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The Verify® 270FP Challenge Pack is a test pack consisting of three emulating indicator inks situated on a test sheet surrounded by a steam penetration barrier, intended for use in SFPP (steam-flush pressure-pulse) and pre-vacuum steam sterilization. The Verify® 270FP Challenge Pack indicators change color from yellow to blue/purple when exposed to the following conditions at 270°F (132°C):

• 4 minute indicator SFPP and pre-vacuum steam sterilization for 4 minutes. .
• 10 minute indicator Pre-vacuum steam sterilization for 10 minutes. .
• 20 minute indicator Pre-vacuum steam sterilization for 20 minutes. ●

The proposed Verify® 270FP Challenge Pack consists of three emulating indicator inks situated on a test sheet surrounded by a steam penetration barrier. The indicator inks on the proposed Verify® 270FP Challenge Pack test sheet change from yellow to blue/purple color when exposed to saturated steam at 270°F (132°C) for the following times.

• 4 minute indicator The 4 minute indicator ink on the Verify® 270FP . Challenge Pack can be used to monitor a 4 minute SFPP (steam-flush pressure-pulse) and pre-vacuum steam sterilization cycle.
• 10 minute indicator The 10 minute indicator ink on the Verify 270FP . Challenge Pack can be used to monitor a 10 minute pre-vacuum steam sterilization cycle.
• 20 minute indicator The 20 minute indicator ink on the Verify® 270FP . Challenge Pack can be used to monitor a 20 minute pre-vacuum steam sterilization cycle.

The process indicator outside of the packs undergoes a visual color change from pink to dark purple when exposed to steam in a temperature range of 250°F (121°C) to 275°F (135°C).

The STERIS Verify® 270FP Challenge Pack is a chemical indicator used to monitor steam sterilization cycles. The provided text from the 510(k) summary describes its acceptance criteria and the studies conducted to demonstrate its performance.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample size for the test set used for the performance testing of the emulating indicator inks or the barrier material. It mentions that "further testing was conducted to demonstrate the efficacy of the barrier material using a 16-towel test pack with biological indicators as a reference" and that "predicate test packs were included in this testing." This implies a comparative study but doesn't provide specific numbers for the Verify® 270FP Challenge Pack itself or the number of runs.

The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. However, given that this is a 510(k) summary for a medical device submitted to the FDA (United States), it is highly probable that the testing was conducted under controlled laboratory conditions, likely in the United States, and was prospective in nature, specifically designed to meet regulatory requirements.

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

The document does not provide details about experts used to establish the ground truth in terms of human interpretation of the indicators. The acceptance criteria are based on objective color changes under specific physical conditions (temperature and time). The primary ground truth for the device's performance is the physical parameters of the sterilization cycles themselves, as measured by a resistometer to ANSI/AAMI/ISO 18472. The color change of the indicator is then assessed against these known physical conditions.

4. Adjudication Method for the Test Set

Not applicable. The performance of the chemical indicator is based on a clear, objective color change. It is not dependent on human adjudication in the way medical imaging interpretation might be. The color change "from yellow to blue/purple" is a binary outcome (changed/not changed) based on exposure to specific conditions, with the resistometer providing the definitive truth of those conditions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or interpretive devices where human readers play a significant role in making decisions based on device output. For a chemical indicator, the output is a direct, objective color change, not subject to human interpretation variability in the same way.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the performance testing described is inherently a standalone assessment of the device (the chemical indicator). Its function is to change color in response to specific physical conditions, independent of human intervention once exposed to the sterilization cycle. The testing verifies this standalone performance against established standards.

7. The Type of Ground Truth Used

The ground truth used is primarily objective physical parameters and standards.

• For the indicator inks: The ground truth is the defined conditions of saturated steam exposure (270°F for 4, 10, or 20 minutes) as measured by a resistometer conforming to ANSI/AAMI/ISO 18472. The specified color change is expected under these conditions.
• For the barrier material: The ground truth is established by the performance of biological indicators within a 16-towel test pack, which are considered the gold standard for verifying sterilization efficacy.

8. The Sample Size for the Training Set

The document does not specify a "training set" sample size. This device is a passive chemical indicator, not an AI/ML algorithm that requires a training set. Its design and formulation are based on chemical principles to react to specific sterilization conditions.

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

Not applicable. As noted above, there is no "training set" for this type of device in the context of AI/ML. The device's performance is intrinsically linked to its chemical composition and physical design, which are developed and verified against known sterilization parameters and industry standards.

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