(65 days)
Use the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 to secure packs and as an external pack process indicator to differentiate unprocessed items from items processed in the following sterilizers:
STERRAD 100® Sterilization System
STERRAD 100S® Sterilization System
STERRAD NX® Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® Sterilization System (Standard, Flex, Express and Duo cycles)
STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles)
V-PRO® 1 Low Temperature Sterilization System (Lumen cycle)
V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles)
V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles)
V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles)
V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast Non Lumen cycles)
V-PRO® s2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast cycles)
STERIZONE® VP4 Sterilizer (Cycle 1)
The tape is suitable for use on non-woven disposable wraps and peel pouches. The chemical indicator stripes turn from blue toward pink after exposure to vaporized hydrogen peroxide.
The 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 consists of a noncellulosic plastic backing material with a pressure-sensitive adhesive on one side and chemical indicator stripes on the other side. The chemical indicator stripes turn from blue toward pink after exposure to vaporized hydrogen peroxide.
Here's a breakdown of the acceptance criteria and the study information regarding the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Color Change in Health Care Facility Cycle | To demonstrate the color change of the device when used in the STERIZONE® VP4 Sterilizer (Cycle 1) | Color change from blue toward pink | Pass |
| Minimum Exposure Parameters | To determine the minimum time required for the color change of the device when used in the STERIZONE® VP4 Sterilizer (Cycle 1) | Determination of the minimum time for color to change from blue toward pink | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific number of samples (e.g., indicator tapes) used for the non-clinical testing. It only mentions the purpose of the tests and the acceptance criteria. The data provenance is "non-clinical testing" conducted to demonstrate performance in the newly claimed sterilizer and cycles. It does not provide details on the country of origin or whether it was retrospective or prospective, although typically such performance testing for medical devices is prospective.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not provided. The study focuses on the chemical indicator's color change in response to sterilization, which is a physical/chemical property rather than an interpretation requiring human expert analysis of complex data.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the "Pass" result for color change, it's likely a direct observation rather than a multi-reader adjudication process.
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 used for diagnostic devices that involve human interpretation of images or other data, where AI might assist or replace human readers. The 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 is a chemical indicator that shows a direct color change, not a system involving a human reader interpreting AI output.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in a sense, a standalone performance was evaluated. The device itself (the chemical indicator tape) is designed to perform its function (color change) independently of human interpretation beyond observing the color. The tests conducted (Color Change in Health Care Facility Cycle and Minimum Exposure Parameters) directly assess the performance of the device without human intervention as a variable in the outcome.
7. The Type of Ground Truth Used
The ground truth for this device is the observable physical color change of the chemical indicator from blue towards pink, confirming exposure to vaporized hydrogen peroxide. This is an objective chemical reaction, not a subjective interpretation.
8. The Sample Size for the Training Set
The document refers to non-clinical testing for the newly claimed sterilizer and cycles. It does not describe a training set in the context of machine learning (AI). This device is a chemical indicator, not an AI or algorithm-based device that typically requires a training set.
9. How the Ground Truth for the Training Set Was Established
As explained above, this device does not utilize a training set in the AI sense. The performance is based on direct chemical reaction and observable color change, not on an algorithm trained on data.
§ 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).