(806 days)
The STERRAD® CycleSure™ Biological Indicator is intended to be used as a standard method for frequent monitoring of the STERRAD® Sterilizer cycles.
The STERRAD® CycleSure™ Biological Indicator is a self-contained stand-alone biological monitor intended for the routine monitoring of the STERRAD® Sterilization Process. It consists of a glass fiber disc containing a minimum of 106 Bacillus stearothermophilus spores placed inside a plastic vial, a glass ampule containing nutrient growth medium also inside the vial, a cap and liner closing the vial and a chemical indicator on top of the cap. The cap contains two small circular openings that allow for diffusion of hydrogen peroxide vapor into the vial. The relatively small size of the circular openings serves as a restriction to this diffusion.
After exposure to the sterilization process, the cap is pressed down until firmly seated against the top of the vial in order to seal the vial is then placed into the supplied tube crusher and squeezed until the media ampule is crushed. The entire device is then placed into an incubator and incubated in an upright position at 55° C to 60° C. After incubation, the medium in the vial is observed for a change in color from purple (indicating no growth) to yellow (indicating growth).
The STERRAD® CycleSure™ Chemical Indicator (on the cap) serves as a chemical process indicator (throughput indicator) [Class A per EN867-1] for the STERRAD® Sterilizer cycle. Exposure of the chemical indicator to the STERRAD® Sterilizer cycle results in a recognizable color change from red to yellow.
The provided text describes the STERRAD® CycleSure™ Biological Indicator and its validation. It does not contain information about an AI/ML powered device. Therefore, I will extract the information for the biological indicator.
Acceptance Criteria and Device Performance for STERRAD® CycleSure™ Biological Indicator
This document describes the validation of the STERRAD® CycleSure™ Biological Indicator (BI), a self-contained biological monitor for routine monitoring of STERRAD® Sterilization Processes. The studies primarily focused on the chemical indicator, spore population, D-value, incubation time, bacteriostasis, and growth media performance and stability.
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Chemical Indicator | ||
| Color Change (STERRAD® 100) | Change from red to yellow when processed under maximum & minimum H2O2 exposure. | Successfully changes color from red to yellow. |
| No Color Change (Water Substitute) | No color change when water substituted for H2O2. | Chemical indicator did not change color. |
| Unprocessed Stability | Maintain red color for at least 24 months at 15°C to 25°C. | Maintained red color for at least 24 months. |
| Post-processing Stability | Indicator color stable for at least 7 months after processing. | Stable for at least 7 months after processing (real time aging). |
| Functionality after Aging | Successfully change color from red to yellow after aging (30°C/75% R.H. up to 24 mos). | Successfully changed color from red to yellow (aged up to 24 months). |
| Biological Indicator | ||
| Spore Population | Determined in accordance with ISO 11138-1 | Determined using a BIER Vessel following ISO 11138-1. |
| D-value | Determined in accordance with ISO 11138-1 | Determined using a BIER Vessel following ISO 11138-1. |
| Incubation Time | Defined minimal time for growth detection. (30-80% surviving samples) | Minimum incubation time determined to be 48 hours (at 55°-60°C). |
| Bacteriostasis (STERRAD® 100) | No bacteriostatic effects observed. | No bacteriostatic effects observed. |
| Bacteriostasis (STERRAD® 50) | No bacteriostatic effects observed. | No bacteriostatic effects observed. |
| Growth Media | ||
| Color Reversion | Yellow color stable for up to 7 days of total incubation. | Yellow color was stable for up to 7 days of total incubation. |
| Growth Promotion (real-time) | Promote growth. | Promoted growth. |
| Bacteriostasis (real-time) | Not bacteriostatic. | Not bacteriostatic. |
| Quality Characteristics (real-time) | Met specification (pH, color, appearance, stability). | Met specification. (Data for 12 months, ongoing). |
| Growth Promotion (accelerated aging) | Promote growth (after 36 months at 55°C). | Promoted growth. |
| Bacteriostasis (accelerated aging) | Not bacteriostatic (after 36 months at 55°C). | Not bacteriostatic. |
| Quality Characteristics (accelerated aging) | Met specification (pH, color, appearance, stability). (after 36 months at 55°C). | Met specification. |
| Performance Validation | Inactivation after half cycle with reduced 59% nominal H2O2. | Inactivation consistently obtained in STERRAD®100, 100S, and 50 Sterilizers. |
| Shelf-Life (Stability) | Within specifications for labeled storage conditions (2°C - 25°C). | Stable for at least 18 months, within specifications. (Data up to 18 mos. |
| ongoing up to 24 mos). |
2. Sample Size Used for the Test Set and Data Provenance
- Chemical Indicator Validation: The specific number of samples for each condition (simulated heavy load, no load, plasma presence, H2O2 absence) is not explicitly stated, but it was "evaluated by observing the color."
- Incubation Time Determination: Three different lots of BIs, each consisting of one hundred samples, were tested.
- Bacteriostasis (STERRAD® 100 & STERRAD® 50): For each sterilizer, twenty STERRAD® CycleSure™ Biological Indicator samples prepared with uninoculated glass fiber discs (10 test, 10 negative controls) and ten additional samples prepared without glass fiber discs (positive controls) were used.
- Growth Media Validation: Media lots were prepared, and testing was conducted, but specific sample sizes for each test are not provided.
- Performance Validation: Not explicitly stated, but performed "using three different spore crops."
- Shelf-Life (Stability) Validation: Three different manufacturing lots of BIs were used, with portions of each lot placed into different storage conditions. Samples were periodically removed and tested.
Data Provenance: The studies were conducted by Advanced Sterilization Products, a division of Ethicon, Inc., based in Irvine, California. Implied to be prospective in nature as the studies were conducted to validate a new device prior to commercialization. The origin is the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for this biological indicator is based on quantifiable biological and chemical responses (e.g., spore inactivation, color change, growth promotion) rather than subjective expert assessment. The testing standards (ISO 11138-1, CDRH Guidance Document) dictate the methodology.
4. Adjudication Method for the Test Set
Not applicable. The tests involve objective measurements and observations (e.g., color change, microbial growth/no growth, D-value calculation) that do not require an adjudication process by multiple reviewers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This product is a biological indicator, not an AI/ML powered device that would involve human readers for interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the device operates "standalone" in the sense that it functions without continuous human intervention during sterilization and incubation, this is not an AI/ML algorithm. Its "performance" refers to its physical and biological function as described.
7. The Type of Ground Truth Used
The ground truth used for this device is based on:
- Biological Activity: The viability and inactivation of Bacillus stearothermophilus spores.
- Chemical Reactions: The color change of the chemical indicator in response to hydrogen peroxide.
- Standardized Methods: Adherence to established industry standards like ISO 11138-1 and CDRH Guidance Documents for biological indicator evaluation.
- Laboratory Testing: Direct measurement of pH, growth promotion, bacteriostasis, and stability in controlled laboratory environments.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML powered device, so there is no "training set" in the context of machine learning. The studies described are validation and performance tests of a physical product.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/ML device, the concept of a "training set" and establishing ground truth for it does not apply.
§ 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).