LONGFIAN OXYGEN CONCENTRATOR

K131968 · Longfian Scitech Co., Ltd. · CAW · Sep 5, 2014 · Anesthesiology

Device Facts

• Record ID: K131968
• Device Name: LONGFIAN OXYGEN CONCENTRATOR
• Applicant: Longfian Scitech Co., Ltd.
• Product Code: CAW · Anesthesiology
• Decision Date: Sep 5, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Oxygen concentrator using pressure swing adsorption (PSA) to separate oxygen from ambient air; utilizes oilless air compressor, cooler, and absorption tower with synthetic zeolite sieve bed. Produces 90%-96% purity oxygen at flow rates up to 5 LPM. Used in homes, institutions, vehicles, and mobile environments; operated by patients or caregivers. Device includes flow meter, humidifier, and nasal cannula for delivery. Provides steady oxygen flow; includes alarms for low/high pressure and power failure. Intended to provide supplemental oxygen for respiratory disorders; does not support life. Healthcare providers use output to manage patient oxygen therapy; benefits include portable, reliable supplemental oxygen supply.

Clinical Evidence

Bench testing only. Performance validated against IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), ISO 8359 (oxygen concentrator safety), ISO 10993-1 (biocompatibility), and ASTM F 1464-93. Additional testing included VOCs (EPA TO-15), PM 2.5, ozone (21 CFR 801.415), and software validation.

Technological Characteristics

Pressure swing adsorption (PSA) system; synthetic zeolite sieve bed; oilless air compressor. Materials: PVC (nasal tube), synthetic zeolite. Electrical: Class II Type B, AC 230V. Dimensions: 365x375x600mm. Connectivity: None. Software: Microprocessor-based control for timing and alarms. Standards: IEC 60601-1, IEC 60601-1-2, ISO 8359, ISO 10993-1, ASTM F 1464-93.

Indications for Use

Indicated for 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

• Yuyue OxygenMaxTM 7F-5 Oxygen Concentrator (K083559)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 5, 2014

Longfian Scitech Co., Ltd. c/o Mr. Jun Peng P&L Scientific, Inc. 6840 SW 45th LN Unit 5 Miami, FL 33155

Re: K131968

Trade/Device Name: OXY.LIFE Oxygen Concentrator, Models Jay-5 Regulation Number: 21 CFR 868.5440 Regulation Name: Oxygen concentrator, portable Regulatory Class: Class II Product Code: CAW Dated: August 1, 2014 Received: August 7, 2014

Dear Mr. 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. 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.

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Page 2 Mr. Peng

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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/1/Picture/8 description: The image shows the name Tejashri Purohit-Sheth, M.D. twice. Below the second instance of the name, the text "Clinical Deputy Director" is present. The text "DAGRID/ODE/CDRH FOR" is located below the title.

Erin I. Keith, M.S. 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

K131968 510(k) Number (if known):

Device Name: The Longfian Oxygen Concentrator, Model Jay-5

### 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.

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: ✓ (Per 21 CFR 801.109) OR

Over-the Counter Use:

Image /page/2/Picture/10 description: The image shows the FDA logo. The logo is in a light gray color. The letters "FDA" are stacked on top of each other.

Anya C. Harry -S 2014.09.04 15:55:34 -04'00'

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### 510(k) Summary

510(k) summary as required in 21 CFR 807.92 upon which Substantial Equivalence is based:

#### The Assigned 510(k) Number is: k131968

- 1. Submitter Information:
- Sponsor/510(K) Owner: . LONGFIAN SCITECH CO., LTD. Longxing Building A(413) No.77 Longxing Road Baoding 071051, China Phone: [phone]

Date: November 12, 2013

#### Contact Name: ●

Mr. Jun Peng P&L SCIENTIFIC, INC. 6840 SW 45TH LN UNIT 5, MIAMI, FL 33155 Phone: [phone] Fax: [phone] Email: [e-mail]

#### 2. Device Name

Trade Name: OXY.LIFE Oxygen Concentrator, Models Jay-5 Common Name: Oxygen concentrator; Classification Name: Oxygen concentrator, portable;

#### 3. Classification:

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

#### 4. Predicate Devices:

| Yuyue OxygenMaxTM 7F-5<br>Oxygen Concentrator | K083559,<br>September 4, 2009 | Cleared | JIANGSU<br>MEDICAL EQUIPMENT<br>& SUPPLY CO., LTD. | YUYUE |
|-----------------------------------------------|-------------------------------|---------|----------------------------------------------------|-------|
|-----------------------------------------------|-------------------------------|---------|----------------------------------------------------|-------|

#### 5. Description of Device

JAY-5 medical oxygen concentrator 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 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

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oxygen that meets medical standards can be supplied. Oxygen is generated by pure physical method.

The concentrator can supply 1-2 patients simultaneously, 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 key parts of the generator adopt anti-tiring and anti-aging design, and the planned life of the whole generator reaches up to 20,000 hours. The weight of Jay-5 is around 25kg (~55lbs). There is no influence on indoor oxygen percent during the generator operating.

JAY-5 medical oxygen concentrator contains the following items:

- · One (1) Jay-5 Oxygen Concentrator Unit
- · One (1) AC Power Supply
- · One (1) Nasal Oxygen Tube
- One (1) Humidifier
- One (1) Operation Manual

## 6. Intended 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.

| Name | Predicate device | Subject device |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K number | K083559 | K131968 |
| Device Trade Name | Yuyue OxygenMax™ 7F-5<br>Oxygen Concentrator | JAY-5 Medical Molecular Sieve<br>Oxygen Concentrator |
| Common Name | Oxygen concentrator | Oxygen concentrator |
| Classification Name | Oxygen concentrator, Portable | Oxygen concentrator, Portable |
| Indications for use | The YuYue OxygenMax™ 7F-5 Oxygen<br>Concentrator is intended solely for<br>medical use in oxygen therapy programs<br>under the supervision of a physician. It is<br>intended to provide supplemental oxygen<br>to patients with respiratory disorders for<br>use in the home or health care facility.<br>This device is available by prescription<br>only and is not intended to support or<br>sustain life | The Longfian Oxygen Concentrator,<br>Model Jay-5 is intended to be used by<br>patients with respiratory disorders who<br>require supplemental oxygen. A high<br>concentration of supplemental oxygen is<br>supplied and a nasal cannula is used to<br>channel oxygen from the concentrator to<br>the patient. The Longfian Oxygen<br>Concentrator, Model Jay-5 can be used in<br>a home, institution, vehicle, and various<br>mobile environments. The Longfian<br>Oxygen Concentrator, Model Jay-5 does<br>not nor is it intended to sustain or support<br>life. |
| Classification | 21 CFR 868.5440 | 21 CFR 868.5440 |

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

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| Feature | | |
|----------------------------------------------------|----------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Power supply | AC 220±22V, 50±1Hz | AC 230±23V, 50±1Hz |
| Input power | 500W | 500W |
| Oxygen concentration | 90%-94% | 93%±3% |
| Oxygen flow | 0.5~5L/min | 0~5L/min |
| Outlet pressure | 40~70kPa | 40~70kPa |
| Noise | ≤53dB(A) | ≤53dB(A) |
| Fuse | / | T6.3AL/250V |
| Operating system | Pressure Swing Adsorption | Pressure Swing Adsorption |
| Electrical classification | Class II Type B | Class II Type B |
| Dimensions | 445×372×680mm | 365×375×600mm<br>(14.37"×14.76"×23.62") |
| Net weight | 25.8Kg | 26Kg |
| Alarm | Low & high pressure | Low & high pressure;<br>Power failure |
| LCD display | Accumulating timing | Accumulating timing;<br>present timing;<br>timing |
| Accessories | Nasal oxygen cannula<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 | Electrical Safety per IEC-60601 | Electrical Safety per IEC-60601 |
| Software/Hardware | Analog and digital electronics with microprocessor | Analog and digital electronics with microprocessor |
| Operating , transportation and storage environment | | |
| Operating conditions | / | Ambient temperature : 10~40℃<br>Relative humidity:30%~85%<br>Atmospheric pressure:700 1060hPa |
| Transportation and storage Conditions | / | Ambient temperature :-20~45℃<br>Relative humidity:≤95%<br>Atmospheric pressure:500-1060hPa |

The Longfian Oxygen Concentrator, Model Jay-5 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

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- Tested to the same electrical and electromagnetic safety standards for medical electrical equipment
- Manufactured under a quality system

Differences between the subject device and predicate do not affect the safety and effectiveness of the device.

## 8. Assessment of Non-Clinical Testing:

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

## 9. Summary Performance Data

- . IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety and essential performance, 1988; Amendment 1, 1991-11, Amendment 2, 1995. (General)
- IEC 60601-1-2, (Second Edition, 2001), Medical Electrical Equipment Part 1-2: ● General Requirements for Safety - Collateral Standard: Electromagnetic
- ISO 8359:1996 Oxygen concentrators for medical use -- Safety requirements ●
- ISO 10993-1:2009 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing
- ASTM F 1464-93:2005 Oxygen Concentrators for medical use-Safety Requirements
- Volatile organic compounds (VOC) test per EPA TO-15 ●
- PM 2.5 test per US EPA requirement ●
- Ozone test per 21 CFR 801.415 ●
- . Software validation

## 10. Conclusion

After analyzing both bench and external laboratory testing data, the intended use and supporting data can conclude that the device in the submission is substantially equivalent to the predicate device.