(311 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 SGM Biotech's Self-Contained Biological Indicator Smart-Read EZTest - Steam along with or without SteriScan Integrators.
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The provided text is a 510(k) clearance letter from the FDA for a medical device called the "Dana Reusable Test Pack." While it states the intended use and regulation information, it does not contain the detailed acceptance criteria or a study that proves the device meets those criteria.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts, their qualifications, or adjudication methods for ground truth establishment.
- Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Information about standalone algorithm performance.
- The type of ground truth used.
- Training set sample size or how its ground truth was established.
The letter is a regulatory document confirming that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has met the regulatory requirements for market clearance, but it does not provide the underlying performance study details that would typically include acceptance criteria and specific performance metrics.
§ 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).