(87 days)
The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the following sterilizer cycles:
- Lumen, Non Lumen and Flexible Cycles of the V-PRO® Low Temperature . Sterilization Systems
- Default Cycle of the STERRAD 100S Sterilizer ●
- Default Cycle of the STERRAD 200 Sterilizer .
- Standard and Advanced Cycles of the STERRAD NX Sterilizer .
- Express, Standard and Flex Scope Cycles of the STERRAD 100NX Sterilizer .
The VERIFY V24 Self-Contained Biological Indicator (SCBI) is used by healthcare providers to monitor the V-PRO® Low Temperature Sterilization Systems and the STERRAD® 100S, STERRAD 200, STERRAD NX and STERRAD 100NX (Express, Standard and Flex Scope Cycles) Sterilizers. It is designed to accompany medical devices placed in the sterilizer.
The user places the VERIFY V24 Self-Contained Biological Indicator into the V-PRO Low Temperature Sterilization System or STERRAD Sterilizer and performs a sterilization cycle. After cycle completion, the SCBI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation.
The SCBI is activated by sealing the vial and rupturing the medium ampoule using the STERIS VERIFY SCBI HP activator. The activator automatically seals the SCBI vial and releases the growth media.
The activated SCBI is incubated at 55 – 60 °C for ≥ 24 hours. The SCBI indicates a pass if the media remains orange and non-turbid. The SCBI indicates a failure of sterilization if the media changes from orange to yellow and/or if the media is turbid.
The VERIFY® V24 Self-Contained Biological Indicator (SCBI) is intended to monitor specific cycles of V-PRO® Low Temperature Sterilization Systems and various STERRAD® Sterilizers. The acceptance criteria and supporting study are outlined below:
1. Table of Acceptance Criteria and Reported Device Performance
| Test & Acceptance Criteria | Reported Device Performance |
|---|---|
| SCBI Half Cycle Performance | |
| SCBIs must be sterile after half-cycle testing. | Pass |
| SCBIs were sterile in half-cycle testing. | |
| SCBI Growth Inhibition Following Exposure to STERRAD Sterilizer Cycles | |
| No growth inhibition and no effect of the sterilization process on the media. | Pass |
| There was no growth inhibition and no effect of the sterilization process on the media. | |
| SCBI Simulated Use in the STERRAD Sterilizer Cycles | |
| Successful performance in simulated use. | Pass |
| Simulated use performance has been successfully demonstrated. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size (number of VERIFY V24 SCBIs) used for each of the performance tests (Half Cycle, Growth Inhibition, Simulated Use).
The data provenance is for testing the device's compatibility with STERRAD Sterilizers. The context implies that the testing was likely conducted in a controlled laboratory or clinical setting in the United States, given that the sponsor and manufacturing facilities are in Mentor, OH, USA, and the submission is to the FDA. The study appears to be prospective, specifically designed to demonstrate the device's performance with the new sterilizer indications.
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. For biological indicators, the ground truth is typically established by observing the growth or non-growth of the bacterial spores, which is a direct, objective biological outcome. It doesn't usually rely on expert interpretation in the same way an imaging diagnostic might.
4. Adjudication method for the test set
The document does not describe an adjudication method for the test set. Given the nature of a biological indicator, where the outcome is a clear biological response (growth or no growth, indicated by a color change), an adjudication method by multiple experts is generally not applicable. The results are typically objectively measured.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation and often AI assistance. The VERIFY V24 Self-Contained Biological Indicator is a direct biological indicator without a human-in-the-loop component for reading the primary outcome.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device itself is a standalone indicator. Its performance is evaluated directly based on the biological outcome (spore inactivation and subsequent growth or no growth of Geobacillus stearothermophilus). This is essentially a standalone performance evaluation in that there is no "human-in-the-loop" for the primary interpretation of the device's result (color change or turbidity).
7. The type of ground truth used
The ground truth used is the biological outcome – specifically, the successful inactivation of Geobacillus stearothermophilus spores and the presence or absence of their growth after exposure to a sterilization process. This is determined by observing the color change of the media (orange to yellow) and/or turbidity, which indicates viable spores. The specification ranges for D-value, survival time, and kill time are also integral to establishing the efficacy (ground truth) of the indicator.
8. The sample size for the training set
The document does not detail a separate "training set" or its size, as this device is a biological indicator and not an AI/ML-based system that typically requires a training set. The existing biological indicator has been previously cleared, and the current submission focuses on extending its use to additional sterilizers.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a "training set" in the context of an AI/ML model for this biological indicator. The existing performance characteristics of the Geobacillus stearothermophilus spores and the indicator's components (media, etc.) were established through previous studies (K073244, K090514) according to FDA guidance for biological indicators.
§ 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).