(123 days)
The SporView® Rapid Read Biological Indicator is intended to be used with the 3M Attest Auto-Reader to monitor the effectiveness of dynamic-air-removal (prevacum) steam sterilization cycles of 4 minutes at 132°C. The SporView Rapid Read Biological Indicator provides a final fluorescent result in 3 hours. An optional pH color change is observed after 48 hours.
The SporView Rapid Read Biological Indicator is a self-contained biological indicator designed to be used with the 3M Attest 390 auto-reader to qualify or routinely challenge dynamic-airremoval (pre-vacuum) steam sterilization cycles of 4 minutes at 270°F (132°C). The SporView Rapid Read Biological Indicator is composed of a polypropylene vial containing a spore carrier and media ampoule enclosed with a vented cap. Similar to the predicate device, 3M's 1292 Rapid Read-Out Biological Indicator cleared under 510(k)s K090569 and K926364, the subject device contains ≥ 105 viable spore population of G. stearothermophilus. It utilizes the a-glucosidase system, which is generated naturally within growing G. stearothermophilus. A successful steam sterilization cycle will result in no growth of G. stearothermophilus. A failure in the sterilization cycle creates a fluorescence change, which is detected upon incubation in the 3M 390 Attest Auto-reader. This provides an enzymatic result in 3 hours to indicate a steam sterilization process failure. The biological indicator will also detect the presence of G. stearothermophilus organism by a visual color change reaction. Biochemical activity of the orqanism will produce acid by-products that cause the media to change color after 48 hours. A visual pH color change after 48 hours also indicates a steam sterilization process failure.
This document describes the SporView Rapid Read Biological Indicator, a device designed to monitor the effectiveness of steam sterilization cycles.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Viable Spore Population Assay | Spore population of the BI meets specification of $\ge 10^5$. | Pass |
| Resistance Characteristics Testing | Steam 132°C: | |
| D-Value: $\ge$ 10 seconds | ||
| Z-Value: $\ge$ 10°C | ||
| Survival Time: $\ge$ 1 minute (Calculated as D-value x (Log10[viable spore population] - 2] per FDA guidance) | Pass | |
| Carrier and Primary Packaging Materials | Must not have inhibitory effects on the growth of test organisms of the BI after sterilization. | Pass |
| Holding Time Assessment | 7-day holding time must have no effects on the performance of the subject BI. | Pass |
| Growth Promotion and Media Suitability | The media of the biological indicator must support growth and recovery to be suitable. | Pass |
| Reduced Incubation Time | Verification of 3-hour fluorescent and 48-hour biological readout per FDA's Validation of Reduced Incubation Protocol. | Pass |
| Verification of Full and Fractional Cycle | Partial kill achieved after a fractional cycle and full biological inactivation after a full cycle in a marketed sterilizer. | Pass |
| 3M 390 Auto-Reader Compatibility Testing | Evaluation that the compatibility of the SporView Rapid Read BI and 3M 390 Auto-Reader system such that the auto-reader reads and displays accurate results and alarms appropriately upon BI removal. | Pass |
| Shelf Life Testing | Verification of the viable spore population, resistance characteristics, and media stability at the end of the shelf life. | Pass |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each specific test in the "Performance Characteristics Testing" section. However, the testing was conducted by Medivators in accordance with FDA Guidance on Biological Indicators to demonstrate that the device meets or exceeds acceptance criteria. The data provenance is implied to be from laboratory testing conducted by the manufacturer, Medivators (Crosstex/SPSmedical). The type of data is non-clinical performance data. There is no information regarding country of origin or whether the data is retrospective or prospective, although typically, pre-market submissions involve prospective testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The "ground truth" for a biological indicator would be based on the known state of sterilization (e.g., whether a sterilization cycle was effective or not) and the measurable biological response of the indicator (e.g., spore growth or no growth). This is determined by the experimental setup rather than expert consensus on individual results.
4. Adjudication method for the test set:
Not applicable. The "ground truth" for the performance of a biological indicator in these types of tests is typically objective (e.g., based on known sterilization parameters and direct observation of microbial growth/killing), rather than requiring adjudication among human experts.
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 for sterilization monitoring, not an AI-assisted diagnostic or interpretation tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. The device is a biological indicator itself, which is then read by an auto-reader (3M Attest 390 Auto-Reader). The performance evaluated is the indicator's ability to accurately reflect sterilization efficacy, confirmed by its interaction with the auto-reader. There is no "algorithm only" performance reported in the sense of a software-based diagnostic.
7. The type of ground truth used:
The ground truth used for these tests is based on objective biological and physical measurements related to sterilization efficacy. This includes:
- Spore viability: Direct counts of viable spores.
- Resistance characteristics (D-value, Z-value, Survival Time): Determined by exposing the biological indicators to precisely controlled steam sterilization conditions and observing the killing kinetics of the spores.
- Growth promotion: Observing the ability of the media to support the growth of G. stearothermophilus.
- Fractional and full cycle inactivation: Observing partial kill after a fractional cycle and complete inactivation after a full cycle in a marketed sterilizer.
8. The sample size for the training set:
Not applicable as this is not an AI/machine learning device that requires a training set. The "training set" concept is traditionally associated with statistical models or machine learning algorithms that learn from data.
9. How the ground truth for the training set was established:
Not applicable for the reasons stated in point 8.
§ 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).