(160 days)
The Andersen EOGas 4 SteriTest consists of a self-contained biological indicator inoculated with viable Bacterial spores that is placed in a dedicated BI receptacle in the sterilizer. It monitors the 3 hour sterilization cycle at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer.
The Andersen EOGas 4® SteriTest consists of a single-use self-contained biological indicator (SCBI) placed in a reusable BI receptacle. It is designed for monitoring the efficacy of the 3 hour sterilization cycle at 50°C in an EOGas 4 Ethylene Oxide Gas Sterilizer.
The SCBI, the EZTest - Gas Biological Indicator, consists of a plastic vial that serves as the culture tube and a cap including a filter material port to allow ethylene oxide to enter the vial. The plastic vial contains Bacillus atrophaeus spores inoculated onto a paper carrier, and a glass ampoule containing modified soybean casein digest broth and phenol red acting as a pH indicator. There is a chemical indicator printed on the unit label of the SCBI to indicate EO exposure.
Following manufacturer's instructions, the operator inserts the Andersen EOGas 4 SteriTest into the reusable BI receptacle on the purge probe of the EOGas 4 Ethylene Oxide Gas Sterilizer, and initiates a 3 hour cycle at 50°C. After cycle completion, the SCBI is retrieved and activated by crushing the glass ampoule. The chemical indicator on the SCBI changes from blue to a green/brown color depending on the duration of ethylene oxide exposure. The activated SCBI and an unprocessed control are incubated at 30-35℃ for 48 hours, and monitored for any color change and/or turbidity. Evidence of microbial growth by color change from red-orange to yellow and/or turbidity must be interpreted as a failure to meet the conditions necessary for sterilization (cycle failed); no color change or turbidity indicates conditions for sterilization were achieved (cycle passed).
The provided text describes the Andersen EOGas 4 SteriTest, a self-contained biological indicator designed to monitor the efficacy of ethylene oxide gas sterilization cycles.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functionality | 1) Critical parameters include temperature, time, and gas concentration under a relative humidity of 35-90%; 2) Device is appropriate for monitoring the efficacy of the sterilization process claimed (specifically the 3-hour cycle at 50°C in an EOGas 4 Ethylene Oxide Gas Sterilizer). | Pass |
| Shelf Life | Maintains performance specifications (resistance characteristics and correctly indicate pass/fail in cycles) throughout the stated shelf life of 2 years; Stability demonstrates reasonable assurance for effectiveness. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for the "test set" in terms of the number of biological indicators (BIs) used for functionality or shelf-life testing. It refers to "tests" and "studies" but doesn't quantify the number of units involved in each.
The data provenance is not explicitly stated in terms of country of origin, but it is implied to be laboratory testing conducted by the manufacturer, Andersen Sterilizers, Inc., likely within the USA given the FDA application. The studies appear to be prospective as they are designed to validate the performance of the device under specified conditions.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts or their qualifications used to establish ground truth for the test set. Ground truth for biological indicators in sterilization typically relies on established microbiological methods and standards rather than expert consensus on individual "cases." The "pass" or "fail" of a BI after processing is determined by the presence or absence of microbial growth, which is a direct, objective outcome, not an interpretation by an expert.
4. Adjudication Method for the Test Set
No adjudication method (e.g., 2+1, 3+1) is mentioned as it's not applicable for this type of device. The outcome for a biological indicator (growth or no growth) is an objective determination rather than a subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study was mentioned. This type of study (human readers with/without AI assistance) is not relevant for a biological indicator, which is a physical device used to monitor a sterilization process, not an diagnostic imaging or decision support AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable to the Andersen EOGas 4 SteriTest. It is a physical biological indicator, not an algorithm or software-based device. Its performance is inherent in its design and microbiological properties. The "human-in-the-loop" aspect exists in the reading of the indicator after incubation (observing color change/turbidity), but this is a direct observation of a physical outcome, not interpretation of an algorithm's output.
7. The Type of Ground Truth Used
The ground truth used for performance assessment of the biological indicator is microbiological growth/no growth (colony formation and/or turbidity, and color change due to pH indicator). This is a direct, objective measurement of the survival or inactivation of the Bacillus atrophaeus spores inoculated onto the carrier within the BI, following exposure to the sterilization cycle.
8. The Sample Size for the Training Set
No training set is mentioned or applicable. Biological indicators are physical devices, not machine learning algorithms that require training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no training set for this device.
§ 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).