(19 days)
SteriTec Process Indicator Container Cards, Labels, and DOTS are intended for use by health care providers with steam sterilization wraps, container, cassettes, or pouches to distinguish between processed and unprocessed items. The Cards, Labels, and DOTS can be used in 121° C gravity steam sterilizers or 132° – 134° C pre-vacuum steam sterilizers. Indicators turn to dark gray/black after exposure to steam sterilization processes.
Not Found
This document is a 510(k) clearance letter from the FDA for Steritec Process Indicators. It does not contain information about acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory clearance and substantial equivalence to a predicate device, not on performance studies with specific metrics.
§ 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).