(371 days)
The HMEF SK203 is a disposable single-use device indicated for adult patients who require humidification during the delivery of ventilator gases and provide filtration for reducing contamination between patient and equipment. The HMEF SK203 is for use in hospital, ICU, anesthesia, respiratory therapy, during transport and for associated uses. The device can be used on adult patients. The device is indicated for use by qualified medical personnel only.
Not Found
I am sorry, but the provided text does not contain the information required to 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, which confirms that the Kung Shin HMEF SK203 device is substantially equivalent to a legally marketed predicate device.
Specifically, the text does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample size for test sets or their data provenance.
- Information on the number or qualifications of experts used for ground truth.
- Adjudication methods.
- Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
- Details about standalone algorithm performance studies.
- The type of ground truth used.
- The sample size for the training set or how its ground truth was established.
The document primarily focuses on the FDA's regulatory decision regarding substantial equivalence based on the provided 510(k) application, rather than detailed study results or performance metrics.
§ 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).