(236 days)
Process indicators are intended for the use with individual units, to demonstrate that the unit has been exposed to a process at stated conditions and distinguish between processed and unprocessed units.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "Steritite Process Indicator Accessories". It does not contain the detailed study information, acceptance criteria, or performance data typically found in a scientific paper or a more comprehensive regulatory submission. The letter confirms substantial equivalence to a predicate device and allows market entry.
Therefore, I cannot provide the requested information based on the provided text. The document primarily serves as an FDA clearance letter, not a technical report detailing the device's performance study.
§ 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).