(41 days)
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.
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. 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.
Acceptance Criteria and Study for Portable Oxygen Generator System: POGS 33C
This document describes the acceptance criteria and the study that demonstrates the Portable Oxygen Generator System: POGS 33C meets these criteria, based on the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Oxygen output flow | Up to a total maximum flow of 33 liters-per-minute (LPM) at 50 psig | 33 liters-per-minute at 50 psig |
| Oxygen concentration purity | 93% minimum | 93% minimum, with an oxygen purity level average of 95% |
| Medical air output flow | Up to a total of 30 liters per minute (LPM) at 50 PSIG | Up to a total of 30 liters per minute at 50 PSIG |
| Compatibility | Compatible with specified commercial oxygen-consuming equipment and accessories (D, E, H, K cylinder-filling accessories, ventilators, cannulas, Draeger Narkomed Anesthesia machines and Impact Univent/Eagle 754/754M Ventilators). | 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. |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary explicitly states that "Non-clinical bench testing" was conducted.
- Test Set Sample Size: The document does not specify the sample size used for the bench testing. It's implied that typical engineering validation and verification protocols would be followed, but no specific numbers are provided.
- Data Provenance: The testing was conducted by On Site Gas Systems, Inc. This indicates the data is prospective as it was generated specifically for the 510(k) submission. The country of origin for the data is implicitly the United States, where On Site Gas Systems, Inc. is located.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable/not mentioned. This was non-clinical bench testing, not a study involving expert interpretation of medical data.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The "ground truth" for the performance parameters (flow, pressure, purity) would be established by calibrated measurement instruments rather than human adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an oxygen generator, and its performance is evaluated through objective physical measurements rather than human interpretation of medical cases.
6. Standalone Performance Study
- Standalone Study: Yes, a standalone performance evaluation was conducted. The "non-clinical bench testing" described evaluates the algorithm (or the device's functional components) directly on its ability to produce oxygen and medical air according to specifications, without human intervention as part of the primary performance assessment.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this device's performance is based on objective physical measurements obtained from calibrated instrumentation. This includes measurements of oxygen purity, flow rate, and pressure. These are quantifiable, verifiable physical properties.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is a physical medical device (an oxygen generator), not an algorithm or AI model that requires a training set in the conventional sense. The "training" for such a system would involve engineering design, prototyping, and iterative testing, but not a distinct "training set" of data.
9. How Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. As this is a physical device, a "training set" with established ground truth is not relevant to its development in the context of typical AI/algorithm studies. The device's design and engineering parameters are based on scientific principles and industry standards for oxygen generation, which are validated through rigorous bench testing.
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JUL 2 9 2004
510(k) Summary for Portable Oxygen Generator System: POGS 33C
| Date: | July 16, 2004 |
|---|---|
| Applicant: | On Site Gas Systems, Inc35 Budney RoadNewington, CT 06111 |
| Fax: | 860.667.8888 |
| Phone: | 860.667.2222 |
| Contact: | C. Bart Gullong, Vice-President, Marketing and Technical Services |
| Email: | bgullong@onsitegas.com |
| Trade Name: | Portable Oxygen Generator System: POGS 33C |
| Common Name: | Oxygen Concentrator |
| EstablishmentRegistration Number: | 3003637574 |
| Manufactured at: | (Same as Applicant) |
| Classification Name: | Oxygen Concentrator |
| Reason for 510(k): | Design changes (1) adding additional compatible equipment (Impact754/MUnivent/Eagle) and (2) reducing weight. |
| Product code: | CAW, CFR 21 § 868.5440 Class II |
| Legally Marketed Device to whichSubstantial 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 (301) 594-4646. 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 (301) 443-6597 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: _
§ 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).