Search Results

SteriTec Integraph Flash is a steam sterilization integrator for use in either a pre-vacuum or gravity displacement steam sterilization process of 3 minutes or longer at 132° C (270° F), or a flash steam sterilization process for a 3 Minute cycle or 10 Minute cycle in gravity displacement sterilizers. When exposed to steam sterilization conditions the Integraph Flash strips give an integrated response and visible indication that sterilization conditions were met by changing from a purple to a green color. The stated value in a laboratory test sterilizer for the 3-Minute indicator spot is 5 minutes at 132° C, and for the 10-Minute indicator spot is 11.5 minutes at 132° C.

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, a specific study, sample sizes, expert qualifications, adjudication methods, or MRMC studies. The document is a 510(k) clearance letter from the FDA for a device called "SteriTec Integraph Flash," which is a sterilization process indicator.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and mentions its indications for use. However, it does not describe the data or studies that led to this determination.

Ask a specific question about this device