(121 days)
High flow oxygenation for patients requiring supplemental oxygen for the treatment of hypoxemia
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called "Transtracheal High Flow 1000" (TTHF 1000). It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information regarding acceptance criteria or the study that proves the device meets acceptance criteria.
The 510(k) process is primarily a premarket notification to demonstrate substantial equivalence to a predicate device, not necessarily to establish detailed performance metrics or conduct extensive clinical studies with specific acceptance criteria as you would see for a PMA (Premarket Approval) device, or in more recent AI/ML device submissions.
Therefore, I cannot provide the requested information based solely on the provided text. To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data, a design control document, or a clinical study report for the TTHF 1000, which are typically more detailed than a 510(k) clearance letter.
§ 868.5440 Portable oxygen generator.
(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).