(76 days)
The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the following sterilizer cycles:
· Lumen, Non Lumen, Flexible, Fast, Fast Non Lumen and Specialty Cycles of the V-PRO® 1, 1 Plus, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems
· STERRAD® 100S Sterilizer (Default Cycle)
· STERRAD® 200 Sterilizer (Default Cycle)
· Standard and Advanced Cycles of the STERRAD® NX Sterilizer to include sterilizers with ALLClear® Technology
· Express, Flex Scope and Standard Cycles of the STERRAD® 100NX Sterilizer to include sterilizers with ALLClear® Technology.
The Celerity 20 HP Biological indicator is intended for the routine monitoring of the following sterilizer cycles:
· Lumen, Non Lumen, Fast, Flexible and Specialty Cycles of the V-PRO 1, 1 Plus, maX, maX, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems
· STERRAD® 100S Sterilizer (Default Cycle)
- Standard and Advanced Cycles of the STERRAD® NX Sterilizer with or without ALLClear® Technology
· Standard, Flex Scope, Express, and DUO Cycles of the STERRAD® 100NX Sterilizer with or without ALLClear® Technology
When used in conjunction with the Celerity HP Incubator or the Celerity Incubator, the Celerity HP BI provides a fluorescent result within 20 minutes.
The product is intended to monitor the vapor phased hydrogen peroxide sterilization cycles described in the indication for use. It produces an optical change in signal that is detected by the STERIS proprietary reader, Celerity 20 HP Incubator, within 20 minutes to confirm the viability of the biological indicator at the end of a sterilization process. The product consists of Geobacillus stearothermophilus spores and a defined nutrient media in a plastic vial. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.
The VERIFY V24 Self-Contained Biological Indicator (SCBI) is used by healthcare facilities 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 SCBI 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℃ 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 is a 510(k) premarket notification for two biological indicators: the Celerity 20 HP Biological Indicator and the VERIFY V24 Self-Contained Biological Indicator, both manufactured by STERIS Corporation. The purpose of the submission is to obtain clearance for these devices to routinely monitor additional sterilizer cycles, specifically the "Specialty Cycle" of the V-PRO® maX 2 Low Temperature Sterilization System, as well as several other specified STERRAD® cycles.
It's important to note that this document is for a sterilization process indicator, not a medical device in the typical sense (e.g., a diagnostic AI tool). Therefore, many of the typical acceptance criteria and study designs associated with AI/ML-driven medical devices (like MRMC studies, expert consensus for imaging, etc.) do not apply here. This is a technical performance study for a biological measurement device, focusing on its ability to accurately reflect sterilization efficacy.
Based on the provided text, here's a breakdown of the acceptance criteria and the study that proves the device meets them for each of the two devices mentioned:
For the Celerity 20 HP Biological Indicator:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Performance (Conclusion) |
|---|---|---|
| Verification of Celerity HP BI Performance after V-PRO Specialty Cycle Extended Aeration | Celerity BIs exposed to the Specialty Cycle demonstrate essentially equivalent or not significantly different resistance as compared to SCBIs exposed to the 136L V-PRO Sterilizer Fast Non Lumen Cycle. | Pass |
| Final Process Qualification of the VPRO maX2 Sterilizer Specialty Cycle | The V-PRO maX 2 Sterilizer Specialty Cycle final process qualification was successful. | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in the provided text. The term "Celerity BIs" and "SCBIs" are used, implying multiple biological indicators were tested, but the exact number is not given.
- Data Provenance: The studies were non-clinical tests conducted by STERIS Corporation. The location (Mentor, OH) of the manufacturing and sponsor facility would suggest the studies were conducted in the USA. The data appears to be prospective as it's specifically for a new cycle qualification.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable in the context of this device. Ground truth for a biological indicator is typically established by the physical inactivation of bacterial spores under controlled, validated sterilization conditions, and the subsequent growth/no-growth determination. This is a direct measurement of sterility, not an interpretation of an image or signal that would require human expert consensus in the medical imaging sense.
4. Adjudication Method for the Test Set:
- Not applicable as this is a direct biological and physical process validation, not a diagnostic interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret output (e.g., images) with and without AI assistance. This device is a sterility indicator; its performance is measured by its biological response to sterilization, not by how humans interpret its output in a diagnostic scenario.
6. If a Standalone (algorithm only without human-in-the-loop performance) was Done:
- Yes, in principle. The performance of the biological indicator itself is "standalone." Its function is to respond directly to the sterilization process. The "reading" of the Celerity 20 HP BI is performed by the Celerity HP Incubator which detects a fluorescent signal within 20 minutes to confirm viability. While an instrument is involved, it's not an "algorithm" in the AI sense, but rather a direct measurement device. The studies described are assessing the BI's intrinsic performance against the sterilization cycle.
7. The Type of Ground Truth Used:
- Biological Inactivation/Sterility: The ground truth is the actual biological state of the spores on the biological indicator (e.g., killed or survived) after exposure to varying sterilization conditions. This is determined by observing the growth (or lack thereof) of the Geobacillus stearothermophilus spores under specific culture conditions, which then produces a fluorescent moiety if growth occurs. The "successfully qualified" aspect of the sterilizer cycle itself is the ultimate ground truth for the process the BI is monitoring.
8. The Sample Size for the Training Set:
- Not applicable. Biological indicators are not "trained" in the machine learning sense. Their function relies on the pre-defined biological characteristics of the Geobacillus stearothermophilus spores and the biochemical reaction designed into the device.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. (See #8)
For the VERIFY V24 Self-Contained Biological Indicator:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Performance (Conclusion) |
|---|---|---|
| Verification of V24 SCBI Performance after V-PRO Specialty Cycle Extended Aeration | SCBIs exposed to the Specialty Cycle demonstrate essentially equivalent or not significantly different resistance as compared to SCBIs exposed to the 136L V-PRO Sterilizer Fast Non Lumen Cycle. | Pass |
| Final Process Qualification of the VPRO maX2 Sterilizer Specialty Cycle | The V-PRO maX 2 Sterilizer Specialty Cycle final process qualification was successful. | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. Similar to the Celerity BI, "SCBIs" (Self-Contained Biological Indicators) are mentioned, implying multiple units were tested, but the exact count is not provided.
- Data Provenance: The studies were non-clinical tests conducted by STERIS Corporation (likely in the USA). The data appears to be prospective for the new cycle qualification.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable. Ground truth for a biological indicator is typically established by the direct biological response of the bacterial spores to sterilization. While there's a visual detection of growth (color change/turbidity), this is a direct observation of a biological event, not a subjective interpretation requiring expert consensus.
4. Adjudication Method for the Test Set:
- Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, an MRMC study was not done.
6. If a Standalone (algorithm only without human-in-the-loop performance) was Done:
- Yes, in principle. The performance of the biological indicator itself is "standalone." Its function is to respond directly to the sterilization process. The "reading" of the VERIFY V24 SCBI involves visual detection of growth (media color change/turbidity) after incubation. While this involves human observation, it's observing a biological fact (growth/no growth), not interpreting an image or signal in a diagnostic sense. The studies described are assessing the BI's intrinsic performance against the sterilization cycle.
7. The Type of Ground Truth Used:
- Biological Inactivation/Sterility: The ground truth is the actual biological state of the spores on the biological indicator (e.g., killed or survived) after exposure to varying sterilization conditions. This is determined by observing the growth (color change from orange to yellow and/or turbidity) or no-growth (media remains orange and non-turbid) of the Geobacillus stearothermophilus spores after incubation. The "successfully qualified" aspect of the sterilizer cycle itself is the ultimate ground truth for the process the BI is monitoring.
8. The Sample Size for the Training Set:
- Not applicable. Biological indicators are not "trained."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable.
§ 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).