(85 days)
The 3M™ Attest™ Steam Chemical Integrators are designed to respond to all critical parameters over a specified range of steam sterilization cycles. The integrating indicator is intended to be placed in each pack, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:
| Cycle Type | Temperature | Exposure Time |
|---|---|---|
| Gravity | 250°F/121°C | 30 minutes |
| Gravity | 270°F/132°C | 3 minutes |
| Gravity | 270°F/132°C | 4 minutes |
| Gravity | 270°F/132°C | 10 minutes |
| Gravity | 270°F/132°C | 15 minutes |
| Gravity | 270°F/132°C | 25 minutes |
| Gravity | 275°F/135°C | 3 minutes |
| Gravity | 275°F/135°C | 10 minutes |
| Dynamic Air Removal | 250°F/121°C | 30 minutes |
| Dynamic Air Removal | 270°F/132°C | 4 minutes |
| Dynamic Air Removal | 270°F/132°C | 5 minutes |
| Dynamic Air Removal | 270°F/132°C | 6 minutes |
| Dynamic Air Removal | 270°F/132°C | 7 minutes |
| Dynamic Air Removal | 270°F/132°C | 8 minutes |
| Dynamic Air Removal | 270°F/132°C | 9 minutes |
| Dynamic Air Removal | 270°F/132°C | 10 minutes |
| Dynamic Air Removal | 273°F/134°C | 3 minutes |
| Dynamic Air Removal | 273°F/134°C | 4 minutes |
| Dynamic Air Removal | 275°F/135°C | 3 minutes |
Minimum Stated Values for 3M™ Attest™ Steam Chemical Integrators as determined in a resistometer:
| 250°F/121°C
16.5 Minutes | 270°F/132°C
2.0 Minutes | 273°F/134°C
1.4 Minutes | 275°F/135°C
1.2 Minutes |
|-----------------------------|----------------------------|----------------------------|----------------------------|
3M™ Attest™ Steam Chemical Integrators are chemical indicators consisting of a paper wick and a 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 window marked REJECT; the extent of migration depends on steam, time, and temperature.
Here's a breakdown of the acceptance criteria and the study information for the 3M™ Attest™ Steam Chemical Integrators, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| SV at 250°F/121°C Testing | To identify the critical parameters required to achieve a stated inactivation, by referring to a stated test organism with stated D and z values. The integrator must turn to "ACCEPT" end point at the stated value time and must also remain "REJECT" when exposed to conditions of -1°C/-15% of the SV temperature time. All testing is completed in a saturated steam resistometer. Integrator temperature coefficient and correlation coefficient are calculated to confirm alignment to biological indicator performance. | > 16.5 minutes | Pass |
| SV at 270°F/132°C Testing | (Same purpose as above) | > 2.0 minutes | Pass |
| SV at 273°F/134°C Testing | (Same purpose as above) | > 1.4 minutes | Pass |
| SV at 275°F/135°C Testing | (Same purpose as above) | > 1.2 minutes | Pass |
| Integrator coefficient Correlation | (Part of the SV testing purpose) | > 0.9 | Pass |
| Health Care Facility Simulated Use Testing | Confirm integrators provide customer acceptable performance in cleared customer use sterilization cycles. | Device reaches "ACCEPT" endpoint when exposed to customer acceptable performance in customer use cycles. Device does not reach endpoint ("REJECT") when exposed to failing conditions in customer use cycles. | Pass |
| Dry Heat Testing | Verify device requires the presence of saturated steam to turn to reach endpoint. | Endpoint must not be met following dry heat exposure at 140°C for 30 min. | Pass |
| Side-by-Side Testing with Biological Indicator | Confirm integrators are parallel in performance to biological indicators (BI) and does not reach endpoint before BI is inactivated. | Chemical integrator parallels performance of BI and does not reach endpoint before BI is inactivated. | Pass |
| Endpoint Color Stability | Confirm endpoint color stability for samples exposed to passing and failing conditions in a steam resistometer. | Endpoint decision must remain unchanged after 6 months. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document states that the testing was performed on the 3M™ Attest™ Steam Chemical Integrators, which are identical to previously cleared devices (K193254) and were tested using "identified test methodology". However, the specific sample sizes used for each test criterion in the current submission's test set are not explicitly mentioned.
The data provenance is implied to be from 3M Company's internal testing, as it's a submission for their device. The nature of the tests (resistometer, simulated use, dry heat, side-by-side with BI, color stability) suggests controlled laboratory and simulated clinical environments. It is a nonclinical study, likely prospective for the specific tests performed to demonstrate equivalence or performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The tests seem to rely on objective measures (e.g., time to reach endpoint, color change, resistometer readings) rather than subjective expert assessment of an outcome. For 'Endpoint Color Stability', the "endpoint decision must remain unchanged" implies a clear, objective visual criterion rather than expert consensus on interpretation.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method (e.g., 2+1, 3+1, none). Given the tests are physical/chemical performance evaluations, it's likely they rely on objective measurements and established criteria, reducing the need for adjudication by multiple human observers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a MRMC comparative effectiveness study was not done. This type of study typically involves human readers interpreting diagnostic images or data with and without AI assistance to measure improvement in diagnostic accuracy or efficiency. The 3M™ Attest™ Steam Chemical Integrators are physical/chemical sterilization process indicators, not an AI-powered diagnostic device, so such a study would not be applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the studies reported are standalone performance evaluations of the device itself. The chemical integrators function independently to indicate sterilization parameters; there is no human "in-the-loop" once the integrator is placed in the sterilization cycle. The performance described (e.g., time to "ACCEPT" or "REJECT", endpoint not met in dry heat, correlation with BI) is inherent to the device's chemical and physical properties.
7. Type of Ground Truth Used
The ground truth for these tests is based on established physical and chemical principles and standards for sterilization.
- For SV (Stated Value) testing: It refers to a "stated test organism with stated D and z values," indicating a biological effectiveness standard. The ground truth for what constitutes a successful sterilization cycle (leading to an "ACCEPT" reading) is benchmarked against the known inactivation kinetics of biological indicators (BIs) and the physical parameters (time, temperature, steam) required for sterilization.
- For Health Care Facility Simulated Use Testing: The ground truth is "customer acceptable performance in cleared customer use sterilization cycles" and "failing conditions." This implies real-world or simulated real-world conditions where the outcome of sterilization (successful or failed) is known through other means (e.g., standard monitoring, biological indicators).
- For Dry Heat Testing: The ground truth is the absence of saturated steam, and the expected outcome for the device (not reaching endpoint).
- For Side-by-Side Testing with Biological Indicator: The ground truth is the performance of the biological indicator (BI), which is considered the gold standard for sterilization efficacy. The chemical integrator's performance is compared directly against the BI's inactivation.
- For Endpoint Color Stability: The ground truth is the initial "ACCEPT" or "REJECT" endpoint color, with the expectation that it should not change over time.
8. Sample Size for the Training Set
This question is not applicable as the 3M™ Attest™ Steam Chemical Integrators are not an AI or machine learning device that requires a training set. They are physical/chemical indicators.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as above.
§ 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).