(94 days)
For use with pulmonary function testing (PFT) equipment only, to filter air between the patient's exhaled air and the testing equipment. Single patient use, disposable. Duraton of use
The MRD NeumoFilt pulmonary function filter ("PFT filter") is a standard electrostatic filter that is placed between the patient and the pulmonary function testing equipment to keep a patient inhaled and exhaled breath from contaminating the equipment. There are 2 models with the only difference being the patient end piece which is either a biteblock shape (BiteOn) or the mouthpiece shape (Ergo).
Here's a breakdown of the acceptance criteria and the study information for the NeumoFilt Ergo and NeumoFilt BiteOn devices, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Predicate: Air Safety Model 2800 PFT filter (K051712)) | Reported Device Performance (NeumoFilt PFT Filter) |
|---|---|---|
| Resistance to flow @ 1 l/sec | 0.5 cm H2O | 0.56 cmH2O |
| Resistance to flow @ 5 or 12 l/sec | 0.7 cm H2O @ 12 l/sec | 0.74 cmH2O @ 5 l/sec |
| Resistance to flow @ 14 l/sec | Not reported | 1.47 cmH2O |
| Bacterial Filtration Efficiency (BFE) | 99.9999% | 99.9998% |
| Viral Filtration Efficiency (VFE) | 99.999+% | 99.9939% |
| Weight (gm) | 40 grams | 30 grams |
| Internal volume / Dead space | 75 ml | 70 ml (Ergo), 68 ml (BiteOn) |
| Housing Burst Pressure | Not reported | > 120 cm H2O |
| Biocompatibility | Not reported (implied to be acceptable) | Tested per ISO 10993 (Cytotoxicity, Sensitization, Irritation) |
Notes on the Table:
- Acceptance Criteria for Resistance to Flow: The document primarily uses the predicate's reported values as the basis for substantial equivalence, with an additional measurement for the NeumoFilt at 14 l/sec which wasn't reported for the predicate. The ATS standard for spirometry is mentioned for flow rates, implying these values are compared against that standard.
- "Not Reported" for Acceptance Criteria: For some items (like Housing Burst Pressure and Biocompatibility), the predicate's values are not explicitly stated as "acceptance criteria" but rather as "not reported." The NeumoFilt's performance in these areas is presented as additional testing to demonstrate safety and efficacy.
- Small Differences: The document explicitly states that "The slight differences in BFE / VFE, weight, and Dead Space do not raise any new safety concern and thus can be considered substantially equivalent."
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the sample size (number of filters) used for the performance testing (Resistance to flow, BFE, VFE, Dead space, Housing burst strength, Age testing). It refers to "a number of non-clinical tests" and "performance data and testing."
- Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. It only states that the tests were performed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the device is a physical medical filter, not an AI/software device that requires expert review for ground truth establishment. The performance is measured through laboratory tests against established standards (e.g., MIL-M-36954C for BFE/VFE, ATS standard for spirometry for resistance to flow, ISO 10993 for biocompatibility).
4. Adjudication Method for the Test Set
This section is not applicable as the performance is measured through objective laboratory tests, not through subjective assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable as the device is a physical medical filter and not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable as the device is a physical medical filter, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance of this device is established through:
- Objective Laboratory Measurements: For resistance to flow, BFE, VFE, dead space, weight, and housing burst strength. These are quantifiable physical properties.
- Standardized Biocompatibility Testing: According to ISO 10993.
8. The Sample Size for the Training Set
This section is not applicable as the device is a physical medical filter and does not involve a training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as the device is a physical medical filter and does not involve a training set for an algorithm.
§ 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).