Portable Oxygen Concentrator (Model: P2-E7, P2-E) is a portable oxygen generator that is intended to release oxygen for respiratory 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.

Model difference: The only different between model P2-E7 and P2-E is that P2-E7 has biggest output oxygen flow of 1.4L/min (at 7 gears) and P2-E has biggest output oxygen flow of 1.0L/min (at 5 gears).

AI/ML Overview

The provided document is a 510(k) Summary for a Portable Oxygen Concentrator. It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence for regulatory clearance. It does not present information about a study that assesses the device's performance against clinical acceptance criteria using human subjects or an AI algorithm.

Therefore, I cannot provide the requested information regarding:

A table of acceptance criteria and reported device performance (in a clinical context).
Sample size used for a test set or data provenance related to clinical performance.
Number of experts or their qualifications for establishing ground truth for a clinical test set.
Adjudication method for a clinical test set.
MRMC comparative effectiveness study or related effect sizes.
Standalone (algorithm only) performance.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for clinical evaluation.
Sample size for a training set (as no AI algorithm requiring a training set is discussed).
How ground truth for a training set was established.

The document focuses on non-clinical testing and engineering standards to demonstrate safety and effectiveness, and substantial equivalence to a predicate device, not clinical performance against acceptance criteria in a human study, nor does it involve an AI component.

The relevant information from the document related to testing and "acceptance" is as follows:

Acceptance Criteria (Implied by Standards and Comparison to Predicate):

While not explicitly stated as "acceptance criteria" in a clinical performance sense, the document demonstrates the device meets various safety, performance, and compatibility standards. The "reported device performance" in this context refers to the device's adherence to these standards and its characteristics in comparison to the predicate.

Acceptance Criteria (Standard/Characteristic)	Reported Device Performance (Adherence/Values)
Safety Standards Adherence:
ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 (Medical Electrical Equipment - General Requirements For Basic Safety And Essential Performance)	Complies with the standard.
IEC 60601-1-2: 2014 (EMC)	Complies with the standard.
IEC 60601-1-11: 2015 (Requirements for Medical Electrical Equipment and Medical Electrical Systems used in the home healthcare environment)	Complies with the standard.
IEC 60601-1-8: 2006+A1:2012 (Alarm Systems)	Complies with the standard.
ISO 80601-2-69: 2014 (Particular requirements for the basic safety and essential performance of oxygen concentrator equipment)	Complies with the standard. Specifically, risks from increased output flow (P2-E7) were mitigated by tests according to this standard. Maximum oxygen discharge pressure differences (ID_29) were also validated against this standard. Acoustic Noise differences (ID_32) also validated against this standard.
ISO 80601-2-67: 2014 (Particular requirements for basic safety and essential performance of oxygen-conserving equipment)	Complies with the standard.
IEC 62133: 2012 (Secondary cells and batteries, Safety requirements)	Complies with the standard.
Biocompatibility Standards Adherence:
ISO 10993-5:2009 (Tests for in vitro cytotoxicity)	Tested for Cytotoxicity; Complies with the standard.
ISO 10993-10:2010 (Tests for irritation and skin sensitization)	Tested for Sensitization and Irritation; Complies with the standard.
ISO 18562-2: 2017 (Biocompatibility evaluation of breathing gas pathways - Particulate matter)	Tested for Particulate matter; Complies with the standard. Specifically, risks from increased particulate matter (P2-E7) were mitigated by tests according to this standard.
ISO 18562-3: 2017 (Biocompatibility evaluation of breathing gas pathways - Emissions of volatile organic compounds (VOCs))	Tested for Volatile Organic Compounds; Complies with the standard (4 VOC's less than ambient).
Software Standards Adherence:
IEC 62304:2006+A1:2015 (Medical device software - Software life cycle processes)	Complies with the standard. Software verification and validation performed in accordance with FDA guidance for "moderate" level of concern. No failures or latent flaws expected to result in minor injury.
Functional Performance (compared to predicate, within acceptable differences):
Oxygen Concentration	90%-3%/+6% at all settings (Same as predicate)
Pulse mode bolus size	P2-E7: 50mL per breath at setting 5 with 20BPM; P2-E: 50mL per breath at setting 5 with 20BPM (Same as predicate)
Breath rate	10 - 40 Breath per minute (Same as predicate)
Battery Duration	P2-E7: Up to 4.5 hours at 0.21 LPM; P2-E: Up to 4.5 hours at 0.21 LPM (Same as predicate)
Operating Environment (Temperature, Humidity, Altitude) and Shipping/Storage Environment (Temperature, Humidity)	Same as predicate; device performs as intended in these conditions. Examples: Operating 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).
Maximum oxygen discharge pressure (P2-E7, P2-E vs. P2-E6 predicate: 18.3 PSI (126KPa))	P2-E7: 20.6 PSI (142KPa); P2-E: 20.9 PSI (144KPa). Differences reviewed and do not raise new questions of safety and effectiveness as validated by ISO 80601-2-69: 2014 tests.
Acoustic Noise (P2-E7, P2-E vs. P2-E6 predicate: 58.2 dBA at 1.2 LPM)	P2-E7: 58.8 dBA at 1.4 LPM; P2-E: 52.0 dBA at 1.0 LPM. Differences reviewed and do not raise new questions of safety and effectiveness as validated by ISO 80601-2-69: 2014 and ANSI AAMI ES60601-1 tests.
Settings (P2-E7: 1 to 7; P2-E: 1 to 5 vs. P2-E6 predicate: 1 to 6)	P2-E7 has an extra setting (7). The risks associated with this (increased output flow, increased emission of particulate matter) were mitigated by tests according to ISO 80601-2-69: 2014, ISO 80601-2-67: 2014 and ISO 18562-2: 2017. Therefore, the difference does not raise new questions of safety and effectiveness.

Study Proving Device Meets Criteria:

The "study" in this context refers to the non-clinical testing and validation performed to demonstrate substantial equivalence and adherence to recognized standards.

A table of acceptance criteria and the reported device performance: See table above.
Sample sized used for the test set and the data provenance: Not applicable in the context of human clinical data for this submission. The "test sets" refer to the specific units of the device models (P2-E7, P2-E) subjected to various engineering and functional tests. The data provenance is from Qingdao Kingon Medical Science and Technology Co., Ltd. (China) through bench testing. The document refers to "non-clinical tests performed." The testing is retrospective in the sense that the results were submitted for regulatory review after completion.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in this context, is established by adherence to internationally recognized engineering and medical device standards (e.g., ISO, IEC, AAMI ANSI) and direct measurement of device characteristics. The expertise would lie in the engineers and testing personnel who conducted these standard tests.
Adjudication method: Not applicable. Standard technical testing and comparison against predicate.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This type of study is for evaluating human performance, often with or without AI assistance, in diagnostic tasks. This device is a portable oxygen concentrator, not an imaging or diagnostic AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The "software" in this device controls hardware functions (e.g., alarms, breath detection, display) and is deeply embedded, not a standalone AI algorithm for interpretation or diagnosis.
The type of ground truth used: For hardware performance, the ground truth is defined by the specifications in the relevant industry standards (e.g., oxygen concentration, pressure, noise levels) and the functional requirements of the device. For software, the "ground truth" is adherence to software development life cycle processes (IEC 62304) and correct execution of defined functions without critical errors.
The sample size for the training set: Not applicable. This device does not use an AI algorithm that requires a training set in the typical machine learning sense. The software is embedded control software.
How the ground truth for the training set was established: Not applicable. See point 8.

Summary

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June 22, 2023

Qingdao Kingon Medical Science and Technology Co., Ltd. Zhang Benrong Technical Supervisor RM.1711, Building K, NO.101 Science Ave International Creative Valley Qingdao Free Trade Zone, Shandong 266555 China

Re: K223379

Trade/Device Name: Portable Oxygen Concentrator (Model: P2-E7, P2-E) Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: Class II Product Code: CAW Dated: May 24, 2023 Received: May 24, 2023

Dear Zhang Benrong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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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 and Part 809); 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,

Ting Song -S

For James J. Lee, Ph.D. 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 Ouality Center for Devices and Radiological Health Enclosure

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Indications for Use

510(k) Number (if known) K223379

Device Name

Portable Oxygen Concentrator (Model: P2-E7, P2-E)

Indications for Use (Describe)

The Portable Oxygen Concentrator (Model: P2-E7, P2-E) is intended to provide supplemental oxygen in a home, institutional, or travel environment.

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)

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)

Date of the summary prepared: 10/30/2022 l.

Administrative Information ll.

Manufacturerinformation	Establishmentregistrationnumber	3014777423
	Owner/OperatorNumber	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 ZhangAddress: Room 301-302, No.15 HanchengRoad, Qingdao Free Trade Zone, Shandong, China, 266555TEL: +86-18565833539FAX: +86 532 58792324Email: augus@kingonmed.com
SubmissionCorrespondent	Contact Person	Name: Tracy NananAddress: Room 301-302, No.15 HanchengRoad, Qingdao Free Trade Zone, Shandong, China, 266555TEL: +86-18565833539FAX: +86 532 58792324Email: ptg2022ptg@163.com

III. Device Information

Type of 510(k)	Special 510(k): Device Modification
Prior submission	No prior submission
Common Name	Generator, Oxygen, Portable
Classification name	Portable oxygen generator
Trade Name	Portable Oxygen Concentrator (Model: P2-E7, P2-E)
Review panel	Anesthesiology

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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

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VI. Principle of operation

Both model P2-E7 and P2-E 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 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.

VII. Indications for Use

The Portable Oxygen Concentrator (Model: P2-E7, P2-E) is intended to provide supplemental oxygen in a home, institutional, or travel environment.

ID	ComparisonItems	Subject device	Predicate device	Comparison
1.	510K Number	/	K210371	/
2.	Manufacturer	Qingdao Kingon Medical Science andTechnology Co., Ltd.	Qingdao Kingon Medical Science andTechnology Co., Ltd.	Same
3.	Device name	Portable Oxygen Concentrator	Portable Oxygen Concentrator	/
4.	Model	P2-E7, P2-E	P2-E6	/
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-E7, P2-E) is intended toprovide supplemental oxygen in ahome, institutional, or travelenvironment.	The Portable Oxygen Concentrator,model: P2-E6 is intended to providesupplemental oxygen in a home,institutional, or travel environment.	Same
9.	Environment ofUse	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 ofPatient contactcomponents	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 list ofall thebiocompatibilitytests performed	ISO 10993- 5 tested for Cytotoxicity;ISO 10993-10 tested for Sensitizationand Irritation;ISO 18562-2 tested for Particulatematter;ISO 18562-3 tested for Volatileorganic Compounds;	ISO 10993- 5 tested for Cytotoxicity;ISO 10993-10 tested for Sensitizationand Irritation;ISO 18562-2 tested for Particulatematter;ISO 18562-3 tested for Volatileorganic Compounds;	Same
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	6.30"H3.35"W8.70"L	6.30"H3.35"W8.70"L	Same
20.	Weight	4.34lbs±0.07lbs (with standardbattery)	4.34lbs±0.07lbs (with standardbattery)	Same
21.	OxygenConcentration	90%-3%/+6% at all settings	90%-3%/+6% at all settings	Same
22.	Setting	P2-E7: adjustable in 1 incrementsfrom 1 to 7.P2-E: adjustable in 1 increments from1 to 5.	adjustable in 1 increments from 1 to 6	Different(See below noteID_22)
23.	Pulse modebolus size	P2-E7: 50mL per breath at setting 5with 20BPMP2-E: 50mL per breath at setting 5with 20BPM	50mL per breath at setting 5 with20BPM	Same
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
27.	User Interface	Buttons, LCD Display	Buttons, LCD Display	Same
28.	Powerrequirements	AC adaptor: 100-240VAC ;50-60 Hz	AC adaptor: 100-240VAC ;50-60 Hz	Same
29.	Maximumoxygendischargepressure	P2-E7: 20.6 PSI (142KPa)P2-E: 20.9 PSI (144KPa)	18.3 PSI (126KPa)	Different(See below noteID_29)
30.	Inspiratorytriggersensitivity	-0.12cm/H20	-0.12cm/H20	Same
31.	Software	Embedded	Embedded	Same
32.	Acoustic Noise	P2-E7: 58.8 dBA at 1.4 LPMP2-E: 52.0 dBA at 1.0 LPM	58.2 dBA at 1.2 LPM	Different(See below noteID_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.		Compressor Failure	Compressor Failure	Same
38.	Alarms	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.		Flow rates	Flow rates	Same
44.	Status Indicator	Battery Condition	Battery Condition	Same
45.		Alarms	Alarms	Same
46.	BatteryDuration	P2-E7: Up to 4.5 hours at 0.21 LPMP2-E: Up to 4.5 hours at 0.21 LPM	Up to 4.5 hours at 0.21 LPM	Same
47.	OperatingEnvironment	Temperature: 41 to 104°F (5 to 40°C)Humidity: 10% to 90%, non-condensingAltitude: 0 to 10,000 ft. (0 to 3048meters)	Temperature: 41 to 104°F (5 to 40°C)Humidity: 10% to 90%, non-condensingAltitude: 0 to 10,000 ft. (0 to 3048meters)	Same
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.	Electrical Safety	AAMI ANSI ES 60601-1	AAMI ANSI ES 60601-1	Same
50.	electromagneticcompatibility	IEC 60601-1-2	IEC 60601-1-2	Same
51.	Biocompatibility	4 VOC's less than ambient	4 VOC's less than ambient	Same
52.	Standards Met	ANSI AAMI ES 60601- 1: 2005 / (R)2012 and A1: 2012	ANSI AAMI ES 60601- 1: 2005 / (R)2012 and A1: 2012	Same
		IEC 60601-1-2: 2014	IEC 60601-1-2: 2014
		IEC 60601-1-11: 2015	IEC 60601-1-11: 2015
		IEC 60601-1-8: 2006+ A1:2012	IEC 60601-1-8: 2006+ A1:2012
		ISO 80601-2-69: 2014	ISO 80601-2-69: 2014
		ISO 80601-2-67: 2014	ISO 80601-2-67: 2014
		ISO 18562-2: 2017	ISO 18562-2: 2017
		ISO 18562-3: 2017	ISO 18562-3: 2017
		IEC 62133: 2012	IEC 62133: 2012
		ISO 10993-5:2009ISO 10993-10:2010	ISO 10993-5:2009ISO 10993-10:2010

VIII. Comparison with predicate device

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kıngon

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Note:

ID 22: The max setting of subject device P2-E7 is 7 and of subject device P2-E is 5 while the predicate device is 6, the extra setting 7 of P2-E7 introduce risks of increased output flow and increased Emission of particulate matter of gas pass way, those risks are mitigated by tests tested according to ISO 80601-2-69: 2014, ISO 80601-2-67: 2014 and ISO 18562-2: 2017, therefore the difference does not raise new questions of safety and effectiveness.
ID_29: The Maximum oxygen discharge pressure of subject device P2-E is different with predicate device P2-E6 (K210371), since the subject device has been tested against ISO 80601-2-69: 2014 with positive result, the difference of subject device with predicate device RS-00500 (K162433) do not raise new questions of safety and effectiveness.
ID 32: The Acoustic Noise of subject device P2-E7 is litter bigger than predicate device P2-E6 (K210371) and subject device P2-E is litter smaller than predicate device P2-E6 (K210371), since the subject device P2-E7 has been tested against ISO 80601-2-69: 2014 and ANSI AAMI ES60601-1 with positive results, the difference of subject device with predicate device P2-E6 (K210371) do not raise new questions of safety and effectiveness.

IX. Discussion of Non-Clinical Tests Performed for Safety and effectiveness are as

follows

The recognized consensus standards for safety of medical equipment: ANSI AAMI ES60601 -1, IEC 60601 - 1 - 1 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:

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kıngo'n

Standards	Standards Name
ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012	Medical Electrical Equipment - Part 1: General Requirements ForBasic Safety And Essential Performance
IEC 60601-1-2: 2014	Medical Electrical Equipment - Part 1-2: General Requirements ForBasic Safety And Essential Performance - Collateral Standard:Electromagnetic Disturbances - Requirements And Tests
IEC 60601-1-11: 2015	Medical Electrical Equipment - Part 1-2: General Requirements ForBasic 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 forbasic safety and essential performance - Collateral Standard:General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
ISO 80601-2-69: 2014	Medical electrical equipment. Particular requirements for the basicsafety and essential performance of oxygen concentratorequipment
ISO 80601-2-67: 2014	Medical electrical equipment. Particular requirements for basicsafety and essential performance of oxygen-conserving equipment
ISO 18562-2: 2017	Biocompatibility evaluation of breathing gas pathways in healthcareapplications - Part 3: Tests for emissions of volatile organiccompounds
ISO 18562-3: 2017	Biocompatibility evaluation of breathing gas pathways in healthcareapplications. Tests for emissions of volatile organic compounds(VOCs)
IEC 62133: 2012	Secondary cells and batteries containing alkaline or other non-acidelectrolytes - Safety requirements for portable sealed secondarycells, and for batteries made from them, for use in portableapplications
ISO 10993-5:2009	Biological evaluation of medical devices - Part 5: Tests for in vitrocytotoxicity
ISO 10993-10:2010	Biological evaluation of medical devices - Part 10: Tests for irritationand 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.

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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 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, display task, monitor task, startup task, breath task, as well as dealing with USART1-interrupt, USART2-interrupt, WDT-interrupt, and controlling the sensor module.

A Programming language
STMicroelectronics and Texas Instruments.
Hardware platform
a) Applicable Device Name: Portable Oxygen Concentrator
b) Applicable model: P2-E7, P2-E
Micro-controller used: STM32F103RCT6, STM32F103C8T6, MSP430G2755 C)
ROM Size: STM32F103RCT6 256K, STM32F103C8T6 64K, MSP430G2755 32K ರು)
RAM Size: STM32F103RCT6 48K, STM32F103C8T6 20K, MSP430G2755 -4K e)
Software Release Version Number: Keil uVision5 V5.25.20, IRA for 430 V7.12.1 f)

X. Discussion of Clinical Accuracy Testing Performed

There was no clinical testing performed.

XI. Conclusions

The Portable Oxygen Concentrator (Model: P2-E7, P2-E) 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-E7, P2-E) 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 software verification and validation demonstrate that the Portable Oxygen Concentrator (Model: P2-E7, P2-E) performs as intended in the specified use conditions are same with predicate device. The performance tests demonstrate that the Portable Oxygen Concentrator (Model: P2-E7, P2-E) performs comparably to the predicate device that is currently marketed for the same intended use. Thus, Portable Oxygen Concentrator (Model: P2-E7, P2-E) is Substantially Equivalent (SE) to the predicate device.

Regulation Number and Section

§ 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).