(272 days)
AG Industries filters are replacement filters intended for use in oxygen concentrator machines to help remove contaminants, including air borne bacteria and other particulate debris from an air stream. When used with oxygen concentrator machines, the replacement filters may be used in the home, nursing home, hospital, patient care facility, etc.
Room air is drawn into the compressor of a respiratory device through the bacterial intake filter. From the compress, the air passes through the Compressor Filter, if one is installed on the machine and proceeds to the sieve beds. The sieve beds condition the air by removing nitrogen from the air stream, which results in higher concentration of oxygen. The air then passes through the final filter before being supplied to the patient.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the AG Industries Compressor & Bacteria Filters:
1. Table of Acceptance Criteria and Reported Device Performance
For the purpose of this analysis, the "acceptance criteria" are implied by the performance of the legally marketed predicate devices, and the "reported device performance" is that of the AG Industries filters. The key performance metric explicitly stated for comparison is Bacterial Filtration Efficiency (BFE) and Air Flow Resistance. Other features like material and connection type are also compared.
| Feature | Predicate Device (Acceptance Criteria) | AG Industries Device (Reported Performance) |
|---|---|---|
| AG1038831 | ||
| Filtration Efficiency | 99.999% BFE | 99.9+% BFE |
| Air Flow Resistance | 3.0 cm H2O @ 100 scfh | 1.3 cm H20 @ 10 Lpm |
| LL205 | ||
| Filtration Efficiency | 99.999% BFE | 99.99+% BFE |
| Air Flow Resistance | 4.0 cm H2O @ 100 scfh | .78 cm H20 @ 10 Lpm |
| LL201 | ||
| Filtration Efficiency | 99.999% BFE | 99.999+% BFE |
| Air Flow Resistance | 4.0 cm H2O @ 100 scfh | 12.02 cm H20 @ 85 Lpm |
| LL202 | ||
| Filtration Efficiency | 99.999% BFE | 99.9+% BFE |
| Air Flow Resistance | 4.0 cm H2O @ 100 scfh | .39 cm H20 @ 10 Lpm |
| HCF100 | ||
| Filtration Efficiency | 99.999% BFE | 99.999+% BFE |
| Air Flow Resistance | 3.0 cm H2O @ 100 scfh | .33 cm H20 @ 10.5 Lpm |
| BF910 (Platinum) | ||
| Filtration Efficiency | 99.999% BFE | 99.99+% BFE |
| Air Flow Resistance | 18 in H2O (Platinum 10) | .4 cm H20 @ 5 Lpm |
| BF900 (Non-Platinum) | ||
| Filtration Efficiency | 99.999% BFE | 99.999+% BFE |
| Air Flow Resistance | 7 in H2O (Non-Platinum) | 1.6 cm H20 @ 84.9 LPM (Non-Platinum) |
| BF950 (Platinum & Non-Platinum) | ||
| Filtration Efficiency | 99.999% BFE | 99.999+% BFE |
| Air Flow Resistance | 18 in H2O (Platinum 10) / 7 in H2O (non-Platinum) | .45 cm H2O @ 10.3 LPM |
| BF200C | ||
| Filtration Efficiency | 99.999% BFE | 99.999+% BFE |
| BF100 | ||
| Filtration Efficiency | 99.999% BFE | 99.999+% BFE |
| BF500 | ||
| Filtration Efficiency | 99.97% BFE | 99.999+% BFE |
| BF600 | ||
| Filtration Efficiency | 99.999% BFE | 99.999+% BFE |
Note on Acceptance Criteria: The submission implicitly uses the predicate device's performance as the acceptance criteria for "substantial equivalence." The AG Industries devices are expected to meet or exceed these values for key performance indicators like filtration efficiency and demonstrate comparable (or better) airflow resistance. For some models, the AG Industries device states a slightly lower BFE (e.g., 99.9+% vs 99.999%), but the overall conclusion of "substantial equivalence" suggests these differences were deemed acceptable by the FDA for the intended use. The air flow resistance is presented with different units (scfh vs Lpm) and flow rates sometimes, making direct numerical comparison difficult without conversion, but the goal is to show comparable or better (lower) resistance.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the performance tests (Bacterial Filtration Efficiency, Dioctyl Phthalate (DOP) Aerosol Test) or biocompatibility tests (ISO Guinea Pig Maximization Test, ISO Acute Systemic Injection Test, MEM Elution Test, Material Mediated Rabbit Pyrogen Test).
The data provenance is not specified (e.g., country of origin, retrospective/prospective). It is implied that these are laboratory tests conducted to demonstrate the performance characteristics of the manufactured filters.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" for filter performance is established through standardized laboratory testing methods (e.g., BFE, DOP aerosol tests) rather than expert human interpretation of results. Biocompatibility tests also follow established protocols.
4. Adjudication Method for the Test Set
This is not applicable. As mentioned above, the performance assessment relies on standardized test methods and quantitative measurements, not on expert adjudication of outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. This submission is for medical device filters, not an AI or imaging diagnostic device that would involve human readers or cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This submission is for medical device filters, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance claims of these filters is based on standardized laboratory test results. Specifically:
- Performance (Filtration Efficiency, Air Flow Resistance): Established by physical and microbiological testing methods (e.g., Bacterial Filtration Efficiency, Dioctyl Phthalate (DOP) Aerosol Test) that quantitatively measure the filter's ability to remove particulates and resist airflow under controlled conditions.
- Biocompatibility: Established by adherence to ISO standards for evaluating biological effects of medical devices (e.g., ISO Guinea Pig Maximization Test, ISO Acute Systemic Injection Test, MEM Elution Test, Material Mediated Rabbit Pyrogen Test).
8. The Sample Size for the Training Set
This is not applicable. This submission is for medical device filters and does not involve AI or machine learning that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8.
§ 868.5260 Breathing circuit bacterial filter.
(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).