(66 days)
Model 2800 is indicated for use with pulmonary function testing equipment, to filter air between the patient's exhaled air and the testing equipment. Single patient use.
The EMS PFT Filter is a compact, electrostatic filter with various end-fitting adaptable to various pulmonary function testing circuits. It has 75 ml deadspace of 0.7 cm H2O at 720 lpm per ATS spirometry guidelines or 0.5 cm H2O @ 60 lpm. There are various connectors to allow connection to various PFT equipment. Single patient use.
Air Safety Model 2800 PFT Filter Acceptance Criteria and Study Findings
This document outlines the acceptance criteria for the Air Safety Model 2800 PFT Filter and the study that demonstrates its conformance.
1. Acceptance Criteria and Reported Device Performance
The Air Safety Model 2800 PFT Filter underwent testing to demonstrate substantial equivalence to the predicate device, the Engineered medical Systems - K013123. The acceptance criteria were based on the performance characteristics of this predicate device.
| Attribute | Acceptance Criteria (Predicate EMS K013123) | Reported Device Performance (Model 2800) |
|---|---|---|
| Intended use | Filter air between patient's exhaled air and PFT equipment | Meets criteria |
| Intended for single patient use | Yes | Yes |
| Prescription | Yes | Yes |
| Intended population | Any patient | Any patient |
| Intended Environment of Use | Hospital, sub-acute | Hospital, sub-acute, physician office |
| Can be used with several different PFT machines | Yes | Yes |
| Compact housing | Yes | Yes |
| Various end-fittings | Yes | Yes |
| Dead Space (ml) | 75 ml | 75 ml |
| Resistance to flow at 720 lpm (ATS standard) | $0.7 cm H_2O$ | $0.7 cm H_2O$ |
| Resistance to flow at 60 lpm | $0.5 cm H_2O$ | $0.5 cm H_2O$ |
| Bacterial filtration | 99.9999% | 99.9999% |
| Viral filtration | 99.999+% | 99.999+% |
| Weight | 40 gm | 40 gm |
| Housing material | Polystyrene | Polystyrene |
| Filter media | Electrostatic polypropylene | Electrostatic polypropylene |
The study demonstrates that the Air Safety Model 2800 PFT Filter meets all specified acceptance criteria, showing identical performance characteristics to the predicate device for all listed attributes.
2. Sample Size and Data Provenance
- Sample Size for the Test Set: Not explicitly stated for each specific test (BFE, VFE, flow resistance). However, the narrative indicates that "BFE and VFE testing has been performed by Nelson Laboratories to demonstrate substantial equivalence to the predicate device."
- Data Provenance: The data was generated by Nelson Laboratories, a third-party testing facility. The country of origin for the testing is not explicitly stated, but the submission is from Air Safety Ltd. in England. The study appears to be retrospective in the sense that it evaluates the performance of the manufactured device against pre-established criteria based on the predicate.
3. Number of Experts and Qualifications for Ground Truth
This type of device (PFT filter) does not typically involve expert human interpretation or "ground truth" in the diagnostic sense (e.g., image interpretation by radiologists). Instead, its performance is objectively measured against physical and biological metrics. Therefore, the concept of "experts establishing ground truth" as it applies to medical imaging algorithms is not relevant here. The "ground truth" for this device's performance is derived from standardized testing protocols and the established performance of the predicate device.
4. Adjudication Method for the Test Set
Not applicable. As described above, the evaluation relies on objective laboratory testing against defined performance metrics, not on human interpretation or adjudication of ambiguous cases.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not applicable and therefore not performed. This device is a passive filter and does not involve human readers or AI in its operation. Its effectiveness is measured through physical and microbiological performance characteristics.
6. Standalone Performance Study
A standalone performance study was done for the device. The study involved BFE (Bacterial Filtration Efficiency) and VFE (Viral Filtration Efficiency) testing performed by Nelson Laboratories. This testing was conducted on the Air Safety Model 2800 PFT Filter independently of human interaction to objectively measure its filtration capabilities and other physical properties (e.g., dead space, resistance to flow). The results of these standalone tests were then compared directly to the established performance characteristics of the predicate device.
7. Type of Ground Truth Used
The ground truth used for evaluating the Air Safety Model 2800 PFT Filter was objective performance data from standardized laboratory testing. This includes:
- Bacterial and viral filtration efficiency percentages.
- Measured resistance to flow at specified rates (cm H2O).
- Measured dead space (ml).
- Material composition and physical dimensions.
This "ground truth" was established by comparing the results of the Model 2800's tests against the known, documented performance parameters of the legally marketed predicate device (EMS K013123), demonstrating substantial equivalence.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical component, not a software algorithm that requires a training set.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).