(113 days)
The 3M™ Comply™ 1248 Gas Plasma Chemical Indicator is indicated for use as an internal pack process indicator to indicate exposure to vapor hydrogen peroxide in the STERRAD® 100, STERRAD® 100S, and STERRAD® 50 Sterilization processes.
The 3M™ Comply™ 1248 Gas Plasma Chemical Indicator is indicated for use as an internal pack process indicator to verify exposure to vapor hydrogen peroxide in the STERRAD® 100, STERRAD® 100S, and STERRAD® 50 Sterilization processes. The chemical indicator bar turns from blue to pink after exposure to vapor hydrogen peroxide in these sterilization processes.
The 3M Comply 1248 Gas Plasma Chemical Indicator is a sterilization process indicator and is comprised of a blue chemical indicator ink bar printed on a white plastic strip. A comparison color match is also printed on the plastic strip, below the blue indicator ink bar. The chemical indicator changes color from blue to pink upon exposure to vapor hydrogen peroxide in the STERRAD®100, STERRAD®100S and the STERRAD®50 Sterilization processes.
The provided text describes the acceptance criteria and study results for the 3M™ Comply™ 1248 Gas Plasma Chemical Indicator.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What the device should do) | Reported Device Performance (What the device did) |
|---|---|
| Cycle Conditions Required for Color Change (STERRAD 100): Indicator accurately changes color from blue to pink when exposed to the STERRAD 100 sterilization cycle within a specified minimum time. | Cycle Conditions Required for Color Change (STERRAD 100): All indicators turned from blue to pink and indicated a "pass" within 10 to 15 minutes of exposure to the STERRAD 100 cycle. |
| Cycle Conditions Required for Color Change (STERRAD 100S): Indicator accurately changes color from blue to pink when exposed to the STERRAD 100S sterilization cycle within a specified minimum time. | Cycle Conditions Required for Color Change (STERRAD 100S): All indicators turned from blue to pink and indicated a "pass" within 4 to 8 minutes of exposure to the STERRAD 100S cycle. |
| Cycle Conditions Required for Color Change (STERRAD 50): Indicator accurately changes color from blue to pink when exposed to the STERRAD 50 sterilization cycle within a specified minimum time. | Cycle Conditions Required for Color Change (STERRAD 50): All indicators turned from blue to pink and indicated a "pass" within 0.25 to 2.0 minutes of exposure to the STERRAD 50 cycle. |
| Two-Year Stability Study: Indicators maintain the ability to change color correctly after storage for two years (interim results for one month also monitored). | Two-Year Stability Study: One-month interim results verified all indicators turned from blue to pink when exposed to complete STERRAD 100S cycles and cancelled cycles (12-minute diffusion), confirming continued stability. (Two-year testing ongoing at the time of report). |
| Open-Pouch Stability Testing: Indicators maintain the ability to change color correctly after the package is opened (interim results for one month also monitored). | Open-Pouch Stability Testing: One-month interim results verified all indicators turned from blue to pink when exposed to complete STERRAD 100S cycles and cancelled cycles (12-minute diffusion), confirming continued stability after opening. (Eight-week testing ongoing at the time of report). |
| Light Stability Testing: Processed and unprocessed indicators retain their color after exposure to fluorescent light for a specified period. | Light Stability Testing: Processed and unprocessed indicators retained their color after four (4) weeks of exposure to fluorescent light. |
| Performance After Exposure to Light: Indicators perform correctly (change color) after exposure to fluorescent light. | Performance After Exposure to Light: All indicators continued to meet the color match criteria when exposed to complete STERRAD 100S cycles and 12-minute cancelled cycles, confirming stability after four (4) weeks of fluorescent light exposure. |
| Effect of the Absence of Hydrogen Peroxide on the Color Change: Indicators should not change color in the absence of hydrogen peroxide. | Effect of the Absence of Hydrogen Peroxide on the Color Change: Indicators did not exhibit any color change following exposure to a cycle containing deionized water instead of hydrogen peroxide. |
| Effects of Steam and Ethylene Oxide Sterilization: Indicators should not indicate "pass" for steam or ethylene oxide, and their physical integrity should be understood. | Effects of Steam and Ethylene Oxide Sterilization: Indicators were unaffected by ethylene oxide (no color change). Indicators were grossly deformed but retained blue color in steam sterilization. (Instructions For Use to include precaution against using for steam/EO). |
| Effects of Acid and Base: Indicators' color change mechanism should not be unduly affected by acidic or basic environments, or specific precautions should be noted. | Effects of Acid and Base: Indicators were not sensitive to an acidic environment. Processed indicators were not sensitive to a basic environment. Unprocessed indicators were sensitive to a basic (alkaline) environment. (Instructions For Use to include precaution to store away from alkaline chemicals). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size for the test set (number of indicators tested in each condition). Instead, it uses phrases like "all indicators" or "the Comply™ 1248 Gas Plasma Chemical Indicators" without quantifying.
The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, the tests were conducted by the manufacturer, 3M Company, based in St. Paul, MN, USA. The testing appears to be prospective, specifically designed to demonstrate the device's performance against defined criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of chemical indicator relies on a direct physical color change, which is then compared to a "comparison color match" printed on the indicator itself. The "ground truth" for the color change is the pre-defined comparison color. Therefore, there is no mention of human experts (like radiologists) being used to establish the ground truth for the color change interpretation in the provided text. The color change is an objective, visual comparison against a standard.
4. Adjudication Method for the Test Set
Not applicable. The "adjudication method" typically refers to how discrepancies in human interpretation of results are resolved. Since the device's performance is based on an objective color change compared to a printed standard, and no human interpretation requiring adjudication is mentioned, this section is not relevant.
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 is a chemical indicator, not an AI-assisted diagnostic device that would involve human readers or MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
The device itself is a "standalone" chemical indicator. Its performance is evaluated based on its physical properties (color change) in response to stimuli, without any "human-in-the-loop" interpretation beyond observing the color and comparing it to the reference. There is no algorithm involved.
7. The Type of Ground Truth Used
The ground truth used is an objective, pre-defined color standard (the "comparison color match" printed on the plastic strip) for evaluating the chemical indicator's color change. Additionally, the ground truth for "pass" or "fail" is tied to exposure to specific sterilization cycles (STERRAD 100, 100S, 50) and also includes conditions where a color change should not occur (absence of H2O2, steam, EO, acid/base sensitivity tests).
8. The Sample Size for the Training Set
Not applicable. This is a chemical indicator, not a machine learning device that requires a "training set."
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).