(31 days)
Use the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 to secure packs and as an external pack process indicator to differentiate unprocessed items from items processed in the following sterilizers:
STERRAD 100® Sterilization System
STERRAD 100S® Sterilization System
STERRAD NX® Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® Sterilization System (Standard, Flex, Express and Duo cycles)
STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles)
V-PRO® 1 Low Temperature Sterilization System (Lumen cycle)
V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles)
V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles)
V-PRO® 60 Low Temperature Sterilization System (Lumen and Flexible cycles)
V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Flexible, and Fast Non Lumen cycles)
V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles)
The tape is suitable for use on non-woven disposable wraps and peel pouches. The chemical indicator stripes turn from blue toward pink after exposure to vaporized hydrogen peroxide.
The 3MTM ComplyTM Hydrogen Peroxide Indicator Tape 1228 consists of a noncellulosic plastic backing material with a pressure-sensitive adhesive on one side and chemical indicator stripes on the other side. The chemical indicator stripes turn from blue toward pink after exposure to vaporized hydrogen peroxide.
This document describes the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228, a chemical indicator for sterilization processes. The acceptance criteria and the study proving the device meets these criteria are detailed, primarily for its use with the V-PRO® s2 Low Temperature Sterilization System.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance:
Test | Purpose | Acceptance Criteria | Result |
---|---|---|---|
Color Change in Health Care Facility Cycle | To demonstrate the color change of the device when used in the V-PRO® s2 Low Temperature Sterilization System | Color change from blue toward pink | Pass |
Minimum Exposure Parameters | To determine the minimum time required for the color change of the device when used in the V-PRO® s2 Low Temperature Sterilization System | Determination of the minimum time for color to change from blue toward pink | Pass |
End Point Color Stability | To demonstrate the post-sterilization color stability of the device after use in the V-PRO® s2 Low Temperature Sterilization System | No significant color change after exposure to fluorescent light for a minimum of twelve (12) months. | Pass |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the specific sample sizes used for each test (Color Change, Minimum Exposure Parameters, End Point Color Stability) within the test set. It mentions "nonclinical testing was performed," but quantitative details on the number of tapes tested or the number of cycles run are not provided.
The data provenance is from non-clinical testing conducted specifically for this submission, focusing on the newly claimed sterilizer and cycles (V-PRO® s2 Low Temperature Sterilization System). The document does not specify the country of origin, but given it's an FDA submission for a US-based company (3M Company, St. Paul, Minnesota), the testing was likely conducted in the US. The testing appears to be prospective as it was done to demonstrate performance for new claims.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. For a chemical indicator like this, the "ground truth" is typically the physical-chemical reaction (color change) itself under specified conditions, rather than expert interpretation of complex clinical imagery. The "Pass" results suggest that the required color change was observed consistently.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
The document does not mention any adjudication method. For the type of device (chemical indicator with a clear visual color change), a formal adjudication process involving multiple human observers is typically not necessary if the color change is unambiguous and measurable by standardized methods. The "Pass" results imply a straightforward assessment against the defined visual criteria.
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:
Not applicable. This device is a chemical indicator, not an AI-assisted diagnostic tool. Therefore, an MRMC study or an assessment of human reader improvement with AI assistance is not relevant to its functionality.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a physical chemical indicator, not a software algorithm. Its performance is directly observed through a color change, which is a "human-in-the-loop" observation in that a human visually checks the tape. There is no automated algorithmic assessment.
7. The type of ground truth used:
The ground truth for this device is the physical-chemical reaction of the indicator within the specified sterilization environments. Specifically, it's the expected color change from blue toward pink upon exposure to vaporized hydrogen peroxide under effective sterilization conditions, and the stability of that color change over time.
8. The sample size for the training set:
Not applicable. This device is a pre-manufactured chemical indicator, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As explained above, 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).