Search Results

The STERRAD® CYCLESURE® 24 PLUS Biological Indicator is intended to be used as a standard method for frequent monitoring of the following STERRAD® Sterilizer Systems used in Healthcare facilities:

• · STERRAD® 50
• · STERRAD® 100S
• · STERRAD® 200
• · STERRAD® NX Standard Cycle
• · STERRAD® NX Advanced Cycle
• · STERRAD® 100NX STANDARD Cycle
• · STERRAD® 100NX FLEX Cycle
• · STERRAD® 100NX DUO Cycle
• · STERRAD® 100NX EXPRESS Cycle

Not Found

This document is a 510(k) premarket notification acceptance letter from the FDA for a STERILIZATION PROCESS INDICATOR, specifically the STERRAD® CYCLESURE® 24 PLUS Biological Indicator. This device is used to monitor the effectiveness of sterilization processes in healthcare facilities.

The document does not contain the acceptance criteria or device performance data for this type of device in the way it would for a software-based medical device (e.g., an AI algorithm for image analysis). The "acceptance criteria" for a biological indicator refer to its ability to reliably indicate whether a sterilization cycle has been successful by killing a defined population of microorganisms. The testing for such a device typically involves challenging the indicator with a specific sterilization process and then culturing the indicator to see if growth occurs.

Therefore, I cannot extract the specific information requested in your prompt (e.g., sample sizes for test/training sets, number of experts for ground truth, MRMC studies, effect size of human improvement with AI, etc.) because these concepts are not applicable to the type of device described in this FDA letter. This document is a regulatory approval letter, not a detailed study report for an AI-powered diagnostic device.

The information provided in the document is limited to:

• Device Name: STERRAD® CYCLESURE® 24 PLUS Biological Indicator
• Regulation Number: 21 CFR 880.2800(a) (Sterilization Process Indicator)
• Regulatory Class: II
• Product Code: FRC
• Intended Use: Used as a standard method for frequent monitoring of specified STERRAD® Sterilizer Systems.

To answer your specific questions, one would need to refer to the actual testing protocols and results submitted by Mesa Laboratories Incorporated to the FDA for their 510(k) submission K140589, which are not detailed in this public letter. These would typically include:

• Acceptance Criteria for a Biological Indicator:
  • Expected performance: Growth (positive result) if not sterilized.
  • Expected performance: No growth (negative result) if adequately sterilized.
  • Specific D-value (decimal reduction time) or other resistance parameters demonstrating adequate challenge to the sterilization process.
  • Population of microorganisms (e.g., Geobacillus stearothermophilus) used.
• Proof of device meets criteria:
  • Results from laboratory testing demonstrating the indicator's resistance to the specified sterilization processes and its ability to consistently show no growth after successful cycles and growth after failed cycles.

Without the specific study details from the 510(k) submission, direct answers to your numbered points are not possible from the provided text.

Ask a specific question about this device