MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS

K053229 · Merits Health Products Co., Ltd. · CAW · Mar 23, 2006 · Anesthesiology

Device Facts

• Record ID: K053229
• Device Name: MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
• Applicant: Merits Health Products Co., Ltd.
• Product Code: CAW · Anesthesiology
• Decision Date: Mar 23, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Oxygen Concentrators are indicated for the delivery of supplemental oxygen in the home or medical institutions. The devices are not intended for life support nor do they provide any patient monitoring capabilities.

Device Story

Prescription oxygen concentrator; provides supplemental oxygen up to 10 LPM; home or institutional use. Operates via molecular sieve technology; compressor draws room air; dual-chamber aluminum extruded tanks bind nitrogen/water; outputs ~93% oxygen. Optional oxygen-driven nebulizer available for prescribed aerosol therapy. Device not life-supporting/sustaining; no patient monitoring. Healthcare providers prescribe therapy; patients or caregivers operate device. Benefits include inexpensive, continuous high-purity oxygen supply.

Clinical Evidence

Bench testing only. No clinical data provided. Testing confirmed device meets performance specifications and is substantially equivalent to predicate devices.

Technological Characteristics

Molecular sieve technology for oxygen separation; dual-chamber aluminum extruded tanks; compressor-driven; 10 LPM maximum output. Optional pediatric flowmeter and oxygen-driven nebulizer. Prescription device; non-life-supporting.

Indications for Use

Indicated for patients requiring supplemental oxygen therapy in home or medical institutional 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

• Merits Health Products Oxygen Concentrators 5-liter (K011844)
• INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10 (K042262)
• AIRSEP NEWLIFE AIR OUTLET OPTION (K944020)

Submission Summary (Full Text)

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K053229

#### SUMMARY OF SAFETY AND EFFECTIVENESS 9.0

## "510(k) SUMMARY"

9.1 Submitter: Steve Chao Merits Health Products Co., LTD. 9, Road 36, Taichung Industrial Park Taichung, Taiwan R.O.C. Tel: [phone] ext. 240 Fax: [phone] E-mail: [e-mail]

Prepared - March 1, 2005

- 9.2 Trade/Proprietary Name:
- વે 3 Common/Usual Name:
- 9.4 Classification Name:
- Merits Health Products Oxygen Concentrators Oxyqen Concentrator
- Oxygen Generator
- 9.5 Comparison to Currently Marketed Devices

The modified 10-liter Merits Health Products Oxygen Concentrators are substantially equivalent to the currently marketed 5-liter Merits Health Products Oxygen Concentrators (K011844) in main structure. And the functions are substantially equivalent to the 10-liter INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10 (K042262). The oxygen driven nebulizer option are substantially equivalent to the currently marketed 5-liter AIRSEP NEWLIFE AIR OUTLET OPTION (K944020) which incorporates a nebulizer with concentrator. The equivalence is supported by the attached documentation.

9.6 Device Description

The Merits Health Products Oxygen Concentrators are prescription devices designed to provide an inexpensive supply of supplemental oxygen in a home or institution without a continuous source of purified oxygen. They are not for life-supporting nor life-sustaining devices. The devices operate through the use of molecular sieve material that binds with the water and nitrogen in filtered room air to leave a gas that is approximately 93% oxygen when delivered to the patient. The compressor creates a vacuum to draw room air into a holding tank. At the same time, downstream of the compressor, the air from the previous cycle is pressurized into first chamber of the dual-chambers aluminum extruded molecular sieve tank. As the oxygen is forced out of the end of the first chamber and then enters the Oxygen tank for patient use. As the remaining Oxygen flush the nitrogen out of the first molecular sieve chamber into the ambient air, the air is directed into the second molecular sieve chamber and continuing the supply to the patient. This repetitive cycle generates the oxygen necessary to flush and prepare the saturated sieve tank while supplying the patient with a continuous flow of high concentration oxygen.

Optional oxygen-driven-nebulizer is provided for patients who are prscribed for oxygen aerosol therapy by physician, using higher purity oxygen to drive a nebulizer while oxygen therapy is being undertaken. Optional oxygen-driven-nebulizer allows a single wnit to meet the different needs of oxygen or oxygen-aerosol therapy patients.

This submission covers a model that will have a maximum output of 10-liters per minute as compared to the currently marketed model. Options will include an Oxygen alarm, pediatric flowmeter and nebulizer.

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#### 9.7 Intend Use

The Oxyqen Concentrators are intended for the administration of supplemental oxygen up to 10 LPM. Our proposed Oxygen-Driven Nebulizer option is intended to provide higher purity of oxygen to drive the nebulizer, pursuant to prescribed oxygen-aersol therapy application by physician. The device is not intended for life support nor does it provide any patient monitoring capabilities.

#### Technological Characteristics 9.8

The oxygen concentrator operates by using molecular sieve material to absorb water and nitrogen from filtered air. The resulting gas has an increased oxygen purity. This technology is well established and has been used in other legally marketed products. There are no major technological differences.

#### ਰ ਰ Performance Data

The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device.

#### 9.10 Conclusion

Based on the design, performance specifications, testing and intended use, the Merits Health Products Oxygen Concentrators are substantially equivalent to the currently marketed device.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services. The seal features an abstract image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are written around the eagle in a circular pattern. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 2006

Mr. Steve Chao Merits Health Products Company, Limited 9. Road 36 Taichung Industrial Park Taichung China (Taiwan) 407

Re: K053229

Trade/Device Name: Merits Health Products Oxygen Concentrator Regulation Number: 868.5440 Regulation Name: Respiratory gas humidifier Regulatory Class: II Product Code: CAW Dated: February 17, 2006 Received: February 21, 2006

Dear Mr. Chao:

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 (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.

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

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### Page 2 -- Mr. Steve Chao

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); 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.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Suen Runo
Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, 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) File Number: | K053229 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Merits Health Products Oxygen Concentrator |
| Indications For Use: | The Oxygen Concentrators are indicated for the delivery of<br>supplemental oxygen in the home or medical institutions. The<br>devices are not intended for life support nor do they provide any<br>patient monitoring capabilities. |

Prescription Use _ V (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Auy Salem

ology General Hospital
cal Dental Devices
K052229