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(115 days)
Terragene**®** Bionova**®** BT20 Biological Indicator
Terragene® Bionova® BT20 Biological Indicator is a Self-Contained Biological Indicator (SCBI) intended for routine monitoring of the efficacy of the following steam sterilization processes:
• Gravity-displacement Steam Sterilization Cycles
- 121 °C, 30 minutes
- 132 °C, 25 minutes
- 132 °C, 15 minutes
- 132 °C, 10 minutes
- 134/135 °C, 10 minutes
• Vacuum-assisted Steam Sterilization Cycles
- 121 °C, 20 minutes
- 132 °C, 4 minutes
- 134/135 °C, 3 minutes
Terragene® Bionova® BT20 provides a final result after a 24 hour incubation at 60 ± 2 °C.
Terragene® Bionova® BT20 Biological Indicators are single-use Self-Contained Biological Indicators (SCBIs) that consist of a polypropylene tube, a filter paper spore carrier inoculated with a minimum of 10⁶ viable Geobacillus stearothermophilus ATCC® 7953 spores and a glass ampoule containing purple culture medium, enclosed with a plastic colored cap and a barrier permeable to steam. The culture medium contains a pH indicator that changes color upon acidification by the metabolism of living spores. On each BT20 Biological Indicator there is a propylene label printed with a chemical process indicator that changes from pink to brown when exposed to steam.
Final results: 24-hour readout after incubation at 60 °C. If the sterilization process was successful, culture medium will remain purple. If sterilization was not successful, culture medium will turn to yellow during incubation, thus indicating the presence of live G. stearothermophilus spores.
This document describes the acceptance criteria and the study proving the Terragene® Bionova® BT20 Biological Indicator meets these criteria.
It's important to note that this device is a Biological Indicator for sterilization, not an Artificial Intelligence (AI) or medical imaging device. Therefore, some of the requested information (like multi-reader multi-case studies, ground truth establishment for AI training, etc.) is not applicable. The information provided focuses on the rigorous testing required for biological indicators to demonstrate their efficacy in monitoring sterilization processes.
1. A table of acceptance criteria and the reported device performance
The following table summarizes the acceptance criteria and the "Results" कॉलम में "Passed" यह बताता है कि डिवाइस ने उन सभी मापदंडों को सफलतापूर्वक पूरा किया है।
| Test Performed | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Viable Spore Population Assay | Demonstrate that the product meets specifications for spore population. | - 50 to 300% of manufacturer's nominal population (ISO 11138-1:2017). |
- ≥ 10⁵ CFU/BI unit (FDA Guidance, ISO 11138-3:2017). | Passed |
| Resistance Characteristics Study | Evaluate the resistance characteristics (D-value, Z-value, Survival Time, Kill Time). | - D-value₁₂₁°C: ≥ 1.5 minutes - D-value₁₃₂°C: ≥ 10 seconds
- D-value₁₃₅°C: ≥ 8 seconds
- Z-value: ≥ 10°C
- Minimum Expected Survival Time₁₂₁°C: ≥ 5 minutes
- Minimum Expected Survival Time₁₃₂°C: ≥ 1 minute
- Minimum Expected Survival Time₁₃₄/₁₃₅°C: ≥ 40 seconds
- No negative results at Minimum Expected Survival Time.
- No positive results at Maximum Expected Kill Time. | Passed |
| Recovery Protocols: Recovery Medium Test | Test suitability of the culture medium. | - All inoculated samples show positive result (color change to yellow) after 7-day incubation at 60°C. - Negative controls (uninoculated) show negative result (medium remains purple) after 7-day incubation at 60°C. | Passed |
| Carrier and Primary Packaging Materials Evaluation | Evaluate effect of materials on spore viability and suitability. | - No "no growth" in exposed carrier samples. - No "no growth" in unexposed carrier samples.
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