PORTABLE OXYGEN GENERATOR SYSTEM

K062153 · Molecular Products , Ltd. · CAW · Nov 21, 2006 · Anesthesiology

Device Facts

• Record ID: K062153
• Device Name: PORTABLE OXYGEN GENERATOR SYSTEM
• Applicant: Molecular Products , Ltd.
• Product Code: CAW · Anesthesiology
• Decision Date: Nov 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Portable Oxygen Generator (POG) is intended to produce oxygen for emergency use at 6 lpm for at least 15 minutes.

Device Story

POG is a self-contained, dry chemical-based portable oxygen generator. Device produces 99% oxygen at 6 lpm flow rate for at least 15 minutes. Oxygen is delivered to user via standard face mask or nasal cannula. Intended for emergency use in any environment by any individual (OTC). Device operation is purely chemical; no electronic or mechanical power source required. External canister temperature remains below 45°C during operation.

Clinical Evidence

Bench testing only. Performance verified for 6 Lpm flow rate, 15-minute duration, 99% oxygen concentration, and external canister temperature < 45°C.

Technological Characteristics

Dry chemical-based oxygen generation. Portable form factor. Delivers 99% oxygen at 6 Lpm. External canister temperature < 45°C. No software or electronic components.

Indications for Use

Indicated for emergency oxygen production for any individual in any environment. No contraindications.

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

• OxySure Systems - OxySure - K052396

Submission Summary (Full Text)

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#### 510(k) Summary 5

K062153

## Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 25-Jul-06

| Molecular Products Ltd.<br>Mill End<br>Thaxted, Essex CM6 2LT UK | Tel -- 011-44-1371-830676<br>Fax - 011-44-1371-830998 | | NOV 21 2006 |
|------------------------------------------------------------------|-------------------------------------------------------|--|-------------|
| Official Contact: | Mandy Crudace, PhD, Technical Manager | | |
| Proprietary or Trade Name: | POG | | |
| Common/Usual Name: | Portable oxygen generator | | |
| Classification Name: | Portable oxygen generator | | |
| Device: | POG | | |
| Predicate Devices: | OxySure Systems - OxySure - K052396 | | |
| Device Description: | | | |

The Molecular Products' POG is a chemical based portable oxygen generator which generates 99% oxygen for 15 minutes at a flow rate of 6 lpm. It is a self-contained device with the oxygen delivered via a standard oxygen face mask or nasal cannula.

| Indications for Use: | |
|-----------------------|-----------------------------------------------|
| Indicated Use -- | Intended to produce oxygen for emergency use. |
| Patient Population -- | Any individual |
| Environment of Use -- | Any environment |
| Contraindications -- | None |

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## Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 25-Jul-06

Device Attributes:

| Over-the-counter (OTC) | Yes |
|------------------------|-----|
|------------------------|-----|

Design

| Dry chemical based technology | Yes |
|-------------------------------|-----|
| Portable | Yes |

Testing

| Test flow rate | 6 Lpm |
|-------------------------------|---------------------|
| Duration | At least 15 minutes |
| % Oxygen | 99% |
| External canister temperature | < 45°C |

# Differences Between Other Legally Marketed Predicate Devices

The POG is viewed as substantially equivalent to the following predicate device -OxySure - K052396.

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

:

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Molecular Products Limited C/O Mr. Paul Dryden President ProMedic, Incorporated 3460 Pointe Creek Court, #102 Bonita Springs, Florida 34134

NOV 2 ] 2006

Re: K062153

Trade/Device Name: POG Portable Oxygen Generator Regulation Number: 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: October 11, 2006 Received: October 12, 2006

Dear Mr. Dryden:

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. Dryden

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,

Susan Runoe
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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#### 4 Indications for Use Statement

| | Page 1 of 1 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: | K662153 (To be assigned) |
| Device Name: | POG |
| Indications for Use: | The Portable Oxygen Generator (POG) is intended to produce oxygen for emergency use at 6 lpm for at least 15 minutes. |

Prescription Use (Part 21 CFR 801 Subpart D) Over-the-counter use XX (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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