(175 days)
The POGS 33C is intended to generate and deliver USP 93% supplemental oxygen and medical grade air. This device is intended to be used only by trained personnel in disaster relief and emergency preparedness situations, or military settings where bottled oxygen is not readily available.
The Portable Oxygen Generation System 33 (POGS 33C) has been designed to accommodate medical personnel with a source of supplemental oxygen in a setting where liquid oxygen may be unavailable, and of medical air to drive respiratory equipment. Aero-medical evacuation and ground based medical missions require medical support systems capable of providing therapeutic oxygen. Requirements are based on the mobile, deployment oxygen system, operational requirements document that has been issued by the United States Air Force. This system is based on the Pressure Swing Absorption principle and uses a molecular sieve to separate gasses 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 90% +/- 3%. Included with the generator is a secured accessory kit including medical-grade oxygen hose and flow regulators for the outlets. The POCS 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. Medical air output of up to a total of 30 liters-per-minute at 50 PSIG is also provided.
The provided document is a 510(k) summary for the POGS 33C Portable Oxygen Generation System. It focuses on establishing substantial equivalence to a predicate device rather than detailing specific clinical studies against predefined acceptance criteria for novel device performance. Therefore, much of the requested information, particularly regarding typical AI/software device evaluation, is not applicable or available in this document.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal acceptance criteria or a detailed quantitative performance table as would be found for a novel device undergoing extensive clinical trials. Instead, it relies on substantial equivalence to a predicate device.
The key performance claims are related to the device's capability and purity:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Oxygen Concentration Purity | 90% +/- 3% |
| Total Oxygen Flow | 33 liters-per-minute |
| Oxygen Pressure | 50 PSIG |
| Medical Air Output | 30 liters-per-minute |
| Medical Air Pressure | 50 PSIG |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The evaluation performed was "Non-clinical bench testing," not a clinical study on a test set of data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This was a non-clinical bench test of a physical device, not an evaluation requiring expert-established ground truth on a dataset.
4. Adjudication Method for the Test Set
Not applicable. This was a non-clinical bench test.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. The document describes a physical oxygen generation system, not an AI or imaging device that would typically undergo such a study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is hardware for generating oxygen and medical air, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for the device's performance (specifically oxygen purity) was established through non-clinical bench testing conducted by On-Site Gas Systems, Inc. This means the device's output was measured and verified against specifications using laboratory equipment rather than expert consensus or pathology.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth for it.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets its performance claims and is substantially equivalent to its predicate device is described as "Non-clinical bench testing conducted by On-Site Gas Systems, Inc." This testing was sufficient to establish substantial equivalence for the POGS 33C to the predicate device (POGS 33, K041664), including oxygen purity evaluations. The specific standard used for performance evaluation was ASTM F-1464-93.
The improvements made to the device (stainless steel fittings, aluminum sieve beds, Microboost reliability, feed air compression packaging, improved connectors, manuals, and labeling) were also part of this non-clinical evaluation to ensure they did not negatively impact the safety or effectiveness of the device compared to the predicate. The expanded indications for use did not change the function or therapeutic value of the device, implying that the non-clinical performance remained consistent with the predicate device for these broader uses.
{0}------------------------------------------------
1063454 te Gas Systems, Inc.
Manufacturers / Designers of Oxygen & Nitrogen Generating Equipment
5. 510(k) Summary
MAY - 9 2007
POGS 33 Portable Oxygen Generation System
This 510(k) summary information is being submitted in accordance with the requirements of 21 CFR 807.92.
Submitter:
On-Site Gas Systems, Inc. 35 Budney Road Newington, CT 06111
Contact Person:
Guy T. Hatch, Chief Operating Officer Phone: 860-667-8888, extension 267 Fax: 860-667-2222 e-mail: ghatch@onsitegas.com
Date Prepared: October 3, 2006
Trade Name: POGS 33C, Portable Oxygen Generation System Common Name: POGS
Classification Names: Oxygen Concentrator
Device Classification:
Regulatory Class: Class II CAW Product Code: Classification Panel: Anesthesiology Regulation Number: 21 CFR 868.5440
Predicate Devices:
POGS 33, 510(k) K041664, On-Site Gas Systems, Inc.
Description of Device:
The Portable Oxygen Generation System 33 (POGS 33C) has been designed to accommodate medical personnel with a source of supplemental oxygen in a setting where liquid oxygen may be unavailable, and of medical air to drive respiratory equipment. Aero-medical evacuation and ground based medical missions require medical support systems capable of providing therapeutic oxygen. Requirements are based on the mobile, deployment oxygen system, operational requirements document that has been issued by the United States Air Force. This system is based on the Pressure Swing Absorption principle and uses
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 INCORPORATED IN THE STATE OF CONNECTICUT, U.S.A.
{1}------------------------------------------------
SITE e Gas Systems, Inc.
Manufacturers / Designers of Oxygen & Nitrogen Generating Equipment
a molecular sieve to separate gasses 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 90% +/- 3%. Included with the generator is a secured accessory kit including medical-grade oxygen hose and flow regulators for the outlets. The POCS 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.
Medical air output of up to a total of 30 liters-per-minute at 50 PSIG is also provided.
Indications for Use:
The POGS is intended to generate and deliver USP 93%supplemental oxygen and medical grade air. This device is intended to be used only by trained personnel in disaster relief and emergency preparedness situations, or military settings where bottled oxygen is not readily available.
Difference with Predicate Device:
The POGS 33 C device, cleared through K041664, is fundamentally the same device as the POGS 33C in this submission, with several minor improvements. The technological characteristics are identical to the predicate device. The indications for use now include populations other than military facilities. The expanded indications do not change the function of the device or the intended therapeutic value of the device. The large number of devices utilized in hostile environments and in mobile operations make this device uniquely suited for disaster and emergency preparedness situations and where bottled oxygen may be unavailable, not changing the safety or effectiveness of the device. Labeling will continue to require that trained personnel operate this equipment.
Improvements from Previously Cleared Device:
Several minor improvements have been made to the predicate device. Fittings have been converted to stainless steel to eliminate corrosion, the sieve beds were converted to aluminum for weight considerations, and reliability improvements to the Microboost were made. Improvements to the feed air compression packaging, improved connectors to minimize breakage, improved operator manuals and labeling are provided with the new device.
Non-Clinical Performance:
Performance Standard ASTM F-1464-93 was used.
Non-clinical bench testing conducted by On-Site Gas Systems, Inc. is sufficient in establishing substantial equivalence on the POGS 33C to the predicate device on which substantial equivalence is claimed, including oxygen purity evaluations.
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 incorporated in the state of connecticut, u.s.a.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its body, representing the department's mission to protect the health of all Americans and provide essential human services. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Guy Hatch Chief Executive Officer On-Site Gas Systems, Incorporated 35 Budney Road Newington, Connecticut 06111
MAY - 9 2007
Re: K063454
Trade/Device Name: POGS 33C Portable Oxygen Generation System Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: April 26, 2007 Received: April 27, 2007
Dear Mr. Hatch:
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.
{3}------------------------------------------------
Page 2 - Mr. Hatch
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 (240) 276-. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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
{4}------------------------------------------------
Indications for Use 4.
510(k) Number K063454:
Device Name: POGS 33C Portable Oxygen Generation System
Indications for Use:
The POGS 33C is intended to generate and deliver USP 93% supplemental oxygen and medical grade air. This device is intended to be used only by trained personnel in disaster relief and emergency preparedness situations, or military settings where bottled oxygen is not readily available
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Chellto
் கிழா-Off) on of Anesthesiology, General Hospital, Jon Control, Dental Devices
(k) Number: K063454
§ 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).