(290 days)
The Oxygen Concentrator is used on a prescriptive basis by patients requiring supplemental oxygen. 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 is intended to provide supplemental oxygen in a home, institutional, or travel environment (not include emergency medical services environment). The oxygen concentrator for adult use, providing pulsed oxygen flow.
Portable Oxygen Concentrator, model: JAY-1000P 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 JAY-1000P 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.
N/A
FDA 510(k) Clearance Letter - Portable Oxygen Concentrator (JAY-1000P)
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
September 29, 2025
Longfian Scitech Co., Ltd
℅ Ivy Wang
Technical Manager
Shanghai SUNGO Management Consulting Co., Ltd.
Room 1401, Dongfang Building, 1500# Century Ave.
Shanghai, 200122
China
Re: K243833
Trade/Device Name: Portable oxygen concentrator (JAY-1000P)
Regulation Number: 21 CFR 868.5440
Regulation Name: Portable Oxygen Generator
Regulatory Class: Class II
Product Code: CAW
Dated: September 25, 2025
Received: September 25, 2025
Dear Ivy Wang:
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"
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K243833 - Ivy Wang Page 2
(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).
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 QS 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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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.
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K243833 - Ivy Wang Page 3
See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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 Anesthesia, Respiratory, and Sleep Devices
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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FORM FDA 3881 (8/23) Page 1 of 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K243833
Device Name: Portable oxygen concentrator (JAY-1000P)
Indications for Use (Describe):
The Oxygen Concentrator is used on a prescriptive basis by patients requiring supplemental oxygen. 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 is intended to provide supplemental oxygen in a home, institutional, or travel environment (not include emergency medical services environment). The oxygen concentrator for adult use, providing pulsed oxygen flow.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
510(k) Summary
I. SUBMITTER
Name: LONGFIAN SCITECH CO., LTD
Address: Building B5,Kechuang Branch,National University Science Park,No.666 Lixing Street,Baoding, Hebei, China
Name of contact person: Shi Lei
Telephone: +86-18931272456
Email: Lei0755@126.com
Date prepared: 2025-09-22
Submission Correspondent:
Primary contact: Ms. Ivy Wang
Shanghai SUNGO Management Consulting Co., Ltd.
14th floor, 1500# Century Ave., Shanghai 200122, China
Tel: +86-21-58817802
Email: haiyu.wang@sungoglobal.com
Secondary contact: Mr. Raymond Luo
14th floor, 1500# Century Ave., Shanghai 200122, China
Tel: +86-21-68828050
Email: zxfda@sungoglobal.com
II. Device
Device trade name: Portable oxygen concentrator
Model: JAY-1000P
Common name: Portable oxygen concentrator
Classification name: Generator, Oxygen, Portable
Regulation class: 2
Regulation number: 21CFR 868.5440
Panel: Anesthesiology
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Product code: CAW
III. Predicate device
Predicate device: K210371
Portable Oxygen Concentrator, model: P2-E6
Qingdao Kingon Medical Science and Technology Co., Ltd.
Reference device 1: K242736
Portable Oxygen Concentrator, model: Spirit-3
Jiangsu Yuyue Medical Equipment & Supply Co., LTD.
Reference device 2: K111885
Respironics SimplyGo Mini Oxygen Concentrator
Respironics, Inc.
IV. Device description
Portable Oxygen Concentrator, model: JAY-1000P 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 JAY-1000P 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.
V. Indication for use
The Oxygen Concentrator is used on a prescriptive basis by patients requiring supplemental oxygen. 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 is intended to provide supplemental oxygen in a home, institutional, or travel environment (not include emergency medical services environment). The oxygen concentrator for adult use, providing pulsed oxygen flow.
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VI. Comparison of technological characteristics with the predicate device
| Attribute | Subject device | Predicate device | Reference device 1 | Reference device 2 | Discussion/Conclusion |
|---|---|---|---|---|---|
| Manufacturer | LONGFIAN SCITECH CO., LTD | Qingdao Kingon Medical Science and Technology Co., Ltd. | Jiangsu Yuyue Medical Equipment & Supply Co., LTD. | Respironics, Inc. | / |
| Proprietary name, model | Portable oxygen concentrator Model: JAY-1000P | Portable Oxygen Concentrator, model: P2-E6 | Portable Oxygen Concentrator, model: Spirit-3 | Respironics SimplyGo Mini Oxygen Concentrator | / |
| 510(k) number | K243833 | K210371 | K242736 | K111885 | / |
| Device classification name | Class II | Class II | Class II | Class II | Same |
| Classification regulations | 21 CFR 868.5440 | 21 CFR 868.5440 | 21 CFR 868.5440 | 21 CFR 868.5440 | Same |
| Product code | CAW | CAW | CAW | CAW | Same |
| Indication for use | The Oxygen Concentrator is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal | The Portable Oxygen Concentrator, model: P2-E6 is intended to provide supplemental oxygen in a home, institutional, or travel environment. | The Portable Oxygen Concentrator, model: Spirit-3, is intended to provide supplemental oxygen in a home, institutional, or travel environment. | The Nuvo Nano Portable Oxygen Concentrator is for prescription use by patients requiring high concentrations of oxygen on a | Same |
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| Attribute | Subject device | Predicate device | Reference device 1 | Reference device 2 | Discussion/Conclusion |
|---|---|---|---|---|---|
| cannula to channel oxygen from the concentrator to the patient. The Portable Oxygen Concentrator is intended to provide supplemental oxygen in a home, institutional, or travel environment (not include emergency medical services environment). The oxygen concentrator for adult use, providing pulsed oxygen flow. | And the device is used with adult only, not used with pediatrics, infant, or neonate patients, etc. | supplemental basis. It is small, portable, and is capable of continuous use in the home, institutional, and travel / mobile environments. | |||
| Environment of use | Home, institutional, or travel environment. | Home, institutional, or travel environment. | Home, institutional, or travel environment. | Home, institutional, or travel environment. | Same |
| Design | Table type | Table type | Table type | Table type | Same |
| Prescriptive | Yes | Yes | Yes | Yes | Same |
| Patient population | Adult | Adult | Adult | Adult | Same |
| Material of patient contact components | Interface panel and button: PET Main housing: PC+ABS Nozzle fitting: Aluminum alloy | Wiring cover: PC+ABS Intake hood: PC+ABS Nozzle fitting: Aluminum alloy Top cover: PC/PMMA Coextruded film Housing shell: ABS | Button panel: PET Main housing: PC+ABS | Not publicly available | Discussion 1 |
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| Attribute | Subject device | Predicate device | Reference device 1 | Reference device 2 | Discussion/Conclusion |
|---|---|---|---|---|---|
| Duration and type of contact | surface device; Duration: permanent (> 30 d); | surface device; Duration: permanent (> 30 d); | surface device; Duration: permanent (> 30 d); | surface device; Duration: permanent (> 30 d); | Same |
| Biocompatibility tests performed | ISO 10993- 5 tested for Cytotoxicity; ISO 10993-10 tested for Sensitization; ISO 10993-23 tested for Irritation; ISO 18562-2 tested for Particulate matter; ISO 18562-3 tested for Volatile organic Compounds; | ISO 10993- 5 tested for Cytotoxicity; ISO 10993-10 tested for Sensitization and Irritation; ISO 18562-2 tested for Particulate matter; ISO 18562-3 tested for Volatile organic Compounds; | ISO 10993- 5 tested for Cytotoxicity; ISO 10993-10 tested for Sensitization and Irritation; ISO 18562-2 tested for Particulate matter; ISO 18562-3 tested for Volatile organic Compounds; | ISO 10993-1 / ISO 10993-10 / ISO 10993-5 ISO 18562-1 / ISO 18562-2 / ISO 18562-3 | Discussion 2 |
| Single patient, multi-use | Yes | Yes | Yes | Yes | Same |
| Patient interface | Cannula Port | Cannula Port | Cannula Port | Cannula Port | Same |
| Technology | Pressure Swing Adsorption with molecular sieve | Pressure Swing Adsorption with molecular sieve | Pressure Swing Adsorption with molecular sieve | Pressure Swing Adsorption with molecular sieve | Same |
| Dimensions | 183Lx86Wx199H mm (7.20"L3.38"W7.83"H) | 6.30"H3.35"W8.70"L | 22 × 8 × 22 (cm) | 9.4 in x 8.3 in x 3.6 in (std battery) | Discussion 3 |
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| Attribute | Subject device | Predicate device | Reference device 1 | Reference device 2 | Discussion/Conclusion |
|---|---|---|---|---|---|
| Weight | 1.98±0.3kgs (4.36lbs±0.66lbs) | 4.34lbs±0.07Ibs (with standard battery) | 2.4 kg (with battery) | 5.0 lbs (std battery) | Discussion 4 |
| Oxygen concentration | 93±3%at all settings | 90%-3%/+6% at all settings | 90%-3%/+6% at all settings | At least 87% at all settings (maximum of 96%) | Discussion 5 |
| Setting | 5 settings: 1-5 settings | 6 settings: adjustable in 1 increment from 1 to 6 | 4 settings: adjustable in 1 increments from 1 to 4 | 5 settings: 1-5 settings | Discussion 6 |
| Flow rates | 0.2L to 1.0L LPM from setting 1 to setting 5 | 0.21 to 1.2 LPM from setting 1 to setting 6 | Not available | Not available | Discussion 7 |
| Principle of operation | By means of molecular sieve | By means of molecular sieve | By means of molecular sieve | By means of molecular sieve | Same |
| Filters | Input Filter, Patient Filter | Input Filter, Patient Filter | Input Filter, Patient Filter | Input Filter, Patient Filter | Same |
| Breath rate | 15 to 40 BPM | 10 - 40 Breath per minute | 15- 40 Breath per minute | 15- 40 Breath per minute | Same as reference device |
| User interface | Buttons, LCD Display | Buttons, LCD Display | Buttons, LCD Display | Capacitive Touch Screen | Same |
| Power requirements | AC power 100-240VAC, 50-60Hz in, 2.0-1.0A, 20VDC, 5A out | AC adaptor: 100-240VAC ;50-60 Hz in，19VDC 5.26A out DC adaptor: 12 - 16V DC in，19V 6A out | AC power supply: 100-240V AC, 50-60Hz,2.0A; 12.0VDC 10.0A out Lithium Ion Battery | AC Power (100 to 240 VAC, 50/60Hz) DC Power (12-16 VDC) | Discussion 8 |
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| Attribute | Subject device | Predicate device | Reference device 1 | Reference device 2 | Discussion/Conclusion |
|---|---|---|---|---|---|
| DC Power Supply: DC 12-16V, 10A Battery: DC 14.4V | |||||
| Maximum oxygen discharge pressure | 17.4 PSI (120Kpa) | 18.3 PSI (126KPa) | 21.8psi (150kPa) | Not available | Discussion 9 |
| Inspiratory trigger sensitivity | ≤-0.2 cm H²O | -0.12cm/H2O | -0.12cm/H2O | ≤-0.2 cm H²O | Same with reference device 2 |
| Software | Embedded | Embedded | Embedded | Embedded | Same |
| Acoustic noise | 51 dBA at 1.0 LPM | 49 dBA at 1.2 LPM | 55 dBA at 0.75 LPM | 43 dBA typical at setting 2 49 dBA typical at setting 5 | Discussion 11 |
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| Attribute | Subject device | Predicate device | Reference device 1 | Reference device 2 | Discussion/Conclusion |
|---|---|---|---|---|---|
| Alarms | Low pressure High Temp Compressor Failure Fan Failure Low Flow Low Battery No Breath Detected Battery empty | Low pressure No pulse High Temp Compressor Failure Fan Failure Low Flow Low Battery No Breath Detected EEPROM Failure Empty battery | Pressure failure including high pressure and low pressure No flow System over temperature Battery over temperature Compressor Failure Low oxygen concentration Low battery No breath detected Start-up failure | No breath / High Breath Rate Low Oxygen Concentration Low Battery / Depleted Battery Technical Fault Alarm / External Power Failure No Flow Alarm | Discussion 12 |
| Status indicator | Flow rates Battery condition Alarms | Flow rates Battery Condition Alarms | Flow rates Battery Condition Alarms | Flow rates Battery Condition Alarms | Same |
| Battery duration | 5.5hours at 0.21LPM | Up to 4.5hours at 1. 2 LPM | 5 hours at 0.21LPM | Up to 4.5 hours (setting 2 at 20 BPM – standard battery) | Discussion 13 |
| Operating environment | Temperature: 41 to 104˚F (5 to 40˚C) Humidity: 15% to 93%, noncondensing Atmospheric pressure: 86 kPa to 106 kPa | Temperature: 41 to 104˚F (5 to 40˚C) Humidity: 10% to 90%, noncondensing Altitude: 0 to 10,000 ft. (0 to 3048 meters) | Temperature: 10˚C to 35˚C Humidity: 15% to 75%, noncondensing Atmosphere pressure: 70kPa to 106 kPa Altitude: 0 to 3000 meters | 41 to 95 F/5 to 35 C 15% to 93% Up to 10,000 ft | Discussion 14 |
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| Attribute | Subject device | Predicate device | Reference device 1 | Reference device 2 | Discussion/Conclusion |
|---|---|---|---|---|---|
| Shipping storage | Temperature: -13 to 158˚F (-25 to 70˚C) Humidity: ≤ 90%, noncondensing Store in a dry environment | Temperature: -4 to 158˚F (-20 to 70˚C) Humidity: 5% to 90%, noncondensing Store in a dry environment | Temperature: -20 to +60˚C Humidity: ≤ 93%, noncondensing Atmosphere pressure: 70 to 106 kPa | -4 to 140 F/-20 to 60 C | Discussion 15 |
| Electrical safety | AAMI ANSI ES 60601-1 | AAMI ANSI ES 60601-1 | IEC 60601-1 | IEC 60601-1 3rd edition | Same |
| Electromagnetic compatibility | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | Same |
| Biocompatibility | 4 VOC's less than ambient noncondensing Atmospheric pressure: 86 kPa to 106 kPa | 4 VOC's less than ambient noncondensing Altitude: 0 to 10,000 ft. (0 to 3048 meters) | 4 VOC's less than ambient noncondensing Atmosphere pressure: 70kPa to 106 kPa Altitude: 0 to 3000 meters | 4 VOC's less than ambient | Same |
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VII. Summary of substantial equivalence discussion
The discussion of difference exist between the subject and predicate devices is listed in following:
D1: The subject device has been tested for Cytotoxicity, Sensitization and Irritation against ISO 10993-5, ISO10993-10 and ISO10993-23, and particulate matter and volatile organic compounds against ISO 18562-2 and ISO 18562-3 standards and the test results are positive, this difference between subject and predicate device do not raise new issues of safety or effectiveness.
D2: The subject device has been tested for Cytotoxicity, Sensitization and Irritation against ISO 10993-5, ISO10993-10 and ISO10993-23, and particulate matter and volatile organic compounds against ISO 18562-2 and ISO 18562-3 standards, while the predicate device was tested for Cytotoxicity, Sensitization and Irritation against ISO 10993-5 and ISO10993-10, and particulate matter and volatile organic compounds against ISO 18562-2 and ISO 18562-3 standards. The Irritation test method was changed from ISO 10993-10 to ISO 10993-23, which will not raise new issues of safety since both of the test standards are recognized by FDA.
D3: The dimension of subject device is different with predicate device, which will not affect the safety and effectiveness.
D4: The weight of subject device is different with predicate device, which will not affect the safety and effectiveness.
D5: The oxygen concentration range of subject device is narrower than predicate device, which will not affect safety and effectiveness.
D6: The setting of subject device is 5 and that of predicate device is 6. Tests were done to subject device according to ISO 80601-2-69: 2020, ISO 80601-2-67: 2020, ISO 18562-2: 2017, ISO18562-3: 2017, ISO 10993-5:2009, ISO10993-10:2021 and ISO10993-23:2021 and the results are positive. This difference does not raise new issues of safety or effectiveness.
D7: The flow rate of subject device is smaller than that of predicate device, has a maximum flow rate is 1 LPM. Those risks are mitigated by test conducted according to ISO 80601-2-67: 2020, therefore this difference does not raise new issues of safety or effectiveness.
D8: The Power of subject device are different with predicate devices, the difference introduces risks mitigated by the electromagnetic compatibility and electrical safety testing in accordance
Page 15
with IEC 60601-1-2 and ANSI AAMI ES60601-1 provided in this submission, therefore the difference does not raise new questions of safety and effectiveness.
D9: The maximum oxygen discharge pressure of subject device is different with predicate device. 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 issues of safety or effectiveness.
D10: The Inspiratory trigger sensitivity of subject device is different with predicate device, while same with the reference device. Since the subject device has been tested against ISO 80601-2-67: 2020 with positive result, the difference of subject device do not raise new issues of safety or effectiveness.
D11: The Acoustic noise of subject device is litter bigger than predicate device. 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 issues of safety or effectiveness.
D12: The alarm condition of subject device is different with predicate device. 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 issues of safety or effectiveness.
D13: The battery duration of subject device is different with predicate device. The difference introduces risks mitigated by the electromagnetic compatibility, electrical safety and battery safety testing in accordance with IEC 60601-1-2, ANSI AAMI ES60601-1 and IEC 62133 provided in this submission, therefore the difference do not raise new issues of safety or effectiveness.
D14: The operating condition of subject device is slightly different with predicate device, the difference introduce risks mitigated by testing in accordance with IEC 60601-1-11 and ANSI AAMI ES60601-1 provided in this submission, therefore the difference do not raise new issues of safety or effectiveness.
D15: The Shipping Storage of subject device is slightly different with predicate device, since the Shipping Storage of subject device had been verified (IEC 60601-1-11) with positive result, therefore the difference of subject device with predicate device do not raise new issues of safety or effectiveness.
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VIII. Summary of non-clinical testing
Performance testing-bench
The following performance data were provided to verify that the subject device met all design specifications and provided support of the substantial equivalence determination.
- Software validation
- ANSI AAMI ES 60601- 1: 2005 /A1:2012 and A2:2021, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
- IEC 60601-1-2: 2014+ A1:2020, Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests
- IEC 60601-1-11: 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 60601-1-6: 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
- IEC 62133-2: 2017/ A1:2021, 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 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)
- ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro
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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
Biocompatibility of patient-contacting material
Biocompatibility testing were conducted on the subject device and complies with the ISO 10993-5, ISO 10993-10, ISO 10993-23, ISO 18562-2, ISO 18562-3 standards.
IX. Summary of clinical testing
No animal study and clinical studies are available for our device.
X. Conclusions
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device K210371.
§ 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).