(205 days)
The VERIFY Process Indicator for Reliance Endoscope Processing Systems is intended for routine monitoring of the Reliance Endoscope Processing System (EPS) and the Reliance Advance EPS employing Reliance DG Dry Germicide. The device is a peracetic acid dose indicator that changes color from orange to white (colorless) upon exposure to an effective dose of peracetic acid.
The VERIFY Process Indicator for Reliance Endoscope Processing Systems is a single-use chemical indicator strip with indicator ink printed on one end that monitors the peracetic acid (PAA) dose at the point of use in a Reliance EPS Endoscope Processing System or a Reliance Advance Endoscope Processing System employing Reliance DG Dry Germicide.
The process indicator shows an incomplete color change when exposed to peracetic acid at a dose of ≤ 9000 mg/L PAA min. in an Endoscope Processing Cycle. It shows a complete color change from orange to white (colorless) when exposed to peracetic acid at a dose of ≥ 11,500 mg/L PAA min. in an Endoscope Processing Cycle.
The chemical indicator performs equivalently in Reliance Endoscope Processing System (EPS) and in Reliance Advance Endoscope Processing System.
Acceptance Criteria and Study for VERIFY™ Process Indicator for Reliance TM Endoscope Processing Systems
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Unprocessed CI strip | Color matches the orange 'start' color block on the bottle label prior to use | PASS |
| Response to PAA dose ≥ 11,500 mg/L PAA min | Colorless (complete change, Pass) at end of the Reliance Advance Endoscope Processing Cycle | PASS |
| Response to PAA dose ≤ 9000 mg/L PAA min | NOT colorless (incomplete change, Fail) at end of the Reliance Advance Endoscope Processing Cycle using the minimum effective dose PAA, or with no PAA | PASS |
| Stability | After 12 months storage in each of three test environments, the product correctly indicated Pass and Fail in cycles of corresponding PAA dose. | PASS |
| Opened bottle use life | Opened PI containers stored in each of three test environments were re-opened repeatedly for 6 months and tested. The PI from the opened bottles correctly indicated Pass and Fail in cycles of corresponding PAA dose through 6 months. | PASS |
| Endpoint color stability | Reliance PIs processed through cycles of Pass and Fail PAA dose levels, evaluated after processing and read again 6 months later, each gave the same outcome. The end color is stable for 6 months. | PASS |
2. Sample Size and Data Provenance
The document does not explicitly state the specific "sample size" for the test set in terms of number of individual indicators or test runs. It describes repeated testing ("re-opened repeatedly for 6 months and tested," "each of three test environments"). The data provenance is not specified regarding country of origin, but the testing was conducted to support a submission to the US FDA, implying internal testing by STERIS Corporation. The study appears to be prospective, as it involves testing the device's performance under various conditions, including stability and use life.
3. Number of Experts used to establish Ground Truth and Qualifications
The document does not provide information on the number of experts used to establish a ground truth or their qualifications. The evaluation of the indicator's color change (Pass/Fail) is based on a predefined visual criterion ("Colorless1: Pass" and "Incomplete color change2: Fail"). This suggests that the ground truth is established by the intrinsic design of the indicator and its expected color response to specific Peracetic Acid (PAA) doses, rather than interpretation by human experts.
4. Adjudication Method
The document does not describe an adjudication method for the test set. The determination of "Pass" or "Fail" is based on the visual color change of the indicator in relation to specified PAA dose levels and a reference color block. This implies a direct, objective assessment against predetermined criteria rather than a consensus-based adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor any evaluation of human reader improvement with AI assistance. This device is a chemical indicator, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
This information is not applicable. The device is a chemical indicator, not an algorithm, so a "standalone algorithm only" performance study was not conducted.
7. Type of Ground Truth Used
The ground truth used is based on predetermined physical and chemical responses to specific concentrations of peracetic acid. The "Pass" and "Fail" states are defined by the visual color change of the indicator relative to known PAA dose levels (≥ 11,500 mg/L PAA min. for Pass and ≤ 9000 mg/L PAA min. for Fail) and a reference "start" color. This is an objective, mechanism-based ground truth.
8. Sample Size for the Training Set
The document does not mention a "training set." The device is a chemical indicator, not a machine learning model, and therefore does not undergo a training process in the conventional sense.
9. How the Ground Truth for the Training Set was Established
This question is not applicable, as there is no training set for this type of device.
§ 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).