HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2

K991569 · 02 Marketing Group, Inc. · CAW · Aug 3, 1999 · Anesthesiology

Device Facts

• Record ID: K991569
• Device Name: HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2
• Applicant: 02 Marketing Group, Inc.
• Product Code: CAW · Anesthesiology
• Decision Date: Aug 3, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Home/Commercial Oxygen Unit by system O2™ is intended to provide oxygen for emergency first aid. The Home/Commercial Oxygen Unit by system O2™ delivers in excess of 5 liters per minute for more than 15 minutes. Because the unit does not yet exceed 6 liters per minute average flow rate, the packaging will include the following statement: CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a licensed physician.

Device Story

Home/Commercial Oxygen Unit provides supplemental oxygen for emergency first aid. Device delivers oxygen flow exceeding 5 liters per minute for duration of at least 15 minutes. Intended for use in home or commercial settings. Operated by individuals following physician prescription. Output provides immediate respiratory support during emergencies. Benefits patient by ensuring oxygen availability during acute need.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Oxygen delivery system; flow rate >5 L/min for >15 minutes; average flow rate <6 L/min. Prescription-only device.

Indications for Use

Indicated for emergency first aid oxygen administration. Restricted to prescription use by or on the order of a licensed physician.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with outstretched arms, resembling a bird in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 3 1999

Mr. Lester Ford President 0, Marketing Group Inc. 11285 Elkins Rd. Suite H5 Roswell, GA 30076

Re : K991569 Home/Commercial Oxygen Unit By System 02 Trade Name: Requlatory Class: II Product Code: CAW Dated: April 30, 1999 Received: May 5, 1999

Dear Mr. Ford:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, Druq, and Cosmetic Act (Act). 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, labelinq, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such Existing major regulations affecting your device additional controls. can be found in the Code of Federal Regulations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Mr. Lester Ford

This letter will allow you to begin marketing your device as described in your 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 and additionally 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K99/569

## Indications for Use

The Home/Commercial Oxygen Unit by system O2™ is intended to provide oxygen for emergency first aid.

The Home/Commercial Oxygen Unit by system O2™ delivers in excess of 5 liters per minute for more than 15 minutes. Because the unit does not yet exceed 6 liters per minute average flow rate, the packaging will include the following statement:

Federal Law (USA) restricts this device to sale by or on the order of a CAUTION: licensed physician.

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(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number

prescription use
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