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The 3M™ Comply™ Lead Free Process Indicators for Steam are designed to demonstrate that the unit or load has been exposed to a steam sterilization process and to distinguish between processed and unprocessed units or loads.

3M Comply Lead Free Process Indicators for Steam include:

• Comply 68200 Lead Free Record Card .
• Comply 1322 Lead Free Indicator Tape .
• Lead Free Test Pack Labels to be used on test packs including the following -.
  • Comply 41380 Steam-Plus Test Pack o
  • Comply 41360 Steam Test Pack o
  • 3M Attest™ 1276 Steam Test Pack 0
  • 3M Attest™ 1296 Steam Test Pack O
  • 3M Attest™ 41382 Steam-Plus Test Pack O
  • Comply 1233LF, 00132LF, 00135LF Bowie Dick Test Packs

Use the 3M™ Comply™ Lead Free Process Indicators for Steam in steam sterilization processes described below.

The 3MTM ComplyTM Lead Free Process Indicators for Steam provides immediate identification of processed items. The chemical indicator ink does not contain lead as part of the reaction chemistry and can be printed onto suitable paper substrates. As an example, the ink is printed onto adhesive-coated crepe paper for autoclave tape, onto cardstock for record cards, and onto adhesive-coated labelstock for indicator labels on test packs.

The purpose of this submission is to:

• Replace the lead ink in the current 3M™ Comply™ Autoclave Tape with Lead . Free Ink. The current Comply Autoclave Tape was cleared under K932129
• Apply the Lead Free Ink to cardstock as a new 3M™ Comply™ Record Card .
• Replace the lead ink in the process indicators on the labels currently used to . secure all 3M™ Comply™ test packs. The use of the Lead Free Ink in process indicators on labels securing the Lead Free Bowie Dick test pack was cleared under K093199. This filing will extend its use to other test packs for steam.

Here's an analysis of the provided text regarding the acceptance criteria and study for the 3M™ Comply™ Lead Free Process Indicators for Steam:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it states that the testing "met the process indicator requirements of FDA's Premarket Notification [510(k)] Submissions for Chemical Indicators: Guidance for Industry and FDA Staff, December 19, 2003 and ANSI/AAMI/ISO 11140-1:2005 Sterilization of health care products - Chemical indicators, Part 1: General Requirements."

Therefore, the acceptance criteria are implicitly the standards set forth in these regulatory guidance documents and international standards.

The reported device performance is that the device "met the process indicator requirements" of these standards. The document also states that the device is "substantially equivalent to the predicate device 3M™ Comply™ Autoclave Tape, cleared under K932129 in terms of intended use, performance, physical properties and technological characteristics." This implies that the new device performs at least as well as the predicate device, which would have previously met similar standards.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not explicitly state the sample size used for the test set. It mentions "testing that was conducted," but no specific number of units tested is provided.
• Data Provenance: The data provenance is internal testing conducted by 3M Health Care for the purpose of seeking FDA clearance. It is inherently prospective as it was performed to evaluate the performance of the new lead-free indicators. The location of the testing is not specified, but it can be inferred to be within the US given the submission to the FDA.

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

This information is not provided in the document. For chemical indicators, the "ground truth" is typically established by the physical and chemical properties of the indicator's reaction to sterilizing agents under controlled conditions, as defined by the referenced standards (e.g., color change at specific temperature/time/steam exposure). It's unlikely that human experts in the traditional sense (like radiologists reading images) were used for establishing ground truth for individual indicator performance, but rather the performance was judged against objective photometric or visual color change criteria defined within the standards.

4. Adjudication Method for the Test Set

This information is not applicable/not provided as the ground truth determination for chemical indicators relies on objective physical/chemical reactions rather than human interpretation requiring adjudication.

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 imaging devices where human readers interpret patient cases. For a chemical indicator, the performance is assessed by its physical reaction to sterilization conditions, not by human interpretation of complex data that could be aided by AI.

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

Yes, a standalone performance assessment was done. The "device" in this context is the chemical indicator itself, which performs its function (color change) without human intervention during the sterilization process. The testing conducted to meet the FDA and ISO standards evaluated the indicator's performance independently.

7. The Type of Ground Truth Used

The ground truth used is based on objective physical and chemical reactions of the indicator to specific steam sterilization conditions, as defined and specified by the referenced regulatory guidance (FDA's 510(k) Guidance for Chemical Indicators) and the international standard (ANSI/AAMI/ISO 11140-1:2005). This involves precise control of temperature, time, and steam saturation, and then observing the indicator's color change against defined acceptable outcomes for "processed" and "unprocessed" states.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The device is a passive chemical indicator, not an AI or machine learning algorithm that requires a "training set" in the computational sense. Its design and material composition are developed through chemical engineering and materials science, not through a data-driven training process.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided for the same reason as in point 8.

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