(218 days)
No
The description focuses on the physical mechanism of oxygen concentration (molecular sieve) and standard electronic components (compressor, battery, solenoid valve, circuit control system, etc.). There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies summary.
Yes
The device description explicitly states "Portable Oxygen Concentrator ... is a portable oxygen generator that is intended to release oxygen for respiratory therapy." "Respiratory therapy" indicates a therapeutic purpose.
No
The device is an oxygen concentrator intended to provide supplemental oxygen, which is a therapeutic function, not a diagnostic one. It does not mention any capabilities for detecting, monitoring, or diagnosing medical conditions.
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 embedded software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body ("in vitro").
- Device Function: The Portable Oxygen Concentrator described here is a therapeutic device. It provides supplemental oxygen directly to the patient's respiratory system. It does not analyze any biological samples.
- Intended Use: The intended use clearly states it's for providing supplemental oxygen for respiratory therapy.
The description focuses on the physical mechanism of generating oxygen and delivering it to the patient, not on analyzing biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
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.
Product codes
CAW
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.
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)
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.
- Electrical safety and electromagnetic compatibility (EMC) testing were conducted on the subject device.P2-K4,P2-K3,P2-S4,P2-S3. The system complies with the AAMI ANSI 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 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.
- The battery equipped with the device is tested according to the IEC62133 standard. The battery meets the IEC622133 standard.
- 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.
- There was no clinical testing performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). 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).
1
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
2
Enclosure
3
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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4
510(k) Summary as required by section 807.92(c)
I. Date of the summary prepared: 15/08/2023
II. Administrative Information
| Manufacturer
information | Establishment registration
number | 3014777423 |
|-----------------------------|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Owner/Operator
Number | 10061814 |
| | 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 | Name: Benrong Zhang
Address: Room 301-302, No.15
HanchengRoad, Qingdao Free
Trade Zone, Shandong, China, 266555
TEL: +86-18565833539
FAX: +86 532 58792324
Email: augus@kingonmed.com |
| | Submission
Correspondent | 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 |
5
| (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.
6
| 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 same | ||||
| appearance. | P2-S4 and P2-S3 have the same | |||
| appearance. | ||||
| 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.
7
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 | Comparis
on |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| D | Items | | | |
| 1 | 510K Number | / | K210371 | / |
| 2 | Manufacturer | Qingdao Kingon Medical Science and
Technology Co., Ltd. | Qingdao Kingon Medical Science
and 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 for
Use | The 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. | The Portable Oxygen Concentrator,
model: P2-E6 is intended to provide
supplemental oxygen in a home,
institutional, or travel environment. | Same |
| 9 | Environment
of Use | Home, institutional, or travel
environment. | Home, institutional, or travel
environment. | Same |
| 10 | Design | Table type | Table type | Same |
| 11 | Prescriptive | Yes | Yes | Same |
| 12 | Patient
Population | Adult | Adult | Same |
| 13 | Material of
Patient
contact
components | Wiring cover: PC+ABS
Intake hood: PC+ABS
Nozzle fitting: Aluminum alloy
Button panel: PET
Main housing: PC+ABS | Wiring cover: PC+ABS
Intake hood: PC+ABS
Nozzle fitting: Aluminum alloy
Button panel: PET
Main housing: PC+ABS | Same |
| 14 | Duration and
type of contact | Type of contact: surface device;
Duration: permanent (> 30 d); | Type of contact: surface device;
Duration: permanent (> 30 d); | Same |
| 15 | Complete list
of all the
biocompatibili
ty tests | ISO 10993- 5 tested for Cytotoxicity;
ISO 10993-10 tested for Skin
Sensitization;
ISO 10993-23 tested for Skin | ISO 10993- 5 tested for
Cytotoxicity;
ISO 10993-10 tested for
Sensitization | Same |
| | performed | Irritation;
ISO 18562-2 tested for Particulate
matter;
ISO 18562-3 tested for Volatile
organic Compounds; | and Irritation;
ISO 18562-2 tested for Particulate
matter;
ISO 18562-3 tested for Volatile
organic Compounds; | |
| 16 | Single Patient,
multi-use | Yes | Yes | Same |
| 17 | Patient
Interface | Cannula Port | Cannula Port | Same |
| 18 | Technology | Pressure Swing Adsorption with
molecular sieve | Pressure Swing Adsorption with
molecular sieve | Same |
| 19 | Dimensions | P2-S4/P2-S3:6.69"H3.39"W6.18"L
P2-K4/P2-K3:6.69"H3.39"W5.51"L | 6.30"H3.35"W8.70"L | Subject
device is
smaller
and more
portable |
| 20 | Weight | 3.31lbs±0.07lbs (with BA-K201
battery) | 4.34lbs±0.07lbs (with standard
battery) | Subject
device
weighs
less than
Predicate
device |
| 21 | Oxygen
Concentration | 90%-3%/+6% at all settings | 90%-3%/+6% at all settings | Same |
| 22 | Setting | P2-S4/P2-K4: adjustable in
increments from 1 to 4.
P2-S3/P2-K3: adjustable in
increments from 1 to 3. | Adjustable in increments from 1
to 6 | Different
(See below
note
ID_22) |
| 23 | Pulse mode
bolus size | P2-S4/P2-K4: 42 mL per breath at
setting 4 with 20 BPM
P2-S3/P2-K3: 31.5 mL per breath at
setting 3 with 20 BPM | 60 mL per breath at setting 6 with
20BPM | Different
(See below
note
ID_23) |
| 24 | Principle of
operation | 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 |
| | | | | |
| 28
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: 100-240VAC ;50-60 Hz
In,19VDC 5.26A out
DC adaptor: 12 - 16V DC in,19V 6A out | Same | |
| 29
Maximum
oxygen
discharge
pressure | P2-S4/P2-K4: 16.0 PSI (110KPa)
P2-S3/P2-K3 : 14.1 PSI (97KPa) | 18.3 PSI (126KPa) | Different
(See below
note
ID_29) | |
| 30
Inspiratory
trigger
sensitivity | -0.12cm/H20 | -0.12cm/H20 | Same | |
| 31
Software | Embedded | Embedded | Same | |
| 32
Acoustic Noise | P2-S4: 55.3dBA at 0.84 LPM
P2-S3: 55.8dBA at 0.63 LPM
P2-K4: 55.3dBA at 0.84 LPM
P2-K3: 55.1dBA at 0.63 LPM | 58.2 dBA at 1.2 LPM | Different
(See below
note
ID_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 | |
| 37
Alarms | 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 | |
| 43
Status | Flow rates | Flow rates | Same | |
| 44
Indicator | Battery Condition | Battery Condition | Same | |
| 45 | Alarms | Alarms | | |
| 46
Battery
Duration | BA-K201:Up to 2.5 hours at 0.21 LPM
BA-K200/BA-S200:Up to 4.8 hours at 0.21 LPM
BA-K202/BA-S202:Up to 7.2 hours at 0.21 LPM | Up to 4.5 hours at 0.21 LPM | Different
(See below
note
ID_46) | |
| 47
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) | Temperature: 41 to 104°F (5 to 40° C)
Humidity: 10% to 90%, non condensing
Altitude: 0 to 10,000 ft. (0 to 3048 | Same | |
| | | | meters) | |
| 48 | Shipping
Storage | Temperature: -4 to 158°F (-20 to
70°C)
Humidity: 5% to 90%,
non-condensing
Store in a dry environment | Temperature: -4 to 158°F (-20 to
70°C)
Humidity: 5% to 90%,
non-condensing
Store in a dry environment | Same |
| 49 | Electrical
Safety | AAMI ANSI ES 60601-1 | AAMI ANSI ES 60601-1 | Same |
| 50 | Electromagnetic
compatibility | 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 A2:2020
IEC 60601-1-2: 2014
IEC 60601-1-11: 2015/A1:2020
IEC 60601-1-8: 2006/ A1:2012
/A2:2020
IEC 60601-1-6: 2010/ A1:2013
/A2:2020
ISO 80601-2-69: 2020
ISO 80601-2-67: 2020
ISO 18562-2: 2017
ISO 18562-3: 2017
IEC 62133: 2017
ISO 10993-5:2009
ISO 10993-10:2021
ISO 10993-23:2021 | 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
ISO 10993-10:2010 | The main
equipment
conforms
to the
latest
standards |
8
9
10
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.
11
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 and | |
| A2:2020 | 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/A1:2020 | 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 /A2:2020 | 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 | |
| IEC 60601-1-6: 2010/ | |
| A1:2013 /A2:2020 | Medical electrical equipment - Part 1-6: General requirements |
| for basic safety and essential performance - Collateral | |
| standard: Usability | |
| ISO 80601-2-69: 2020 | Medical electrical equipment. Particular requirements for the |
| basic safety and essential performance of oxygen concentrator | |
| equipment | |
| ISO 80601-2-67: 2020 | 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: 2017 | 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-Part2: Lithium systems | |
| ISO 10993-5:2009 | Biological evaluation of medical devices - Part 5: Tests for in |
| vitro cytotoxicity | |
| ISO 10993-10:2021 | Biological evaluation of medical devices - Part 10: Tests for |
| skin sensitization | |
| ISO 10993-23:2021 | Biological evaluation of medical devices - Part 23:Tests for |
| irritation |
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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.