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510(k) Data Aggregation
(150 days)
The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the following sterilizers and cycles:
- · Non Lumen, Flexible, Lumen and Fast Non Lumen Cycles of the V-PRO 1, 1 Plus, maX, 60 and maX 2 Sterilizers
- · Standard Cycle of the STERRAD® 100S Sterilizer
- · Standard and Advanced Cycles of the STERRAD® NX Sterilizer
- · Express, Flex Scope and Standard Cycles of the STERRAD® 100 NX Sterilizer
The VERIFY V24 Challenge Pack is intended for qualification testing of the V-PRO 1 Plus, V-PRO maX, V-PRO maX 2 and V-PRO 60 Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs.
The VERIFY V24 Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.
The VERIFY V24 Challenge Pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing the Sterilizers.
The VERIFY V24 Self-Contained Biological Indicator (SCBI) is used by healthcare facilites to monitor the V-PRO® Low Temperature Sterilization Systems. 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 and performs a sterilization cycle. After cycle completion, the VERIFY V24 Self-Contained Biological Indicator 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 VERIFY V24 Self-Contained Biological Indicator is activated by sealing the vial and rupturing the medium ampoule using the STERIS VERIFY SCBI HP activator. The activator automatically seals the VERIFY V24 Self-Contained Biological Indicator vial and releases the growth media.
The activated SCBI is incubated at 55-60°C for ≥ 24 hours. The VERIFY V24 Self-Contained Biological Indicator indicates a pass if the media remains orange and non-turbid. The VERIFY V24 Self-Contained Biological Indicator indicates a failure of sterilization if the media changes from orange to yellow and/or if the media is turbid.
The VERIFY V24 Challenge Pack is used by healthcare facilities for qualification testing of the V-PRO Low Temperature Sterilization Systems following installation, relocations, malfunctions or major repairs. The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital defined challenge load is not included.
The user places the VERIFY V24 Challenge Pack into the V-PRO Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the VERIFY HPU Chemical Indicator (CI) and the VERIFY V24 Self-Contained Biological Indicator (SCBI) contained in the challenge pack are retrieved. The CI is assessed for a passing color change immediately and 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.
This document describes the acceptance criteria and study proving the VERIFY® V24 Self-Contained Biological Indicator (SCBI) and the VERIFY® V24 Challenge Pack meet these criteria.
VERIFY® V24 Self-Contained Biological Indicator
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance/Conclusion |
|---|---|---|
| 1/4, 1/2 & 3/4 Cycle Performance | Partial positive results obtained in 1/4 and 1/2 cycles; all negative results obtained in 3/4 cycle evaluations. | PASS |
| Growth Inhibition | Uninoculated VERIFY V24 SCBIs processed in a Fast Non Lumen Cycle and inoculated with low numbers (<100 CFU) of Geobacillus stearothermophilus should all exhibit growth. | All tested SCBIs exhibited growth. PASS |
| Simulated Use | VERIFY V24 SCBIs processed in the Fast Non Lumen Cycle under simulated use conditions should result in: All processed SCBIs exhibit negative growth results; All processed SCBI Label PIs exhibit a “pass” result; All processed CIs exhibit a “pass” result. | PASS |
| Reduced Incubation Time (RIT) Testing | 30 – 80% survival of exposed BI with a ≥ 97% correspondence between the 24-hour results and the conventional incubation time of 7 days. | PASS |
| Viable Spore Population | 2.0 – 3.4 x 10^6 spore/SCBI | PASS (met the range) |
| D-value | 4-8 seconds (at 2.7 mg/L H₂O₂) | PASS (met the range) |
| Survival Time | 4-30 seconds (at 2.7 mg/L H₂O₂) | PASS (met the range) |
| Kill Time | ≤ 16 minutes (at 2.7 mg/L H₂O₂) | PASS (met the criteria) |
| Hold Time | Performance of VERIFY V24 SCBIs held for 72 hours after exposure to VHP was evaluated. | PASS |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in the provided text for individual tests, but implied to be sufficient for each test type.
- Data Provenance: The studies were conducted by STERIS Corporation, the manufacturer. The information does not specify country of origin for specific data sets, but the company is located in the USA. The studies appear to be prospective, designed specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for a biological indicator and its performance characteristics (like D-value, survival time, kill time, and growth/no-growth) are established through microbiological laboratory methods and adherence to recognized standards (e.g., FDA guidance on BI submissions, ISO 11138-1), not through expert consensus in the same way an AI diagnostic tool might be. The interpretation of results (growth/no growth, color change) is objective.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is a scientific and objective assessment of a biological and chemical indicator's performance against defined quantifiable metrics, not a subjective human interpretation requiring 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 not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a biological indicator that provides a visual readout.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth is established through microbiological testing and adherence to established industry-specific standards and guidelines. This includes:
- Direct enumeration of viable spores.
- Controlled exposure to the sterilant (H₂O₂ at specific concentrations and times) to determine D-value, survival time, and kill time.
- Incubation under controlled conditions to observe microbial growth (turbidity, color change) as an indicator of sterilization failure.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
VERIFY® V24 Challenge Pack
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance/Conclusion |
|---|---|---|
| Comparative Dose Response to Biological Model | The VERIFY V24 Challenge Pack shall demonstrate equal or greater resistance as compared to the worst-case biological model in the Fast Non Lumen Cycle. | PASS |
| Simulated Use | VERIFY V24 Challenge Packs processed in the Fast Non Lumen Cycle under simulated use conditions should result in: All processed SCBIs exhibit negative growth results; All processed SCBI Label PIs exhibit a “pass” result; All processed CIs exhibit a “pass” result. | PASS |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in the provided text for individual tests, but implied to be sufficient for each test type.
- Data Provenance: The studies were conducted by STERIS Corporation, the manufacturer, in the USA. The studies appear to be prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Similar to the SCBI, the ground truth for the challenge pack's performance is based on objective microbiological and chemical indicator principles, not expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth is established through microbiological testing and adherence to established industry-specific standards and guidelines for process challenge devices. This includes:
- Comparison to a "worst-case biological model" to ensure adequate challenge.
- Observation of growth/no-growth for the contained SCBI and color change for chemical indicators after exposure to sterilization cycles.
8. The sample size for the training set:
- Not applicable.
9. How the ground truth for the training set was established:
- Not applicable.
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