(825 days)
SWEDEN & MARTINA SURGICAL TRAY (Model "ZSHORTY-INT") is designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. Soiled-used tools should never be placed back into the tray or silicone grommets.
The tray is to be enclosed in an FDA cleared steam sterilization validation was completed by: - Method Autoclave (Pre-vacuum Dynamic-Air-Removal Cycles) at a temperature of 134 ℃ (273 ℃) with an exposure of four (4) minutes and a minimum drying time of twenty (20) minutes.
The validated load weight is 230 grams.
Not Found
The provided text is related to an FDA 510(k) clearance for a surgical tray. It discusses regulatory matters, product classification, and indications for use. It does not contain any information regarding acceptance criteria or a study that proves a device meets such criteria.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval for a medical device (a surgical tray) and not on the performance evaluation of an AI-powered or diagnostic device that would typically have acceptance criteria and associated study details as outlined in your prompt.
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).