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510(k) Data Aggregation
(140 days)
VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED VH202 STERILIZATION PROCESSES
The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the Lumen, Non Lumen and Flexible cycles of V-PRO® Low Temperature Sterilization Systems.
The VERIFY V24 Biological Indicator Challenge Pack is intended for qualification testing of the Lumen. Non Lumen and Flexible Cycles in V-PRO Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs.
The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.
The challenge pack is not intended for routine monitoring of V-PRO Sterliizers. It has been tested and validated solely for use in periodic testing of the Sterilizers.
The VERIFY V24 Self-Contained Biological Indicator (SCBI) is used by healthcare providers 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 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 Biological Indicator Challenge Pack is used by healthcare providers for qualification testing of the V-PRO Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs. The challenge pack is placed in an otherwise empty sterilizer chamber; a hospitaldefined challenge load is not included.
The user places the VERIFY V24 Biological Indicator Challenge Pack into the V-PRO Sterilizer and performs a sterilization cycle. After cvcle 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 media 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 ℃ for ≥ 24 hours. The SCBI indicates a pass if the media remains orange and non-turbid. The SCBI indicates a failure if the media changes from orange to vellow and/or if the media is turbid.
This document describes two devices, the VERIFY® V24 Self-Contained Biological Indicator (SCBI) and the VERIFY® V24 Biological Indicator Challenge Pack. Both submissions are focused on qualifying these devices for use with the new V-PRO 60 Low Temperature Sterilization System, demonstrating substantial equivalence to their respective predicate devices.
VERIFY® V24 Self-Contained Biological Indicator (SCBI)
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| SCBI Half Cycle Performance Evaluation in the V-PRO 60 Sterilizer | SCBIs must be sterile after half-cycle testing. | Pass (SCBIs were sterile) |
| SCBI Growth Inhibition Following Exposure to V-PRO 60 Cycle | No growth inhibition or effect on media detected. | Pass (No growth inhibition) |
| SCBI Simulated Use in the V-PRO 60 Sterilizer | Successful demonstration of simulated use performance. | Pass |
| SCBI Worst Case Location in the V-PRO 60 Sterilizer | The worst-case location for SCBI placement must be determined. | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document summarizes nonclinical tests without providing specific sample sizes for each test. The studies were conducted by STERIS Corporation. The data provenance is described as being for "the new V-PRO 60 unit," implying prospective testing for this specific sterilizer. The K numbers (K073244, K090514) indicate prior clearances and associated data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided within the document. The "ground truth" for biological indicators is inherently based on the viability of Geobacillus stearothermophilus spores, which is determined by culturing and observing growth or no-growth.
4. Adjudication Method for the Test Set:
This information is not provided within the document. The outcome (Pass/Fail, or sterile/non-sterile) for biological indicators is typically a direct observation of microbial growth or lack thereof.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This type of study is not applicable as the device is a biological indicator, not an imaging or diagnostic AI tool that involves human readers.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):
This is a standalone performance study. The device, a biological indicator, functions independently without a human in the loop for its direct performance, though human observation is required for interpreting its results (color change, turbidity).
7. Type of Ground Truth Used:
The ground truth used is the viability of Geobacillus stearothermophilus ATCC 7953 spores. A successful sterilization cycle should kill all spores, resulting in no growth (sterile). If spores survive, they will grow, indicating a sterilization failure. This is effectively a biological assay for sterility.
8. Sample Size for the Training Set:
The document does not specify a separate "training set" in the context of machine learning, as this is a biological indicator. All listed tests are performance evaluations for the device itself rather than training data for an algorithm.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set in the machine learning sense. The biological principles of spore inactivation and growth underpin the ground truth for biological indicators.
VERIFY® V24 Biological Indicator Challenge Pack
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Resistance Characterization | Challenge Pack resistance must be equivalent or greater than the biological models used to validate the V-PRO 60 Low Temperature Sterilization System cycles. | Pass |
| Simulated Use Evaluation | VERIFY HPU Chemical Indicator and VERIFY V24 SCBI must yield passing results under worst-case simulated use conditions. | Pass |
| Worst Case Location | The worst-case location within the V-PRO 60 Sterilizer Chamber must be identified. | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document summarizes nonclinical tests without providing specific sample sizes for each test. The studies were conducted by STERIS Corporation. The data provenance is described as being for "the new V-PRO 60 Sterilizer," implying prospective testing for this specific sterilizer. K103331 is cited as the predicate.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided within the document. Similar to the SCBI, the ground truth for the challenge pack relies on the biological viability of Geobacillus stearothermophilus spores and the visual change of the chemical indicator.
4. Adjudication Method for the Test Set:
This information is not provided within the document. The outcome (Pass/Fail) is based on the biological indicator's growth/no growth and the chemical indicator's color change.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This type of study is not applicable as the device is a biological indicator challenge pack.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):
This is a standalone performance study. The challenge pack, containing a biological indicator and a chemical indicator, functions independently in the sterilizer without a human in the loop for its direct performance. Human observation is required for interpreting the results of both indicators.
7. Type of Ground Truth Used:
The ground truth used is the viability of Geobacillus stearothermophilus ATCC 7953 spores for the biological indicator component and the color change of the chemical indicator. Both are indicators of effective sterilization.
8. Sample Size for the Training Set:
The document does not specify a separate "training set" in the context of machine learning, as this is a biological indicator challenge pack. All listed tests are performance evaluations for the device itself.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set in the machine learning sense. The biological principles of spore inactivation and growth, along with established chemical indicator responses to sterilization processes, underpin the ground truth.
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