(205 days)
RSI Process Challenge Device is intended to be used in conjunction with RSI Rapid Indicators for Monitoring Steam Sterilization to monitor the effectiveness of wrapped loads at 132°C/134°C vacuum assisted steam sterilization cycles.
Not Found
I am sorry, but the provided text from the FDA 510(k) letter dated April 23, 1999, for the "RSI® Process Challenge Device for Monitoring Steam Sterilization Process" does not contain the detailed information required to answer your request about acceptance criteria and a study proving device performance.
The letter primarily:
- Acknowledges receipt and review of the 510(k) submission.
- States that the device is substantially equivalent to pre-amendment devices.
- Informs the manufacturer that they can market the device, subject to general controls and good manufacturing practices.
- Provides contact information for further inquiries.
- Includes an "Indications for Use Statement" for the device.
It does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Details on experts used for ground truth or adjudication methods.
- Information about MRMC or standalone studies.
- The type of ground truth used.
- Sample size for a training set or how its ground truth was established.
To obtain this information, one would typically need to refer to the full 510(k) submission document itself, which would contain the detailed testing protocols and results that the FDA reviewed to make its substantial equivalence determination. The letter provided is simply the FDA's decision communication.
§ 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).