(351 days)
Intended to remove microbiological and particulate matter from the gases in the breathing circuit.
The Iso-Gard Filter Angled/Iso-Gard Filter Straight are breathing circuit bacterial filters intended to remove microbiological and particulate matter from the gases in the breathing circuit as described in 21 CFR 868.5260. This product is substantially equivalent to the Dryden Mini Bacteria Filter.
The Iso-Gard Filter Angled/Iso-Gard Filter Straight are similar in design and function to the Dryden Mini Bacteria Filter with reduced size, dead space and lighter weight. The Iso-Gard Filter Angled/Iso-Gard Filter Straight incorporates a luer port in the housing to allow for connection of carbon dioxide or pressure monitoring equipment. The Iso-Gard Filter Angled also incorporates an angled housing to allow for the option of omitting the connection of angled patient connectors. The bacterial/viral filtration efficiency of the filter medium is 99+% for both the Iso-Gard Filter Angled/Iso-Gard Filter Straight and the Dryden Mini Bacteria Filter.
The provided text is a 510(k) summary for the Gibeck Iso-Gard™ Filter Angled/Iso-Gard™ Filter Straight. This document is focused on establishing substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria or a comprehensive study demonstrating direct performance against such criteria. Instead, it relies on comparison to a legally marketed predicate device.
However, based on the information provided, we can infer some aspects and highlight what is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from device description) | Reported Device Performance (from K965016 summary) |
|---|---|
| Bacterial/Viral Filtration Efficiency (effectiveness in removing microbiological and particulate matter) | 99+% filtration efficiency for both Iso-Gard Filter Angled/Straight and the predicate device (Dryden Mini Bacteria Filter). |
| Size | Reduced size compared to the predicate device. |
| Dead Space | Reduced dead space compared to the predicate device. |
| Weight | Lighter weight compared to the predicate device. |
| Functional Features (e.g., ability to connect monitoring equipment) | Incorporates a luer port for CO2 or pressure monitoring (Iso-Gard models). |
| Angled Housing Option | Incorporates an angled housing for optional omission of angled patient connectors (Iso-Gard Angled model). |
| Safety and Effectiveness (overall performance compared to predicate) | "Substantially equivalent" to predicate device; "not considered to be critical to the intended therapeutic, diagnostic, prosthetic or surgical use of the device nor should this change significantly affect the safety or effectiveness of the device when used as labeled." |
2. Sample size used for the test set and the data provenance
The document does not specify a sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective). The submission relies on a comparison to a predicate device and the claim of substantial equivalence for product performance rather than presenting a new, dedicated clinical or performance study with a specific test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention any specific experts or their qualifications used to establish ground truth for a test set. This type of detail is typically associated with clinical studies or performance evaluations that generate new data, which is not the primary focus of this 510(k) summary.
4. Adjudication method for the test set
The document does not describe any adjudication method for a test set.
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 document is for a medical device (bacterial filter), not an AI or diagnostic imaging device. Therefore, an MRMC study and discussions of human readers improving with AI assistance are not applicable.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
This document is for a medical device (bacterial filter). It does not involve an algorithm or AI, so the concept of standalone performance for an algorithm is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not describe specific ground truth establishment for a new study. Instead, the "ground truth" for the submission is the established performance and safety of the predicate device (Dryden Mini Bacteria Filter), which the new device claims to be substantially equivalent to, especially regarding bacterial/viral filtration efficiency. The 99+% filtration efficiency is presented as a known characteristic of both the new device and the predicate.
8. The sample size for the training set
This document is for a medical device and does not involve machine learning algorithms, so there is no training set in the context of AI/ML.
9. How the ground truth for the training set was established
As there is no training set mentioned or implied for an AI/ML context, this question is not applicable.
Summary of Device Performance and Substantial Equivalence Basis:
The Gibeck Iso-Gard filter's performance is primarily established by demonstrating "substantial equivalence" to the Dryden Mini Bacteria Filter. The key performance metric mentioned is bacterial/viral filtration efficiency of 99+%. The new device is stated to have this same efficiency while offering improvements in size, dead space, and weight, and incorporating additional features like a luer port. The submission asserts that these changes do not adversely affect 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).