(195 days)
The Zefon Anesthesia Circuit with Bacterial Filter is intended for use in the administration of medical gases during anesthesia. The circuit connects the anesthesia gas machine to the patient by means of an oronasal face mask or by a connection to an artificial airway, such as an endotracheal tube. In the case of the Zefon circuit, a heat moisture exchange filter is included to minimize viral and bacterial contamination of the inspiratory and expiratory limbs of the circuit.
Not Found
I am sorry, but based on the provided document, I cannot describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a device called "Zefon Anesthesia Circuit with Bacterial Filter." This letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.
However, the letter does not contain any details about:
- Acceptance criteria for performance evaluation.
- Specific studies (e.g., clinical trials, bench testing) conducted for the device.
- Sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, types of ground truth, or training set details.
The letter primarily focuses on the regulatory clearance process and the device's classification. To obtain the information you're asking for, one would typically need to consult the original 510(k) submission document or a more detailed technical report on the device's testing.
§ 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).