(156 days)
The EOGas 4 Endo-SteriTest Rapid Readout Biological Indicator 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 the 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 Rapid Readout Biological Indicator (RRBI) 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 EOCas 4 Ethylene Oxide Gas Sterilizer.
The Bionova BT110 Rapid Readout Biological Indicator (K191021) 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 culture medium and a pH indicator. There is a chemical indicator printed on the unit label of the SCBI to indicate EO exposure by changing color from brown/red to green.
Following manufacturer's instructions, the operator inserts the Bionova BT110 Rapid Readout 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°C. After cycle completion, the SCBI is retrieved and activated by crushing the glass ampoule. The chemical indicator on the SCBI changes from brown/red to a green color after ethylene oxide exposure.
The activated SCBI and an unprocessed control are incubated in a Terragene Bionova IC10/20FR, IC10/20FRLCD or MiniBio Auto-Reader Incubator for 4 hours to detect fluorescent activity or 48 hours to detect color change. Evidence of microbial growth by presence of fluorescent activity or color change from blue to yellow must be interpreted as a failure to meet the conditions necessary for sterilization (cycle failed); no fluorescence or no color change indicates conditions for sterilization were achieved (cycle passed).
The provided document describes the EOGas 4 Endo-SteriTest RRBI, a rapid readout biological indicator for monitoring ethylene oxide sterilization cycles. The submission seeks to demonstrate substantial equivalence to a predicate device.
Here's a breakdown 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 time, temperature, gas concentration, and relative humidity 35-90% are met; 2) Device is appropriate for monitoring the efficacy of the sterilization process claimed. | 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 |
| Viable Spore Population | $\ge 1.0 \times 10^6$ Bacillus atrophaeus (ATCC 9372) spores. | $\ge 1.0 \times 10^6$ |
| Resistance Characteristics | (Implicitly) Must be greater than the same biological indicator placed in the worst-case location of endoscope validation loads. | Met (Implied by "Pass" of full functionality) |
| Growth Inhibition | No inhibition of viable spore growth by carrier or primary packaging materials. | Met (Implied by "Pass" of full functionality) |
| Holding Time Assessment | (Details not explicitly stated, but expected for BI performance) | Met (Implied by "Pass" of individual studies) |
| Reduced Incubation Time Validation | (Details not explicitly stated, but expected for RRBI performance) | Met (Implied by "Pass" of individual studies) |
| Recovery Protocols for Recovery Medium | (Details not explicitly stated, but expected for BI performance) | Met (Implied by "Pass" of individual studies) |
| Visual Readout Stability | (Details not explicitly stated, but expected for RRBI performance) | Met (Implied by "Pass" of individual studies) |
| In-Field Evaluation | (Details not explicitly stated, but expected for BI performance) | Met (Implied by "Pass" of individual studies) |
Notes on Acceptance Criteria:
- The document explicitly lists "Functionality" and "Shelf Life" tests with their acceptance criteria and "Pass" results.
- For the individual studies performed for the Bionova BT110 Rapid Readout Biological Indicators (which is a component of the EOGas 4 Endo-SteriTest RRBI), the document states that "The results of all studies met the established acceptance criteria," without enumerating the specific criteria for each.
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not provide specific sample sizes (e.g., number of BIs or sterilization cycles) for the "test set" studies. It mentions that "The EOGas 4 Endo-SteriTest RRBI has been validated using applicable tests in FDA 2007 'Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions', and ANSI/AAMI/ISO 11138-1:2017 'Sterilization of health care products -Biological indicators - Part 1: General requirements'." These standards typically define the requirements for testing, including sample sizes, but the specific numbers used in this submission are not stated.
Data provenance is not explicitly mentioned but is assumed to be prospective bench testing conducted by the manufacturer as part of the validation process for regulatory submission. There is no mention of country of origin for data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a biological indicator designed to directly measure sterilization efficacy, not to be interpreted by human experts like medical images. The "ground truth" for a biological indicator is the direct observation of microbial growth (or lack thereof) after exposure to a sterilization process, relative to positive and negative controls.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the device's output (microbial growth/no growth, or fluorescent activity/no fluorescent activity) is a direct, objective measurement, not subject to subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is not an AI-assisted diagnostic or imaging interpretation device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI algorithm. The device itself (the biological indicator) is a standalone measurement tool.
7. The Type of Ground Truth Used
The ground truth used for biological indicators is the viability of the Bacillus atrophaeus bacterial spores.
- Failed Sterilization: Indicated by observable fluorescent activity or a color change from blue to yellow in the culture medium, signifying spore survival and growth.
- Successful Sterilization: Indicated by no fluorescence and no color change, signifying spore inactivation.
- Positive controls (unprocessed BIs) are expected to show growth, and negative controls (processed BIs from a successful cycle) are expected to show no growth, confirming the validity of the test.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of 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).