(219 days)
This device is indicated for use on all patient populations, in conjunction with other respirations devices containing standard 15mm and/or 22mm fittings (such as breathing circuits) to filter respiratory gases where infection from airborne bacteria and viruses is a concern.
The A-M SYSTEMS VIROMAX Viral and Bacterial Filter is a non-sterile, single patient use breathing filter consisting of a gas permeable filter membrane enclosed in a transparent plastic housing. When the A-M SYSTEMS Viral and Bacterial Filter is inserted into a breathing circuit, the respiratory gas passes through the electrostatically-charged hydrophobic filter membrane, thus trapping bacteria and viruses.
The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria for the A-M SYSTEMS VIROMAX Viral and Bacterial Filter.
The document is a 510(k) summary for the device, focusing on its substantial equivalence to a predicate device (K961914). It describes the device, its intended use, and a comparison of technological characteristics with the predicate device. However, it does not include details on specific performance metrics, acceptance criteria, or studies conducted to establish the device's performance against such criteria.
The "Safety and Effectiveness of the device" section explicitly states, "This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)." This indicates that the safety and effectiveness are established by demonstrating substantial equivalence to a legally marketed predicate device, rather than by presenting results from a de novo performance study against explicit acceptance criteria.
Therefore, I cannot extract the requested information (table of acceptance criteria and reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from the provided text.
§ 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).