(293 days)
The Verify Biological Indicator Challenge Pack for Vaporized VH2O2 Sterilization Processes is intended for qualification testing of the Amsco® V-PRO™ 1 (cleared under K073618), Aunsco V-PRO 1 Plus (Lumen and Non Lumen Cycles, K092906), and Amsco V-PRO max (Lumen, Non Lumen and Flexible Cycles) 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 Sterilizers. It has been tested and validated solely for use in periodic testing of the V-PRO 1, V-PRO 1 Plus and V-PRO maX Sterilizers.
The Verify Biological Indicator Challenge Pack for Vaporized VH2O2 Sterilization Processes is intended for qualification testing of the following cycles.
| Sterilization Cycle | Sterilant/
Injection
(g) | #
Injections | Sterilant
Exposure Time
(min) |
|------------------------------------|--------------------------------|-----------------|-------------------------------------|
| Amsco V-PRO I Cycle | | | |
| Amsco V-PRO 1 Plus Lumen Cycle | 2.1 | 4 | 32 |
| Amsco V-PRO maX Lumen Cycle | | | |
| Amsco V-PRO 1 Plus Non Lumen Cycle | | | |
| Amsco V-PRO maX Non Lumen Cycle | 2.1 | 4 | 12 |
| Amsco V-PRO maX Flexible Cycle | 2.1 | 4 | 12 |
The Verify Biological Indicator Challenge Pack for Vaporized | VH2O2 Sterilization Processes is used by healthcare providers for qualification testing of the Amsco V-PROTM 1 Low Temperature Sterilization System, the Amsco® V-PRO™ 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen Cycles) and the V-PROT maX (Flexible, Lumen and Non Lumen Cycles) 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 user places the Verify Biological Indicator Challenge Pack into the Amsco V-PRO Sterilizer and performs a sterilization cycle. After cycle completion, the Verify V-PRO Chemical Indicator (CI) and the Verify V24 Self-Contained Biological Indicator (SCBI) contained in the challenge pack are retrieved. The CI is accessed 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 yellow and/or if the media is turbid.
The provided text describes the 510(k) summary for the STERIS Verify Biological Indicator Challenge Pack for Vaporized VH2O2 Sterilization Processes, specifically focusing on its qualification for the V-PRO maX Sterilizer Flexible Cycle. The document serves as a regulatory submission to the FDA.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Resistance Characterization | Challenge Pack resistance should be equivalent or greater than the biological model used to validate the sterilizer cycles (Lumen and Non Lumen Cycles of the V-PRO 1 Plus Low Temperature Sterilization System, and Flexible Cycle of the V-PRO maX Low Temperature Sterilization System). This implies the BI should represent a sufficient challenge to the sterilization process. | Pass. Challenge Pack resistance is equivalent or greater than the biological model used to validate the Lumen and Non Lumen Cycles of the V-PRO 1 Plus Low Temperature Sterilization System. Challenge Pack resistance is equivalent or greater than the biological model used to validate the Flexible Cycle of the V-PRO maX Low Temperature Sterilization System. |
| Simulated Use Evaluation | The Verify V-PRO Chemical Indicator (CI) and Verify V24 Self-Contained Biological Indicator (SCBI) should consistently yield "passing results" under worst-case simulated use conditions, indicating effective sterilization. | Pass. The Verify V-PRO CI and Verify V24 SCBI yielded passing results when evaluated under worst case simulated use conditions. |
| Process Indicator Performance Evaluation | The Process Indicator (CI) in the Challenge Pack must demonstrate a complete color change under "Pass" (sterilization successful) conditions and an incomplete or no color change under "Fail" (sterilization unsuccessful) conditions. | Pass. The Process Indicator in the Challenge Pack demonstrated a complete color change under "Pass" conditions and an incomplete color change under "Fail" conditions. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the specific sample sizes (number of challenge packs, number of tests run) used for the "Resistance Characterization," "Simulated Use Evaluation," and "Process Indicator Performance Evaluation." It only states "Pass" for each test.
Regarding data provenance: The studies were conducted by STERIS Corporation for their 510(k) submission to the FDA in the USA. This suggests the data is likely retrospective, as it's being submitted for device clearance. There is no mention of country of origin for the data other than the company's location in Mentor, Ohio, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not provide information on the number of experts or their qualifications for establishing ground truth for the test set. The nature of the device (biological indicator) suggests that "ground truth" is typically established by observing the growth or non-growth of microorganisms after exposure to sterilization cycles, rather than expert interpretation of images or clinical data.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
The document does not specify any adjudication method involving multiple human readers for the test set. Given that this is a biological indicator and chemical indicator, the evaluation is based on scientific measurement (microbial growth/no growth, color change) rather than 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
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 of images with or without AI assistance. The STERI Verify Biological Indicator is a device that provides a direct biological or chemical indication of sterilization effectiveness, not a diagnostic imaging device requiring human interpretation in this context. There is no AI component mentioned with human-in-the-loop.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to the device described. The device is a physical biological and chemical indicator. It does not involve an algorithm or AI that operates in a standalone manner without human intervention. The "human-in-the-loop" here is the user who activates the BI and interprets the color change or growth media.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For this device, the ground truth is established through:
- Microbiological viability: For Biological Indicators (BIs), the ground truth is determined by whether the test microorganisms (e.g., Geobacillus stearothermophilus) survive (growth, indicated by color change to yellow and/or turbidity) or are killed (no growth, media remains orange and non-turbid) after exposure to the sterilization process. This is a direct measure of sterilization efficacy.
- Chemical reaction: For Chemical Indicators (CIs), the ground truth is a specific and predictable color change in response to exposure to sterilant conditions (e.g., hydrogen peroxide).
The "biological model" mentioned in the "Resistance Characterization" implicitly refers to these established microbiological and chemical principles of sterilization assessment.
8. The Sample Size for the Training Set
The document does not mention a training set. This concept is typically associated with machine learning or AI models, which are not components of this biological indicator device. The device's performance is demonstrated through validation testing against established microbiological and chemical criteria.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as there is no mention of a training set for an AI or machine learning model.
§ 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).