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The SporView® VH2O2 BI is a self-contained biological indicator intended for use in the following STERRAD® sterilization system:
• STERRAD® 100NX® (Standard Cycle)

The SporView® VH2O2 Bl is a self-contained biological indicator (SCBI) designed to monitor hydrogen peroxide sterilization efficacy in healthcare facilities, specifically within a STERRAD® 100NX® Standard Cycle. Each unit consists of a glass fiber disc inoculated with a minimum of 10° spores of Geobacillus stearothermophilus ATCC® 7953 and a hermetically sealed glass ampoule of modified growth medium, both contained within a polypropylene vial with a polypropylene filter lined within the top of a polypropylene cap. A chemical process indicator on the vial label allows for differentiation between processed and unprocessed units. Following exposure to the sterilization cycle, the Bl is activated by squeezing the sides of the vial, causing the media ampoule to break and immerse the inoculated carrier in growth medium. The Bl is then incubated at 55 - 60°C for 24 hours. The growth medium, comprised of soybean casein digest broth modified with bromocresol purple (a pH indicator), remains purple and free of turbidity if the sterilization cycle was effective. Spore growth produces acidic waste (carbonic acid) which causes a shift down in pH (acidic) within the growth medium, transitioning the media from a purple to a yellow color and/or exhibiting turbidity which both indicate a failed sterilization cycle.

The provided document describes the SporView® VH2O2 BI, a self-contained biological indicator designed to monitor hydrogen peroxide sterilization. The document presents performance data to demonstrate the device's substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and the Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not explicitly state the specific sample sizes used for each individual test (e.g., spore population, D value, survival/kill response). However, it implies that sufficient samples were tested to demonstrate compliance with the defined acceptance criteria.

The data provenance is from nonclinical tests performed by the manufacturer, Crosstex/SPSmedical. The document does not specify the country of origin of the data or whether it was retrospective or prospective, but given it's a submission to the FDA for a new device, the testing would generally be prospective and conducted under controlled laboratory conditions.

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

This information is not provided in the document. For biological indicators, the "ground truth" is typically established by the inherent biological and chemical properties of the spores and growth media, as measured by established laboratory standards and protocols, rather than expert human interpretation of results in the same way medical imaging might require. The "experts" would be the scientists and technicians conducting the tests according to standardized methods.

4. Adjudication method for the test set

This information is not applicable in the conventional sense. The "adjudication" is based on the objective measurement of biological and chemical parameters (e.g., spore count, D-value, color change) against predefined specifications. There is no mention of human-expert adjudication of results as would be found in diagnostic studies.

5. 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

An MRMC comparative effectiveness study was not performed. This type of study is typically relevant for medical imaging or diagnostic devices where human readers (e.g., radiologists) interpret results, and the device might offer AI assistance. Biological indicators for sterilization assurance do not involve human "readers" interpreting complex results from the device itself in a clinical diagnostic setting.

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

This concept is not directly applicable to this device. The SporView® VH2O2 BI is a physical biological indicator that provides a visual output (color change or turbidity). Its performance is inherently "standalone" in that it functions without a human actively making a diagnostic interpretation based on complex data. The human interaction is limited to observing the physical change and interpreting its meaning based on the device's design (purple = sterile, yellow = not sterile). There is no "algorithm" in the sense of software processing data for a diagnostic outcome.

7. The type of ground truth used

The ground truth used is primarily objective laboratory data derived from standardized biological and chemical assays. This includes:

• Spore population counts: Direct measurement of the number of viable spores.
• Survival/Kill Response: Observation of spore viability after exposure to specific sterilization parameters for defined periods (absence or presence of growth).
• D-value determination: A measure of the resistance of the spores to the sterilizing agent, calculated from experimental data.
• Growth media color change: A direct chemical indicator of metabolic activity (spore growth).
• Stability and material suitability testing: Physical chemistry and material science tests.

This ground truth is established through rigorous, controlled laboratory experiments adhering to industry standards for biological indicator testing.

8. The sample size for the training set

This information is not applicable as the SporView® VH2O2 BI is not an AI/machine learning device that requires a training set. Its performance is based on its inherent biological and chemical properties, not learned patterns from data.

9. How the ground truth for the training set was established

This question is not applicable for the same reason as point 8.

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The SPSmedical H2O2 Chemical Indicators are indicated for use as process indicators for all vaporized hydrogen peroxide cycles in the STERRAD® 100S, 200, 100NX, NX and STERIS® V-Pro 1, V-Pro 1 Plus and V-Pro maX sterilizers. They are intended to be used by health care providers with articles such as sterilization wraps, containers, cassettes, or pouches to distinguish between processed and unprocessed items. Indicators change to a signal color of Blue after exposure to vapor hydrogen peroxide.

SPSmedical Vaporized Hydrogen Peroxide (HzOn) Chemical Indicators are process indicators which are cleared for use in verifying exposure to vapor hydrogen peroxide in the STERRAD® 100S, 200, 100NX, NX, STERIS® V-Pro lumen and non lumen sterilization processes. Testing has been performed which validates the SPSmedical Vaporized Hydrogen Peroxide (H2O2) Chemical Indicators for use in the STERIS® V-Pro flexible sterilization cycle and the STERIS® V-Pro maX sterilizer.

Indicators will identify if an item has seen H2O2 during the STERIS® V-Pro flexible sterilization process by changing to a Blue signal color. They provide a visual indication to help distinguish between processed and unprocessed items.

The provided text describes a 510(k) summary for the SPSmedical Vaporized Hydrogen Peroxide Chemical Indicators. The information focuses on the device's similarity to a predicate device and its intended use, rather than a detailed study with specific acceptance criteria and performance metrics typically seen in AI/software device submissions. Therefore, a direct response to some of the requested points is not possible given the nature of the document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format of a table as would be expected for a sophisticated AI/software device. Instead, it states that:

• "All lots of SPSmedical Vaporized Hydrogen Peroxide Chemical Indicators gave acceptable results for all test performed."

This implies that the indicators successfully changed color as expected when exposed to vaporized hydrogen peroxide and did not change color when not exposed, or when exposed to conditions that should not trigger a change. The acceptance is qualitative (color change) rather than quantitative (e.g., sensitivity, specificity, AUC).

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

The document states:

• "Multiple lots of indicators with various levels of shelf life were included in testing."

However, it does not specify an exact sample size for the test set or the number of indicators from each lot.
The data provenance is not explicitly mentioned as "country of origin," but the testing was performed to AAMI/ANSVISO 11140:2005 requirements and in simulated use in the STERIS® V-Pro maX sterilizer. It can be inferred that the testing occurred in a controlled lab environment associated with the device manufacturer, SPSmedical Supply Corp. in Rush, NY, U.S.A. The study is prospective in the sense that controlled experiments were conducted specifically for this submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Those Experts

This information is not applicable to this type of device. The "ground truth" for a chemical indicator is a visible color change, which is a direct physical reaction, not an interpretation requiring expert human judgment (like a radiologist reading an image).

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3. There is no ambiguous result that would require adjudication by multiple experts. The color change is a clear binary outcome.

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

This information is not applicable. This is a physical chemical indicator, not an AI or software device that assists human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this product.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not applicable. The device is a physical chemical indicator, not an algorithm. Its performance is inherently "standalone" in that it physically reacts to the presence of vaporized hydrogen peroxide; human observation is required to interpret the color change, but there is no "algorithm" or "computer" involved in its core function.

7. The Type of Ground Truth Used

The ground truth used is the direct physical exposure to vaporized hydrogen peroxide under controlled conditions and the expected visual color change of the indicator. For example, indicators exposed to a validated sterilization cycle should change color to "Blue," while unexposed indicators or those exposed to inadequate cycles should not.

8. The Sample Size for the Training Set

This information is not applicable. As a physical chemical indicator, there is no "training set" in the context of machine learning or AI. The indicators are manufactured to a specific chemical formulation, and their performance is verified through testing, not trained through data.

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

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

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SporView® Steam is a self-contained biological indicator inoculated with viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of saturated steam sterilization processes operating at 121℃ and 132℃ gravity displacement, 132℃ flash gravity displacement and 121°C - 134°C prevacuum cycles.

The SPSmedical SporView® 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 Tryptic Soy Broth with Bromnocresol Purple acting as a pH indicator encased in a plastic vial that serves as the culture tube.

Here's an analysis of the provided text regarding the acceptance criteria and study for the SporView® Steam Self-Contained Biological Indicator:

This document describes a 510(k) premarket notification for a Class II medical device, a biological indicator used in sterilization. It focuses on demonstrating substantial equivalence to a predicate device, rather than a novel claim requiring extensive clinical trials or complex AI performance metrics. Therefore, many of the typical acceptance criteria and study details for AI/software devices (like expert adjudication, MRMC studies, or training set details) are not applicable here.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "All test results met the defined acceptance criteria" generally, but does not provide specific numerical values for each criterion. The criteria listed above are inferred from the types of non-clinical testing performed to validate the device's label claims and performance characteristics.

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

The document does not explicitly state the numerical sample size for each specific test (e.g., number of indicators tested for resistance). It mentions "Multiple lots of indicators were tested."

• Sample Size: Not explicitly stated as a numerical value, but described as "Multiple lots of indicators."
• Data Provenance: The testing was "Non-Clinical Testing" performed by the manufacturer, SPSmedical Supply Corp., in the USA (Rush, NY). The document does not specify if the testing was retrospective or prospective, but given it's for a new product, it would inherently be prospective in nature.

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; its performance is measured against objective laboratory standards (e.g., spore count, resistance to sterilization, color change) rather than requiring expert interpretation like in image-based diagnostics.

4. Adjudication Method for the Test Set

Not applicable. The performance is determined by objective scientific measurements, not by human adjudication of ambiguous findings.

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

No. This type of study is not relevant for a biological indicator device. It is designed to demonstrate equivalence through non-clinical laboratory testing, not to compare human reader performance with or without AI assistance.

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

Yes, in essence. The documented testing (resistance, spore population, media recovery, etc.) is the standalone performance of the biological indicator itself, as it functions independently within the sterilization process. There is no "human-in-the-loop" component to its primary function or performance assessment.

7. The Type of Ground Truth Used

The ground truth for this device is based on established scientific principles and standards for biological indicators, including:

• Microbiological Standards: Known characteristics of Geobacillus stearothermophilus spores (e.g., population, D-value, Z-value).
• Sterilization Cycle Parameters: Objective measurements of temperature, pressure, and time in steam sterilization cycles.
• Chemical Indicators: The physical and chemical properties of the Tryptic Soy Broth with Bromnocresol Purple pH indicator, which changes color based on microbial growth.
• Regulatory Standards: Compliance with relevant FDA regulations (e.g., 21 CFR 880.2800) and consensus standards for biological indicators.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its function is based on biological and chemical reactions, not learned patterns from data.

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

Not applicable, as there is no training set for this type of device.

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