(352 days)
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.
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.
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.
§ 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).