(176 days)
Opportunity Inc.'s Tracheostomy Care Kit is intended for use by a licensed professional or other medical personnel as deemed appropriate by the using facility. The intended use of the medical products assembled in these kits will not change from the manufacturers original intended use. This kit is used for performing or assisting in performing tracheostomy procedures.
Not Found
This document is a 510(k) clearance letter from the FDA for several medical kits, including the "Opportunity Tracheostomy Care Kit." It primarily addresses regulatory aspects and does not contain information about the acceptance criteria, study details, or performance of a specific device in the context of a clinical or performance study.
Therefore, I cannot extract the requested information regarding acceptance criteria and device performance studies from this document. The document confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not include studies related to the device's efficacy or performance characteristics with specific metrics.
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.