(183 days)
1544, 1544-T & 1544-F: For use at the equipment or patient connection. Designed to reduce bacterial/viral transmission to and from patient, equipment. CAUTIONS: When used in the exhalation limb in conjunction with a water bath humidifier, a water trap should be placed between the filter and the patient;
1541, 1541-T & 1541-F: For use at the patient connection. Designed to reduce bacterial/viral transmission and to reduce the loss of patient heat and humidity. CAUTIONS: This product is not suitable for patients with thick or copious secretions; Do not use this product in conjunction with other humidification sources.
1544, 1544-T, 1544-F, 1541, 1541-T, 1541-F: ISO connections: When assembling any connections use a push and twist action to ensure a secure fit. Single patient use. Non conductive. Non sterile. Do not autoclave. CAUTIONS: Never position any filter on the inspiratory limb downstream of a water bath humidifier. Do not use this product between the patient and a source of nebulized drugs: When nebulized drugs are administered, resistance should be monitored and the product should be exchanged following standard hospital procedure; All ports should remain capped when not in use; Replace every 24 hours or more frequently if visible deterioration is observed, following standard hospital procedure: Federal law restricts this device to sale by or on the order of a physician.
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I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) clearance letter from the FDA for a medical device (breathing circuit bacterial filter and HMEF). It states that the device is substantially equivalent to legally marketed predicate devices, but it does not contain any information about acceptance criteria, a study proving device performance against those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement in a study.
The document primarily focuses on the regulatory aspects of the device's clearance for market.
§ 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).