(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.
§ 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).