Search Results

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

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.

Ask a specific question about this device