(110 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 steam sterilization cycles with a 3M TM Attest ™ Super Rapid Readout Biological Indicator 1492V along with or without SteriScan Integrators.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a medical device called "Dana Reusable Test Pack." It primarily discusses regulatory compliance and does not contain scientific study details, acceptance criteria, or performance data beyond the statement of substantial equivalence to a predicate device.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance from the provided document. The document confirms that the device is cleared for marketing based on substantial equivalence, but it does not include the specifics of performance metrics, study designs, sample sizes, or ground truth establishment that would typically be found in 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).