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3M™ Comply™ Lead Free Steam Indicator Tape 1322 is designed for use by a health care provider to accompany individual units (e.g. wrapped packs) to demonstrate that the unit has been exposed to the sterilization process and to distinquish between processed and unprocessed units. Use the 3M™ Comply™ Lead Free Steam Indicator Tape 1322 in steam process below:

Lead Free Steam Indicator Tape 1322 to demonstrate that packs have Comply ! been exposed to the sterilization process. The 3M™ Comply™ Lead Free Steam Indicator Tape 1322 is designed to secure packs wrapped with untreated woven and disposable non-woven paper and paper/plastic wraps.

3M™ Attest™ Lead Free Steam Indicator Tape 1355 for disposable wraps is designed for use by a health care provider to accompany individual units (e.g., wrapped packs) to demonstrate that the unit has been exposed to the sterilization process and to distinguish between processed and unprocessed units. Use the 3M™ Attest™ Lead Free Steam Indicator Tape 1355 in steam process below:

3M™ ComplyTM Lead Free Steam Indicator Tape 1322: The 3M™ Comply™ Lead Free Indicator Tape 1322 for steam sterilization consists of an adhesive, backing, and chemical indicator stripes. The adhesive is an aggressive, pressuresensitive adhesive designed to adhere to a variety of wraps, including untreated woven (i.e., reusable 100% cotton and cotton/poly blends) and disposable non-woven, paper and paper/ plastic wraps in order to secure the pack during steam sterilization. After sterilization, the tape is designed to remove easily and cleanly from untreated woven wraps. The backing is a beige colored crepe paper and provides the stretch needed for pack expansion during sterilization. The chemical indicator lines will show a visual color change from off-white/tan to darker color when exposed to a steam sterilization process. 3M™ Comply™ Lead Free Steam Indicator Tape is a Type 1 (Category e1) Process Indicator as categorized by ISO 11140-1:2014. This Product Is Not Made With Natural Rubber Latex.

3MTM Attest™ Lead Free Steam Indicator Tape 1355: The 3MTM Attest™ Lead Free Steam Indicator Tape 1355 for disposable wraps consists of an adhesive, backing, and chemical indicator stripes. The adhesive is an aggressive, pressuresensitive adhesive designed to adhere to a variety of disposable non-woven, paper and paper/plastic wraps in order to secure the pack during steam sterilization. The backing is bluecolored crepe paper and provides the stretch needed for pack expansion during sterilization. The chemical indicator lines will show a visual color change from off-white/tan to darker color when exposed to a steam sterilization process. 3M™ Attest™ Lead Free Steam Indicator Tape for Disposable Wraps is a Type 1 (Category e1) Process Indicator as categorized by ISO 11140-1:2014. This Product Is Not Made With Natural Rubber Latex.

This document is a 510(k) premarket notification for the 3M™ Comply™ Lead Free Steam Indicator Tape 1322 and 3M™ Attest™ Lead Free Steam Indicator Tape 1355. It describes the acceptance criteria and the studies performed to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided information regarding acceptance criteria and study details:

Device: 3M™ Comply™ Lead Free Steam Indicator Tape 1322 and 3M™ Attest™ Lead Free Steam Indicator Tape 1355

Type of Device: Chemical Process Indicators (Type 1 (e1) Process Indicator as categorized by ISO 11140-1:2014)

Function: Designed to show a visual color change from off-white/tan to darker color when exposed to a specific steam sterilization process, distinguishing between processed and unprocessed units.

Acceptance Criteria and Reported Device Performance

The acceptance criteria and performance are outlined in "Table 6.1 Summary of Nonclinical Testing" on page 9.

1. Table of Acceptance Criteria and Reported Device Performance:

Study Details

Given the nature of the device (chemical indicators) and the provided document (510(k) summary), many of the typical AI/ML study components (e.g., sample size for test/training sets of images, number of experts for ground truth, MRMC studies, standalone AI performance) are not applicable. This document describes the validation of a physical chemical indicator, not a software algorithm for diagnostic imaging.

However, based on the information provided, here's what can be inferred/stated:

2. Sample Sized Used for the Test Set and the Data Provenance:

• Sample Size: Not explicitly stated in terms of number of indicator tapes tested. The tests are described by the conditions (temperature, time) and the expected color change.
• Data Provenance: The tests were conducted according to ISO 11140-1:2014 standards in a "saturated steam Resistometer" and through "Health Care Facility Simulated Use Testing." This suggests controlled laboratory environments and simulated real-world usage. The country of origin for the data is implicitly the location where 3M conducts its R&D and testing, which for this US FDA submission suggests tests that align with US regulatory expectations. The studies appear to be prospective in nature, as they involve testing the performance of the manufactured devices under specified conditions.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

• Not Applicable in the traditional sense for chemical indicators. The ground truth for chemical indicators is typically established by the physical and chemical principles governing their color change in response to specific sterilization parameters (temperature, time, presence of steam). The "expertise" involved would be in setting up and validating the test equipment (resistometer) to ensure it accurately delivers the specified sterilization conditions, and in visually assessing color changes against defined reference standards. This is generally performed by qualified laboratory personnel following standardized test methods (e.g., ISO standards).

4. Adjudication Method for the Test Set:

• Not Applicable in the traditional sense. Adjudication methods like "2+1" or "3+1" are characteristic of human reader studies involving subjective interpretations of complex data like medical images. For chemical indicators, the interpretation of the "endpoint" (color change) is objective and defined (e.g., "visible color change" or "no change or change that is markedly different from the visible color change"). The testing process would involve trained technicians observing and recording these objective changes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. MRMC studies are for evaluating the change in human reader performance (e.g., radiologists interpreting images) with or without AI assistance. This is not relevant for a chemical indicator.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:

• This question is not applicable as the device is a chemical indicator, not an algorithm. The "performance" is the physical color change of the tape itself under defined conditions, which is inherently a "standalone" characteristic of the device.

7. The Type of Ground Truth Used:

• The ground truth is based on defined physical and chemical reactions to specific sterilization conditions as outlined in the ISO 11140-1:2014 standard for Type 1 (e1) Process Indicators. It's an objective physical property rather than expert consensus, pathology, or outcomes data typically used for AI/diagnostic devices. The color change is a direct indication of exposure to the sterilization process.

8. The Sample Size for the Training Set:

• Not Applicable. Chemical indicators do not have "training sets" in the context of machine learning. The "development" of the indicator involves chemical formulation and manufacturing processes to achieve the desired reaction and color change.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable. There is no "training set" or "ground truth" established in this manner for a chemical indicator. The performance characteristics are inherent to the product's chemical composition and physical design, verified through controlled testing against established international standards.

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