(119 days)
SteriTec Green Card Pack Bowie-Dick Test is a single designed to detect the presence of residusl air in pro-veauum steam sterilizers operating at 132°C for 3.5 minutes. The indicator card within the Green Card Pack will demonstrate a uniform color change from purple to green when proper sterlization conditions are met and no air is present to create a 2° C (+19-0° C) temperature difference between the center of the towel pack, as identified in ANSVAAMI/ISO 11140-5, and the drain temperature at the beginning of the final one minute of a three and half minute cycle the indicator card within the Green Card Pack will demonstrate a non-uniform color change.
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This document is a marketing authorization letter for a medical device (SteriTec Green Card Pack Bowie-Dick Test) and does not contain the detailed study information required to answer the prompt. The request asks for acceptance criteria and study details, including sample sizes, data provenance, expert qualifications for ground truth, adjudication methods, MRMC study results, standalone performance, and how ground truth for training data was established. This marketing authorization letter, specifically pages 1-3, focuses on regulatory approval, substantial equivalence, and indications for use. It does not provide the technical details of a performance study demonstrating acceptance criteria.
Therefore, I cannot fulfill the request using only 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).