(624 days)
The Propper BI-O.K. steam biological indicator is indicated for use in testing both gravity displacement steam sterilizers at 121°C and prevacuum steam sterilizers at 134°C.
The Propper BI-O.K. self contained steam biological indicator consists of a plastic vial and cap which contain a paper strip impregnated with a known number of B. stearothermophilus spores and a sterile sealed glass ampule containing a modified Soybean Casein Digest Medium with pH indicator. Following exposure in a steam sterilizer, the glass ampule is crushed by squeezing the sides of the plastic vial , thus bringing the medium into contact with the spores. The vial is incubated at 56± 2℃ for at least 24 hours. If any of the spores survived the sterilization process, they will grow and produce acid. This will cause a drop in pH of the medium and change the indicator from red to yellow.
The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the format requested. The document is a 510(k) submission summary for a biological indicator and an FDA clearance letter. It describes the device, its intended use, and its substantial equivalence to previously marketed devices. However, it does not include a detailed study with specific performance metrics against acceptance criteria.
Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, sample sizes, ground truth establishment, or details about MRMC or standalone studies.
§ 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).