MERITS HEALTH PRODUCTS OXYGEN CONCENTRATOR

K050430 · Merits Health Products Co., Ltd. · CAW · Aug 4, 2005 · Anesthesiology

Device Facts

• Record ID: K050430
• Device Name: MERITS HEALTH PRODUCTS OXYGEN CONCENTRATOR
• Applicant: Merits Health Products Co., Ltd.
• Product Code: CAW · Anesthesiology
• Decision Date: Aug 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Oxygen Concentrators with the Oxygen Filling accessory are indicated to provide supplemental oxygen to patients in the home and to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. The device is not intended for life support nor does it provide any patient monitoring capabilities.

Device Story

Profill Q601 series home oxygen filling machine; prescription device for home use. Inputs: oxygen from standard oxygen concentrator. Operation: oxygen inducted into buffer tank; split into two streams. Stream 1: supplemental oxygen for patient use during filling. Stream 2: compressor pressurizes oxygen to fill portable gas cylinders. Output: pressurized oxygen in cylinders. Used by patients in home setting. Benefits: enables ambulatory oxygen supply for patients requiring supplemental oxygen.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Consists of compressor module and portable oxygen cylinder with adapted fitting. Compatible with standard oxygen concentrators. Non-sterile. Mechanical compression system.

Indications for Use

Indicated for home patients requiring supplemental oxygen and pressurized oxygen for personal ambulatory gas cylinder filling. Not for life support; no 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

• Invacare Corporation Model HomeFill II Complete Home Oxygen System (K003939)

Submission Summary (Full Text)

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K050430

#### SUMMARY OF SAFETY AND EFFECTIVENESS 9.0

## "510(k) SUMMARY"

| 9.1 Manufacturer: | Merits Health Products Co., LTD. |
|-----------------------------|------------------------------------------------------|
| | 9, Road 36, |
| | Taichung Industrial Park |
| | Taichung, Taiwan R.O.C |
| 9.2 Submitted By: | Contact - P/L Biomedical |
| | Lee Leichter |
| | 7690 Cameron Circle |
| | Fort Myers, FL 33912 |
| | Tel - 239-768-1118 |
| | Fax - 815-550-0162 |
| | Prepared - April 26, 2005 |
| 9.1 Trade/Proprietary Name: | Merits Health Products Oxygen Tank Filling Accessory |
| 9.2 Common/Usual Name: | Oxygen Concentrator (Accessory) |
| 9.3 Classification Name: | Portable Oxygen Generator |

Comparison to Currently Marketed Devices 9.4

The modified Oxygen Concentrators are substantially equivalent to the currently marketed Invacare Corporation Model HomeFill II Complete Home Oxygen System (K003939).

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#### Device Description 9.5

The Profill Q601 series home oxygen filling machines are prescription devices designed for use in home by patients that require supplemental oxygen. It is intended to pressurize oxygen from an oxygen concentrator to fill gas cylinders for the patient's personal ambulatory use. It is not intended for life support nor does it provide any patient monitoring capabilities.

The device consists of a compressor module and a portable oxygen cylinder with a specially adapted cylinder fitting. It is compatible with available standard oxygen concentrators as the source of oxygen. The oxygen generated by the oxygen concentrator is inducted into a buffer tank. Then it is split into two streams. The first stream flows to the outlet on the control panel. The patients can use this as their source of supplemental oxygen while they are filling their cylinders. The second stream flows to the compressor where the oxygen is pressurized and filled into the cylinder. The devices are not sold or labeled as sterile

#### Indications for Use વે.રે

The Oxygen Concentrators with the Oxygen Filling accessory are indicated to provide supplemental oxygen to patients in the home and to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. The device is not intended for life support nor does it provide any patient monitoring capabilities

#### Technological Characteristics 9.7

The technological characteristics are the same as the predicate devices.

#### ರಿ 8 Performance Data

Verification testing has confirmed the product meets its specifications.

#### Conclusion ರಿ.ಡಿ. ಇದರ ಕಾರಿ ಕಾರಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾ

Based on the design, performance specifications, testing and intended use, the Oxygen Filling Accessories are substantially equivalent to the currently marketed devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 4 - 2005

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

Re: K050430

Trade/Device Name: Merits Health Products Oxygen Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: July 8, 2005 Received: July 8, 2005

Dear Mr. Leichter:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conninered pror to May 20, 1978, in accordance with the provisions of the Federal Food, Drug, de vices that have been recuire approval of a premarket approval application (PMA). and Costiette Tec (110) market the device, subject to the general controls provisions of the Act. The 1 ou may, therefore, thanker the act include requirements for annual registration, listing of general controls provisions 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 If your device is enabilitional controls. Existing major regulations affecting your device can may be subject to sater additions, Title 21, Parts 800 to 898. In addition, FDA may be found inther announcements concerning your device in the Federal Register.

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### Page 2 - Mr Leichter

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issumes of a babbidents with other requirements of the Act that I DA has made a decommandia in administered by other Federal agencies. You must of ally if edital statures und regulations . including, but not limited to: registration and listing (21 Comply with an the Act 3 requirements) on the manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820), and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro risions (Declobs your device as described in your Section 510(k) This letter will anow you to begin marketing your device of your device to a legally premits in the month. The PDF mining of casions 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 If you ucate specific acries ion your at [phone]. Also, please note the regulation entitled, Coniation of Compunisor market notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sinute y. Michino m-D

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 STATEMENT

510(k) File Number:

Merits Health Products Oxygen Concentrator Device Name: The Oxygen Concentrators with the Oxygen Filling accessory are Indications For Use: indicated to provide supplemental oxygen to patients in the home and to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. The device is not intended for life support nor does it provide any patient monitoring capabilities.

Prescription Use ✔ (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Per 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)

Cum Aubrom

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

510(k) Number: