(352 days)
The Humid-Vent HEPA Filters are used for humidification and bacterial/viral filtration during anesthesia and ventilator care.
The Humid-Vent® HEPA is a combined Heat and Moisture Exchanger (HME) and a mechanical Bacterial/Viral Filter. The device is used for humidification and bacterial/viral filtration during anesthesia and ventilator care. The device consists of a housing which incorporates a hydrophobic glass fibre filter and an HME media made of corrugated hygroscopic paper. It contains ISO Standard 15M / 22F conical connectors at the machine end as well as the patient end.
The provided text describes a 510(k) premarket notification for the Humid-Vent® HEPA device, a combined Heat and Moisture Exchanger (HME) and bacterial/viral filter. Unfortunately, the document is quite high-level and does not contain the detailed performance data, acceptance criteria table, or study specifics that would be required to fully answer all the questions. The text explicitly states "The Humid-Vent® HEPA was subjected to a full battery of performance testing including pre-determined acceptance criteria. As expected, the device met all acceptance criteria. The performance data verified that the Humid-Vent® HEPA is substantially equivalent to the currently marketed predicate devices, adequately meets its intended use, and is acceptable for commercial distribution." However, it does not provide the acceptance criteria themselves or the specific results.
Therefore, I can only address some of the questions based on the available information, and will have to state that information about acceptance criteria and detailed study specifics is not provided in the input text for several points.
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document. The document states: "The Humid-Vent® HEPA was subjected to a full battery of performance testing including pre-determined acceptance criteria. As expected, the device met all acceptance criteria." However, the specific criteria (e.g., minimum humidification efficiency, minimum bacterial/viral filtration efficiency, maximum resistance to flow, etc.) and the corresponding quantitative results are not detailed in the provided text. | Met all acceptance criteria. Specific quantitative performance data is not provided in the document. The general statement is that "the device met all acceptance criteria" and "the performance data verified that the Humid-Vent® HEPA is substantially equivalent to the currently marketed predicate devices, adequately meets its intended use, and is acceptable for commercial distribution." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided text.
- Data Provenance: Not specified in the provided text. The submission is from Teleflex Medical Inmed Mfg.Sdn.Bhd, Malaysia, but this does not necessarily indicate the location where the testing was performed or the origin of the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This question is generally applicable to diagnostic devices involving expert interpretation. For a medical device like a breathing circuit filter, the "ground truth" is typically established through laboratory testing against measurable physical and biological parameters (e.g., filtration efficiency measured by challenge with specific microorganisms, humidification effectiveness measured by hygrometers, airflow resistance measured by pressure transducers). There is no mention of human experts establishing ground truth in this context, as the performance is objectively measured by instrumentation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication methods (like 2+1 or 3+1) are typically used when there is subjective human assessment involved in establishing ground truth, such as in clinical image interpretation. Since this device involves objective laboratory performance testing, no adjudication method of this type would be applicable or mentioned.
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 question is specific to AI-assisted diagnostic devices. The Humid-Vent® HEPA is a mechanical bacterial/viral filter and HME, not an AI-powered diagnostic tool. Therefore, no MRMC comparative effectiveness study was performed or is relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is also specific to AI/software-based devices. The Humid-Vent® HEPA is a physical medical device. Therefore, no standalone algorithm performance study was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For a device like the Humid-Vent® HEPA, the "ground truth" for performance is established through objective laboratory measurements against established standards and validated test methods. This includes:
- Bacterial/Viral Filtration Efficiency: Determined by challenging the filter with a known concentration of microorganisms (e.g., bacteria or phages) and measuring the concentration downstream.
- Humidification Efficiency (Moisture Output): Measured by flowing gas through the HME and determining the absolute humidity returned to the breathing circuit.
- Resistance to Flow: Measured by determining the pressure drop across the device at specified flow rates.
- Dead Space Volume: Measured physically.
- The document implies that these standard laboratory tests were conducted, as it mentions "performance testing."
8. The sample size for the training set
- This question is relevant for machine learning models. As the Humid-Vent® HEPA is a physical medical device, there is no "training set" in the context of data-driven model development. Training for such devices involves design verification and validation testing of physical prototypes and production samples.
9. How the ground truth for the training set was established
- As there is no "training set" for an AI model, this question is not applicable. The "ground truth" for the device's performance, as mentioned in point 7, is established through objective, standardized laboratory measurements and physical characterization.
§ 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).