The POGS 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. POGS is compatible with commercial oxygen-consuming equipment and accessories, including D,E,H, K cylinder-filling accessories, ventilators, cannulas, and Draeger Narkomed Anesthesia Machine.

Device Description

The FDA-cleared On Site Gas Systems' Portable Oxygen Generation System 33, "POGS 33", (K020362) is being modified to include medical air, and compatibility with the Draegar Narkomed Anesthesia Machine. The system uses PSA technology, and supplies medical grade air and oxygen (USP oxygen 93%) at 50 PSIG nominal and lower output pressures in battlefield/ hospital settings in military facilities only.

The POGS 33 utilizes the same Draegar Narkomed Anesthesia Machine as the predicate, PVOCS. The POGS 33 utilizes the same oilless scroll feed compressor in the production of medical air as does the predicate, PVOCS.

The variations of the POGS device to the predicate are greater oxygen total flow, to accommodate more cannulas per device. The variations are designed and tested for the same indication of use, safety and effectiveness. Variations are substantially equivalent to the predicate device.

AI/ML Overview

This document, K030920, describes the Portable Oxygen Generation System with Medical Air (POGS 33) manufactured by On Site Gas Systems, Inc. It's a 510(k) summary seeking substantial equivalence to existing legally marketed devices.

Here's an analysis of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the POGS 33 are based on recognized FDA standards for oxygen concentrators and medical air.

Acceptance Criteria	Reported Device Performance
Oxygen: Meets requirements of FDA recognized standard ASTM F 1464-93 and USP Standard covering oxygen.	The device meets the requirements of the FDA recognized standard ASTM F 1464-93 and USP Standard covering oxygen. The device is substantially equivalent to the predicate devices.
Medical Air: Meets requirements of FDA recognized standard covering Medical Air, USP.	The device meets the requirements of the FDA recognized standard covering Medical Air, USP.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for a test set in the context of clinical studies with patients. The performance data presented refers to the device meeting established quality and performance standards rather than results from a pre-market clinical trial involving human subjects or real-world data.

The data provenance is from non-clinical tests conducted by the manufacturer to demonstrate compliance with recognized standards. This is not retrospective or prospective clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Given that this is a 510(k) submission based on non-clinical performance data against established standards, the concept of "ground truth established by experts" as it would apply to a diagnostic or clinical AI device is not applicable in this context. The "ground truth" here is the set of criteria defined by the recognized standards (ASTM F 1464-93 and USP Standards). The expertise lies in the development and validation of these standards themselves, not in a specific set of experts adjudicating results for this particular device's performance test.

4. Adjudication Method for the Test Set

Again, an adjudication method for a "test set" in the sense of expert review of clinical cases is not applicable here. The device's performance is measured against objective, verifiable parameters defined by the ASTM and USP standards. Passing these tests constitutes meeting the "acceptance criteria."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC study was done, as this is a device for generating oxygen and medical air, not a diagnostic imaging device or an AI application intended to assist human readers in interpretation. Therefore, there is no effect size related to human reader improvement with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is a machine that generates gases. Its performance is inherently "standalone" in that it produces oxygen and medical air autonomously based on its design and manufacturing. There is no "algorithm only" performance separate from the physical device's operation. Its performance is evaluated independently against physical/chemical standards.

7. The Type of Ground Truth Used

The "ground truth" used for this device is based on established industry and regulatory standards:

ASTM F 1464-93 for oxygen concentrators.
USP Standard for oxygen.
USP Standard for Medical Air.

These standards define the acceptable purity, concentration, and other performance characteristics for medical-grade oxygen and air.

8. The Sample Size for the Training Set

This device does not utilize a "training set" in the context of machine learning or artificial intelligence. It's a mechanical and chemical system. Therefore, the concept of a training set sample size is not applicable.

9. How the Ground Truth for the Training Set Was Established

Since there is no training set for this type of device, the question of how its ground truth was established is not applicable. The "ground truth" relevant to this device's approval are the performance specifications mandated by the recognized standards it claims to meet.

Summary

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10.0 510 (k) SUMMARY

Submitter's Name 10.1

Francis X. Hursey, President

10.2 Address

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

10.3 Phone

888-748-34:29 (Toll-free) 860-667-8838

Fax 10.4

860-667-2222

Contact Person 10.5

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

10.6 Date of Preparation

March 17, 2003

10.7 Device Name

Portable Oxygen Generator with Medical Air

10.8 Trade Name

On Site Gas Systems Portable Oxygen Generation System with Medical Air

10.9 Common Name Oxygen Concentrator with Medical Air

Proprietary Name 10.10 POGS 33

Classification Name 10.11 Portable Oxygen Generator with Medical Air

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Legally Marketed Device Claiming Substantial 10.12 Equivalency To:

On Site Gas Systems Portable Oxygen Generation System K 020362 Litton Systems Patient Ventilation Oxygen Concentrating K 013223 Svstem (PVOCS)

Description of the Device 10.13

Intended Use of Device 10.14

The POGS is intended to provide oxygen and medical air. 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 the filtered compressed, dry 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.

Medical air is produced when the compressed air leaves the air storage tank and splits-off between the oxygen generator and medical air stream. This compressed air is produced from the same make and model oil-less scroll compressor as the predicate. The medical air passes through a pressure requlator and 0.01 micron filter. 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

Performance Data 10.17

For oxygeri, the device meets the requirements of the FDA recognized For oxygen, the doncentrators, ASTM F 1464-93 and USP Standard covering oxygerantially equivalent to the predicate devices. oxygen box, air, the device meets the requirements of the FDA recognized standard covering Medical Air, USP

10.18 Conclusions

Based on the design, performance specifications, and intended use, the Daygen Concentrators with medical air are substantially equivalent to the currently marketed devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 2004

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

Re: K030920

Trade/Device Name: Portable Oxygen Generation System with Medical Air Regulation Number: 868.5440 Regulation Name: Generator, Oxygen, Portable Regulatory Class: II Product Code: CAW Dated: January 14, 2004 Received: January 15, 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 I va may aterest provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. In addition, if you wish to change or expand your current indications for use to include non-military environments, you will need to submit a new 510(k) premarket notification, and receive FDA clearance prior to marketing the device.

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 Codc 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 Flease oc advised that I Dr is todaints or our device complies with other requirements of the Act that I DA has made a acterines administered by other Federal agencies. You must of any I catal statues and registanents, including, but not limited to: registration and listing (21 comply with an the Act 81equirements (1); good manufacturing practice requirements as set CFN in the quality systems (CS) 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 production conacted conacle in marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally prematics notication "The 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 if you dome specific cof Compliance at (301) 594-4646. Also, please note the regulation entitled, Connect and office of Court Courter notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Clive Liu, Ph.D.

Chiu Lin, Ph.I 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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ogen Generating Equipment

8.10 Statement of Indications for Use

510 (k) File Number 8.10.1

K0309201

Device Name 8.10.2

On Site Gas Systems Portable Oxygen Generation System - 33 (POGS 33)

Indications for Use 8.10.3

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use (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

8-4

CAhwh

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number: K030920

On Site Gas Systems. Inc.

35 Budney Road. Budney Industrial Park, Newington, CT 06111 U.S.A. Telephone: 860.667.8888 · Fax: 860.667.2222 Website: www.onsitegas.com · Email: info@onsitegas.com A BUSINESS NUTHPPORATED IN THE STATE OF CONNECTICUT, U.S.A

Regulation Number and Section

§ 868.5440 Portable oxygen generator.

(a)
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).(b)
Classification. Class II (performance standards).