A&J 5L POCA SERIES OXYGEN CONCENTRATOR

K121531 · Zhongshan A&J Medical Equipment Co., Ltd. · CAW · Jul 17, 2012 · Anesthesiology

Device Facts

• Record ID: K121531
• Device Name: A&J 5L POCA SERIES OXYGEN CONCENTRATOR
• Applicant: Zhongshan A&J Medical Equipment Co., Ltd.
• Product Code: CAW · Anesthesiology
• Decision Date: Jul 17, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Indications for Use

A&J 5L POCA series Oxygen Concentrator is intended for use as an oxygen concentrator to provide supplemental low flow oxygen therapy at home, in nursing homes, at patient care facilities. A&J 5L POCA series Oxygen concentrator is available by prescription only under the supervision of a physician.

Device Story

AC-powered oxygen concentrator; draws ambient air via compressor; utilizes molecular sieve adsorbent to selectively retain nitrogen; releases nitrogen when pressure vents; cycle controlled by motorized valve; delivers high-purity supplemental oxygen via nasal cannula or mask; optional bubble humidifier. Used in homes, nursing homes, or patient care facilities; operated by patients or caregivers. Front panel includes status lights (power, oxygen purity, flow, service), flow meter, and monitor display for pressure/purity/hour meter. Provides supplemental oxygen therapy; does not sustain life.

Clinical Evidence

Bench testing only. Performance validated against design specifications and standards including ASTM F1464, ISO 8359, IEC 60601-1, and IEC 60601-1-2. Gas output tested for particulate matter, VOCs, CO, CO2, and ozone to ensure biocompatibility of gas pathway.

Technological Characteristics

AC-powered portable oxygen generator; Pressure Swing Adsorption (PSA) technology; molecular sieve adsorbent. Flow rate 0-5 LPM; oxygen purity 93% ± 2%; outlet pressure 8.5 psi. Type B equipment. Complies with IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), ASTM F1464, and ISO 8359.

Indications for Use

Indicated for patients requiring supplemental low flow oxygen therapy in home, nursing home, or patient care facility settings. Available by prescription only under physician supervision. Not intended to support or sustain 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

• A&J 5L Oxygen concentrator (K071608)

Submission Summary (Full Text)

{0}------------------------------------------------

### Chapter 4. 510(k) Summary

1121531

JUL 1 7 2012

# 510(k) Summary

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

### 1. Submitter Information

- � Establishment Registration Number: 3004443928
- � Company Name: Zhongshan A&J Medical Equipment Co., Ltd.
- Address: #3 Shenghui South Road, Nantou Town, Zhongshan City, Guangdong, China �
- � Phone: [phone]
- Fax: [phone] �
- � Contact Person (Title): Ms. Hebe An (Management Representative)
- E-mail: [e-mail] �

#### 2. Application Correspondent

- � Company Name: MEDLAB (Shenzhen) Information Service Co., Ltd.
- Address: Room 2706, Block A, ZhongFang JinYuan Buiding, Xinwen Road, Shenzhen, � Guangdong, P.R. China, 518034
- Phone: [phone] �
- � Fax: [phone]
- � Contact Person (Title): Ms. Sabrina Wei (Project Manager)
- � E-mail: [e-mail]

#### Subject Device Information: 3.

- � Product Code: CAW
- Regulation Number: 868.5440 �
- Class: 2 �
- Review Panel: Anesthesiology �
- Classification Name: Generator, oxygen, portable �
- Trade Name: A&J 5L POCA series Oxygen Concentrator �
- Model: POCA01B, POCA03, POCA04, POCA05, POCA06 ◆

{1}------------------------------------------------

Zhongshan A&J Medical Equipment Co., Ltd. Sponsor: Subject Device: A&J 5L POCA series Oxygen Concentrator File No .: 510(k) submission report (V1.0), Chapter 4

#### 4. Predicate Device Information:

- � 510(k) Number: K071608
- Sponsor: Zhongshan A&J Medical Equipment Co., Ltd. �
- Classification Name: Generator, oxygen, portable �
- Trade Name: A&J 5L Oxygen concentrator �
- Product Code: CAW �
- Model: POCA01 �

#### Device Description 5.

A&J 5L POCA series Oxygen concentrator is AC power electrically operated. The unit separates oxygen from room air (ambient air) which allows high-purity supplemental oxygen to be delivered through the oxygen outlet, although the concentrator filters the oxygen in a room, it will not affect the normal amount of oxygen in your room. Air is drawn into the device with a compressor and exposed to molecular sieve adsorbent that selectively retains nitrogen and other components until they are released when the pressure is vented to the atmosphere. This cycle is controlled by a motorized value and protected from over pressurization by the compressor's pressure relief value.

Oxygen provided by the A&J 5L POCA series Oxygen concentrator is delivered to the user by means of standard oxygen supply tubing and a standard nasal cannula or mask. A standard bubble humidifier may be used, if physician has prescribed an oxygen humidifier as part of therapy.

The front panel of the A&J 5L POCA series Oxygen concentrator contains the controls and indicators. These include the status lights (included power light, normal oxygen light, fow oxygen light and service required light), standard power switch, flow meter knob, a circuit breaker which could reset the device after electrical overload shutdown, an oxygen outlet which oxygen is dispersed through, a monitor display which indicates the condition of system status (included pressure status, oxygen purity status and electric hour meter, etc.). The user could operate the device conveniently according to the instructions.

#### 6. Intended Use

A&J 5L POCA series Oxyqen Concentrator is intended for use as an oxygen concentrator to provide supplemental low flow oxygen therapy at home, in nursing homes, at patient care facilities. A&J 5L POCA series Oxygen concentrator is available by prescription only under the supervision of a physician.

Report by Zhongshan A&J Medical Equipment Co., Ltd.

{2}------------------------------------------------

Sponsor: Zhongshan A&J Medical Equipment Co., Ltd. Subject Device: A&J 5L POCA series Oxygen Concentrator 510(k) submission report (V1.0), Chapter 4 File No.:

### 7. Contraindication

The device is not intended to support or sustain life.

#### 8. Performance Summary

Technologies utilized by the A&J 5L POCA series Oxygen Concentrator conduces no questions of safety and effectiveness. The same technologies are being used on the identified predicate device. Bench performance testing has demonstrated that the A&J 5L POCA series Oxygen Concentrator is substantially equivalent to the predicate device.

### 9. Testing

.

Laboratory testing was conducted to validate and verify that the A&J 5L POCA series Oxygen Concentrator met all design specifications and was substantially equivalent to the predicate device. The testing consisted of all environmental testing identified in the FDA's "Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators (October 1, 1993)". Testing was also performed to demonstrate the sponsored device series achieves the standards' requirements of ASTM F1464 and ISO 8359.

Hazard analysis of the system and its software was performed and testing was conducted to validate overall operation of the system. The A&J 5L POCA series Oxygen Concentrator has also been tested to assure its compliance to the requirements of various standards of IEC60601-1, IEC60601-1-2.

### 10. Comparison to Predicate Device

Compare the subject devices to the predicate device: they are same in design principle, intended use, functions, performance, material and applicable standards. The main difference between subject devices and the predicate device is enclosure style and the following list notes. These differences do not raise any new issues of safety or effectiveness.

| Elements of<br>Comparison | Subject Device | Predicate Device | Judgment | | |
|-----------------------------------|--------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|--------------|--|--|
| Device Name | A&J 5L POCA series Oxygen<br>Concentrator, Models:<br>POCA01B, POCA03, POCA04,<br>POCA05, POCA06 | A&J 5L Oxygen Concentrator,<br>Model: POCA01 | | | |
| Operation and Storage Environment | | | | | |
| Operating<br>Conditions | Temperature: 10-40 ℃<br>Humidity: 30-70 %<br>Atmospheric Pressure: 50~106<br>kPa (7.3-15.4 psi) | Temperature: 10-35 ℃<br>Humidity: 30~70 %<br>Atmospheric Pressure: 50~106<br>kPa (7.3-15.4 psi) | SE<br>Note 1 | | |

{3}------------------------------------------------

#### Zhongshan A&J Medical Equipment Co., Ltd. Sponsor: Subject Device: A&J 5L POCA series Oxygen Concentrator

510(k) submission report (V1.0), Chapter 4 File No.:

| Elements of<br>Comparison | Subject Device | Predicate Device | Judgment |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Storage<br>Conditions | Temperature: -40~70 ℃<br>Humidity: 10~100 %<br>Atmospheric Pressure: 50~106 kPa (7.3~15.4 psi) | Temperature: -40~70 ℃<br>Humidity: 10~100 %<br>Atmospheric Pressure: 50~106 kPa (7.3~15.4 psi) | SE |
| Safety Factor | | | |
| Power Input | 115V, 60Hz, 3.1A | 115 V, 60 Hz, 1.8A (Max.) | SE<br>Note 2 |
| Degree of<br>Protection Against<br>Electric Shock | Type B Equipment | Type B Equipment | SE |
| Electrical Safety | Compliance with IEC 60601-1 | Compliance with IEC 60601-1 | SE |
| EMC | Compliance with IEC 60601-1-<br>2 | Compliance with IEC 60601-1-<br>2 | SE |
| Performance and Specification | | | |
| Delivery Rate | 0 to 5 LPM | 0 to 5 LPM | SE |
| Oxygen<br>Percentage | 93% ± 2% | 93% ± 2% | SE |
| Outlet Pressure | 8.5 psi (58.6 kPa) | 8.5 psi (58.6 kPa) | SE |
| Sound Level | < 45 dbA (Overall Average) | 45-47 dbA (Overall Average) | SE<br>Note 3 |
| Operating<br>System | Time Cycle /<br>Pressure Swing Adsorption | Time Cycle /<br>Pressure Swing Adsorption | SE |
| Mode of<br>Operation | Continuous | Continuous | SE |
| Others | | | |
| Biocompatibility | All the patient contacting<br>material and gas pathway<br>material are the same with<br>predicate device. | Conduct the following output<br>gases tests to replace the<br>biocompatibility testing for the<br>materials in the gas pathway:<br>- Particulate Matter per EPA<br>PM 2.5;<br>- Volatile Organic Compounds<br>per ASTM D5466 or equivalent;<br>- Measurement of output gas<br>for carbon monoxide;<br>- Measurement of output gas<br>for carbon dioxide;<br>- Measurement of output gas<br>for ozone. | SE |
| Elements of<br>Comparison | Subject Device | Predicate Device | Judgment |
| Accessories | All the specified accessories<br>are the same with predicate<br>device. | All the following accessories<br>are not included in the<br>package, and need to use the<br>legitimate marketing products<br>in the United States:<br>- Oxygen Mark<br>- Nasal Cannula<br>- Bubble Humidifier<br>- Oxygen Outlet Connector<br>- Oxygen Tubing | SE |

Report by Zhongshan A&J Medical Equipment Co., Ltd.

{4}------------------------------------------------

Sponsor: Zhongshan A&J Medical Equipment Co., Ltd. Subject Device: A&J 5L POCA series Oxygen Concentrator File No.: 510(k) submission report (V1.0), Chapter 4

### Note:

- 1) The operating temperature range of subject device is wider than predicate device. This can seem to be SE.
- 2) Although the power input of subject device is different from predicate device, both of them are complied with IEC 60601-1, the difference will not affect the SE.
- 3) The sound level of subject device is lower than predicate device, and both results are complied with ISO 8359. The difference will not affect the SE.

### 11. Conclusion

As a summary to the above testing results and performance specifications, A&J 5L POCA series Oxygen Concentrator is as same safe and effective as the predicate device, therefore, is Substantial Equivalent to the predicate device.

## 12. Summary Prepared Date: 2012-06-19

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.

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

Zhongshan A&J Medical Equipment Company, Limited C/O Mr. Ned Devine Responsible Third Party Official Underwrites Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062

JUL 1 7 2012

Re: K121531

Trade/Device Name: A&J 5L POCA series Oxygen Concentrator, models: POCA01B, POCA03, POCA04, POCA05 & POCA06 Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: June 26, 2012 Received: July 2, 2012

Dear Mr. Devine:

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 Eederal Register.

{6}------------------------------------------------

### Page 2- Mr. Devine

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

hh f..

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

{7}------------------------------------------------

Zhongshan A&J Medical Equipment Co., Ltd. Sponsor: A&J 5LOxygen Concentrator POCA series Subject Device: 510(k) submission report (V1.0), Chapter 3 File No .:

Chapter 3. Indications for Use

## Indications for Use

510(k) Number (if known):

Device Name: A&J 5L POCA series Oxygen Concentrator, models: POCA01B, POCA03, POCA04, POCA05, POCA06

Indications for Use:

A&J 5L POCA series Oxygen Concentrator is intended for use as an oxygen concentrator to provide supplemental low flow oxygen therapy at home, in nursing homes, at patient care facilities. A&J 5L POCA series is available by prescription only under the supervision of a physician.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Y Shulttin

Page 1 of 1

(Division Sign-Off) (Division of Anesthesiology. General Hospital Infection Control, Dental Devices

510(k) Number: k/ 2153/