(28 days)
Use the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following hydrogen peroxide sterilization sterilizers and cycles: STERRAD® 100S System, STERRAD® NX® System (Standard and Advanced cycles), STERRAD® NX® System with AllClear™ Technology (Standard and Advanced cycles), STERRAD® 100NX® System (Standard, Flex, Express and Duo cycles) STERRAD® 100NX® System with AllClear™ Technology (Standard, Flex, Express and Duo cycles) vaporized hydrogen peroxide sterilizers and STERIS® V-PRO® 1 (Lumen cycle), STERIS ® V-PRO® 1 Plus (Lumen and Non-Lumen cycles) and STERIS ® V-PRO® maX Low Temperature Sterilization System (Lumen, Non-Lumen and Flexible cycles), STERIS® V-PRO® 60 Temperature Sterilization System (Lumen, Non-Lumen and Flexible cycles), STERIS® V-PRO® maX 2 Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles), and the STERIS® V-PRO® s2 Low Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast cycles).
The 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is a chemical indicator consisting of a non-cellulose based coated indicator strip sensitive to vaporized hydrogen peroxide, contained in a film laminate.
The 3M™ Attest™ CI 1348/1348E verifies that the stated values for the three critical parameters of exposure time, temperature, and amount of vaporized hydrogen peroxide have been achieved within a package or containment device (i.e. wrapped trays, rigid containers, sterilization pouches, and other types of packs) and/or at a specific location within the load or empty chamber.
Upon exposure to vaporized hydrogen peroxide, the color of the coated indicator strip progressively changes from blue toward pink along the strip. The progression of the blue to pink color change along the strip is visible through a window with marked "REJECT" and "ACCEPT" zones. The extent of the progression depends on exposure time, temperature, and amount of vaporized hydrogen peroxide.
Here's an analysis of the acceptance criteria and study proving device performance based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Health Care Facility Simulated Use Testing on STERIS V-PRO s2 sterilizer | Assess color change of indicator after exposure to representative complete and incomplete cycles for the STERIS V-PRO s2 sterilizer | Complete Cycles (PASS): The 3M Tri-Metric CI turns from blue toward pink in the ACCEPT region of the indicator window to indicate a "PASS" (reaches endpoint) when exposed to a complete Lumen, Non-Lumen, Flexible, or Fast Cycle in the STERIS V-PRO s2 Low Temperature Sterilization System. | |
| Incomplete Cycles (FAIL): The 3M Tri-Metric CI turns from blue toward pink only within the REJECT region of the indicator window to indicate a "FAIL" (does not reach endpoint) when exposed to an incomplete Lumen, Non-Lumen, Flexible, or Fast Cycle in the STERIS V-PRO s2 Low Temperature Sterilization System. | All Tri-Metric CIs tested met acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided text does not explicitly state the sample size used for the simulated use testing. It mentions "All Tri-Metric CIs tested," but the specific number is not given.
The data provenance is prospective as it describes testing conducted for the purpose of demonstrating performance of the device in new sterilizer cycles (specifically the STERIS V-PRO s2). The country of origin of the data is not specified, but the applicant (3M Company) is based in St. Paul, Minnesota, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The document does not specify the number of experts or their qualifications used to establish the ground truth for the test set. However, for a chemical indicator (CI), the "ground truth" is typically the objective color change against a predefined standard (e.g., a "REJECT" or "ACCEPT" zone on the indicator itself), rather than subjective expert interpretation. The acceptance criteria clearly define what constitutes a "PASS" or "FAIL" based on the visible color change within specific regions of the indicator.
4. Adjudication Method for the Test Set:
The document does not describe an adjudication method in the traditional sense (e.g., 2+1, 3+1). For this type of device (chemical indicator), the assessment of "PASS" or "FAIL" is based on the objective color change relative to the marked "REJECT" and "ACCEPT" zones on the indicator, as defined in the acceptance criteria. It is implied that the assessment is a direct comparison to these internal standards.
5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human interpretation needs to be evaluated. The 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator is an objective chemical indicator, not a device requiring human interpretation for its primary function. The evaluation focuses on the chemical reaction and color change.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
This is effectively a standalone study in the context of a chemical indicator. The "device performance" refers to the intrinsic chemical reaction and color change of the indicator itself when exposed to the sterilization conditions. There is no "human-in-the-loop performance" being evaluated in terms of a diagnostic interpretation, and no AI algorithm is involved. The indicator functions mechanically/chemically to provide a visual result.
7. The Type of Ground Truth Used:
The ground truth used is based on defined physical/chemical properties and objective observation of color change against established reference points (the "REJECT" and "ACCEPT" regions on the indicator). This is directly tied to the efficacy of the sterilization cycle itself as the true determinant of whether the conditions were met. The indicator is designed to reflect this physical reality.
8. The Sample Size for the Training Set:
The provided document does not mention a training set as this device is a chemical indicator and does not employ machine learning or AI algorithms that would require a training set. The performance is based on the chemical formulation and design of the indicator.
9. How the Ground Truth for the Training Set Was Established:
As there is no training set for this chemical indicator device, this question is not applicable.
§ 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).