(162 days)
To provide filtration of a patient's exhaled air and it may reduce the potential of contamination when it is utilized in anesthesia breathing circuit, ventilator circuits, manual resuscitators and during transport.
A filter with a translucent housing and filter media which connects to the patient connector and the circuit tubing and manual resuscitators.
The provided document describes a 510(k) submission for the ProMedic, Inc. Wye Filter, a breathing circuit filter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than outright safety and effectiveness studies in the same way a new drug or novel medical device might. Therefore, the information typically requested in your prompt (e.g., acceptance criteria for a device's performance, sample sizes for test sets, expert-established ground truth, MRMC studies, standalone algorithm performance) is not explicitly present or directly relevant for this specific type of device and submission.
However, I can extract the closest analogous information from the document:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission, "acceptance criteria" are generally based on meeting the functional specifications and performance characteristics of predicate devices. The document compares the ProMedic filter to predicate devices based on various attributes.
| Criteria/Characteristic | ProMedic, Inc. Filter (Reported Performance) | Predicate Device 1 (Dryden) | Predicate Device 2 (Med-Plastics) | Predicate Device 3 (Engstrom) |
|---|---|---|---|---|
| Intended Use | ||||
| Provide filtration in a breathing circuit | Yes | Yes | Yes | Yes |
| Used with anesthesia breathing circuit, ventilator circuits, resuscitators | Yes | Yes | Yes | Yes |
| Environment of use - Hospital, OR, anesthesia, PACU, ICU, transport | Yes | Yes | Yes | Yes |
| Indicated for single patient use | Yes | Yes | Yes | Yes |
| Design | ||||
| Placed in the breathing circuit | Yes | Yes | Yes | Yes |
| Standard 15/22 mm fitting | Yes | Yes | Yes | Yes |
| May have a port for sampling CO2 gases | Yes | Yes | Yes | Yes |
| Media hydrophobic | Yes | Yes | Yes | Yes |
| Has a translucent housing | Yes | Yes | Yes | Yes |
| Compact, low deadspace | Yes | Yes | Yes | Yes |
| Performance Standards / Specifications | ||||
| Filtration efficiency rating of BFE and VFE 99%+ | Yes (Nelson) | 99.9% (Sangtec) | Yes (Nelson) | |
| Fittings - ASTM 1054 | Yes | Yes | Yes | Yes |
| Materials | ||||
| Housing - Polyethylene, polystyrene | Yes | Yes | Yes | Yes |
| Filter media - Electrostatic | Yes | Yes | Yes | Yes |
| Hydrophobic media | Yes | Yes | Yes | Yes |
Note: The table above synthesizes information from the "Comparison to Predicate Devices" section. The "Reported Device Performance" for the ProMedic filter is implied by the "Yes" responses, meaning it meets the characteristic/standard.
2. Sample size used for the test set and the data provenance
The document does not detail specific sample sizes for performance tests in the way one might for diagnostic accuracy studies. The "performance" assessment here is primarily a comparison against established characteristics and standards, often based on existing product specifications or industry standards rather than a new clinical trial with a "test set" of patients.
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 "ground truth" for a device like a breathing circuit filter is its adherence to functional and material specifications and performance standards established by organizations like ASTM, and recognized by regulatory bodies. It's not about expert clinical interpretation of diagnostic images or data.
4. Adjudication method for the test set
Not applicable. There is no mention of a "test set" requiring adjudication in the context of this device and submission.
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 is not an AI-assisted diagnostic device or a device involving human readers for interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The type of ground truth used
The "ground truth" in this context refers to established performance standards, material specifications, and design criteria for breathing circuit filters, as exemplified by the characteristics of legally marketed predicate devices and industry standards like ASTM 1054. For filtration efficiency, methods like "Nelson" and "Sangtec" are mentioned, implying testing against defined laboratory standards.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-driven device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of Study that Proves the Device Meets Acceptance Criteria:
The document indicates that the ProMedic Wye Filter demonstrates substantial equivalence to predicate devices through a comparative analysis of its intended use, design, performance standards/specifications, and materials.
- Intended Use: The ProMedic filter has the same intended use (filtration in a breathing circuit, for various environments and single-patient use) as the predicate devices.
- Design: Its design features (e.g., placement in circuit, standard fittings, potential CO2 port, hydrophobic media, translucent housing, compact size) are consistent with predicate devices.
- Performance Standards/Specifications: The ProMedic filter meets or is comparable to the filtration efficiency ratings (BFE and VFE 99%+) of predicate devices, as demonstrated by testing methods (e.g., "Nelson"). It also conforms to standards for fittings (e.g., ASTM 1054).
- Materials: The materials used for the housing and filter media are consistent with those in predicate devices.
The FDA's letter (Page 3 of the combined document) confirms that they "reviewed your Section 510(k) notification... and we have determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976." This determination signifies that the FDA agreed with the presented evidence that the ProMedic filter meets the criteria for substantial equivalence to its predicate devices without raising new questions of safety or effectiveness.
§ 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).