(151 days)
The Verify® Steam Indicators are emulating indicators intended for use in steam sterilization. The Verify® Steam Indicators change color from yellow to blue/purple when exposed to the appropriate cycle temperature, type, and duration. The indicator models and their cycle temperatures, types, and times are:
| MODEL | TEMPERATURE | STERILIZATION TYPE | TIME |
|---|---|---|---|
| Verify 250F 30 | 250°F (121°C) | gravity steam | 30 minutes |
| Verify 270F 15 | 270°F (132°C) | gravity steam | 15 minutes |
| Verify 270F 3-10 | 270°F (132°C) | gravity flash steam | 3 or 10 minutes |
| Verify 270F 4 | 270°F (132°C) | Steam Flush Pressure Pulse | |
| (SFPP), pre-vacuum and | |||
| Express steam | 4 minutes |
The proposed Verify® Steam Indicators consist of a 22mm x 143 mm strip (7/8" x 5.6") with a 12 mm circular chemical indicator ink spot (or two spots in the case of the 270°F 3-10 Indicator) located on one end, adjacent to a reference circle exhibiting the endpoint color. The indicator ink on the proposed Verify® Steam Indicators changes from yellow to blue/purple color when the steam sterilization cycle is complete.
- The Verify® 250°F 30 Indicator can be used to monitor a 30 minute . 250°F/121°C gravity steam sterilization cycle.
- The Verify® 270°F 15 Indicator can be used to monitor a 15 minute . 270°F/132°C gravity steam sterilization cycle.
- The Verify® 270°F 3-10 Indicator can be used to monitor a 3 minute or10 . minute 270°F/132°C gravity flash steam sterilization cycle.
- The Verify® 270°F 4 Indicator can be used to monitor a 4 minute . 270 F/132°C SFPP, pre-vacuum and Express steam sterilization cycle.
Acceptance Criteria and Device Performance Study for Verify® Steam Indicators
This document summarizes the acceptance criteria and the performance study for the Verify® Steam Indicators, based on the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
The Verify® Steam Indicators are intended to meet the requirements for emulating [Class 6] indicators as defined in ANSI/AAMI/ISO 11140-1:2005. While specific numerical acceptance criteria (e.g., color change within a certain percentage of exposure time) are not explicitly detailed in the provided text, the overall acceptance criterion is the successful color change from yellow to blue/purple when exposed to the proper time and temperature of the designated steam sterilization cycle, in accordance with the standard.
| Acceptance Criterion (Implicit from ANSI/AAMI/ISO 11140-1:2005 for Class 6 Indicators) | Reported Device Performance (as stated in the document) |
|---|---|
| Emulate Class 6 Steam Indicators requirements | The performance of the Verify® Steam Indicators meets the requirements of ANSI/AAMI/ISO 11140-1:2005 for emulating [Class 6] steam indicators. |
| Specific Cycle Parameters for Color Change: | The indicators change color from yellow to blue/purple when exposed to the appropriate cycle temperature, type, and duration. |
| 250°F 30 Indicator: 250°F (121°C) gravity steam, 30 minutes | Monitor a 30 minute, 250°F/121°C gravity steam sterilization cycle, changing from yellow to blue/purple. |
| 270°F 15 Indicator: 270°F (132°C) gravity steam, 15 minutes | Monitor a 15 minute, 270°F/132°C gravity steam sterilization cycle, changing from yellow to blue/purple. |
| 270°F 3-10 Indicator: 270°F (132°C) gravity flash steam, 3 or 10 minutes | Monitor a 3 minute or 10 minute 270°F/132°C gravity flash steam sterilization cycle, changing from yellow to blue/purple. |
| 270°F 4 Indicator: 270°F (132°C) SFPP, pre-vacuum and Express steam, 4 minutes | Monitor a 4 minute, 270°F/132°C SFPP, pre-vacuum and Express steam sterilization cycle, changing from yellow to blue/purple. |
2. Sample Size and Data Provenance
- Test Set Sample Size: The document does not specify the exact sample size for the test set. It broadly states that "Performance testing was conducted."
- Data Provenance: The document does not explicitly state the country of origin for the data or whether the study was retrospective or prospective. Given that STERIS Corporation is based in Mentor, OH, USA, and the 510(k) submission is to the FDA, it is likely the testing was conducted in the USA or under US regulatory guidelines. The testing appears to be prospective, as it was conducted to verify that the proposed indicators meet the requirements.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish ground truth for the test set. The ground truth for chemical indicators typically relies on objective physical/chemical changes observable by trained personnel, often against a reference or standard, rather than expert interpretation of complex images or data.
4. Adjudication Method
As no experts are mentioned for establishing ground truth, there is no adjudication method described. The assessment of chemical indicator performance is usually a direct, objective observation of color change against a specified endpoint color (blue/purple in this case).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. Chemical indicators are read directly for color change, which is a straightforward observation, not requiring the same type of interpretative analysis as, for example, medical imaging.
6. Standalone Performance (Algorithm Only) Study
Yes, a standalone performance study was done. The "Performance Testing" section states: "Performance testing was conducted to verify that the proposed indicators meet the requirements for emulating [Class 6] indicators as defined in ANSI/AAMI ISO 11140-1:2005 using a resistometer to ANSVAAMI ISO 18472." This indicates that the performance of the indicators themselves (the "algorithm only" in a broader sense of device function) was tested against the standards without human interpretation as part of the core performance evaluation, although humans would visually confirm the color change.
7. Type of Ground Truth Used
The ground truth used is based on objective performance standards and physical/chemical properties. Specifically, the ground truth is established by the requirements of ANSI/AAMI/ISO 11140-1:2005 for emulating [Class 6] indicators, and the testing was conducted using a resistometer to ANSI/AAMI ISO 18472. This means the indicators were exposed to precisely controlled sterilization conditions (time, temperature, steam presence) and their color change was assessed against the expected outcome defined by these international standards.
8. Sample Size for the Training Set
The document does not describe a "training set" in the context of an algorithm or machine learning. For a chemical indicator, the manufacturing process and quality control would ensure consistency, but there isn't a "training set" as understood in AI studies. The development process would involve iterative design and testing to optimize the ink formulation and strip design to achieve the desired performance characteristics.
9. How Ground Truth for the Training Set Was Established
As there is no "training set" for an algorithm in this context, the question of how its ground truth was established is not applicable. The development of the chemical indicator itself would have relied on scientific principles of dye chemistry and material science, with iterative testing against known steam sterilization parameters to ensure the correct reaction.
§ 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).