MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS

K014301 · Merits Health Products Co., Ltd. · CAW · Feb 11, 2002 · Anesthesiology

Device Facts

• Record ID: K014301
• Device Name: MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
• Applicant: Merits Health Products Co., Ltd.
• Product Code: CAW · Anesthesiology
• Decision Date: Feb 11, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The oxygen concentrators are intended to provide supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.

Device Story

Prescription oxygen concentrator; provides supplemental oxygen in home or institutional settings. Operates via molecular sieve technology; compressor draws room air; nitrogen/water removed via sieve tanks; produces ~93% oxygen concentration. Continuous flow delivery. Includes optional oxygen alarm and pediatric flowmeter. Not life-supporting or life-sustaining. No patient monitoring capabilities. Healthcare provider uses output to manage patient oxygenation; benefits patient by providing inexpensive, continuous supplemental oxygen supply without requiring external oxygen sources.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Molecular sieve material for nitrogen/water adsorption; aluminum welded sieve tanks; compressor-based vacuum/pressure cycle; 3-liter capacity; optional oxygen alarm and pediatric flowmeter; non-networked; mechanical/pneumatic operation.

Indications for Use

Indicated for the delivery of supplemental oxygen in the home or medical institutions. Not intended 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

• 5-liter Merits Health Products Oxygen Concentrators (K011884)

Submission Summary (Full Text)

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## FEB 1 1 2002

#### SUMMARY OF SAFETY AND EFFECTIVENESS 9.0

### "510(k) SUMMARY"

Submitter: 9.1

0.3

P/L Biomedical 7690 Cameron Circle Fort Myers, FL 33912 Tel - 941-768-1118 Fax - 815-550-0162 Contact - Lee Leichter Prepared - December 12, 2001

- Trade/Proprietary Name: 9.2
Merits Health Products Oxygen Concentrators Oxygen Concentrator Portable Oxygen Generator

- Classification Name: 9.4
Common/Usual Name:

Comparison to Currently Marketed Devices 9.5 The modified 3-liter Merits Heatth Products Oxygen Concentrators are substantially equivalent to the currently marketed 5-liter Merits Health Products Oxygen Concentrators (K011884)

#### Device Description તે છે. દિ

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 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 one of the two aluminum welded molecular sieve tanks. As the oxygen is forced out of the end of the tank, it enters a "T" fitting that directs most of the gas to flush the nitrogen out of the second molecular sieve tank into the ambient air. The remaining oxygen is delivered to the patient. On the next cycle, the air is directed into the second molecular sieve tank with the oxygen generated flushing the first tank 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. Options will include an Oxygen alarm and a pediatric flowmeter

#### Indications for Use 9.7

The oxygen concentrators are intended to provide supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.

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#### SUMMARY OF SAFETY AND EFFECTIVENESS (Con't) 9.0

#### Technological Characteristics ರಿ. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8

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

#### 9.9 Performance Data

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

#### Conclusion 9.10

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

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized abstract design resembling a bird or a human figure in motion. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the central design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB 1 1 2002

Mr. Lee Leichter Merits Health Products Co., Ltd. c/o P/L Biomedical 7690 Cameron Circle Fort Myers, FL 33912

Re: K014301

Oxygen Concentrators Regulation Number: 868.5440 Regulation Name: Generator, Oxygen, Portable Regulatory Class: II (two) Product Code: 73 CAW Dated: January 28, 2002 Received: January 29, 2002

Dear Mr. Leichter:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Lee Leichter

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 or uny 1 odetar bather 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 Of It in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the qualisms control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mo lotter watification. 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oivision 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,

L. Dake Toth

Tram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

1-014301 710(k) File Number: Merits Health Products Oxygen Concentrator Device Name: The Oxygen Concentrators are indicated for the delivery of Indications For Use: supplemental oxygen in the home or medical institutions. The device is not intended for life support nor does it provide any patient monitoring capabilities.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K01430

escription Use √
(Per 21 CFR 801.19)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________