(27 days)
The 3M™ Attest™ Steam Chemical Integrators are designed to all critical parameters over a specified range of steam sterilization cycles. The integrating intended to be placed in each pack, pouch, 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, 4, 10, 15, 25 minute |
| Gravity | 275°F/135°C | 3, 10 minutes |
| Dynamic Air Removal | 250°F/121°C | 30 minutes |
| Dynamic Air Removal | 270°F/132°C | 4, 10 minutes |
| Dynamic Air Removal | 273°F/134°C | 3, 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.
The provided text describes the acceptance criteria and the study that proves the 3M™ Attest™ Steam Chemical Integrators device meets these criteria.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Purpose | Acceptance Criteria | Reported Performance (Results) |
|---|---|---|---|
| Stated Value (SV) 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% set point of the SV 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. | SV at 121°C ≥ 16.5 minutes | |
| SV at 132°C ≥ 2.0 minutes | |||
| SV at 134°C ≥ 1.4 minutes | |||
| SV at 135°C ≥ 1.2 minutes | |||
| Integrator temperature coefficient: 10 - 27°C | |||
| Correlation coefficient ≥ 0.9 | ≥ 16.5 minutes | ||
| ≥ 2.0 minutes | |||
| ≥ 1.4 minutes | |||
| ≥ 1.2 minutes | |||
| 10 - 27°C | |||
| ≥ 0.9 (All PASS) | |||
| Health Care Facility Simulated Use Testing | Confirm integrators provide acceptable performance in cleared customer use sterilization cycles. | Device reaches “ACCEPT” endpoint reaction when exposed to 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). | 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 the Data Provenance
The document does not explicitly state the numerical sample size used for each test. It refers to "testing" and "samples" implying multiple units were tested per condition.
Data Provenance:
- Country of Origin: Not specified, but implied to be from the manufacturer (3M) based in the US (St. Paul, Minnesota).
- Retrospective or Prospective: Not explicitly stated, but the nature of the "Nonclinical Testing" and "Simulated Use Testing" suggests a prospective testing methodology where the device's performance is observed under controlled conditions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This device is a chemical indicator, and its performance is determined by a chemical reaction resulting in a visible color change, not by human interpretation or expert consensus in the way medical images are. The "ground truth" is defined by the physical and chemical parameters of the sterilization cycles (temperature, time, steam saturation) and the comparison to biological indicators.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the endpoint is a direct physical change ("ACCEPT" or "REJECT" window) based on the chemical reaction, not a subjective interpretation requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) comparative effectiveness study was done
No, an MRMC study was not done. This type of study is relevant for AI/radiology devices where human readers interpret medical images and the AI assists in that interpretation. This device is a chemical indicator for sterilization processes.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is typically asked for AI/software devices. For this chemical indicator, its "performance" is inherently "standalone" in that its chemical reaction and color change are intrinsic to the device and do not involve an "algorithm" or "human-in-the-loop" once exposed to the sterilization conditions. The results are observed/read by a human, but the indicator's performance itself is a direct chemical response.
7. The Type of Ground Truth Used
The ground truth for this device's performance is established by:
- Objective physical and chemical parameters: Specific temperatures and exposure times for steam sterilization cycles (e.g., 250°F/121°C for 30 minutes, 270°F/132°C for 3 minutes).
- Comparison to Biological Indicators (BI): The "Side-by-Side Testing with Biological Indicator" confirms that the chemical integrator's performance parallels that of a BI, which is the established standard for demonstrating sterility.
- Controlled resistometer testing: A resistometer provides precisely controlled and verifiable steam, time, and temperature conditions.
8. The Sample Size for the Training Set
Not applicable. This device is a passive chemical indicator, not an AI/machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a chemical indicator.
§ 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).