(108 days)
The Verify® SYSTEM IE Chemical Indicator (SYSTEM 1E Chemical Indicator) is a peracetic acid concentration indicator for routine monitoring of the SYSTEM IE Liquid Chemical Sterilant Processing System employing S40 Sterilant Concentrate.
The Verify® SYSTEM IE Chemical Indicator is a single-use chemical indicator consisting of a polymeric 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 prevents the indicator ink from leaching from the substrate. The indicator was developed to monitor the peracetic acid (PAA) concentration of the STERIS S40 Sterilant Concentrate at the point of use in a SYSTEM IE Liquid Chemical Sterilant Processing System during a processing cycle.
Here's an analysis of the provided text, focusing on acceptance criteria and the study proving the device meets them:
Device: Verify® SYSTEM 1E Chemical Indicator
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the device's function and provides a summary of performance testing with "PASS" results for each. While explicit numerical acceptance criteria are not always stated, the intent is clear from the description of each test.
| Test Category | Acceptance Criteria (Implied/Explicit) | Reported Device Performance |
|---|---|---|
| Comparative Sensitivity and Specificity | The device can correctly differentiate between "PASS" and "FAIL" conditions for Peracetic Acid (PAA) concentrations in the SYSTEM 1E Liquid Chemical Sterilant Processing System. (Implied: High accuracy in detecting PAA above/below the threshold). | PASS |
| Color Read Time | The observed color of the indicator must be stable for at least 30 minutes following completion of the processor cycle to allow for evaluation. | PASS |
| Analytic Specificity | Under normal storage and use conditions as per labeling, any observed color change must exclusively be due to the presence of PAA in the processor use dilution (i.e., no false positives from other factors). | PASS |
| Blind Reader | Blind readers must correctly evaluate a high percentage (ideally all) of processed indicators. | PASS |
| Simulated Use Testing | The addition of a medical device to the processing chamber should not negatively affect the performance of the chemical indicator. | PASS |
| UV Study | The shipping and storage bottle must adequately protect unprocessed indicator strips from the degrading effects of UV light. | PASS |
| Shelf Life | The indicator must maintain its appropriate characteristics after 15 months of storage. | PASS |
| Effects of Aggressive Chemicals | The shipping and storage bottle must protect unprocessed indicator strips from aggressive chemicals. | PASS |
| Effects of Contaminants | The presence of potential contaminants (from inadequate cleaning/rinsing of medical devices) should not affect the expected color change of processed indicators. | PASS |
| Open Bottle Stability | The indicator must demonstrate appropriate FAIL results (presumably when PAA concentration is below the threshold) after 13 months of the bottle being opened. (This criterion is less clearly defined in its "PASS" statement, but implies maintaining functionality for a certain period post-opening). | PASS |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Blind Reader Test: 179 randomly displayed processed Verify SYSTEM 1E Chemical Indicators.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It is a submission to the FDA in the USA, implying studies were conducted to support this submission, likely by STERIS Corporation. The nature of the tests (e.g., "Simulated Use Testing," "Open Bottle Stability") suggests prospective experimental studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The document refers to "Blind Readers" in the "Blind Reader" test, who "correctly evaluated 179 of 179 randomly displayed processed Verify SYSTEM 1E Chemical Indicators."
- Number of Experts: The number of "Blind Readers" is not specified. It is simply pluralized.
- Qualifications of Experts: The qualifications of these "Blind Readers" are not provided. They are implied to be personnel trained in interpreting the chemical indicator's color change.
4. Adjudication Method for the Test Set:
- The document does not describe an adjudication method for establishing ground truth, such as 2+1 or 3+1. For the "Blind Reader" test, it states that "Blind Readers correctly evaluated 179 of 179," suggesting a clear Pass/Fail determination based on the indicator's state, rather than a reconciliation process among multiple independent observers for ground truth determination. The "ground truth" for the indicators themselves (i.e., whether they should be a "PASS" or "FAIL" condition) was likely established by the controlled PAA concentrations they were exposed to, which is not an adjudication process but a direct experimental setup.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study is described in the provided text. The "Blind Reader" test assesses the ability of readers to interpret the indicator, but it does not compare human readers with and without AI assistance. The device is the indicator, not an AI system assisting human interpretation of something else.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Since this device is a chemical indicator that relies on visual color change for interpretation, it is inherently a "human-in-the-loop" device in its intended use. There is no "algorithm only" component that would operate without human interpretation. Therefore, a standalone algorithm-only performance study would not be applicable or described for this type of product. The "Blind Reader" test explicitly assesses the human interpretation aspect.
7. Type of Ground Truth Used:
- The ground truth for the performance tests, particularly for "Comparative Sensitivity and Specificity," "Analytic Specificity," and the color change behavior, appears to be based on controlled experimental conditions with known concentrations of peracetic acid (PAA) at or above the threshold of >1820 ppm.
- For example, if an indicator was exposed to >1820 ppm PAA, the ground truth for that specific indicator would be "PASS" (should change to pink). If exposed to
§ 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).