Oxygen Concentrator

K172234 · Sysmed (China) Co., Ltd. · CAW · Jun 1, 2018 · Anesthesiology

Device Facts

• Record ID: K172234
• Device Name: Oxygen Concentrator
• Applicant: Sysmed (China) Co., Ltd.
• Product Code: CAW · Anesthesiology
• Decision Date: Jun 1, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Oxygen Concentrator is intended for the administration of supplemental oxygen. This device is not intended for life supporting nor does it provide any patient monitoring capabilities. The system will be operated by trained personnel, at home, in community health care and medical institutions.

Device Story

Oxygen concentrator (models M30, M40, M50) utilizes pressure swing adsorption (PSA) technology to extract oxygen from ambient air; delivers continuous flow of supplemental oxygen (93% ± 3% purity). Operated by trained personnel in homes, community health care, or medical institutions. Device includes integrated alarms for high temperature, low oxygen output, and power interruption. Output is supplemental oxygen for patient inhalation; healthcare providers use device to manage oxygen therapy needs. Benefits include consistent oxygen supply for patients requiring supplemental oxygen therapy.

Clinical Evidence

No clinical data. Bench testing only. Compliance verified against AAMI/ANSI ES60601-1, IEC 60601-1-2, ISO 80601-2-69, ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), and VOCs/PM2.5 testing per EPA TO 15 and IP-10.

Technological Characteristics

Pressure swing adsorption (PSA) technology. Continuous flow delivery. Oxygen purity 93% ± 3%. Models M30 (0-3 L/min), M40 (0-4 L/min), M50 (0-5 L/min). Outlet pressure 0.05 MPa ± 10%. Sound level ≤45 dBA. Electrical 110V/220V, 50Hz/60Hz. Standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, ISO 80601-2-69, ISO 10993-5, ISO 10993-10.

Indications for Use

Indicated for the administration of supplemental oxygen in patients requiring such therapy. Intended for use by trained personnel in home, community health care, and medical institution settings. Not for life support or patient monitoring.

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

• Deployable Oxygen Generator System - Small (DOGS-S) (K150930)

Submission Summary (Full Text)

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June 1, 2018

SysMed (China) Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CHINA

Re: K172234

Trade/Device Name: Oxygen Concentrator, Models M30, M40, and M50 Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: Class II Product Code: CAW Dated: April 26, 2018 Received: April 30, 2018

Dear Diana Hong:

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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K172234

Device Name Oxygen Concentrator Models M30, M40, and M50

#### Indications for Use (Describe)

The Oxygen Concentrator is intended for the administration of supplemental oxygen. This device is not intended for life supporting nor does it provide any patient monitoring capabilities. The system will be operated by trained personnel, at home, in community health care and medical institutions.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K172234

- 1. Date of Preparation: 05/31/2018
- 2. Sponsor Identification

#### SysMed (China) Co., Ltd

11-2-3 No. 17 Wensu Str., Hunnan New Dis., Shenyang, 110171, China

Establishment Registration Number: Not yet registered

Contact Person: Jian Yue Position: Quality Manager Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent Ms.
Diana Hong (Primary Contact Person) Betty Xiao (Alternative Contact Person)

#### Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

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#### 4. Identification of Proposed Device

Trade Name: Oxygen Concentrator Common Name: Portable Oxygen Generator Models: M30, M40, M50

Regulatory Information Classification Name: Generator, Oxygen, Portable Classification: 2 Product Code: CAW Regulation Number: 21CFR 868.5440 Review Panel: Anesthesiology

Intended Use Statement:

The Oxygen Concentrator is intended for the administration of supplemental oxygen. This device is not intended for life supporting nor does it provide any patient monitoring capabilities. The system will be operated by trained personnel, at home, in community health care and medical institutions.

#### Device Description

The Oxygen Concentrator adopts the principle of pressure swing adsorption technology. At normal temperature, the device can continuously supply a high concentration of supplemental oxygen (93%±3%).

The main function of the proposed device includes supplying supplemental oxygen. The device also includes alarms for high temperature, low oxygen output, and interruption of power.

The proposed device includes three models, which are M50, M40 and M30. The only difference of the three models is flow rate.

- 5. Identification of Predicate Devices
510(k) Number: K150930 Product Name: Deployable Oxygen Generator System - Small (DOGS-S)

- Non-Clinical Test Conclusion 6.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

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- > AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
- ♪ IEC 60601-1-2:2007/(R)2012, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements And Tests
- > ISO 80601-2-69 First Edition 2014-07-15, Medical Electrical Equipment - Part 2-69: Particular Requirements For Basic Safety And Essential Performance Of Oxygen Concentrator Equipment.
- ♪ ISO 10993-5:2009, Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.
- ♪ ISO 10993-10:2010, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
- A VOCs and PM2.5 test per EPA TO 15 andIP-10 method
- 7. Clinical Test Conclusion

No clinical study is included in this submission.

- 8. Substantially Equivalent (SE) Comparison

| | Table 1 Comparison of Technology Characteristics | |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Proposed Device<br>M30, M40, M50 | Predicate Device<br>K150930 |
| Classification | 2 | 2 |
| Product Code | CAW | CAW |
| Regulation Number | 21 CFR 868.5440 | 21 CFR 868.5440 |
| Intended Use | The Oxygen Concentrator is intended<br>for the administration of<br>supplemental oxygen. This device is<br>not intended for life supporting nor<br>does it provide any patient<br>monitoring capabilities. The system<br>will be operated by trained personnel,<br>at home, in community health care<br>and medical institutions. | The Deployable Oxygen Generator<br>System – Small (DOGS-S) is<br>intended for the administration of<br>supplemental oxygen. This device<br>is not intended for life support nor<br>does it provide any patient<br>monitoring capabilities. The<br>system will be operated by trained<br>personnel. |
| Use environment | home, community health care and<br>medical institutions | Home, hospital and medical<br>facility |
| Operation principle | pressure swing adsorption technology<br>(PSA) | pressure swing adsorption<br>technology (PSA) |
| Oxygen purity | 93% +/- 3% | 93% +/- 3% |

### Table 1 Comparison of Technology Characteristics

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| Flow type | Continuous flow | Continuous flow |
|----------------------------|----------------------------------------------------|---------------------------------|
| Flow rate | M30: 0-3 L/min<br>M40: 0-4 L/min<br>M50: 0-5 L/min | 0.5 - 15 L/min |
| Sound level | ≤45 dBA | <70dBA |
| Oxygen purity<br>warning | <82% | <85% |
| Electrical<br>requirements | 110V/220V, 50Hz/60Hz | 110V/240V, 50Hz/60Hz<br>Battery |
| Outlet pressure | 0.05 Mpa ± 10% | 10.0 psig |

Discussion: The intended use environments of both devices are the same. However, the indications for use of the proposed device identifies the intended use environment while the indications for use of the predicate does not.

The flow rate of proposed device is within that of the predicate device. Although the oxygen purity warning level is less than that of the predicate device, and the outlet pressure of proposed device is 0.05Mp, which is equal to 7.25 psig and less than that of predicate device, both of them comply with the requirements of ISO 80601-2-69. The electrical power requirements of the proposed device is different than that of predicate device, but both of them comply with standards AAMI / ANSI ES60601-1 and IEC 60601-1-2. These differences do not raise different questions of safety and effectiveness.

- 9. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed device models are Substantially Equivalent (SE) to the predicate devices.