(155 days)
SteriTec Integraph-E is a steam sterilization integrator for use in a pre-vacuum steam sterilization process at 132°C (270° F) for 2 minutes or 4 minutes. When exposed to steam sterilization conditions Integraph-E strips give an integrated response and visible indication that sterilization were met by changing from a purple to green color.
SteriTec Integraph-E is a steam sterilization integrator. When exposed to steam sterilization conditions Integraph-E strips give an integrated response and visible indication that sterilization were met by changing from a purple to green color.
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a sterilization indicator, SteriTec Integraph-E. It indicates that the device has been found substantially equivalent to a predicate device for its stated indications for use.
Crucially, it does not include any details about a study with acceptance criteria, device performance, sample sizes, ground truth establishment, or expert reviews. These types of details are typically found in the 510(k) submission summary or in the actual study reports, which are not part of this clearance letter.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the detailed questions about a study based on the provided text.
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).