(281 days)
1 The Medisize Red devices with catheter mount are breathing circuit bacterial/viral filters, which are intended to remove microbiological and particulate matter from the gases in the breathing circuit.
2 The Medisize Blue devices with catheter mount are Filter/HME's. These devices are intended to remove microbiological and particulate matter from the gases in the breathing circuit and at the same time the device is intended to be positioned over a tracheotomy or tracheal tube to warm and humidify by passive means gases breathed in by patient during anesthesia and ventilator care.
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This document is a 510(k) clearance letter from the FDA for two medical devices: "Medisize Red Devices with Catheter Mount" and "Medisize Blue Devices with Catheter Mount." These devices are classified as Breathing Circuit Bacterial Filters. The letter confirms that the devices are substantially equivalent to legally marketed predicate devices.
However, the provided document does not contain any information about acceptance criteria, device performance described in a study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The document is a regulatory approval letter and does not include the detailed technical study data that would typically be found in a 510(k) submission's performance section. Therefore, I cannot generate the requested table and information based on the text provided.
§ 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).