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Raven ProTest - Steam is a self-contained Biological Indicator inoculated with Geobacillus stearothermophilus spores and is intended for monitoring the efficacy of steam sterilization cycles (10 minute 132°C gravity displacement and 3 minute 132°C flash gravity displacement cycles). Raven ProTest has a validated reduced incubation time of 24 hours.

The biological indicator consists of a self-contained unit that includes bacterial spores of Geobacillus stearothermophilus ATCC #7953 inoculated onto a paper filter carrier and a small glass ampoule containing modified Tryptic Soy Broth with Bromocresol Purple acting as a pH indicator encased in a plastic vial that serves as the culture tube. ProTest - Steam is intended for use in 10 minute 132°C gravity displacement and 3 minute 132°C flash gravity displacement cycles.

This document describes a 510(k) submission (K082756) for the Raven ProTest - Steam Biological Indicator, which is intended for monitoring steam sterilization cycles. The submission seeks to expand the label claims to include 132°C gravity/flash gravity cycles. The key information is structured as follows:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Testing was performed on "three separate lots of product manufactured from three different primary spore crops." The exact number of individual biological indicators tested within these lots is not specified.
• Data Provenance: Not explicitly stated, but assumed to be from laboratory testing conducted by Raven Biological Laboratories. The data is retrospective in relation to the submission.

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

Not applicable. This device is a biological indicator, and its function is to change color in the presence or absence of viable spores after a sterilization cycle. The "ground truth" is determined by the biological activity of the Geobacillus stearothermophilus spores and the effectiveness of the sterilization process itself, not by human expert opinion interpreting an output.

4. Adjudication Method for the Test Set

Not applicable. The outcome of the biological indicator (color change, turbidity) is a direct biological and chemical reaction, not subject to human adjudication in the context of establishing ground truth for the device's performance. The "ground truth" for each test condition (e.g., sterilization or no sterilization) would be established by physical/chemical parameters of the sterilizer or deliberate under-processing. A "control unit" is used to confirm spore viability.

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

No. This is a biological indicator, not an imaging or diagnostic device requiring human interpretation of complex data. Therefore, an MRMC study is not relevant.

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

Yes. The described testing focuses solely on the performance of the biological indicator itself, independent of a human interpreter's direct involvement in its primary function. The indicator's performance (color change, spore recovery, resistance) is intrinsic to the device.

7. The Type of Ground Truth Used

The ground truth is based on:

• Biological Activity: The viability and growth of Geobacillus stearothermophilus spores, indicated by metabolic activity leading to a pH change.
• Chemical Change: The color change of the bromocresol purple indicator from purple to yellow, signifying acid production from spore metabolism.
• Physical Parameters of Sterilization: The conditions of the 132°C gravity displacement and 132°C flash gravity displacement steam sterilization cycles, which are designed to kill microorganisms. A successful cycle should result in no growth, while an unsuccessful one should (ideally) show growth.

8. The Sample Size for the Training Set

Not applicable in the typical sense of machine learning training sets. This device is a biological indicator, not an AI/ML algorithm that requires a training set. Its "training" is in its design and manufacturing process to consistently meet biological and chemical specifications.

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

Not applicable. (See point 8). The "ground truth" for manufacturing control and device specification adherence would be established through a robust Quality Management System and adherence to relevant standards (e.g., AAMI/ISO 11138-1:2006). For example, spore counts and D-values (decimal reduction time) are verified during the manufacturing of biological indicators.

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Raven ProTest - Steam is a self-contained Biological Indicator inoculated with viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of steam sterilization cycles (121°C gravity displacement and 121°C - 135°C prevacuum cycles). Raven ProTest - Steam has a validated reduced incubation time of 24 hours.

The biological indicator consists of a self-contained unit that includes bacterial spores of Geobacillus stearothermophilus ATCC #7953 inoculated onto a paper filter carrier and a small glass ampoule containing modified Tryptic Soy Broth with Bromocresol Purple acting as a pH indicator encased in a plastic vial that serves as the culture tube.

This document describes the Raven ProTest - Steam Biological Indicator, a self-contained biological indicator designed to monitor the efficacy of steam sterilization cycles.

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Acceptance Criteria and Device Performance:

The document doesn't explicitly state "acceptance criteria" in a table format with specific numerical targets. However, the performance is described in the context of validating its labeled claims and characteristics during testing. The primary performance goal is to demonstrate effective monitoring of steam sterilization cycles.

Study Information:

1. Sample size used for the test set and data provenance:

   • Sample Size: "Three separate lots of product manufactured from three different primary spore crops" were tested. While the exact number of individual biological indicators within these lots isn't specified, it indicates an evaluation across different production batches.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The testing was "performed in accordance with AAMI ST59:1999," which is a US standard. The study seems to be internal validation by the manufacturer, Raven Biological Laboratories. The study is retrospective in the sense that it evaluates the manufactured product against established standards.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This type of biological indicator study does not typically involve human experts establishing ground truth in the way a diagnostic imaging study would. The ground truth for biological indicators is established by the known conditions of the steam sterilization cycle (e.g., fully successful sterilization vs. partial/failed sterilization conditions). The "ground truth" of whether spores survived or not is determined by their biological response (growth/no growth) and color change.

3. Adjudication method for the test set:

   • Not applicable as the "ground truth" is determined by the biological reaction of the spores themselves and their nutrient media, rather than expert interpretation of complex data. The "adjudication" is essentially the observation of a color change or turbidity.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This device is a biological indicator, not an AI-powered diagnostic tool. There are no "human readers" interpreting images or complex data in the sense of an MRMC study.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is not an algorithm-based device. Its performance is intrinsic to its biological and chemical components.

6. The type of ground truth used:

   • Biological Response: The ground truth is established by the biological viability of the Geobacillus stearothermophilus spores under different sterilization conditions. A successful sterilization cycle should render the spores non-viable, leading to no growth and no color change in the media. An unsuccessful cycle should leave viable spores, leading to growth (turbidity) and a color change (purple to yellow). This is a direct biological and chemical outcome.

7. The sample size for the training set:

   • Not applicable. This device does not use machine learning or AI, so there is no "training set."

8. How the ground truth for the training set was established:

   • Not applicable. There is no training set for this type of device.

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