(91 days)
Dana Reusable Test Pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4 minute 270°F pre-vacuum 4 minute steam sterilization cycles with the Dana Emulating Indicator cleared by FDA under K100891.
Reusable Integrator Test Pack for Dana Emulating Indicator.
This document is a 510(k) clearance letter from the FDA for a medical device called the "Reusable Integrator Test Pack for Dana Emulating Indicator." It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain the detailed study information required to answer your specific questions about acceptance criteria and device performance. It is a regulatory clearance, not a scientific study report.
Therefore, I cannot provide the requested information, such as:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and data provenance
- Number of experts used to establish ground truth
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone performance results
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
To obtain this information, you would typically need to refer to the original 510(k) submission (K110253) made by Dana Products, Inc. to the FDA. Such submissions contain the technical data, study protocols, and results that demonstrate the device meets its intended performance and regulatory requirements. These documents are usually not publicly available in full detail through a simple clearance letter.
§ 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).