(205 days)
To filter a patient's inspiratory and expiratory respiratory gasses to remove bacteria and viruses.
For non-mechanically ventilated tracheostomy patients who are awake and alert or monitored by a trained healthcare provider or caregiver, where filtration of inspired and/or expired gases is desired. Use up to 24 hours.
Environment of use - clinical settings including hospital, sub-acute, pre-hospital, and home. For adults with Tidal Volumes >300 ml and pediatrics with Tidal Volumes >80 ml. Do not use on neonate or infant patients.
The Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) is a non-sterile, lightweight, single-patient use device for non-mechanically ventilated tracheostomy patients to filter viral, bacterial, and other particulate matter. The filter is intended to fit onto the 15mm hub of a tracheostomy tube. The filter is easy to apply and remove with a gentle twist motion.
The provided document is a 510(k) summary for the Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15). It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. Here is a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Conical Connector Compliance | Meet the Standard (FDA Recognized Consensus Standard No. 1-62, ISO 5356-1 Third Edition 2004-05-15) | Met the Standard |
| Leak Testing | No leak at 1 psi for 2 minutes | 0 ml/min |
| Dead Space | Better than predicate (45 ml) | 6 ml |
| Cytotoxicity | Non-cytotoxic (FDA Recognized Consensus Standard No. 2-245, ISO 10993-5 Third edition 2018-08) | Non-cytotoxic |
| Skin Sensitization | Not a contact skin sensitizer (FDA Recognized Consensus Standard No. 2-296, ISO 10993-10 Fourth Edition 2021-11) | Not a contact skin sensitizer |
| Irritation | Non-Irritant (FDA Recognized Consensus Standard No. 2-291, ISO 10993-23 First Edition 2021-11) | Non-Irritant |
| Particulate Matter Testing | 99.9% | |
| Bacterial Filtration Efficiency (BFE) % | Bacterial filtration efficiency is equivalent to predicate (ASTM F2101) | >99.9% |
| Accelerated Aging | Device meets its performance specifications post-conditioning (FDA Recognized Consensus Standard No. 14-497, ASTM 1980-16) | Device met its performance specifications post-conditioning |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (N per test) for each performance test. It only states the acceptance criteria and results. The data provenance is non-clinical, likely laboratory testing, and no geographic origin is specified for these tests. All tests appear to be prospective, laboratory-based evaluations of the device's physical and filtration properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The study described is non-clinical performance testing of a physical filter device, not a study involving human or image interpretation by experts. Ground truth is established by measurable physical and chemical properties according to recognized standards (e.g., ISO, ASTM).
4. Adjudication method for the test set
Not applicable, as this is non-clinical performance testing, not a study requiring adjudication of expert opinions.
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
Not applicable. This device is a passive filtration device, not an AI-assisted diagnostic tool. Therefore, no MRMC study or AI-related effectiveness was assessed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the non-clinical tests is based on pre-defined physical and chemical standards and objective measurements. For example:
- Conical Connector Compliance: Measured against ISO 5356-1 standard.
- Filtration Efficiency (BFE/VFE/PFE): Measured objectively against ASTM F2101 and ASTM F2299 standards.
- Leakage/Dead Space/Flow Resistance: Directly measured physical properties.
- Biocompatibility (Cytotoxicity, Sensitization, Irritation): Assessed according to ISO 10993 series standards, which involve laboratory assays and observations against established biological safety criteria.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
Not applicable. No training set for an algorithm is involved.
§ 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).