Oxygen Concentrator, Model JAY-5AW

K213210 · Longfian Scitech Co., Ltd. · CAW · Dec 8, 2022 · Anesthesiology

Device Facts

• Record ID: K213210
• Device Name: Oxygen Concentrator, Model JAY-5AW
• Applicant: Longfian Scitech Co., Ltd.
• Product Code: CAW · Anesthesiology
• Decision Date: Dec 8, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Longfian Oxygen Concentrator. Model JAY-5AW is intended to be used by patients with respiratory disorders who require supplemental oxygen. A high concentration of supplemental oxygen is supplied and a nasal cannula is used to channel oxygen from the concentrator to the patient. The Longfian Oxygen Concentrator, Model JAY-5AW, can be used at home or healthcare environments. The Longfian Oxygen Concentrator, Model JAY-5AW, does not nor is it intended to sustain or support life. The device is intended for use in adults.

Device Story

Device uses pressure swing adsorption (PSA) to separate oxygen from ambient air; oilless compressor draws in air; air filtered and cooled; control valve directs air into absorption tower containing synthetic zeolite; oxygen separated and collected in tank; output delivered via flow meter and humidifier through nasal cannula. Used in home or healthcare environments; operated by patient or caregiver. Provides up to 5 LPM oxygen flow at 90-96% concentration. Output allows patients to receive supplemental oxygen for respiratory disorders. Device includes alarms for low/high pressure and power failure; LCD displays timing information.

Clinical Evidence

Bench testing only. Evaluated per ISO 80601-2-69 for safety and essential performance. Biocompatibility testing conducted per ISO 18562-1/2/3 and ISO 10993-5/10/17. Electrical safety and EMC testing per IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-1-11. Oxygen concentration and flow performance verified after 8 hours of continuous operation.

Technological Characteristics

PSA oxygen concentrator; synthetic zeolite sieve bed; oilless compressor; PVC nasal cannula; 0-5 LPM flow; 90-96% oxygen concentration; Class II, Type B electrical classification; AC powered; dimensions 280x3485x510mm; weight 16kg; microprocessor-based control; standards: IEC 60601-1, IEC 60601-1-2, ISO 80601-2-69.

Indications for Use

Indicated for adult patients with respiratory disorders requiring supplemental oxygen. Not intended to sustain or support life.

Regulatory Classification

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).

Predicate Devices

• Oxygen Concentrator (Model: JAY-5) (K131968)

Submission Summary (Full Text)

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December 8, 2022

Longfian Scitech Co., Ltd. % Jun Peng Principal Consultant P&L Scientific, Inc. 1430 S. Dixie Hwy Suite 105 Coral Gables, Florida 33146

Re: K213210

Trade/Device Name: Oxygen Concentrator, Model JAY-5AW Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: Class II Product Code: CAW Dated: November 3, 2022 Received: November 7, 2022

Dear Jun Peng:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

James J. Lee -S

James J. Lee, Ph.D. Division Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K213210

Device Name Oxygen Concentrator, Model JAY-5AW

#### Indications for Use (Describe)

The Longfian Oxygen Concentrator. Model JAY-5AW is intended to be used by patients with respiratory disorders who require supplemental oxygen. A high concentration of supplemental oxygen is supplied and a nasal cannula is used to channel oxygen from the concentrator to the patient. The Longfian Oxygen Concentrator, Model JAY-5AW, can be used at home or healthcare environments. The Longfian Oxygen Concentrator, Model JAY-5AW, does not nor is it intended to sustain or support life. The device is intended for use in adults.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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### 510(k) Summary

510(k) summary of Safety and Effectiveness as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which Substantial Equivalence is based:

# K213210

# 1. Submitter Information:

●

Sponsor/510(K) Owner: LONGFIAN SCITECH CO., LTD. 2F&3F, East Section, Building 12, Power Valley Pioneer Park, No.369 Huiyang Street, Baoding 071051, China

Contact: Mr. Shi Lei Technical Manager Phone: [phone]

Date: October 28, 2022

#### Contact Name: ●

Mr. Jun Peng P&L SCIENTIFIC, INC. 1430 S. Dixie Hwy STE 105, Coral Gables, FL 33146 Phone: [phone] Fax: [phone] Email: [e-mail]

# 2. Device Name

Oxygen Concentrator, Model JAY-5AW Trade Name: Common Name: Oxygen concentrator; Classification Name: Oxygen concentrator, portable;

# 3. Classification :

| Classification: | 21 CFR 868.5440; Class II |
|-----------------|---------------------------|
| Product Code: | CAW; |

#### 4. Predicate Devices:

| Oxygen<br>(Model: JAY-5) | Concentrator | K131968,<br>September 5, 2014 | Cleared | LONGFIAN<br>CO., LTD. | SCITECH |
|--------------------------|--------------|-------------------------------|---------|-----------------------|---------|
|--------------------------|--------------|-------------------------------|---------|-----------------------|---------|

# 5. Description of Device

The Longfian Oxygen Concentrator, Model JAY-5AW adopts pressure swing adsorption principle, which can separate oxygen, nitrogen and other gas from the air, at constant temperature. As soon as power is connected, the air is taken in and compressed by oilless

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air compressor through filtering, then the compressed air goes through the cooler and it is cooled. After that, the air is taken into absorption tower by control valve and the oxygen can be separated in the absorption tower. At the same time, the high purity oxygen is collected into the oxygen tank, and it goes through the flow meter and humidifier, finally the oxygen that meets medical standards can be supplied. Oxygen is generated by pure physical method.

The device is capable of providing oxygen flow up to 5 LPM. The concentration of supplied oxygen is from 90%-96%. The weight of Jay-5AW is around 16kg (~351bs). There is no influence on indoor oxygen percent during the generator operating.

The biocompatibility contact classification of the device is as permanent contact externally communicating with dry and humified gas pathway.

The life-time/use life of the oxygen concentrator is set at 5 years or 20.000 hours after the product is sold, whichever comes first.

The reusable components:

- · Intake air filter (two pieces, part number:GL-01)
- · Secondary filter (one piece, part number:GL-02)
- nasal oxygen tube and
- humidifier.

JAY-5AW medical oxygen concentrator contains the following items:

- · One (1) JAY-5AW Oxygen Concentrator Unit
- One (1) AC Power Supply
- · One (1) Nasal Oxygen Tube
- · One (1) Firesafe Cannula Valve
- One (1) Humidifier
- · One (1) Operation Manual

# 6. Intended Use

The Longfian Oxygen Concentrator, Model JAY-5AW, is intended to be used by patients with respiratory disorders who require supplemental oxygen. A high concentration of supplemental oxygen is supplied and a nasal cannula is used to channel oxygen from the concentrator to the patient. The Longfian Oxygen Concentrator, Model JAY-5AW, can be used at home or healthcare environments. The Longfian Oxygen Concentrator, Model JAY-5AW, does not nor is it intended to sustain or support life. The device is intended for use in adults.

#### Summary of Comparison in to Technological Characteristics Predicate Device 7.

| Name | Predicate device | Subject device |
|----------|------------------|----------------|
| K number | K131968 | K213210 |

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| Device Trade Name | JAY-5 Medical Molecular Sieve Oxygen Concentrator | The Longfian Oxygen Concentrator, Model JAY-5AW |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Oxygen concentrator | Oxygen concentrator |
| Classification Name | Oxygen concentrator, Portable | Oxygen concentrator, Portable |
| Indications for use | The Longfian Oxygen Concentrator, Model Jay-5 is intended to be used by patients with respiratory disorders who require supplemental oxygen. A high concentration of supplemental oxygen is supplied and a nasal cannula is used to channel oxygen from the concentrator to the patient. The Longfian Oxygen Concentrator, Model Jay-5 can be used in a home, institution, vehicle, and various mobile environments. The Longfian Oxygen Concentrator, Model Jay-5 does not nor is it intended to sustain or support life. | The Longfian Oxygen Concentrator, Model JAY-5AW, is intended to be used by patients with respiratory disorders who require supplemental oxygen. A high concentration of supplemental oxygen is supplied and a nasal cannula is used to channel oxygen from the concentrator to the patient. The Longfian Oxygen Concentrator, Model JAY-5AW, can be used at home or an institution. The Longfian Oxygen Concentrator, Model JAY-5AW, does not nor is it intended to sustain or support life. The device is intended for use in adults. |
| Classification | 21 CFR 868.5440 | 21 CFR 868.5440 |
| Feature | | |
| Power supply | AC 220±22V, 50±1Hz | AC 230±23V, 50±1Hz |
| Input power | 500W | 460W |
| Oxygen concentration | 93%±3% | 93%±3% |
| Oxygen flow | 0~5L/min | 0~5L/min |
| Outlet pressure | 40~70kPa | 40~70kPa |
| Noise | ≤53dB(A) | ≤53dB(A) |
| Fuse | T6.3AL/250V | F5AL/250V |
| Operating system | Pressure Swing Adsorption | Pressure Swing Adsorption |
| Electrical classification | Class II Type B | Class II Type B |
| Dimensions | 365×375×600mm<br>(14.37"×14.76"×23.62") | 280×3485×510mm<br>(14.37"×14.76"×23.62") |
| Net weight | 26Kg | 16Kg |
| Alarm | Low & high pressure | Low & high pressure;<br>Power failure |
| LCD display | Accumulating timing;<br>present timing;<br>timing | Accumulating timing;<br>present timing;<br>timing |
| Accessories | Nasal oxygen tube<br>Humidifier | Nasal oxygen tube<br>Humidifier |
| Materials | | |
| Sieve Bed | Synthetic Zeolite | Synthetic Zeolite |
| Nasal Oxygen Tube | PVC | PVC |
| Principles of operation | | |
| Operating system | Time cycle/ Pressure Swing Adsorption | Time cycle/ Pressure Swing Adsorption |
| Electronic safety<br>Software/Hardware | Electrical Safety per IEC-60601<br>Analog and digital electronics<br>with microprocessor | Electrical Safety per IEC-60601<br>Analog and digital electronics with<br>microprocessor |
| <b>Operating , transportation and storage environment</b> | | |
| Operating conditions | Ambient temperature : 10~40 ℃<br>Relative humidity:30%~85%<br>Atmospheric pressure:700<br>1060hPa | Ambient temperature : 10~40 ℃<br>Relative humidity:30%~85%<br>Atmospheric pressure:700 1060hPa |
| Transportation and<br>storage Conditions | Ambient temperature :-20~45 ℃<br>Relative humidity: ≤95%<br>Atmospheric pressure 500-<br>1060hPa | Ambient temperature :-40~45 ℃<br>Relative humidity: ≤95%<br>Atmospheric pressure 700-1060hPa |

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The Longfian Oxygen Concentrator, Model JAY-5AW is similar to the predicate devices:

- Has the same intended use and indications for use ●
- Utilizes the same operating principle ●
- Incorporates the same basic design
- Incorporates the same technological characteristics ●
- Tested to the same electrical and electromagnetic safety standards for medical ● electrical equipment
- Manufactured under a quality system ●

The differences are:

- JAY-5AW has different enclosure shape comparing to JAY-5; ●
- The two models use different power of compressor, but compressor principle is the . same, the electronical safety and performance testing has validate the safety and effectiveness of JAY-5AW:
- The differences in dimensions and weight do not raise any issues in safety and ● effectiveness.

# 8. Assessment of Non-Clinical Testing:

Non-clinical testing of the Longfian Oxygen Concentrator, Model JAY-5AW has been performed against requirements for performance, physical attributes, environmental conditions, materials and safety, and to provide objective evidence that the device's intended use is met.

# 9. Test Summary:

The device has been evaluated the safety and performance by lab bench testing as following:

# Biocompatibility testing:

The biocompatibility evaluation for the Longfian Oxygen Concentrator, Model JAY-5AW was conducted in accordance with the ISO18562-1, ISO 18562-2, ISO18562-3, ISO10993-5, ISO10993-10, ISO10993-17.

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#### Electrical safety and electromagnetic compatibility (EMC):

Electrical safety and EMC testing were conducted on the Longfian Oxygen Concentrator, Model JAY-5AW. The system complies with the IEC 60601-1. IEC 60601-1-2, IEC 60601-1-8, IEC60601-1-11, and ISO 80601-2-69 standards for electrical safety and the IEC60601-1-2 standard for EMC.

#### Software Verification and Validation Testing

Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Level of Concern: The software for this device was considered as a moderate level of concern, because the subject device is a supplement to a patient's normal oxygen intake. If a failure of operation or latent design flaw could directly result in minor injury to the patient or operator. The device is not intended to be life supporting or life sustaining.

#### Performance Bench Testing

The basic safety and essential performance Test were evaluated based on ISO 80601-2-69. And Oxygen concentration and maximum flow performance testing was also conducted to verify that oxygen production capacity of the oxygen generator can meet the design requirements after working continuously at the maximum output for 8 hours

### 10. Conclusion

The subject device and the predicate device have the same intended use. The technological differences do not raise different questions of safety and effectiveness