(127 days)
The 3M™ Comply™ SteriGage™ 1243RA, 1243RB, 1243RE Chemical Integrators for Steam are designed for pack control monitoring of the following cycles.
| Cycle Type | Temperature | Exposure Time |
|---|---|---|
| Gravity | 250 °F/121 °C | ≥ 30 minutes |
| Gravity | 270 °F/132 °C | ≥ 3 minutes |
| Vacuum-assisted (prevacuum) | 270 °F/132 °C | ≥ 4 minutes (wrapped) |
| ≥ 3 minutes (unwrapped) | ||
| Vacuum-assisted (prevacuum) | 273 °F/134 °C | ≥ 4 minutes (wrapped) |
| ≥ 3.5 minutes (unwrapped) | ||
| Vacuum-assisted (prevacuum) | 275 °F/135 °C | ≥ 3 minutes |
The Minimum Stated Values for SteriGage as determined using a resistometer are shown below.
Minimum Stated Values for SteriGage
| 250° F
121° C | 270° F
132° C | 273° F
134° C | 275° F
135° C |
|------------------|------------------|------------------|------------------|
| 16.5
minutes | 2.0
minutes | 1.4
minutes | 1.1
minute |
3M Comply SteriGage 1243RA, 1243RB, and 1243RE Steam Chemical Integrators are single-use chemical indicators consisting of a paper wick and steam and temperature sensitive chemical pellet contained in a paper/film/foil laminate. The chemical pellet melts and migrates as a dark color along the paper wick. The migration is visible through a window marked ACCEPT or REJECT; the extent of migration depends on steam, time, and temperature.
The provided text describes the acceptance criteria and the study conducted for the 3M™ Comply™ SteriGage™ 1243RA, 1243RB, and 1243RE Chemical Integrators for Steam (K101249).
Here's the information extracted and organized as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Stated Values in Resistometer | See Minimum Stated Values (e.g., 250°F/121°C: 16.5 minutes; 270°F/132°C: 2.0 minutes; etc.) | Passed |
| Dry Heat | Shows 'Reject' at 137 – 138 °C, 30 min | Passed |
| Comparison to BI (Biological Indicator) | Shows 'Reject' at conditions where BI fails, Shows 'Accept' only at conditions where BI passes | Passed |
| Endpoint Stability | An 'Accept' result or a 'Reject' result does not change after storage for 6 months | Passed |
2. Sample Size and Data Provenance
The document does not explicitly state the specific sample sizes for the test sets (number of integrators tested for each condition). It mentions "testing on multiple lots" which implies a sufficient number of devices were evaluated, but no specific quantity is given.
The data provenance is not explicitly stated in terms of country of origin. The study appears to be retrospective in that it's testing a finished product against established standards, but it's not data collected from real-world usage over time. It's a laboratory-based performance evaluation.
3. Number of Experts and Qualifications for Ground Truth
This type of device (chemical integrator for sterilization) does not typically rely on human expert interpretation for ground truth. The "ground truth" is based on objective physical/chemical reactions and comparison to a "biological indicator" (BI) which is a well-established standard for sterility assurance. Therefore, there are no "experts" in the radiological or medical sense establishing ground truth; rather, the process is validated against scientific standards.
4. Adjudication Method
Not applicable. The evaluation of chemical integrators is objective (visible migration to 'ACCEPT' or 'REJECT' window) and doesn't involve subjective human judgment that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a standalone chemical indicator, not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.
6. Standalone (Algorithm Only) Performance Study
Yes, the studies described are standalone performance evaluations of the chemical integrator itself. There is no human-in-the-loop for the primary function of determining if sterilization conditions were met. The device's performance (showing Accept/Reject) is the standalone algorithm's output.
7. Type of Ground Truth Used
The ground truth used for this study is:
- Established scientific standards for sterilization conditions: Demonstrated by "Minimum Stated Values" determined using a resistometer, which provides precise control over temperature and time.
- Comparison to Biological Indicators (BI): Biological indicators contain resistant bacterial spores and are considered the gold standard for monitoring the effectiveness of sterilization processes. The chemical integrator's performance is compared directly to the BI's "fail" or "pass" conditions.
- Physical/chemical properties: The dry heat and endpoint stability tests rely on the inherent physical and chemical properties of the integrator to behave consistently under specified conditions.
8. Sample Size for the Training Set
Not applicable. This device is a chemical integrator, not a machine learning model that requires a "training set." Its design and performance are based on chemical engineering principles, not data-driven learning.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a chemical integrator 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).