygen generator |
| name | |
| Trade Name | Portable Oxygen Concentrator |
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| (Model:P2-K4,P2-K3,P2-S4,P2-S3) | |
|---|---|
| Review panel | Anesthesiology |
| Product code | CAW |
| Regulation Number | 868.5540 |
| Regulation Class | 2 |
IV. Predicate Device Information
| Common Name | Generator, Oxygen, Portable |
|---|---|
| Classification name | Portable oxygen generator |
| Trade Name | Portable Oxygen Concentrator, model:P2-E6 |
| Review panel | Anesthesiology |
| Product code | CAW |
| Regulation Number | 868.5540 |
| Regulation Class | 2 |
V. Device description
Portable Oxygen Concentrator (Model:P2-K4,P2-K3,P2-S4,P2-S3) 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 Portable Oxygen Concentrator is small, portable and may be used in home, institutional, or travel environment.
The portable oxygen concentrator consists of two parts: an oxygen concentrator and accessories. The oxygen concentrator is composed of compressor, battery, solenoid valve, molecular sieve, circuit control system, heat dissipation system, and a flow control device. Accessories include power adapters.
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| Model | P2-K4 | P2-K3 | P2-S4 | P2-S3 |
|---|---|---|---|---|
| Appearance | Image: P2-K4 and P2-K3 | Image: P2-K4 and P2-K3 | Image: P2-S4 and P2-S3 | Image: P2-S4 and P2-S3 |
| P2-K4 and P2-K3 have the sameappearance. | P2-S4 and P2-S3 have the sameappearance. | |||
| Gear setting | Select 1-4 gears | Select 1-3 gears | Select 1-4 gears | Select 1-3 gears |
0.63 L/min
0.84 L/min
BA-K201/BA-S200/BA-S202
0.63 L/min
The differences of the four models declared this time are shown in the table below :
VI. Principle of operation
0.84 L/min
Max flow
Battery model
Both model (Model:P2-K4,P2-K3,P2-S4,P2-S3) has the same principle of operation. The portable oxygen concentrator works by getting use of the molecular sieves character that the internal pressure of a sealed container containing of molecular sieve will increase when injecting air into it. At this time, the molecular sieve will absorb a lot of nitrogen in the air with the increasing of ambient pressure, while the oxygen in
BA-K201/BA-K200/BA-K202
the air is still existed in gaseous form, then the oxygen are collected through some pipelines. When the nitrogen absorption process in the container reaches a certain level, then exhaust of the vacuum container and nitrogen will be released from molecular sieve with the ambient pressure decreases. It will detect when the user begins to take a breath and then delivers a pulsed volume of oxygen during the inhalation period. The volume of the oxygen pulse is dependent on the setting value.
VII. Indications for Use
Use:The Indications for Portable Oxygen Concentrator (Model:P2-K4,P2-K3,P2-S4,P2-S3) is intended to provide supplemental oxygen in a home, institutional, or travel environment.
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It supplies a high concentration of oxygen and is used with a nasal cannula to channel the concentrator to to the patient. The Portable oxygen from Oxygen Concentrator(Model: P2-K4,P2-K3,P2-S4,P2-S3) is small, portable and may be used in home, institution and various mobile environments. However, there is not any type of humidifier that is suitable for use with this device because of its pulse dose delivery mode.
VIII. Comparison with predicate device
| I | Comparison | Subject device | Predicate device | Comparison |
|---|---|---|---|---|
| D | Items | |||
| 1 | 510K Number | / | K210371 | / |
| 2 | Manufacturer | Qingdao Kingon Medical Science andTechnology Co., Ltd. | Qingdao Kingon Medical Scienceand Technology Co., Ltd. | Same |
| 3 | Device name | Portable Oxygen Concentrator | Portable Oxygen Concentrator | Same |
| 4 | Model | P2-K4,P2-K3,P2-S4,P2-S3 | P2-E6 | Same |
| 5 | Classification | 21CFR 868.5440 | 21CFR 868.5440 | Same |
| 6 | Product Code | CAW | CAW | Same |
| 7 | FDA Class | II | II | Same |
| 8 | Indications forUse | The Portable Oxygen Concentrator(Model:P2-K4,P2-K3,P2-S4,P2-S3) isintended to provide supplementaloxygen in a home, institutional, ortravel environment. | The Portable Oxygen Concentrator,model: P2-E6 is intended to providesupplemental oxygen in a home,institutional, or travel environment. | Same |
| 9 | Environmentof Use | Home, institutional, or travelenvironment. | Home, institutional, or travelenvironment. | Same |
| 10 | Design | Table type | Table type | Same |
| 11 | Prescriptive | Yes | Yes | Same |
| 12 | PatientPopulation | Adult | Adult | Same |
| 13 | Material ofPatientcontactcomponents | Wiring cover: PC+ABSIntake hood: PC+ABSNozzle fitting: Aluminum alloyButton panel: PETMain housing: PC+ABS | Wiring cover: PC+ABSIntake hood: PC+ABSNozzle fitting: Aluminum alloyButton panel: PETMain housing: PC+ABS | Same |
| 14 | Duration andtype of contact | Type of contact: surface device;Duration: permanent (> 30 d); | Type of contact: surface device;Duration: permanent (> 30 d); | Same |
| 15 | Complete listof all thebiocompatibility tests | ISO 10993- 5 tested for Cytotoxicity;ISO 10993-10 tested for SkinSensitization;ISO 10993-23 tested for Skin | ISO 10993- 5 tested forCytotoxicity;ISO 10993-10 tested forSensitization | Same |
| performed | Irritation;ISO 18562-2 tested for Particulatematter;ISO 18562-3 tested for Volatileorganic Compounds; | and Irritation;ISO 18562-2 tested for Particulatematter;ISO 18562-3 tested for Volatileorganic Compounds; | ||
| 16 | Single Patient,multi-use | Yes | Yes | Same |
| 17 | PatientInterface | Cannula Port | Cannula Port | Same |
| 18 | Technology | Pressure Swing Adsorption withmolecular sieve | Pressure Swing Adsorption withmolecular sieve | Same |
| 19 | Dimensions | P2-S4/P2-S3:6.69"H3.39"W6.18"LP2-K4/P2-K3:6.69"H3.39"W5.51"L | 6.30"H3.35"W8.70"L | Subjectdevice issmallerand moreportable |
| 20 | Weight | 3.31lbs±0.07lbs (with BA-K201battery) | 4.34lbs±0.07lbs (with standardbattery) | Subjectdeviceweighsless thanPredicatedevice |
| 21 | OxygenConcentration | 90%-3%/+6% at all settings | 90%-3%/+6% at all settings | Same |
| 22 | Setting | P2-S4/P2-K4: adjustable inincrements from 1 to 4.P2-S3/P2-K3: adjustable inincrements from 1 to 3. | Adjustable in increments from 1to 6 | Different(See belownoteID_22) |
| 23 | Pulse modebolus size | P2-S4/P2-K4: 42 mL per breath atsetting 4 with 20 BPMP2-S3/P2-K3: 31.5 mL per breath atsetting 3 with 20 BPM | 60 mL per breath at setting 6 with20BPM | Different(See belownoteID_23) |
| 24 | Principle ofoperation | by means of molecular sieve | by means of molecular sieve | Same |
| 25 | Filters | Input Filter, Patient Filter | Input Filter, Patient Filter | Same |
| 26 | Breath rate | 10 - 40 Breath per minute | 10 - 40 Breath per minute | Same |
| 28Powerrequirements | AC adaptor: 100-240VAC ;50-60 Hzin,19VDC 5.26A outDC adaptor: 12 - 16V DC in,19V 6A out | AC adaptor: 100-240VAC ;50-60 HzIn,19VDC 5.26A outDC adaptor: 12 - 16V DC in,19V 6A out | Same | |
| 29Maximumoxygendischargepressure | P2-S4/P2-K4: 16.0 PSI (110KPa)P2-S3/P2-K3 : 14.1 PSI (97KPa) | 18.3 PSI (126KPa) | Different(See belownoteID_29) | |
| 30Inspiratorytriggersensitivity | -0.12cm/H20 | -0.12cm/H20 | Same | |
| 31Software | Embedded | Embedded | Same | |
| 32Acoustic Noise | P2-S4: 55.3dBA at 0.84 LPMP2-S3: 55.8dBA at 0.63 LPMP2-K4: 55.3dBA at 0.84 LPMP2-K3: 55.1dBA at 0.63 LPM | 58.2 dBA at 1.2 LPM | Different(See belownoteID_32) | |
| 33 | Battery empty | Battery empty | Same | |
| 34 | Low pressure | Low pressure | Same | |
| 35 | No pulse | No pulse | Same | |
| 36 | High Temp | High Temp | Same | |
| 37Alarms | Compressor Failure | Compressor Failure | Same | |
| 38 | Fan Failure | Fan Failure | Same | |
| 39 | Low Flow | Low Flow | Same | |
| 40 | Low Battery | Low Battery | Same | |
| 41 | No Breath Detected | No Breath Detected | Same | |
| 42 | EEPROM Failure | EEPROM Failure | Same | |
| 43Status | Flow rates | Flow rates | Same | |
| 44Indicator | Battery Condition | Battery Condition | Same | |
| 45 | Alarms | Alarms | ||
| 46BatteryDuration | BA-K201:Up to 2.5 hours at 0.21 LPMBA-K200/BA-S200:Up to 4.8 hours at 0.21 LPMBA-K202/BA-S202:Up to 7.2 hours at 0.21 LPM | Up to 4.5 hours at 0.21 LPM | Different(See belownoteID_46) | |
| 47OperatingEnvironment | Temperature: 41 to 104°F (5 to 40°C)Humidity: 10% to 90%, non condensingAltitude: 0 to 10,000 ft. (0 to 3048 meters) | Temperature: 41 to 104°F (5 to 40° C)Humidity: 10% to 90%, non condensingAltitude: 0 to 10,000 ft. (0 to 3048 | Same | |
| meters) | ||||
| 48 | ShippingStorage | Temperature: -4 to 158°F (-20 to70°C)Humidity: 5% to 90%,non-condensingStore in a dry environment | Temperature: -4 to 158°F (-20 to70°C)Humidity: 5% to 90%,non-condensingStore in a dry environment | Same |
| 49 | ElectricalSafety | AAMI ANSI ES 60601-1 | AAMI ANSI ES 60601-1 | Same |
| 50 | Electromagneticcompatibility | IEC 60601-1-2 | IEC 60601-1-2 | Same |
| 51 | Biocompatibility | VOC's less than ambient | VOC's less than ambient | Same |
| 52 | Standards Met | ANSI AAMI ES 60601-1: 2005/A1:2012 and A2:2020IEC 60601-1-2: 2014IEC 60601-1-11: 2015/A1:2020IEC 60601-1-8: 2006/ A1:2012/A2:2020IEC 60601-1-6: 2010/ A1:2013/A2:2020ISO 80601-2-69: 2020ISO 80601-2-67: 2020ISO 18562-2: 2017ISO 18562-3: 2017IEC 62133: 2017ISO 10993-5:2009ISO 10993-10:2021ISO 10993-23:2021 | ANSI AAMI ES 60601-1: 2005/(R) 2012 and A1: 2012IEC 60601-1-2: 2014IEC 60601-1-11: 2015IEC 60601-1-8: 2006+ A1:2012ISO 80601-2-69: 2014ISO 80601-2-67: 2014ISO 18562-2: 2017ISO 18562-3: 2017IEC 62133: 2012ISO 10993-5:2009ISO 10993-10:2010 | The mainequipmentconformsto thelateststandards |
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Note:
ID_22: The max setting of subject device P2-E6 is 6 and of subject device
P2-S4/P2-K4 is 4(P2-K4,P2-S4 has a different appearance),P2-S3/P2-K3 is 3(P2-K4,P2-S4 has a different appearance).Those risks are mitigated by tests tested according to ISO 80601-2-69: 2020, ISO 80601-2-67: 2020 ,ISO 18562-2: 2017, ISO 18562-3: 2017,ISO 10993-5:2009,ISO10993-10:2021 and ISO10993-23:2021 therefore the difference does not raise new questions of safety and effectiveness.
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ID 23: The pulse modebolus size subject device P2-S4/P2-K4/P2-S3/P2-K3 is
smaller than predicate device P2-E6 (K210371).P2-S4/P2-K4,P2-S4 has a different appearance) maximum gear is 4, and the maximum flow rate is 0.84 LPM.P2-S3/P2-K3,P2-K3,P2-S3 has a different appearance) maximum gear is 3,and the maximum flow rate is 0.63 LPM.Those risks are mitigated by tests tested according to ISO 80601-2-67: 2020 therefore the difference does not raise new questions of safety and effectiveness.
ID 29: The Maximum oxygen discharge pressure of subject device P2-S4/P2-K4 and
P2-S3/P2-K3 is different with predicate device P2-E6 (K210371).Since the subject device has been tested against ISO 80601-2-69: 2020 with positive result,the difference of subject device do not raise new questions of safety and effectiveness.
ID 32: The Acoustic Noise of subject device P2-S4/P2-K4/P2-S3/P2-K3 is litter
smaller than predicate device P2-E6 (K210371).Since the subject device has been tested against ISO 80601-2-69: 2020 and ANSI AAMI ES 60601- 1: 2005 /A1:2012 and A2:2020 with positive result,the difference of subject device do not raise new questions of safety and effectiveness.
ID 46: The subject device P2-S4/P2-K4/P2-S3/P2-K3 can be equipped with three
different types of battery, BA-K201 for P2-S4/P2-K4/P2-S3/P2-K3, BA-K200, BA-K202 for P2-K4/P2-K3. BA-S200.BA-S202 for P2-S/P2-S3.Those risks are mitigated by tests tested according to IEC 62133: 2017 therefore the difference does not raise new questions of safety and effectiveness.
IX. Discussion of Non-Clinical Tests Performed for Safety and
effectiveness are as follows
The device has been tested and verified in various phases, internal testing, verification and validation as well as external testing and validation. The design was verified throughout the design process. Risk analysis was done, appropriate measures were implemented and their effectiveness verified. The standard for external test execution are shown in the following table:
| Standards | Standards Name |
|---|---|
| ANSI AAMI ES 60601-1:2005 /A1:2012 andA2:2020 | Medical Electrical Equipment - Part 1: General RequirementsFor Basic Safety And Essential Performance |
| IEC 60601-1-2: 2014 | Medical Electrical Equipment -- Part 1-2: GeneralRequirements For Basic Safety And Essential Performance --Collateral Standard: Electromagnetic Disturbances --Requirements And Tests |
| IEC 60601-1-11:2015/A1:2020 | Medical Electrical Equipment - Part 1-2: GeneralRequirements For Basic Safety And Essential Performance -Collateral Standard: Electromagnetic Disturbances -Requirements And Tests |
| IEC 60601-1-8: 2006/A1:2012 /A2:2020 | Medical electrical equipment - Part 1-8: General requirementsfor basic safety and essential performance - CollateralStandard: General requirements, tests and guidance for alarmsystems in medical electrical equipment and medical electricalsystems |
| IEC 60601-1-6: 2010/A1:2013 /A2:2020 | Medical electrical equipment - Part 1-6: General requirementsfor basic safety and essential performance - Collateralstandard: Usability |
| ISO 80601-2-69: 2020 | Medical electrical equipment. Particular requirements for thebasic safety and essential performance of oxygen concentratorequipment |
| ISO 80601-2-67: 2020 | Medical electrical equipment. Particular requirements forbasic safety and essential performance of oxygen-conservingequipment |
| ISO 18562-2: 2017 | Biocompatibility evaluation of breathing gas pathways inhealthcare applications - Part 3: Tests for emissions of volatileorganic compounds |
| ISO 18562-3: 2017 | Biocompatibility evaluation of breathing gas pathways inhealthcare applications. Tests for emissions of volatile organiccompounds (VOCs) |
| IEC 62133: 2017 | Secondary cells and batteries containing alkaline or othernon-acid electrolytes - Safety requirements for portable sealedsecondary cells, and for batteries made from them, for use inportable applications-Part2: Lithium systems |
| ISO 10993-5:2009 | Biological evaluation of medical devices - Part 5: Tests for invitro cytotoxicity |
| ISO 10993-10:2021 | Biological evaluation of medical devices - Part 10: Tests forskin sensitization |
| ISO 10993-23:2021 | Biological evaluation of medical devices - Part 23:Tests forirritation |
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●Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the subject device.P2-K4,P2-K3,P2-S4,P2-S3. The system complies with the AAMI ANSI
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ES60601-1, IEC 60601-1, IEC 60601-1-8, IEC 60601-1-6, 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.
● Biological compatibility Testing
Biological compatibility testing were conducted on the subject device(P2-S4),The device complies with the ISO 10993-5,ISO 10993-10, ISO 10993-23,ISO 18562-2, ISO 18562-3 standards.
●Battery Testing
The battery equipped with the device is tested according to the IEC62133 standard. The battery meets the IEC622133 standard.
●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.
The test platform ensures compliance to recognized consensus standards and therefore does not raise new questions of safety and effectiveness.
X. Discussion of Clinical Accuracy Testing Performed
There was no clinical testing performed.
XI. Conclusions
The Portable Oxygen Concentrator (Model: P2-K4,P2-K3,P2-S4,P2-S3) have the same intended use and similar characteristics as the cleared predicate device Portable Oxygen Concentrator, model: P2-E6. Moreover, bench testing contained in this submission supplied demonstrate that the differences existed between Portable Oxygen Concentrator (Model: P2-K4,P2-K3,P2-S4,P2-S3) and Portable Oxygen Concentrator, model: P2-E6 (K210371) do not raise any new questions of safety or effectiveness.
The non-clinical tests support the safety of the device and the hardware and software verification and validation demonstrate that the Portable Oxygen Concentrator (Model: P2-K4,P2-K3,P2-S4,P2-S3) performs as intended in the specified use conditions are same with predicate device. The performance tests demonstrate that the Portable Oxygen Concentrator (Model: P2-K4,P2-K3,P2-S4,P2-S3) performs comparably to the predicate device that is currently marketed for the same intended use. Thus,
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Portable Oxygen Concentrator (Model: P2-K4,P2-K3,P2-S4,P2-S3) is Substantially Equivalent (SE) to the predicate device.
§ 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).