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510(k) Data Aggregation
(385 days)
The EOGas 4 Endo-SteriTest consists of a self-contained biological indicator inoculated with viable Bacillus atrophaeus bacterial spores that is placed in a dedicated biological indicator receptacle mounted on a gold-colored purge probe in the sterilizer. It monitors the efficacy of the 6-hour gas exposure at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer.
The EOGas 4 Endo-SteriTest consists of a single-use self-contained biological indicator (SCBI) placed in a reusable biological indicator (BI) receptacle. It is designed for monitoring the efficacy of the 6-hour gas exposure 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 EZTest-Gas Biological Indicator into the reusable BI receptacle on the dedicated purge probe of the EOGas 4 Ethylene Oxide Gas Sterilizer, and initiates a 6-hour gas exposure at 50℃. After cycle completion, the EZTest-Gas Biological Indicator 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°C 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 acceptance criteria and the results of studies conducted for the EOGas 4 Endo-SteriTest, a biological indicator for ethylene oxide sterilization.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| EZTest-Gas Biological Indicator Performance Characteristics | ||
| Viable Spore Population Assays | ≥ 10^6 microorganisms per unit; Stable for the stated 2-year shelf life | Meets the specifications for spore population according to 2007 FDA BI guidance and ANSI/AAMI/ISO 11138-1 |
| Resistance Characteristics Study (D-value) | D-value ≥ 3 min; Survival/Kill Time: 15 min; D-values remain ±20% of the stated value for the claimed 2-year shelf life | Meets the specifications for resistance characteristics according to 2007 FDA BI guidance and ANSI/AAMI/ISO 11138-1 |
| Growth Inhibition | All exposed carriers and packaging components are not bacteriostatic in a worst-case situation | Compliance with 2007 FDA BI guidance and ANSI/AAMI/ISO 11138-1 |
| Holding Time Assessment | The resistance characteristics are not altered significantly over a 7-day hold time prior to incubation. | Compliance with 2007 FDA BI guidance |
| Recovery Protocols, Medium and Incubation Time | Growth of an inoculum of 10-100 spores of Bacillus atrophaeus after being subjected to the sterilization process. | Compliance with 2007 FDA BI guidance and ANSI/AAMI/ISO 11138-1; Data generated supports an incubation time of 48 hours for EZTest-Gas biological indicators. |
| D-Value Comparison for EZTest-Gas Biological Indicator | ||
| D-value (in vacuum BIER vs. A-BIER) | D-values are within 20% of the original stated values for all lots of biological indicators tested. | There is no significant difference in the D-values measured in a vacuum BIER vs. an A-BIER. |
| Performance Testing for the EOGas 4 Endo-SteriTest | ||
| Half Dose Validation | Device is appropriate for monitoring the efficacy of the sterilization process claimed | Partial kill of biological indicators in PCD in half dose cycles, and complete kill in full dose cycles; Biological indicators at the worst-case locations in the endoscope loads are completely inactivated in both half and full dose cycles; EO concentration in the full dose cycles are twice the concentration in the half dose cycles for each endoscope load. |
| Pass/Fail Results from the EOGas 4 Sterilizer | Correctly indicate pass/fail in cycles | Data demonstrate the EOGas 4 Endo-SteriTest correctly indicates passed and failed 6-hour gas exposures in the EOGas 4 throughout the stated shelf life. |
| Endpoint Color Stability of the Chemical Indicator | Stability to provide reasonable assurance of effectiveness | The endpoint green/brown color was stable for at least 28 days when EZTest-Gas BIs were stored at 20-25°C or at 35-39°C after the EOGas 4 sterilization cycles. |
| Shelf Life | Stability of the D-Value and spore population; Correctly indicate pass/fail in cycles throughout the stated shelf life | Maintains performance specifications throughout the stated shelf life of 2 years |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes (number of biological indicators, number of runs, etc.) for each individual test. It mentions that "lots of biological indicators" were tested for D-value comparison, and refers to "half dose cycles" and "full dose cycles" for the half-dose validation. It does not provide information on the country of origin or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a biological indicator for sterilization. Its performance is evaluated through microbial growth/inactivation and chemical indicator changes, not by human expert interpretation of images or other data typically requiring expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The ground truth for this device is based on objective biological and chemical responses, not subjective expert judgment that would require adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a biological indicator for monitoring sterilization efficacy, not an AI-assisted diagnostic device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is a standalone device in the context of it generating its own result (color change, microbial growth/no growth). Its performance is evaluated directly through its biological and chemical responses to sterilization conditions, independent of human intervention for its core function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for this biological indicator is primarily the inactivation or survival of Bacillus atrophaeus bacterial spores when subjected to defined sterilization conditions, and the physical/chemical change of an indicator. This is an objective, measurable biological and chemical response, rather than expert consensus, pathology, or outcomes data.
8. The sample size for the training set
Not applicable. This device is a biological indicator, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As this is not a machine learning model, there is no training set or associated ground truth establishment process in that context. The "ground truth" for evaluating the BI's performance is established by microbiological standards for spore inactivation.
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