EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR

K043520 · Emg Technology Co., Ltd. · CAW · Oct 21, 2005 · Anesthesiology

Device Facts

• Record ID: K043520
• Device Name: EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR
• Applicant: Emg Technology Co., Ltd.
• Product Code: CAW · Anesthesiology
• Decision Date: Oct 21, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EMG CTX01-XXX Series Oxygen Concentrator is designed to provide 1 to 5 liters per minute oxygen for the patient who has been prescribed oxygen therapy by a physician. This device is used in home type environments, nursing homes, patient care facilities, etc.

Device Story

The EMG CTX01-XXX Series Oxygen Concentrator is a portable device designed to deliver supplemental oxygen to patients. It functions by concentrating oxygen from ambient air to provide a continuous flow of 1 to 5 liters per minute. The device is intended for use in home, nursing home, and clinical care settings. It is operated by patients or caregivers under physician prescription. The device provides a therapeutic benefit by ensuring a consistent supply of oxygen for patients with respiratory needs.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Portable oxygen concentrator; flow rate 1-5 LPM; operates via ambient air concentration; intended for home and clinical use; class II device (21 CFR 868.5440).

Indications for Use

Indicated for patients requiring supplemental oxygen therapy at flow rates of 1 to 5 liters per minute as prescribed by a physician. Suitable for use in home, nursing home, and patient care facility environments.

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).

Submission Summary (Full Text)

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OCT 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EMG Technologies Company Limited C/O Mr. Leonard Frier Official Correspondent MET Laboratories, Incorporated 914 West Patapsco Avenue Baltimore, MD 21230

Re: K043520

Trade/Device Name: EMG CTX01-XXX Series Oxygen Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Concentrator Regulatory Class: II Product Code: CAW Dated: September 6, 2005 Received: September 15, 2005

Dear Mr. Frier:

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. Frier

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); 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 begin 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/industry/support/index.html.

Sincerely vours.

Susan Runon

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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

510K number: K043520

Device Name: EMG CTX01-XXX Series Oxygen Concentrator

Indications For Use: The EMG CTX01-XXX Series Oxygen Concentrator is designed to provide 1 to 5 liters per minute oxygen for the patient who has been prescribed oxygen therapy by a physician. This device is used in home type environments, nursing homes, patient care facilities, etc.

(Part 21 CFR 801 Subpart D) Prescription Use _XXXX__ (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cun Suim

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

510(k) Number __