(59 days)
The 3M™ Comply™ 1228 Gas Plasma Indicator Tape is indicated for use to secure packs and as an external pack process indicator to differentiate processed from unprocessed items when exposed to vapor hydrogen peroxide in the STERRAD® 100, STERRAD® 100S, and STERRAD® 50 Sterillization processes.
The 3M Comply™ 1228 Gas Plasma Indicator Tape is a sterilization process indicator and is comprised of non-cellulosic plastic backing material with a pressure sensitive adhesive on one side and indicator stripes on the other side. A color match is printed in the Comply 1228 Technical Information Sheet. The chemical indicator stripes turn from blue to pink after exposure to vapor hydrogen peroxide in the STERRAD® 100, STERRAD® 100S and the STERRAD® 50 Sterilization processes.
Here's an analysis of the provided text regarding the 3M™ Comply™ 1228 Gas Plasma Indicator Tape, structured to address your specific questions.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test | Reported Device Performance and Acceptance |
|---|---|
| Color Change after Exposure to Sterrad Cycles (100) | Acceptance: Indicator tape turns from blue to pink. Performance: Testing verified that the 3M Comply™ 1228 Gas Plasma Indicator Tape samples turned from blue to pink when exposed to the STERRAD 100 Sterilization cycle. The minimum time required for all indicator tape samples to indicate a "pass" in relation to the color match was found. |
| Color Change after Exposure to Sterrad Cycles (100S) | Acceptance: Indicator tape turns from blue to pink. Performance: Testing verified that the 3M Comply™ 1228 Gas Plasma Indicator Tape samples turned from blue to pink when exposed to the STERRAD 100S Sterilization cycle. The minimum time required for all indicator tape samples to indicate a "pass" in relation to the color match was found. |
| Color Change after Exposure to Sterrad Cycles (50) | Acceptance: Indicator tape turns from blue to pink. Performance: Testing verified that the 3M Comply™ 1228 Gas Plasma Indicator Tape samples turned from blue to pink when exposed to the STERRAD 50 Sterilization cycle. The minimum time required for all indicator tape samples to indicate a "pass" in relation to the color match was found. |
| Eighteen-Month Color Change Stability | Acceptance: Indicator tape continues to turn from blue to pink when exposed to complete STERRAD 100S cycles over 18 months. Performance: Six-month interim results verified that all indicator tape turned from blue to pink when exposed to the complete STERRAD 100S Sterilization cycles, thereby confirming the continued stability of the 3M Comply™ 1228 Gas Plasma Chemical Indicator to date. (18-month testing ongoing) |
| Eighteen-Month Adhesive Stability | Acceptance: No significant degradation in peel force, and wrap security maintained over 18 months. Performance: Six-month interim results found no initial trends in the peel force over time for both unprocessed tape and processed tape when removed from Kimberly-Clark Spungard One-Step wrap. Six-month interim results verified wrap security. (18-month testing ongoing) |
| Light Stability (Unprocessed & Processed Colors) | Acceptance: No significant color change after 4 weeks of fluorescent light exposure. Performance: Testing verified that the colors of the processed and unprocessed 3M Comply™ 1228 Gas Plasma Indicator Tape samples did not change significantly after four (4) weeks of exposure to fluorescent light. |
| Performance After Exposure to Light (Post-Exposure) | Acceptance: Indicator tape continues to meet the color match after 4 weeks of fluorescent light exposure and then exposure to STERRAD 100S cycles. Performance: Testing verified that all indicator tape samples continued to meet the color match when exposed to both the complete STERRAD 100S Sterilization cycles, thereby confirming the stability of the 3M Comply™ 1228 Gas Plasma Indicator Tape samples following four (4) weeks of exposure to fluorescent light. |
| Effect of Absence of Hydrogen Peroxide | Acceptance: No color change when exposed to a cycle without hydrogen peroxide. Performance: Testing verified that the 3M Comply™ 1228 Gas Plasma Indicator Tape samples 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 | Acceptance: Unaffected by steam or ethylene oxide (with a precaution not to use for these cycles). Performance: Testing verified that the 3M Comply™ 1228 Gas Plasma Indicator Tape samples were found to be unaffected by the steam or ethylene oxide sterilization process. (A precaution is included in the Instructions For Use). |
| Effects of Acid and Base | Acceptance: Not sensitive to acid or base resulting in a "processed" color change (pink) when unprocessed. Performance: Testing verified that the 3M Comply™ 1228 Gas Plasma Indicator Tape samples were not sensitive to the presence of an acidic or basic (alkaline) environment, meaning they did not turn pink. The unprocessed color was found to be sensitive to acid/base, but this did not result in a "processed" color. (A precaution is included for storage). |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the numerical sample size used for the test set for each test. It refers to "samples" and "all indicator tape samples" without providing specific counts.
The data provenance is from the manufacturer, 3M Company, and appears to be prospective testing conducted specifically for this 510(k) submission. There is no information about the country of origin of the data beyond "3M Company 3M Medical Division... St. Paul, MN."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not mention the use of experts or their qualifications for establishing the ground truth of the test set. For a chemical indicator, the "ground truth" is typically the objective color change (blue to pink) as defined by the manufacturer's color match and the known exposure to the sterilant.
4. Adjudication Method for the Test Set
No explicit adjudication method (e.g., 2+1, 3+1) is mentioned or implied. The determination of "pass" (color change from blue to pink in relation to the color match) for the indicator tapes appears to be a direct, objective observation of the chemical reaction.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This type of study is not applicable to a chemical indicator device like this. MRMC studies are typically used for diagnostic devices where human interpretation of medical images or data is involved and the goal is to evaluate reader performance with and without AI assistance. The 3M Comply™ 1228 Gas Plasma Indicator Tape is a passive, objective chemical indicator.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a way. The "performance" of the device is its standalone chemical reaction. The tests describe the device's inherent behavior (color change, stability, etc.) under various conditions, independent of human interpretation or intervention beyond initial observation. There isn't an "algorithm" in the typical AI sense, but the device's function is purely automatic chemical response.
7. The Type of Ground Truth Used
The ground truth used is based on objective physical/chemical properties and observations:
- Color change: The visual transformation from blue to pink, referenced against a defined "color match" in the technical information sheet (though the sheet itself isn't provided here).
- Presence/absence of sterilant: Knowing whether the indicator was exposed to the STERRAD sterilization process (vapor hydrogen peroxide) or not.
- Physical stability: Measurement of properties like peel force for adhesive stability.
- Environmental conditions: Controlled exposure to light, acid, base, steam, ethylene oxide.
This is fundamentally a chemical/physical property ground truth.
8. The Sample Size for the Training Set
This device is a chemical indicator, not an AI/machine learning algorithm. Therefore, there is no training set in the typical sense. The "training" of such a device is its manufacturing process to ensure consistent chemical composition and reaction.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI algorithm, this question is not applicable. The performance of the chemical indicator is based on its inherent chemical formulation and manufacturing quality control, rather than learning from data.
§ 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).