(247 days)
SteriTec Emu-Graph is a steam sterilization emulator for use in a pre-vacuum steam sterilizer at 132°C (270° F) or 135° C (275° F). When exposed to a steam sterilization process, the 2 MIN and 4 MIN indicator bars will turn from purple to green giving an integrated response and visible indication that sterilization conditions were met. If only the 2 MIN indicator bar turns green and the 4 MIN indicator bar displays an incomplete color change, insufficient sterilization conditions occurred.
Critical Parameters in a standard hospital pre-vacuum steam sterilizer
| Temperature | 4 MIN Indicator |
|---|---|
| 132°C (270°F) | 4 minutes |
| 135°C (275°F) | 3 minutes |
Not Found
This document is a 510(k) clearance letter for a medical device called the Emu-Graph Emulator, Model No. CI 131, which is a steam sterilization emulator. The letter states that the device is substantially equivalent to legally marketed predicate devices.
The document does not contain the detailed acceptance criteria and the study that proves the device meets those criteria in the format requested. It primarily focuses on the FDA's clearance of the device based on substantial equivalence.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance from the provided text. The document only describes the intended use and the critical parameters for its function.
What is present in the document is a description of the device's function and expected visual indication related to sterilization conditions:
- Indications for Use: SteRiTec Emu-Graph is a steam sterilization emulator for use in a pre-vacuum steam sterilizer at 132°C (270°F) or 135°C (275°F).
- Expected Performance:
- When exposed to sufficient sterilization process, the 2 MIN and 4 MIN indicator bars will turn from purple to green, giving an integrated response and visible indication that sterilization conditions were met.
- If only the 2 MIN indicator bar turns green and the 4 MIN indicator bar displays an incomplete color change, insufficient sterilization conditions occurred.
- Critical Parameters:
- Temperature: 132°C (270°F) - 4 MIN Indicator: 4 minutes
- Temperature: 135°C (275°F) - 4 MIN Indicator: 3 minutes
This information describes what the device is designed to do and how it should visually respond, but it is not presented as formal acceptance criteria with corresponding study results in the structured way requested. The 510(k) clearance process often relies on demonstrating substantial equivalence to a predicate device, rather than requiring extensive de novo clinical studies with detailed acceptance criteria as would be seen for a novel, high-risk device. The details you are asking for would typically be found in the 510(k) submission summary or associated testing reports, which are not included in this FDA 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).