(298 days)
Dana Steam Sterilization Integrators are intended to monitor critical parameters in steam sterilization cycles in healthcare facilities. The critical parameters for which the integrators will respond are time and temperature (when steam is present). The end point is determined by the migration of the steam sensitive dye to an area marked safe on the indicator. The integrators are intended to be used in 30 minute gravity cycles at 250 degrees F and 3 minute gravity and pre- vacuum cycles at 270 degrees F.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "Dana Steam Sterilization Integrator." It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the document does not contain specific information about:
- Acceptance criteria and reported device performance in a table.
- Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details for a study.
- Training set sample size or how its ground truth was established.
The document primarily focuses on the regulatory approval process and the indications for use of the device, which are described as:
- Indications for Use: Dana Steam Sterilization Integrators are intended to monitor critical parameters in steam sterilization cycles in healthcare facilities. The critical parameters for which the integrators will respond are time and temperature (when steam is present). The endpoint is determined by the migration of the steam-sensitive dye to an area marked safe on the indicator. The integrators are intended to be used in 30-minute gravity cycles at 250 degrees F and 3-minute gravity and pre-vacuum cycles at 270 degrees F.
Therefore, I cannot provide the requested table or study details based on the given information. The document is a regulatory approval letter, not a study report.
§ 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).