(128 days)
The tape is designed to secure packs wrapped with untreated woven (i.e., reusable 100% cotton and cotton/poly blends) and disposable non-woven, paper/plastic, and spunbond polyolefin/plastic wraps.
Use the EO indicator tape to demonstrate that packs have been exposed to one of the EO sterilization processes in the table below and to distinguish between processed and unprocessed packs.
| EO Gas Concentration | Exposure Time | Temperature | Relative Humidity % |
|---|---|---|---|
| 736 mg/L | 4.5 hours | 38°C | 40 - 80 % |
| 736 mg/L | 1 hour | 55°C | 40 - 80 % |
| 759 mg/L | 4.5 hours | 38°C | 40 - 80 % |
| 759 mg/L | 1 hour | 55°C | 40 - 80 % |
| 736 mg/L | 1 hour | 54°C | >35% |
| 736 mg/L | 4.5 hours | 38°C | >35% |
| 736 mg/L | 1 hour | 55°C | >35% |
| 736 mg/L | 3 hours | 37°C | >35% |
| 759 mg/L | 1 hour | 55°C | >35% |
| 759 mg/L | 3 hours | 37°C | >35% |
The 3M Comply™ 1224 Indicator Tape for Ethylene Oxide (EO) Sterilization is a green, pressure sensitive adhesive tape with yellow stripes that can be used to secure packages for EO sterilization. Post-sterilization the yellow stripes turn to red-maroon.
This document describes the 3M Comply™ 1224 Indicator Tape for Ethylene Oxide (EO) Sterilization, a chemical indicator designed to confirm exposure to EO sterilization processes.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Derived from ISO 11140-1 Class 1 EO process indicator requirements) | Reported Device Performance (3M Comply™ 1224 Indicator Tape) |
|---|---|
| Color Change in Resistometer Samples: Must demonstrate detectable color change post-exposure to ISO specified EO conditions. | Samples from 3 different lots were verified to meet the requirements for detectable color change post-exposure to ISO conditions in a resistometer. |
| Color Change in Health Care Facility Cycle Samples: Must demonstrate detectable color change post-exposure in a healthcare facility sterilizer cycle. | Samples from 3 different lots were verified to meet the requirements for detectable color change post-exposure in an FDA cleared 3M Steri-Vac 5XL sterilizer cycle. |
| End-point Color Stability: Must maintain stable color for a specified duration under typical storage conditions post-exposure. | Samples from 3 different lots were verified to be stable to storage under typical office lighting conditions up to 6 months post-exposure in an FDA cleared 3M Steri-Vac 5XL sterilizer cycle. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: "Samples from 3 different lots" were used for each of the effectiveness tests (Color Change in Resistometer, Color Change in Health Care Facility Cycle, End-point Color Stability). The exact number of individual tapes within each lot tested is not specified.
- Data Provenance: The document does not explicitly state the country of origin of the data, but the company (3M Health Care) is based in St. Paul, MN, USA, and the testing involved an "FDA cleared 3M Steri-Vac 5XL sterilizer cycle," suggesting the testing was conducted within the United States. The study is retrospective in the context of the device's development to demonstrate substantial equivalence to a pre-amendment device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not provided in the document. For a physical/chemical indicator like this, "ground truth" is typically established by physical/chemical measurement and observation of the color change against predefined specifications, rather than expert interpretation. The "detectable color change" implies objective observation, though the document doesn't specify if this was an automated or human-observed process, or if any specific experts were involved in judging the change.
4. Adjudication Method for the Test Set:
- This information is not applicable and not provided. The testing involves observing a physical color change against a standard, not a subjective interpretation that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical data was included in this premarket application submission." This type of study is for comparing human performance with and without AI assistance, which is not relevant for this physical/chemical indicator.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, a standalone performance evaluation was conducted. Although not an "algorithm" in the conventional AI sense, the device (the indicator tape) is designed to independently produce a visual output (color change) based on exposure to sterilization conditions. Its performance was tested inherently as a standalone product; there's no human "in the loop" required for the tape to change color. The "effectiveness" section details the tape's performance in controlled and real-world sterilization cycles.
7. The Type of Ground Truth Used:
- The ground truth is based on physical/chemical parameters and observable color change as defined by the ISO 11140-1:2005/R2010 consensus standard.
- For "Color Change in Resistometer Samples," the ground truth is whether the tape successfully changed color after exposure to the specific EO gas concentration, exposure time, temperature, and relative humidity defined by ISO standards.
- For "Color Change in Health Care Facility Cycle Samples," the ground truth is whether the tape changed color after being subjected to an actual, validated FDA-cleared sterilization cycle.
- For "End-point Color Stability," the ground truth is whether the color change remained stable for 6 months after exposure.
8. The Sample Size for the Training Set:
- This information is not applicable and not provided. This device is a physical/chemical indicator, not an AI/machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
- This information is 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).