(181 days)
For use with ventilators, anesthesia machines, and open flow systems where filtration of inspired and / or expired gases is desired and to add and retain moisture in the circuit as required.
For patients with a tidal volume 150-500 ml (pediatrics) and >250 ml (adults).
Single patient use. Duration of use up to 24 hours.
The Munktell Bacstop Filter and Filter / HME are available in multiple sizes and incorporate standard 15 / 22 mm connectors with a gas sampling luer port. The depth filter uses electrostatic media for filtration and a foam media for the HME media.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Munktell Bacstop Filter and Filter/HME:
Acceptance Criteria and Device Performance
| Attribute | Acceptance Criteria (from Predicate/Standard) | Reported Device Performance (Munktell Bacstop) |
|---|---|---|
| Resistance to Flow (Adult) | 250 ml | |
| Dead Space | (Implied by predicate devices' performance for similar devices) | 23 to 85 ml |
| Intended Use | For use with ventilators, anesthesia machines, and open flow systems where filtration of inspired/expired gases is desired and to add and retain moisture. For pediatric (150-500ml TV) and adult (>250ml TV) patients. Up to 24 hours use. | Same |
| Single Patient Use | Yes | Yes |
| Environment of Use | Home, Hospital, Sub-acute Institutions, Emergency Services | Same |
| Gas Sampling Port | Yes (as per predicate design, implicitly) | Yes |
| Standard 15/22 mm connectors | Yes (as per predicate design, implicitly) | Yes |
| ISO 5356-1 Conical 15/22 | Yes (Standard conformance) | Yes |
| ISO 594-2 Luer Fittings | Yes (Standard conformance) | Yes |
| ISO 9360- HME moisture output | Yes (Standard conformance) | Yes |
Study Information
Based on the provided Non-Confidential Summary of Safety and Effectiveness (510(k) K014282), the "study" is primarily a bench-testing and comparison to predicate devices to demonstrate substantial equivalence, rather than a clinical trial with human subjects.
Here's the breakdown of the requested information based on the document:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not explicitly stated for specific tests. The document refers to "Nelson Lab." for bacterial and viral filtration, implying laboratory testing. For other parameters like resistance and humidification, it would involve testing multiple units to ensure consistency, but specific numbers are not provided.
- Data provenance: "Nelson Lab." is mentioned for BFE and VFE, which is a known independent testing laboratory. The overall data likely originates from testing performed by or for Munktell Filter AB (Sweden). The studies appear to be prospective bench tests designed to evaluate specific performance attributes.
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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 not applicable to this type of device submission. Medical device filters do not typically use expert ground truth for performance metrics in the same way an imaging AI algorithm would. Performance is measured against physical standards and laboratory methods (e.g., measuring pressure drop, bacterial retention, water vapor content). The "ground truth" is defined by the physical or microbiological measurement standards themselves.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- None. Adjudication methods are typically used in clinical studies or expert review of image interpretation, which is not relevant for the bench testing of a breathing circuit filter.
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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
- No. An MRMC study is relevant for an AI-powered diagnostic imaging device involving human readers. This submission is for a medical filter, which does not involve human readers or AI assistance in its function.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, in spirit. The performance metrics (BFE, VFE, resistance, humidification) are "standalone" in that they measure the device's intrinsic physical and biological filtering capabilities without human intervention during its operation. There is no "algorithm" in the sense of software interpreting data, but the filter itself performs its function independently.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the performance claims in this submission is the measured output from standardized laboratory testing. For example:
- Bacterial Filtration (BFE) and Viral Filtration (VFE): Ground truth is established by standardized microbiological testing methods (e.g., aerosol challenge tests) that measure the percentage of bacteria/viruses retained by the filter.
- Resistance to flow: Ground truth is established by physical measurement of pressure drop across the filter at specified flow rates using calibrated equipment.
- Humidification Output: Ground truth is established by standardized tests (e.g., ISO 9360) that measure the absolute humidity delivered by the HME.
- The "ground truth" for the performance claims in this submission is the measured output from standardized laboratory testing. For example:
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The sample size for the training set
- Not applicable. This device is hardware (a filter), not an AI algorithm that requires a "training set."
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How the ground truth for the training set was established
- Not applicable. As above, there is no "training set" for this type of device.
§ 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).