(75 days)
STERRAD® SealSure™ Chemical Indicator Tape is a process indicator intended for use by health care providers to secure non-woven sterilization packs and wraps to be sterilized in the STERRAD® Sterilization System.
The color of the STERRAD® SealSure™ Chemical Indicator Tape changes from red to gold (or lighter) when exposed to hydrogen peroxide and is intended to differentiate between processed and unprocessed loads. Reference the color comparator bars on the package box label.
STERRAD® SealSure™ Chemical Indicator Tape (Class A per EN867-1 and Class 1 ISO 11140-1) is a through-put process indicator tape to be used with ASP's STERRAD® Sterilization System. STERRAD® SealSure™ Chemical Indicator Tape offers an additional way to verify processing in the sterilization cycle. It should be used in addition to, not in place of, the biological indicator. STERRAD® SealSure™ Chemical Indicator Tape does not signify sterilization; it only indicates that the indicator has been exposed to hydrogen peroxide.
There are six rolls of STERRAD® SealSure™ Chemical Indicator Tape per box. Each roll contains 55 meters (60 yards) of indicator tape.
The STERRAD® SealSure™ Chemical Indicator Tape is a process indicator designed to confirm exposure of medical devices to hydrogen peroxide within the STERRAD® Sterilization System. The device changes color from red to gold (or lighter) when exposed to hydrogen peroxide, differentiating between processed and unprocessed loads.
Here's an analysis of its acceptance criteria and the studies conducted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Functionality: Color change (red to yellow/gold) at half-cycle conditions. | All tape samples changed from red to yellow at half-cycle conditions in each STERRAD® Sterilization System. |
| Resistance to Chemicals: Adequate resistance to various chemicals. | Demonstrated adequate resistance to chemicals, with the exception of organic solvents with high polarity and strong acids. |
| Differentiation of Processed vs. Unprocessed Loads: Ability to distinguish. | Ability to distinguish between a processed load and a load where the cycle was canceled prior to hydrogen peroxide exposure. |
| Shipping Stability: Maintenance of stability in a simulated shipping environment. | Maintained stability in a simulated shipping environment. |
| Shelf-Life Color Stability (Unopened Package): Pre-processed color and functionality, Post-processed color. | Pre-processed samples maintained pre-processing color and functionality at both ambient and accelerated aging conditions for four months. Post-processed tape samples retained their post-processing color after aging in both ambient and accelerated aging conditions for two months. (Note: functionality stability for post-processed tapes not explicitly mentioned here, but indicated for pre-processed). |
| Shelf-Life Color and Functionality Stability (Opened Package): Pre-processed color and functionality, Post-processed color. | Pre-processed tape samples' color and functionality stability were maintained in both simulated hospital sterilizer room and central supply storage room ambient conditions for one month. Post-processing color was stable for one month. (Note: pre-processed studies will continue for a total of two months). |
| Impact on Sterilization Efficacy: No significant effect on the performance of the STERRAD® Sterilization System when using an extreme amount of tape. | The effect on sterilization efficacy of each STERRAD® System was insignificant, regardless of using an extreme amount of chemical indicator tape on each validation tray. Complete inactivation of challenge microorganisms was achieved in each system. |
| Adhesion Strength and Stability: Meeting minimum adhesion requirements and maintaining them over time. | Meets minimum adhesion strength requirements. Stability testing demonstrated maintenance of minimum adhesion strength over three months in accelerated and room temperature aging environments. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific numerical sample size for each test set (e.g., how many rolls of tape were tested for functionality, or how many trays were used for efficacy testing). It generally refers to "all tape samples," "each of the STERRAD® Sterilization Systems," and "an extreme amount of STERRAD® SealSure™ Chemical Indicator Tape on each validation tray."
The data provenance is not explicitly stated in terms of country of origin. Given the applicant is "Advanced Sterilization Products Division of Ethicon, Inc. 33 Technology Drive Irvine, CA 92618" in the United States, it is highly likely the studies were conducted in the US. The studies appear to be prospective as they describe controlled laboratory-style testing performed to validate the device prior to marketing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The document does not mention the use of human experts to establish ground truth for the chemical indicator's performance. The ground truth for chemical indicators like this is typically based on the physical and chemical properties of the indicator itself, its interaction with the sterilant, and established industry standards (such as EN867-1 and ISO 11140-1, which are referenced). The "ground truth" here is objective chemical reaction and physical performance, not subjective interpretation.
4. Adjudication Method for the Test Set
Not applicable. The device's performance (color change, adhesion, resistance) is based on objective measurements and established chemical/physical criteria, rather than human interpretation requiring adjudication.
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 relevant for interpretative devices where human readers assess cases (e.g., radiology images) and compare their performance with and without AI assistance. The STERRAD® SealSure™ Chemical Indicator Tape is an objective process indicator, not an interpretative device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The studies described are inherently "standalone" in the sense that the device's performance (color change, adhesion, etc.) is tested directly without human interpretation in the loop. The "algorithm" here is the chemical reaction of the indicator itself.
7. The Type of Ground Truth Used
The ground truth used for these studies is based on:
- Objective Chemical Reaction: The known and expected color change in response to hydrogen peroxide exposure.
- Physical Properties: Measurable characteristics like adhesion strength, stability over time, and resistance to chemical degradation.
- Microbiological Efficacy (for impact on sterilizer): The complete inactivation of challenge microorganisms, which is a definitive, objective measure of sterilization success.
- Industry Standards: Compliance with standards like Class A per EN867-1 and Class 1 ISO 11140-1 provides a framework for defining acceptable performance.
8. The Sample Size for the Training Set
Not applicable. This device is a passive chemical indicator, not an AI or machine learning algorithm that requires a "training set." Its function is based on a predetermined chemical formulation.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this 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).