(69 days)
The SteriTite "11 product line is a Reusable Rigid Sterilization Container system intended to be used for the sterilization of surgical instruments for a hospital or other health care institution.
Not Found
I am sorry, but the provided text from the FDA 510(k) letter for the Steritite™ Rigid Sterilization Containers does not include the detailed information regarding acceptance criteria, study design, and performance metrics that you are requesting.
The letter primarily confirms that the device is "substantially equivalent" to predicate devices marketed before May 28, 1976, and outlines the general regulatory requirements for marketing the device. It does not contain a summary of the performance testing or the specific acceptance criteria and study results.
To answer your questions, I would need access to the actual 510(k) submission document or a summary of its contents, which typically contains the technical details of the device's testing and performance.
§ 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).