(445 days)
RSI Rapid Indicator, a multiple, interactive, bacterial enzyme indicator, is used for monitoring saturated steam sterilization processes operating at 121°C gravity, 132°C vacuum assisted 134°C vacuum assisted cycles.
RSI, Rapid Indicator
The provided document is a 510(k) clearance letter from the FDA for the "RSI™ Rapid Indicator for Monitoring Steam Sterilization." This type of document does not contain the detailed study information or acceptance criteria requested.
A 510(k) clearance primarily establishes substantial equivalence to a predicate device already on the market. It confirms that the new device is as safe and effective as a legally marketed device and does not typically delve into the specifics of performance studies in the way you've outlined for AI or diagnostic devices.
Therefore, I cannot provide the requested information from this document. The document confirms the device name, its use for monitoring steam sterilization processes, and its substantial equivalence determination, but no detailed performance metrics, study designs, sample sizes, or ground truth establishment methods are present.
To obtain such information, one would typically need to refer to the original 510(k) submission document itself (which is usually much more extensive than the clearance letter) or published studies related to the device.
§ 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).