(38 days)
The Celerity™ HP Chemical Indicator (CI) is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when placed within packs to be sterilized, through a visible change from red to orange/yellow, when the device has been exposed to the:
· Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or
· Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD® System, including those systems with ALLClear Technology.
A version of the Celerity™ HP Chemical Indicator (CI) may be utilized on the V24 Self-Contained Biological Indicator Vial Label and is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed SCBIs, whilst affixed to SCBI vials to be sterilized, through a visible change from red to orange/yellow, when the SCBI has been exposed to the:
· Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or
• Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD® System, including STERRAD NX and 100NX with ALLClear Technology.
The Celerity™ HP Chemical Indicator (CI) is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when placed within packs to be sterilized, through a visible change from red to orange/yellow, when the device has been exposed to the:
- . Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or
- Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP ● STERRAD® System, including those systems with ALLClear Technology.
A version of the Celerity™ HP Chemical Indicator may be utilized on the V24 Self-Contained Biological Indicator Vial Label and is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed SCBIs, whilst affixed to SCBI vials to be sterilized, through a visible change from red to orange/yellow, when the SCBI has been exposed to the:
- Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle . of a V-PRO® Low Temperature Sterilization System, or
- Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP ● STERRAD® System, including those systems with ALLClear Technology
The CI is composed of the following components:
- Substrate ●
- Indicator Ink
The PI is composed of the following components
- Substrate
- Indicator Ink
- Adhesive ●
- Backing Paper
This document describes the Celerity™ HP Chemical Indicator (CI), a Type 1 vaporized hydrogen peroxide sterilization process indicator. The device is designed to distinguish between processed and unprocessed units through a visible color change from red to orange/yellow when exposed to specific sterilization cycles of V-PRO® Low Temperature Sterilization Systems and ASP® STERRAD® Systems.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test Name | Description / Standard | Reported Device Performance |
|---|---|---|
| Type 1 Performance Testing | Conformance to ANSI/AAMI/ISO 11140-1:2014 requirements for a Type 1 Hydrogen Peroxide Chemical Indicator. | Pass |
| Simulated Use Testing | Simulation of typical in-use applications to verify performance. | Pass |
| Fluorescent Light Stability Testing | Assessment of indicator stability under fluorescent light exposure. | Pass |
| Temperature Extremes Exposure (Freeze/Thaw) Testing | Evaluation of indicator performance after exposure to extreme temperatures. | Pass |
| Transference Testing | Evaluation to ensure ink does not transfer from the indicator to other materials. | Pass |
| Adhesion Stability (Vials) Testing | Evaluation of the adhesive's stability for the version used on Self-Contained Biological Indicator Vial Labels. | Pass |
| Shelf Life Testing | Determination of the product's stability and performance over its intended shelf life. | Pass |
| Post-Processing Stability Testing | Evaluation of the indicator's stability and color integrity after being processed through sterilization cycles. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test or the data provenance (e.g., country of origin, retrospective/prospective). However, it implies that the testing was conducted by STERIS Corporation or its subsidiary Albert Browne Ltd., located in the United Kingdom. Given the nature of chemical indicator testing, it is likely that the testing involved multiple samples for each stress/condition investigated. The studies are non-clinical performance data, implying these were laboratory-based experiments.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to a chemical indicator device. The "ground truth" for chemical indicators is based on whether the indicator changes color in response to specific sterilization parameters (e.g., presence of hydrogen peroxide) and according to established international standards (ANSI/AAMI/ISO 11140-1:2014). This is a physical or chemical reaction, not a subjective interpretation requiring expert consensus.
4. Adjudication Method for the Test Set
Not applicable. The color change of a chemical indicator is a direct, observable outcome, not subject to human adjudication in the same way as, for example, image interpretation. The "adjudication" is essentially a pass/fail determination based on the observable color change as per the device's design and specified standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for devices that rely on human interpretation, such as imaging AI algorithms, to assess the impact of the device on reader performance. Chemical indicators do not involve human interpretation in this manner.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies described are standalone performance tests of the chemical indicator itself. The device is a "Type 1 process indicator," meaning it provides a visual confirmation of exposure to the sterilization process. Its function is entirely automated in terms of its chemical reaction to sterilization conditions; there is no "human-in-the-loop" performance aspect in the mechanism of the indicator itself. Its performance is assessed purely on its ability to change color accurately under specified conditions.
7. The Type of Ground Truth Used
The ground truth used for this chemical indicator's performance evaluation is based on controlled exposure to validated sterilization cycles and conformance to established international standards (ANSI/AAMI/ISO 11140-1:2014). The expected color change (red to orange/yellow) when exposed to these conditions, and the lack of change when not exposed, constitutes the ground truth.
8. The Sample Size for the Training Set
No training set is mentioned or applicable. Chemical indicators operate based on chemical reactions; they do not involve machine learning algorithms that require training data.
9. How the Ground Truth for the Training Set Was Established
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).