Owgels Oxygen Concentrator

K191875 · Guangzhou Life Light Electronic Technology Co., Ltd. · CAW · Jul 20, 2020 · Anesthesiology

Device Facts

• Record ID: K191875
• Device Name: Owgels Oxygen Concentrator
• Applicant: Guangzhou Life Light Electronic Technology Co., Ltd.
• Product Code: CAW · Anesthesiology
• Decision Date: Jul 20, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Owgels Oxygen Concentrator 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 Owgels Oxygen Concentrator can be used in a home, institution environments. The Owgels Oxygen Concentrator 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) with synthetic zeolite molecular sieve to separate oxygen from ambient air; provides continuous oxygen flow up to 5 LPM at 90%-96% concentration. Operated in home or institutional settings by patients or caregivers. Device includes alarms for low oxygen purity, low pressure, and power outage. Healthcare providers prescribe the device to manage respiratory disorders; output is delivered via nasal cannula. Benefits include providing supplemental oxygen to patients with respiratory needs. Device is a stationary unit weighing approximately 19kg.

Clinical Evidence

Bench testing only. No clinical data required. Performance verified via ISO 80601-2-69 testing, including oxygen concentration and flow capacity over 8 hours of continuous operation. Biocompatibility, electrical safety (IEC 60601-1), and EMC (IEC 60601-1-2) testing performed.

Technological Characteristics

Pressure swing adsorption (PSA) oxygen concentrator; synthetic zeolite sieve bed; 5 LPM max flow; 90-96% oxygen concentration; 19kg weight. Electrical safety per IEC 60601-1, IEC 60601-1-8, IEC 60601-1-11, ISO 80601-2-69. EMC per IEC 60601-1-2. Biocompatibility per ISO 18562-1/3 and ISO 10993-5/10/17.

Indications for Use

Indicated for adult patients with respiratory disorders requiring supplemental oxygen. Not for life support or life-sustaining use.

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

• OXY.LIFE Oxygen Concentrator (K131968)

Submission Summary (Full Text)

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Guangzhou Life Light Electronic Technology Co., Ltd. % Iris Fung Project Manager SGS-CSTC Standards Technical Services Co., Ltd. 108 Kezhu Road Scientech Park Guangzhou Economic & Technology Guangzhou, 510060 Cn

# Re: K191875

Trade/Device Name: Owgels Oxygen Concentrator, Model: OZ-5-02TW0 Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: Class II Product Code: CAW Dated: March 15, 2020 Received: April 7, 2020

# Dear Iris Fung:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (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 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,

Todd Courtney Assistant Director DHT1C: Division of ENT, 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) K191875

Device Name

Owgels Oxygen Concentrator, Model : OZ-5-02TW0

Indications for Use (Describe)

The Owgels Oxygen Concentrator 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 Owgels Oxygen Concentrator can be used in a home, institution environments. The Owgels Oxygen Concentrator 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

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

#### Date of the summary prepared: 2020-07-06 1.

#### 2. Submitter's Information

Company Name: Guangzhou life light Electronic Technology Co.,Ltd. Address: No.A102,No.1 Kesheng Road,Baiyun District,Guangzhou,510540,P.R.China Phone: [phone] or [phone] URL: www.owgelsglobal.com Contact Person: Erika meng

E-mail: info@@owgels.com

#### Application response:

SGS-CSTC Standards Technical Services Co., Ltd. Address: 198 KEZHU Road, SCIENTECH Park Guangzhou Economic & Technology Development District, Guangzhou, Guangdong, CHINA Contact Person: Ms. Iris Fung Tel: [phone] Email: [e-mail]

#### 3. Subject Device Information

Type of 510(k) submission: Traditional Common Name: Oxygen Concentrator Trade Name: Owgels Oxygen Concentrator, Model : OZ-5-02TW0 Classification Name: Generator, Oxygen, Portable Review Panel: Anesthesiology Product Code: CAW Regulation Number: 868.5440 Regulation Class: 2

#### 4. Predicate Device Information

| Sponsor | LONGFIAN SCITECH CO., LTD. |
|-------------------|------------------------------|
| Device Name | OXY.LIFE Oxygen Concentrator |
| 510(k) Number | K131968 |
| Product Code | CAW |
| Regulation Number | 868.5440 |
| Regulation Class | 2 |

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#### Device Description 5.

Owgels Oxygen Concentrator, Model : OZ-5-02TW0 adopts pressure swing adsorption principle, which can separate oxygen, nitrogen and other gas from the air, at constant temperature. The concentrator can generate oxygen with steady oxygen flowing out and reliable, adjustable flow. The device is capable of providing oxygen flow up to 5 LPM. The concentration of supplied oxygen is from 90%-96%. The weight of Owgels Oxygen Concentrator, Model : OZ-5-02TW0 is around 19kg.

#### 6. Intended Use / Indications for Use

### Intended Use

The Owgels Oxygen Concentrator 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 Owgels Oxygen Concentrator can be used in a home. institution environments. The Owgen Concentrator does not nor is it intended to sustain or support life. The device is intended for use in adults.

#### Indications for use

The Owgels Oxygen Concentrator 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 Owgels Oxygen Concentrator can be used in a home, institution environments. The Owgels Oxygen Concentrator does not nor is it intended to sustain or support life. The device is intended for use in adults.

### 7. Test Summary

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

### Biocompatibility testing

The biocompatibility evaluation for the Owgels Oxygen Concentrator, Model : OZ-5-02TW0 was conducted in accordance with the ISO18562-1,ISO 18562-3,ISO10993-5 ,ISO10993-5 ,ISO10993-10, ISO10993-17.

# Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Owgen Concentrator, Model : OZ-5-02TW0 . 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 minor level of concern,because the subject device is a supplement to a patient's normal oxygen intake. A software failure will not result in injury to a patient or user. The device is not intended to be lifesupporting or life sustaining.

# Performance Bench Testing

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The basic safety and essential performance Test was 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

# Animal Study

Animal testing was not required for this submission.

# Clinical Testing

Clinical testing was not required to demonstrate substantial equivalence to the predicate device.

### 8. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, mode of operation, and intended use of Owgels Oxygen Concentrator, Model : OZ-5-02TW0 is substantially equivalent to the predicate devices quoted above.

| Elements of<br>Comparison | Subject Device | Predicate<br>Device(Primary) | Remark | |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|------------|
| Device Name and<br>Model | Owgels Oxygen<br>Concentrator, Model :<br>OZ-5-02TWO | JAY-5 Medical<br>Molecular Sieve Oxygen<br>Concentrator | -- | |
| 510 (K) Number | Applying | K131968 | -- | |
| Product Code | CAW | CAW | SE | |
| Regulation<br>Number | 21 CFR868.5440 | 21 CFR868.5440 | SE | |
| Indications for use | The Owgels Oxygen<br>Concentrator is intended<br>to be used by patients<br>with respiratory<br>disorders who require<br>supplemental oxygen. A<br>high concentration of<br>supplemental oxygen is<br>supplied and a nasal<br>cannula is used to<br>channel oxygen from the<br>concentrator to the<br>patient. The Owgels<br>Oxygen Concentrator<br>can be used in a home,<br>institution environments.<br>The Owgels Oxygen<br>Concentrator does not<br>nor is it intended to<br>sustain or support life. | The Longfian Oxygen<br>Concentrator, Model<br>Jay-5 is intended to be<br>used by patients with<br>respiratory disorders<br>who require<br>supplemental oxygen. A<br>high concentration of<br>supplemental oxygen is<br>supplied and a nasal<br>cannula is used to<br>channel oxygen from<br>the concentrator to the<br>patient. The Longfian<br>Oxygen Concentrator,<br>Model Jay-5 can be<br>used in a home,<br>institution, vehicle, and<br>various mobile<br>environments. The<br>Longfian Oxygen<br>Concentrator, Model | SE, Note 1 | |
| | | The device is intended<br>for use in adults. | Jay-5 does not nor is it<br>intended to sustain or<br>support life. | |
| Principles of<br>operation | | Pressure Swing<br>Adsorption with<br>molecular sieve | Pressure Swing<br>Adsorption with<br>molecular sieve | SE |
| Operating system | | Time cycle/ Pressure<br>Swing Adsorption | Time cycle/ Pressure<br>Swing Adsorption | SE |
| Electronic safety | | Electrical Safety per<br>IEC-60601 | Electrical Safety per<br>IEC-60601 | SE |
| | Software/Hardware | Analog and digital<br>electronics<br>with microprocessor | Analog and digital<br>electronics<br>with microprocessor | SE |
| Feature | | | | |
| Oxygen<br>Concentration | | 93% ±3% | 93% ± 3% | SE |
| Flow Specifications | | 0 LPM-5 LPM | 0 LPM-5 LPM | SE |
| Acoustic Noise | | < 55 dB(A) | ≤53dB(A) | SE Note 2 |
| Alarms | Low<br>oxygen<br>purity | Yes | Yes | SE |
| | Low<br>Pressure | Yes | Yes | SE |
| | power<br>outage | Yes | Yes | SE |
| Power<br>requirements | | 120V /60 Hz | AC 230±23V, 50±1Hz | SE, Note 3 |
| Dimensions | | 340 x 300 x 650 mm<br>( 13.4 inches×11.8<br>inches×25.6 inches ) | 365x375×600mm<br>(14.37"x14.76"x23.62") | SE Note 3 |
| Weight | | 19 kg | 26Kg | SE |
| Materials | | | | |
| Sieve Bed | | Synthetic Zeolite | Synthetic Zeolite | SE |

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#### Note 1:

The Indications for use of the Subject Device and Predicate Device is slightly different on its use environment, but both are prescribed by a doctor with the ultimate goal of providing patients with adequate oxygen. Both devices are not life supporting or life sustaining. Therefore, the differences in the indications for use of the subject and predicate devices do not impact safety and effectiveness.

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#### Note 2:

The subject device and the predicate device have differences in Acoustic Noise. However, the proposed device meets the requirements of the standard ISO80601-2-69 and IEC60601-1-8. Hence, there are no different questions of safety and effectiveness questions pertaining to Performance of the subject device.

#### Note 3:

Although the Dimensions and Power supply specifications is different from the predicate device, but both the predicate device and the proposed device has passed the IEC60601-1 test. Hence, there are no different questions of safety and effectiveness questions pertaining to Electrical Safety.

#### Finial Conclusion:

The subject device Owgels Oxygen Concentrator, Model : OZ-5-02TW0 is Substantial Equivalence to the predicate device.