OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 615

K052396 · Oxysure Systems, Inc. · CAW · Dec 9, 2005 · Anesthesiology

Device Facts

• Record ID: K052396
• Device Name: OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 615
• Applicant: Oxysure Systems, Inc.
• Product Code: CAW · Anesthesiology
• Decision Date: Dec 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OxySure™ System is intended to produce oxygen for emergency use.

Device Story

OxySure Model 615 is a portable oxygen generator for emergency use. It utilizes a chemical reaction between dry compounds and a catalyst to produce USP-grade oxygen. The system consists of an outer housing, self-contained disposable cartridges containing the reactants, and a single-use mask and tubing for delivery. Upon activation, the device generates oxygen at an average flow rate of 6.5 liters per minute for 15 minutes. The reaction is instantaneous and requires no external power, stirring, or agitation. It is designed for emergency settings to provide immediate supplemental oxygen to patients.

Clinical Evidence

Bench testing only. Testing measured flow rate, oxygen purity, humidity, and temperature at 15-second intervals following the initiation of the chemical reaction. No clinical data was provided.

Technological Characteristics

Portable oxygen generator utilizing a catalytic chemical reaction of dry compounds. Components include an outer housing, disposable reactant cartridges, and a single-use mask/tubing delivery system. Produces USP-grade oxygen at 6.5 L/min for 15 minutes. No external energy source required.

Indications for Use

Indicated for emergency oxygen production for patients requiring supplemental oxygen.

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

• Canogen Portable Oxygen Generator Model 615 (K982243)

Submission Summary (Full Text)

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DEC 9 2005

K052396

8/29/2005

Proprietary and Confidential © 2005 OxySure™ Systems, Inc. All Rights Reserved Worldwide

#### VIII. 510(k) Summary

| Submitted By: | OxySure Systems, Inc. |
|---------------|-------------------------------|
| | 2611 Internet Blvd. Suite 109 |
| | Frisco, Texas 75034 |

Contact:

Mr. Julian Ross Chief Executive Officer OxySure Systems, Inc. 2611 Internet Blvd, Suite 109 Frisco, Texas 75034 Telephone: [phone] Fax: [phone]

### Device:

| Device Classification Name: | Portable Oxygen Generator | |
|-----------------------------|------------------------------------|--|
| Device Generic Name: | Portable Oxygen Generator | |
| Device Trade Name: | OxySure™ Portable Oxygen Generator | |
| | Model 615 | |

Predicate Device:

Canogen Portable Oxygen Generator Model 615 Canogen International, Ltd. Syosset, New York 510(k) Number: K982243

## Device Description:

The OxySure™ System creates medically pure [USP] oxygen at an average flow rate of 6.5 liters per minute for 15 minutes from a catalytic reaction of dry compounds.

### Intended Use:

The OxySure™ System is intended to produce oxygen for emergency use.

## Technological Characteristics:

The OxySure 1 System is comprised of an outer housing, self-contained disposable cartridges that house the dry compounds and water, and a single-use mask and tubing system to deliver the oxygen to the user.

### Testing:

Predetermined amounts of base powder, water and catalyst were combined in the system to commence the chemical reaction and the chemical reaction commenced instantaneously. There was no stirring, swirling, or agitation of any kind administered or required to commence the reaction. Measurements of flow rate, oxygen purity, humidity and temperature were recorded at 15-second intervals, commencing upon the addition of the catalyst.

### Conclusion:

The OxySure™ System is substantially equivalent to the legally marketed Portable Oxygen Generator device in intended use and performance.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three stripes forming its wing, symbolizing the department's mission to protect and enhance the health and well-being of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2005 DEC 9

2005

Mr. Julian T. Ross President & CEO OxySure Systems, Incorporated 2611 Internet Boulevard, Suite 109 Frisco. Texas 75034

Re: K052396

Trade/Device Name: OxySure Portable Oxygen Generator, Model 615 Regulation Number: 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: November 30, 2005 Received: December 1, 2005

Dear Mr. Ross:

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. Ross

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 yours,

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

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# INDICATIONS FOR USE

510(k) Number (if known):

OxySure™ Portable Oxygen Generator, Model 615 Device Name:

Indications for Use:

The OxySure™ System is intended to produce oxygen for emergency use.

Prescription Use □ (21 CFR 801 Subpart D)

And/Or

Over-The-Counter Use (21 CFR 807 Subpart C)

Do Not Write Below This Line - Continue on Another Page if Needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

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K052396