(162 days)
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The Humid-Vent Filter Compact Angled/Humid-Vent Filter Compact Straight are heat and moisture exchangers as described in 21 CFR 868.5375 These products are substantially equivalent to the Gibeck Humid-Vent Filter heat and moisture exchanger.
The Humid-Vent Filter Compact Angled/Humid-Vent Filter Compact Straight are similar in design, materials and function to the Humid-Vent Filter with reduced size, dead space and lighter weight. The reduced dead space of the Humid-Vent Filter Compact Angled/Humid-Vent Filter Compact Straight allows for a tidal volume range of 150-1000 ml.
This document, K964382, is a 510(k) summary for a medical device: Gibeck Humid-Vent® Filter Compact Angled/Humid-Vent® Filter Compact Straight. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving performance against specific acceptance criteria through a study measuring diagnostic or predictive accuracy.
Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment cannot be provided from this document for the following reasons:
- No Diagnostic or Predictive Performance: The device is a "heat and moisture exchanger" (21 CFR 868.5375). Its function is to condition inspired air, not to diagnose, predict, or interpret medical conditions. Therefore, metrics like sensitivity, specificity, AUC, or accuracy, which are typical for AI/ML device acceptance criteria, are not applicable here.
- Substantial Equivalence, Not De Novo Performance Testing: 510(k) submissions primarily focus on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing design, materials, intended use, and performance claims to the predicate, rather than conducting new, large-scale clinical studies to establish novel performance metrics or acceptance criteria for diagnostic accuracy.
- Lack of AI/ML Component: There is no indication that this device incorporates AI or machine learning. The questions provided in the template are highly specific to AI/ML device evaluations.
In summary, the provided document does not contain the information requested because it is a 510(k) summary for a non-AI/ML device, focusing on substantial equivalence rather than diagnostic performance studies.
§ 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).