(122 days)
The VERIFY Assert Self-Contained Biological Indicator (SCBI) is for routine monitoring, qualification testing, load monitoring and product testing of the following steam sterilization processes.
| Cycle Type | Temperature | Time |
|---|---|---|
| Dynamic Air Removal | 270°F (132°C) | 4 minutes |
| Dynamic Air Removal | 275°F (135°C) | 3 minutes |
| Gravity | 250°F (121°C) | 30 minutes |
| Gravity | 270°F (132°C) | 15 minutes |
When used in conjunction with the Reader for the VERIFY Assert Self-Contained Biological Indicator, the VERIFY Assert Self-Contained Indicator provides a fluorescent result within 40 minutes
The product is intended to monitor the critical parameters of steam sterilization cycles described in the indications for use by producing an optical change (signal) that is detected by the STERIS proprietary reader, VERIFY Incubator for Assert Self-Contained Biological Indicator, in 40 minutes to confirm the viability of the biological indicator at the end of a steam sterilization process. The product consists of a biological organism known to be resistant to steam (Geobacillus stearothermophilus) and a defined nutrient media. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.
The STERIS Corporation VERIFY Assert Self-Contained Biological Indicator (SCBI) is a Class II device (21 CFR 880.2800, Product code FRC) intended for monitoring steam sterilization processes.
Here's an analysis of its acceptance criteria and the study proving its performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Purpose of the Test | Acceptance Criteria | Reported Device Performance | Conclusion |
|---|---|---|---|---|
| Reduced Incubation Time (RIT) Testing | Validate the labeled incubation time of the SCBI | Meets FDA's requirement of > 97% alignment of the 40-minute results with the conventional incubation time of 7 days*, ‡ | Not explicitly quantified in this section, but stated to "PASS" | PASS |
| Viable spore population | Enumerate the number of viable spores per SCBI | 1.0 - 4.0 x 10^6 spore/SCBI**, ‡ | 2.7 - 3.7 x 10^6 spore/SCBI | PASS |
| Resistance | Determine the resistance of the SCBI to steam | D121 ≥ 1.5 min * | ||
| D132 ≥ 10 s * | ||||
| D135 ≥ 8 s * | D121 ≥ 2.13 min | |||
| D132 ≥ 42 s | ||||
| D135 ≥ 31 s | PASS | |||
| Signal Generation | Validate that the SCBI will produce signal in its reader | All unexposed SCBI show positive growth signal in reader within 40 minutes of incubation‡ | Not explicitly quantified in this section, but stated to "PASS" | PASS |
| Hold Time | Demonstrate that performance of the SCBI is not affected by delaying incubation up to 72 hours | Performance not affected if incubated within 72 hours of exposure to steam sterilization‡ | Not explicitly quantified in this section, but stated to "PASS" | PASS |
| Simulated Use | Demonstrate SCBI performance in a steam sterilizer with the AAMI reference load (16 towel pack) | Demonstrate growth when exposed to abbreviated cycle and all kill in a full cycle‡ | Abbreviated cycle – growth | |
| Full cycle – no growth | PASS |
Notes on Acceptance Criteria:
*: Based on recommendations in FDA Guidance Biological Indicator (BI) Premarket Notification [510(k)] Submissions**: Minimum acceptance criteria based on recommendations in FDA Guidance Biological Indicator (BI) Premarket Notification [510(k)] Submissions‡: Based on specifications of the reference device, VERIFY Assert Self-Contained BI
2. Sample size used for the test set and the data provenance
The document does not explicitly state the specific sample sizes used for each non-clinical test (e.g., number of SCBIs tested for RIT, viable spore population, etc.). It only provides the acceptance criteria and the conclusion (PASS) or the measured performance range.
The data provenance is from non-clinical testing conducted by STERIS Corporation for their VERIFY Assert Self-Contained Biological Indicator. This would inherently be prospective data collection as it's part of a device validation study. The country of origin of the data is not specified, but the applicant (STERIS Corporation) is based in Mentor, Ohio, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This device is a biological indicator for sterilization processes. The "ground truth" for its performance is established through laboratory testing against well-defined, standardized sterilization parameters and biological growth assessment, rather than expert human interpretation of images or clinical data. Therefore, the concept of "experts establishing ground truth for a test set" in the context of interpretation of results (like in a medical imaging AI study) does not directly apply here. The "experts" involved would be the microbiologists and engineers who designed, executed, and analyzed the validation studies, ensuring adherence to standards like those outlined in FDA guidance documents and AAMI. Their qualifications would typically involve expertise in microbiology, sterilization science, and quality assurance for medical devices.
4. Adjudication method for the test set
Not applicable. As explained above, the "ground truth" is determined by objective biological and physical measurements and adherence to established scientific and regulatory standards for sterilization indicators, not by a panel of human adjudicators.
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 device is a biological indicator, not an AI-powered diagnostic tool requiring human interpretation. Its function is to provide an objective fluorescent signal detected by a reader to indicate sterilization success or failure.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a way. The performance testing described is essentially a "standalone" assessment of the device's ability to accurately indicate sterilization conditions. The VERIFY Assert SCBI, when used with its proprietary reader, provides a fluorescent result within 40 minutes. This means the device itself, in conjunction with its automated reader, generates the result without human interpretation of a complex output. The human role is to observe the positive or negative signal from the reader. The tests confirm the device's intrinsic biological resistance and signal generation properties under various sterilization conditions and incubation parameters.
7. The type of ground truth used
The ground truth used for this device is based on:
- Microbiological Growth Assessment: Direct observation of bacterial growth (or lack thereof) after exposure to sterilization cycles, often confirmed by conventional incubation methods (e.g., 7 days of incubation) to establish true viability.
- Physical and Biological Standards: Adherence to established performance metrics ($D_{value}$, spore population) defined by regulatory guidance (FDA Guidance Biological Indicator (BI) Premarket Notification [510(k)] Submissions) and industry consensus standards (e.g., AAMI for sterilization processes).
- Controlled Sterilization Cycles: Exposure to precisely controlled steam sterilization cycles (e.g., abbreviated cycles to show growth, full cycles to show kill) to challenge the BI.
8. The sample size for the training set
Not applicable. This device is a biological indicator and does not employ machine learning or AI algorithms that would require a "training set." Its biological and chemical principles of operation are deterministic, based on the survival and metabolic activity of a target microorganism.
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).