(181 days)
For use with ventilators, anesthesia machines, and open flow systems where filtration of inspired and / or expired gases is desired. To be placed at the machine-side of the circuit only. Single patient use. Duration of use up to 24 hours.
The Munktell Gard Filter is a machine-side filter and incorporate standard 15 / 22 mm connectors. The depth filter uses a pleated paper fiber for filtration.
Here's a breakdown of the acceptance criteria and study information for the Munktell Gard Filter, based on the provided documents:
Acceptance Criteria and Device Performance
| Attribute | Acceptance Criteria (Predicate Reference/Standard) | Reported Device Performance (Munktell Gard Filter) |
|---|---|---|
| Indications for use - To filter inspired and / or expired gases | Same as predicates | Same |
| Intended for single patient use, up to 24 hours | Yes (Predicate functionality) | Yes |
| Prescription | Yes (Predicate functionality) | Yes |
| Intended population | Any patient (adult) (Predicate functionality) | Any patient (adult) |
| Intended Environment of Use | Home, Hospital, Sub-acute institutions | Home, Hospital, Sub-acute institutions |
| Placement at machine side of circuit only | Yes (Predicate functionality) | Yes |
| Gas sampling port | Yes (Predicate functionality) | Yes |
| Standard 15/22 mm connectors | Yes (Predicate functionality / ISO 5356-1) | Yes |
| Dead Space (ml) | Not explicitly stated as acceptance criteria | 124 ml |
| Resistance to flow | ≤ 1.6 cm H2O @ 60 lpm | ≤ 1.6 cm H2O @ 60 lpm |
| Bacterial filtration - BFE | Not explicitly stated as acceptance criteria | 99.9999% (Nelson Lab.) |
| Viral filtration - VFE | Not explicitly stated as acceptance criteria | 99.9999% (Nelson Lab.) |
| Weight (gm) | Not explicitly stated as acceptance criteria | 60 gm |
| Housing material | Polystyrene (Predicate functionality) | Housing polystyrene |
| Filter media | Not explicitly stated as acceptance criteria | Paper microfiber |
| Performance Standards | None under Section 514, ISO 5356-1 Conical 15/22 | Yes (conforms to these) |
Study Information:
The provided documents describe a premarket notification (510(k)) for substantial equivalence, not a comprehensive clinical study in the typical sense of evaluating diagnostic performance. The "study" here refers to the data presented to demonstrate substantial equivalence to predicate devices.
1. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of a diagnostic test set. The submission focuses on comparing the technical characteristics and performance specifications of the proposed device against predicate devices and relevant standards.
- Data Provenance: The performance data (Bacterial and Viral filtration effectiveness) is attributed to "Nelson Lab." This suggests laboratory testing data. The other technical characteristics are stated directly for the device, implying internal testing or design specifications. The document does not specify a country of origin for the data beyond Nelson Lab.
- Retrospective or Prospective: Not applicable as this is a device characteristic comparison, not a study on patient data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in this context, refers to established performance standards (e.g., ISO for connectors, or the performance of legally marketed predicate devices for filtration efficacy and resistance). Expert panels for ground truth determination are not mentioned or required for this type of submission.
3. Adjudication method for the test set:
- Not applicable. No "test set" of cases or images requiring adjudication by experts is described.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. An MRMC study was not done. The submission is for a breathing circuit filter, not a diagnostic imaging device that would typically undergo such a study.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, effectively. The performance data (e.g., bacterial/viral filtration efficiency, resistance to flow) are presented as inherent characteristics of the device itself, independent of human interaction once installed. This is the standalone performance of the filter.
6. The type of ground truth used:
- Regulatory Standards and Predicate Device Performance: The primary "ground truth" used is the established performance of predicate devices that are already legally marketed, as well as adherence to relevant industry standards (e.g., ISO 5356-1 for connectors) and general safety principles. For filtration efficiency, the "ground truth" is the measured efficacy by a recognized lab (Nelson Lab).
7. The sample size for the training set:
- Not applicable. There is no mention of a "training set" as this is not an AI/ML device submission involving learned algorithms from datasets.
8. How the ground truth for the training set was established:
- Not applicable for the reasons stated above.
§ 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).