ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATION SYSTEM-1.0 AND 5.0

K021082 · On Site Gas Systems, Inc. · CAW · May 22, 2002 · Anesthesiology

Device Facts

• Record ID: K021082
• Device Name: ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATION SYSTEM-1.0 AND 5.0
• Applicant: On Site Gas Systems, Inc.
• Product Code: CAW · Anesthesiology
• Decision Date: May 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The POGS is intended to provide supplemental oxygen. Device is to be operated by trained medical personnel only for military use only.

Device Story

Portable oxygen generator provides supplemental oxygen in military environments without continuous oxygen sources. Device uses feed air compressor to draw air into holding tank; air passes through two tanks in series containing molecular sieve material. Sieve adsorbs nitrogen (approx. 78% of air); produces gas with approx. 93% oxygen concentration. Operated by trained medical personnel. Variations accommodate different flow rates and cannula counts. Output provides supplemental oxygen to patients; supports clinical decision-making by ensuring oxygen availability in field settings.

Clinical Evidence

Bench testing only. Device meets requirements of FDA recognized standard ASTM F 1464-93 for oxygen concentrators.

Technological Characteristics

Molecular sieve material for nitrogen adsorption; feed air compressor; two-tank series configuration. Produces ~93% oxygen. Meets ASTM F 1464-93.

Indications for Use

Indicated for patients requiring supplemental oxygen. Intended for use by trained medical personnel in military 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).

Predicate Devices

• On Site Gas Systems Portable Oxygen Generation System (K020362)
• On Site Gas Systems Portable Oxygen Generation System (K014078)

Submission Summary (Full Text)

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MAY 2 2 2002

KC21082

## 510(k) SUMMARY 7.0

#### 7.1 Submitter's Name

Francis X. Hursey, President

## 7.2 Address

On Site Gas Systems. Inc. 35 Budney Road Budney Industrial Park Newington, CT 06111

## 7.3 Phone

888-748-3429 (Toll-free) 860-667-8888

## 7.4 Fax

860-667-2222

## Contact Person 7.5

C. Barton ("Bart") Gullong, Vice President, Marketing and Technical Services

- 7.6 Date of Preparation April 1, 2002
## 7.7 Device Name

Portable Oxygen Generator

## 7.8 Trade Name

On Site Gas Systems Portable Oxygen Generation System

## 7.9 Common Name

Oxygen Concentrator

- 7.10 Proprietary Name P.O.G.S. - 1.0
- 7.11 Classification Name Portable Oxygen Generator

7-1 - Revised 5/20/02

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## Legally Marketed Device Claiming Substantial 7.12 Equivalency To:

On Site Gas Systems Portable Oxygen Generation System K 020362 On Site Gas Systems Portable Oxygen Generation System K 014078

#### 7.13 Description of the Device

The On Site Gas Systems portable oxygen generator is a prescription device designed to provide an inexpensive supply of supplemental oxygen in a military environment without a continuous source of The feed air compressor creates a vacuum to draw air into a oxygen. holding talk. The air is then flushed through two tanks in series to provide continuous oxygen. The molecular sieve material adsorbs nitrogen, which comprises approximately 78% of the makeup of air. The resulting gas is approximately 93% oxygen.

The variations of the device are to allow for less total flow, to accommodate fewer cannulas per device. The variations are designed and tested for same indication of use, safety and effectiveness; variations are substantially equivalent to predicate devices.

## 7.14 Intended Use of Device

The POGS is intended to provide supplemental oxygen. Device is to be operated by trained medical personnel for military use only.

## 7.15 Summary of Technological Characteristics of Device Compared to Our Legally Marketed Devices

The oxygen generator operates by using molecular sieve material to adsorb the nitrogen from filtered air. The resulting gas has an increased concentration of oxygen. This technology is well established, and has been used in our legally marketed devices as well as other legally marketed products.

7-2 Revised 5/20/02

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## 7.16 Performance Data

The device meets the requirements of the FDA recognized standard covering Oxygen Concentrators, ASTM F 1464-93, and is substantially equivalent to our legally marketed devices.

## Conclusions 7.17

Based on the design, performance specifications, and intended use, the Oxygen Concentrators are substantially equivalent to our currently marketed devices.

# 7-3 Revised 5/20/02

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850

**MAY 22 2002**

Mr. C. Barton Gullong On Site Gas Systems Inc. 35 Budney Road Budney Industrial Park Newington, CT 06111

Re: K021082

P.O.G.S. 1.0 Portable Oxygen Generator System Regulation Number: 868.5440 Regulation Name: Generator, Oxygen, Portable Regulatory Class: Class II (two) Product Code: 73 CAW Dated: April 1, 2002 Received: April 3, 2002

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. C. Barton 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 and additionally 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Dail Telle

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Statement of Indications for Use 5.7

## 510 (k) File Number 5.7.1

K021082

# 5.7.2 Device Name

On Site Gas Systems Portable Oxygen Generation System- 1.0

# 5.7.3 Indications for Use

The POGS is intended to provide supplemental oxygen. Device is to be operated by trained medical personnel only for military use only.

Prescription

Division of Cardiovascular & Respiratory Devices
510(k) Number K021082

# 5-4 Revised 5/20/02