(120 days)
The VERIFY Chemical Indicator for S40 Sterilant is a peracetic acid concentration indicator for routine monitoring of automated STERIS liquid chemical sterilant processing systems that employ S40 Sterilant Concentrate in a controlled cycle.
The VERIFY® Chemical Indicator for S40 Sterilant is a single-use chemical indicator consisting of a polypropylene strip with indicator ink printed on one end. The indicator is covered by a clear, sterilant-permeable laminate to protect the strip from damage during handling and prevent the indicator ink from leaching from the substrate. The indicator monitors the peracetic acid (PAA) concentration of the STERIS S40 Sterilant Concentrate at the point of use in an automated liquid chemical sterilant processing system that uses S40 Sterilant Concentrate and provides a controlled 6-minute exposure at 45.5 - 60°C during a processing cycle.
The VERIFY Chemical Indicator for S40 Sterilant is a device designed to monitor peracetic acid concentration in STERIS automated liquid chemical sterilant processing systems. Its primary function is to change color from blue to pink (through an intermediate beige) when exposed to a specific concentration of peracetic acid for a set duration and temperature.
Here's an analysis of its acceptance criteria and the study that proves it meets those criteria, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Targeted Performance) | Reported Device Performance |
|---|---|
| Color change from blue through intermediate beige to pink when exposed to >1820 ppm (mg/L) peracetic acid in S40 use dilution. | The indicator changes color from blue through an intermediate beige and then to the endpoint color, pink, when exposed to a concentration of >1820 ppm (mg/L) peracetic acid found in the S40 use dilution during a controlled 6-minute exposure at 45.5 - 60°C. The indicator may become more pink with higher concentrations. |
| Controlled 6-minute exposure at 45.5 - 60°C. | The indicator is designed for a controlled 6-minute exposure at 45.5 - 60°C. |
| Effectively monitors peracetic acid concentration for routine monitoring of STERIS automated liquid chemical sterilant processing systems. | The device passed performance tests including Comparative Sensitivity and Specificity, Analytic Specificity, and Simulated Use Testing, demonstrating its effectiveness in monitoring. |
| Shelf-life of 24 months. | Passed Shelf Life for 24 months testing. |
| Open bottle stability for 6 months. | Passed Open Bottle Stability for 6 months testing. |
| Robustness against environmental factors and contaminants. | Passed UV Study, Effects of Aggressive Chemicals, and Effects of Contaminants testing. |
| Readability of color change. | Passed Color Read Time and Blind Reader testing. |
2. Sample Size Used for the Test Set and Data Provenance:
The document states that the performance testing was "non-clinical." It does not specify the exact sample sizes used for each test. The data provenance is not explicitly mentioned in terms of country of origin, but it is implied to be from the manufacturer's internal testing as part of the 510(k) submission process. The testing appears to be retrospective due to the use of "identical predicate device" data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document mentions "Blind Reader" testing. However, it does not specify the number of experts (readers) used, nor their qualifications (e.g., years of experience, specific professional titles).
4. Adjudication Method for the Test Set:
The document does not describe the adjudication method used for the "Blind Reader" test or any other test where subjective interpretation might be involved.
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:
This device is a chemical indicator, not an AI-powered diagnostic tool for human interpretation. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The VERIFY Chemical Indicator is a standalone device in the sense that its color change is a direct chemical reaction and does not involve an algorithm or human-in-the-loop for its fundamental operation. Its "performance" (color change) is inherent to the device itself. The "Blind Reader" test assesses human interpretation of this standalone indicator.
7. The Type of Ground Truth Used:
The ground truth for the performance testing appears to be based on:
- Known Peracetic Acid Concentrations: Precisely controlled concentrations of peracetic acid (e.g., >1820 ppm) were used to test the indicator's color change.
- Controlled Exposure Parameters: The specified temperature (45.5 - 60°C) and time (6 minutes) were controlled during testing.
- Established Chemical Reactions: The mechanism of action is described as ink ingredients changing color due to oxidation.
8. The Sample Size for the Training Set:
The concept of a "training set" is not applicable here as the device is a chemical indicator, not a machine learning algorithm. Its performance is based on chemical properties, not learned patterns from data.
9. How the Ground Truth for the Training Set Was Established:
As there is no training set for this type of device, this question is not applicable. The device's color-changing chemistry is its inherent "mechanism."
§ 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).