P.O.G.S. 3.3 PORTABLE OXYGEN GENERATOR SYSTEM

K020362 · On Site Gas Systems, Inc. · CAW · Feb 12, 2002 · Anesthesiology

Device Facts

• Record ID: K020362
• Device Name: P.O.G.S. 3.3 PORTABLE OXYGEN GENERATOR SYSTEM
• Applicant: On Site Gas Systems, Inc.
• Product Code: CAW · Anesthesiology
• Decision Date: Feb 12, 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 for military use only.

Device Story

Portable oxygen generator (P.O.G.S. 3.3) provides supplemental oxygen in military environments lacking continuous oxygen sources. Device uses feed air compressor to create vacuum, drawing air into holding tank; air flushed through two tanks in series; molecular sieve material adsorbs nitrogen (approx. 78% of air); produces gas with approx. 93% oxygen concentration. Operated by trained medical personnel in military settings. Output used by clinicians to provide supplemental oxygen to patients. Benefits include portable, reliable oxygen supply in field conditions.

Clinical Evidence

Bench testing only. Device performance verified against ASTM F 1464-93 standard for oxygen concentrators.

Technological Characteristics

Molecular sieve adsorption technology; feed air compressor; dual-tank series configuration; produces ~93% oxygen concentration. Complies with ASTM F 1464-93. No software or electronic algorithm described.

Indications for Use

Indicated for patients requiring supplemental oxygen. Intended for military use only; to be operated by trained medical personnel.

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 (K014078)
• Merits Health Products Oxygen Concentrators (K011844)
• Oxlife Oxygen Concentrators (K955549)

Submission Summary (Full Text)

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K020362

# FEB 1 2 2002

# 10.0 510 (k) SUMMARY

#### Submitter's Name 10.1

Francis X. Hursey, President

#### Address 10.2

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

#### 10.3 Phone

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

#### 10.4 Fax

860-667-2222

#### Contact Person 10.5

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

### 10.6 Date of Preparation

January 28, 2002

#### 10.7 Device Name

Portable Oxygen Generator

#### Trade Name 10.8

On Site Gas Systems Portable Oxygen Generation System

#### Common Name 10.9

Oxygen Concentrator

- Proprietary Name 10.10 P.O.G.S. - 3.3
### Classification Name 10.11 Portable Oxygen Generator

10-1

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### Legally Marketed Device Claiming Substantial 10.12 Equivalency To:

On Site Gas Systems Portable Oxygen Generation System K 014078 Merits Health Products Oxygen Concentrators K 011844

Oxlife Oxygen Concentrators K 955549

#### 10.13 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 oxvaen. 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 greater total flow, to accommodate more cannulas per device. The variations are designed and tested for same indication of use, safety and effectiveness; variations are substantially equivalent to predicate devices.

#### 10.14 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.

### Summary of Technological Characteristics of Device 10.15 Compared to Predicates

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 the predicate device as well as other legally marketed products.

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### Discussion of Non-clinical Test to Support Determination 10.16 of Substantial Equivalency

#### 10.17 Performance Data

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

## 10.18 Conclusions

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

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Image /page/3/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 2 2002

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

Re: K020362

P.O.G.S. 3.3 Portable Oxygen Generator System Regulation Number: 868.5440 Regulation Name: Generator, Oxygen, Portable Regulatory Class: Class II (two) Product Code: 73 CAW Dated: January 28, 2002 Received: February 4, 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 i hat FDA has made a determination that your device complies with other requirements of the Act that I Dr Hab Intato a assoc regulations administered by other Federal agencies. You must or any 1 outlar statutes and states and the mot limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fart 607); adoming (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) I mo letter with and wy of substantial equivalence of your device of your device to a legally promance notifications of 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 Oiner general internation turers, 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,

Deaky Till

am D. uckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/0 description: The image shows the logo for "O2 N2 SITE On Site Gas Systems, Inc." The logo is in black and white, with the text "O2 N2 SITE" in large, bold letters. The text "On Site Gas Systems, Inc." is in smaller letters below the main logo. A line separates the two parts of the logo.

# 8.10 Statement of Indications for Use

- 510 (k) File Number 8.10.1
Kozozio 222222

#### 8.10.2 Device Name

On Site Gas Systems Portable Oxygen Generation System - 3.3

#### 8.10.3 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 Use**
**(Per 21 CFR 801.109)**

Tek
Division of Cardiovascular & Respiratory Devices
510(k) Number K620362

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# On Site Gas Systems, Inc.

35 Budney Road, Budney Industrial Park, Newington, CT 06111 U.S.A. Telephone: [phone] · Fax: [phone] Website: www.onsitegas.com · Email: [e-mail] A BUSINESS INCORPORATED IN THE STATE OF CONNECTICUT, U S A