(109 days)
Filters can be used to provide filtration for reducing possible cross contamination between patient and equipment. Filters are for use in the hospital, ICU, anesthesia, respiratory therapy, during transport and with resuscitators for filtering particles including bacteria, viruses and dust from CO2-absorbers.The Uni-Filter/S, angled Uni-Filter/S and Mini-Filter/S can also be used for gas sampling.
The device for use by qualified medical personnel only.
The Mini-Filter/S, Uni-Filter Junior, Uni-Filter/S, Uni-Filter/S angled and Uni-Filter incorporate an electrostatic filter media into a housing made of translucent plastic.
Dimensions and Matcrials
- Diameter: Mini-Filter/S 45 mm. Uni-Filter Junior, Uni-Filter/S and Uni-Filter/S S angled are 59 mm. Uni-Filter is 80 mm.
- Mini-Filter/S, Uni-Filter Junior, Uni-Filter/S and Uni-Filter/S angled length: 64 mm. Uni-Filter length: 73 mm.
- Housing: PP Polypropylene
- Filter: PP and acrylic fibers
Filtration efficiency:
-
Filtration efficiency viral
Mini-Filter/S 99,98%, Uni-Filter Junior, Uni-Filter/S/ angled Uni-Filter/S 99.999%, Uni-Filter 99.9% -
Filtration efficiency against bacteria
Uni-Filter Junior >99.9999%, Uni-Filter/S/angled Uni-Filter/S 99.9999%, Uni-Filter 99.98%
The Mini-Filter/S, Uni-Filter/S, Uni-Filter/S, Uni-Filter/S angled and Uni-Filter are for use in the hospital, ICU, anesthesia, respiratory therapy, during transport and with resuscitators.
- They incorporate standard fittings for-
- 15 mm ID x 22 mm OD fitting to connect to the endotracheal tube or face mask
- 15 mm OD x 22 mm ID fitting to connect to the breathing circuit Y-piece
- For the Mini-Filter/S, Uni-Filter/S and Uni-Filter/S angled : A gas sampling port
- -- female luer port with cap to allow sampling of expired CO2-gases
The provided text describes a 510(k) premarket notification for several disposable bacterial/viral filters. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than explicit acceptance criteria and studies proving the device meets those criteria.
Therefore, the requested information cannot be fully extracted based on the provided text alone, as it focuses on comparing the new devices to existing ones, not on establishing and meeting new, explicit performance acceptance criteria through independent studies.
However, I can extract the reported device performance characteristics that function as implicit "acceptance criteria" through comparison with predicate devices.
Here's a breakdown of what can be inferred and what cannot:
1. Table of acceptance criteria and the reported device performance:
Since this is a 510(k) submission, the "acceptance criteria" are the performance characteristics of the predicate device. The "reported device performance" is how the new devices compare to those predicates.
| Performance Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (New Devices) |
|---|---|---|
| Mini-Filter/S Filtration Efficiency (Viral) | Datex-Ohmeda Mini-Filter/S (K030990) - Not explicitly stated but assumed to be met or exceeded. | 99.98% |
| Uni-Filter Junior, Uni-Filter/S, angled Uni-Filter/S Filtration Efficiency (Viral) | Intersurgical Clear-Guard (K990949) - Not explicitly stated but assumed to be met or exceeded. | 99.999% |
| Uni-Filter Filtration Efficiency (Viral) | Intersurgical Clear-Guard (K990949) - Not explicitly stated but the new device has "lower viral filtration efficiency" than the predicate. This suggests the predicate's viral filtration was higher. | 99.9% |
| Uni-Filter Junior, Uni-Filter/S, angled Uni-Filter/S Filtration Efficiency (Bacteria) | Intersurgical Clear-Guard (K990949) - Not explicitly stated but new devices are "better or equal" to the predicate. | >99.9999% |
| Uni-Filter Filtration Efficiency (Bacteria) | Intersurgical Clear-Guard (K990949) - Not explicitly stated but new devices are "better or equal" to the predicate. | 99.98% |
| Mini-Filter/S Breathing Resistance | Datex-Ohmeda Mini-Filter/S (K030990) - Updated labeling reflects a "more accurate measurement." New device still has "lower breathing resistances" than Datex-Ohmeda HMEF Mini (K023641). | Lower than Datex-Ohmeda HMEF Mini (K023641). Specific value not provided. |
| Uni-Filter Junior, Uni-Filter/S, angled Uni-Filter/S, Uni-Filter Breathing Resistance | Intersurgical Clear-Guard (K990949) - New devices have "lower resistance" than the predicate. | Lower than Intersurgical Clear-Guard (K990949). Specific values not provided. |
| Uni-Filter Junior, Uni-Filter/S, angled Uni-Filter/S Weight | Intersurgical Clear-Guard (K990949) - New devices have "smaller weight." | Smaller than Intersurgical Clear-Guard (K990949). Specific values not provided. |
| Uni-Filter Weight | Intersurgical Clear-Guard (K990949) - Not explicitly stated, implied to be larger due to larger size. | Specific value not provided. |
| Uni-Filter Junior, Uni-Filter/S, angled Uni-Filter/S Dead Space | Intersurgical Clear-Guard (K990949) - New devices have "smaller dead spaces." | Smaller than Intersurgical Clear-Guard (K990949). Specific values not provided. |
| Uni-Filter Dead Space | Intersurgical Clear-Guard (K990949) - New device is "a little bigger filter," implying a larger dead space. | A little bigger than Intersurgical Clear-Guard (K990949). Specific value not provided. |
| Materials | Medical grade plastic (common to predicate) | Medical grade plastic (PP Polypropylene, PP and acrylic fibers) |
| Biocompatibility | Biocompatible (non-cytotoxic and non-allergic), non-toxic (common to predicate) | Biocompatible (non-cytotoxic and non-allergic), non-toxic |
Note: For 510(k) submissions, the "acceptance criteria" are often implicitly understood as being "at least as good as or better than" the predicate device in aspects related to safety and effectiveness.
2. Sample size used for the test set and the data provenance:
- Not provided. The submission is a regulatory filing focused on substantial equivalence, not a detailed scientific study report with specific test data. It only states performance characteristics as facts.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. This type of information is relevant for studies involving human interpretation or subjective judgment (e.g., medical imaging). For filter performance, objective laboratory tests are typically used.
4. Adjudication method for the test set:
- Not applicable/Not provided. This is not relevant for the type of objective performance testing implied for these devices.
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. These are physical filters, not AI-powered diagnostic devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. These are physical filters, not algorithms.
7. The type of ground truth used:
- Objective laboratory measurements. While implicitly understood, the text doesn't provide details on the specific methods used (e.g., specific standards, test setups) for measuring filtration efficiency, breathing resistance, etc., but these would be based on established scientific and engineering principles. For example, "Filtration efficiency viral" would be determined by challenging the filter with a viral aerosol and measuring the reduction.
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of physical filter performance testing.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set.
§ 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).