PORTABLE OXYGEN GENERATION SYSTEM: POGS 33C

K041664 · On Site Gas Systems, Inc. · CAW · Jul 29, 2004 · Anesthesiology

Device Facts

• Record ID: K041664
• Device Name: PORTABLE OXYGEN GENERATION SYSTEM: POGS 33C
• Applicant: On Site Gas Systems, Inc.
• Product Code: CAW · Anesthesiology
• Decision Date: Jul 29, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The POGS 33C is intended to provide medical grade air and oxygen (USP oxygen 93%) at 50 PSIG nominal and lower output pressures in hospitals, surgical suites, and other clinical settings in military facilities only. The POGS 33C is compatible with commercial oxygen-consuming equipment and accessories, including D, E, H, and K cylinder-filling accessories, ventilators, cannulas, Draeger Narkomed Anesthesia machines and Impact Univent/Eagle 754/754M Ventilators.

Device Story

POGS 33C is a portable oxygen generator for military clinical settings; provides medical-grade oxygen (93% purity) and medical air. Operates via Pressure Swing Adsorption (PSA) using molecular sieves to separate gases from filtered ambient air. Delivers output at 50 PSIG through four ports; max flow 33 L/min for oxygen, 30 L/min for medical air. Used in hospitals and surgical suites to support respiratory equipment like ventilators and anesthesia machines when liquid oxygen is unavailable. Benefits patients by ensuring continuous supply of therapeutic oxygen and air in austere or deployable military medical environments.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Pressure Swing Adsorption (PSA) technology; molecular sieve gas separation. Output: 93% minimum purity oxygen (avg 95%) and medical air at 50 PSIG. Four-port delivery system. Includes medical-grade oxygen hoses and flow regulators. Standalone system.

Indications for Use

Indicated for patients in military clinical settings requiring supplemental oxygen or medical air. Compatible with ventilators, anesthesia machines, and cylinder-filling accessories.

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

• Portable Oxygen Generator System: POGS 33 (K030920)

Submission Summary (Full Text)

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K041664

## JUL 2 9 2004

# 510(k) Summary for Portable Oxygen Generator System: POGS 33C

| Date: | July 16, 2004 |
|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Applicant: | On Site Gas Systems, Inc<br>35 Budney Road<br>Newington, CT 06111 |
| Fax: | 860.667.8888 |
| Phone: | 860.667.2222 |
| Contact: | C. Bart Gullong, Vice-President, Marketing and Technical Services |
| Email: | [e-mail] |
| Trade Name: | Portable Oxygen Generator System: POGS 33C |
| Common Name: | Oxygen Concentrator |
| Establishment<br>Registration Number: | 3003637574 |
| Manufactured at: | (Same as Applicant) |
| Classification Name: | Oxygen Concentrator |
| Reason for 510(k): | Design changes (1) adding additional compatible equipment (Impact<br>754/M<br>Univent/Eagle) and (2) reducing weight. |
| Product code: | CAW, CFR 21 § 868.5440 Class II |
| Legally Marketed Device to which<br>Substantial Equivalence is claimed: | |

Portable Oxygen Generator System: POGS 33 K030920

#### Description:

The Portable Oxygen Generation System 33 (POGS 33C) has been designed to The Fortable Oxygen Ocheration of Supplemental oxygen in a setting where liquid oxygen may be unavailable, and of medical air to drive respiratory equipment. liquid oxygen may be unavaliable, and sed medical missions require medical support systems Aeromedical evacuation and ground ban. The gaseous oxygen generator will also be required Capable of providing therapoule oxygen. The gassessing and the oxygendriven equipment included in the AFMS deployable medical assemblages. Requirements are differi equipment included in the uspicy and mational requirements document that has been issued by the United States Air Force.

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This system is based on the Pressure Swing Adsorption principle and uses a molecular sieve to separate gases from the filtered ambient air. The oxygen is stored and delivered to the patient(s) through one of four ports with a total maximum flow of 33 liters-per-minute at 50 psig. The oxygen concentration purity level is at 93% minimum, with an oxygen purity level average of 95%. Included with the generator is a secured accessory kit including medicalgrade oxygen hose and flow regulators for the outlets.

Medical air output of up to a total of 30 liters per minute at 50 PSIG is also provided.

#### Indications For Use:

The POGS 33C is intended to provide medical grade air and oxygen (USP oxygen 93%) at 50 PSIG nominal and lower output pressures in hospitals, surgical suites, and other clinical settings in military facilities only. The POGS 33C is compatible with commercial oxygenconsuming equipment and accessories, including D, E, H, and K cylinder-filling accessories, ventilators, cannulas, Draeger Narkomed Anesthesia machines and Impact Univent/Eagle 754/754M Ventilators.

#### Conclusion:

Non-clinical bench testing conducted by On Site Gas Systems, Inc, as provided, is sufficient in establishing substantial equivalence of the POGS 33C to the predicate device on which SE is claimed.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 2 9 2004

Mr. C. Bart Gullong Vice President On-Site Gas Systems, Incorporated 35 Budney Road Budney Industrial Park Newington, Connecticut 06111

Re: K041664

Trade/Device Name: Portable Oxygen Generation Systems (POGS) 33C Regulation Number: 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: June 17, 2004 Received: June 25, 2004

Dear Mr. Gullong:

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. Gullong

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/dsma/dsmamain.html

Sincerely yours,

Chiu Lin, Ph.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

510(k) Number: K041664

Device Name: Portable Oxygen Generation System (POGS) 33C

Indications For Use:

The POGS 33C is intended to provide medical grade air and oxygen (USP oxygen 93%) at 50 PSIG nominal and lower output pressures in hospitals, surgical suites, and other clinical settings in military facilities only. The POGS 33C is compatible with commercial oxygen-consuming equipment and accessories, including D, E, H, and K cylinder-filling accessories, ventilators, cannulas, Draeger Narkomed Anesthesia machines and Impact Univent/Eagle 754/754M Ventilators.

Prescription Use X (Part 21 CFR 601 Subpart D)

AND/OR

Over-The-Counter Use (Part 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)

unfrem

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Device 12 041 510(k) Number: _