(264 days)
A chemical indicator for monitoring all cycles within the STERRAD® 100S (Standard & Long), 200, 100NX (Standard, Flex & Express), NX (Standard & Advanced), STERIS® V-PRO™ 1, V-PRO" 1 Plus (Lumen & Non-lumen), V-PRO® maX (Flexible, Lumen & Non-lumen) and Sterilucent™ PSD-85 (Lumen & Non-lumen). The VH2O2 Indicators are intended to be used by health care providers with sterilization wraps, containers, cassettes, or pouches to distinguish between processed and unprocessed units. Colors other than blue such as yellow/green should be treated as a process failure.
The SPSmedical VH2O2 Indicators are single use process indicators which are cleared for use in verifying exposure to all vaporized hydrogen peroxide cycles in the STERRAD® 100S, 200, 100NX, NX, STERIS® V-Pro 1, V-Pro 1 Plus, and V-Pro maX Testing has been performed which validated the SPSmedical VH2O2 Indicators for use in the Sterilucent PSD-85 Sterilizer.
Indicators will identify if an item has seen H2O2 during the Sterilucent PSD-85 sterilization processes by changing to a Blue signal color. They provide a visual indication to help distinguish between processed and unprocessed items.
Here's a breakdown of the acceptance criteria and study information for the SPSmedical VH2O2 Indicators, based on the provided document:
This document is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to an already legally marketed device (the predicate device). Therefore, the "acceptance criteria" and "device performance" are primarily framed in terms of equivalence to the predicate and compliance with relevant standards, rather than specific performance metrics against a clinical gold standard in an AI context. Similarly, the "study" described is a non-clinical verification and validation testing, not a typical clinical trial.
Acceptance Criteria and Reported Device Performance
The core acceptance criterion for this 510(k) submission is that the proposed device (SPSmedical VH2O2 Indicators) is substantially equivalent to its predicate device (SPSmedical VH2O2 Indicators cleared under K110152), particularly for the added indication for use with the Sterilucent PSD-85 sterilizer.
The device's performance is demonstrated through its ability to meet the requirements of relevant standards and its consistent function in specified sterilization processes, mirroring the predicate device.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Intended Use: Process Indicator for Vaporized Hydrogen Peroxide (VH2O2) sterilization. | Equivalent: Proposed device has the same intended use. |
| Indications for Use: Monitor all specified VH2O2 cycles, distinguishing processed from unprocessed items by color change (initial color to signal color blue). Specifically, demonstrate capability with Sterilucent™ PSD-85 (Lumen & Non-lumen) cycles. | "Equivalent" (with expansion): The proposed device includes expanded listed cycles for STERRAD and STERIS V-PRO devices (which were always cleared for, but not explicitly stated in the predicate's IFU) and adds the Sterilucent PSD-85 (Lumen & Non-lumen) cycles. Testing showed the device performs for the PSD-85 cycles, turning blue for complete cycles. Colors other than blue (e.g., yellow/green) indicate process failure. |
| Device Design: Strip, Label, Tape, Card types. | Same: Identical design to the predicate. |
| Endpoint Color: Signal color of Blue upon exposure to VH2O2. | Same: Signal color of Blue. |
| Indicator Agent: H2O2 Indicator Ink. | Same: H2O2 Indicator Ink. |
| Sterilization Method: Vaporized Hydrogen Peroxide. | Same: Vaporized Hydrogen Peroxide. |
| Device Materials: Synthetic Substrates (e.g., Tyvek®, polypropylene, polystyrene) and non-toxic inks. | Same: Identical materials to the predicate. |
| Performance under ISO 11140-1 (Complete reaction cycle): Meet requirements for process indicators when run in VH2O2 sterilization processes. | Equivalent: Demonstrated equivalent performance to the predicate. "All lots of SPSmedical VH2O2 Indicators gave acceptable results for all tests performed." |
| Performance under ISO 11140-1 (Incomplete reaction cycle): Distinguish between complete and incomplete exposure. | Equivalent: Demonstrated equivalent performance to the predicate. Implicitly, the color change to blue signifies a complete exposure, while other colors (yellow/green) indicate a process failure or incomplete reaction. "All lots of SPSmedical VH2O2 Indicators gave acceptable results for all tests performed." |
| Biocompatibility: Non-toxic, safe for human contact, and will not alter the chemical composition of sterilized products. | Equivalent: No modifications made to the proposed device compared to K110152. Manufactured using nontoxic inks and substrates, safe for human contact, will not alter chemical composition. Disposal in general waste. |
| Non-clinical Performance - Sterilucent PSD-85 (Lumen & Non-Lumen cycles): Demonstrate appropriate color change for complete cycles and differentiate process failures. | "Complete Cycle Turns Blue with yellow/green intermediate (Same)": Testing specifically validated the SPSmedical VH2O2 Indicators for use in the Sterilucent PSD-85 Sterilizer, showing a blue signal color for processed items and yellow/green for process failure. |
| Shelf-life: Maintain performance over its stated shelf-life. | Up to 2 years: Multiple lots of indicators with various levels of shelf life were included in testing, giving acceptable results. (Note: The predicate shelf life is not explicitly stated in the table, but the implication is equivalence). |
Study Details
Given this is a 510(k) for a chemical indicator (a relatively low-risk device), the "study" is primarily non-clinical verification and validation testing, not a clinical trial involving human patients or complex data interpretation.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: "Multiple lots of indicators with various levels of shelf life were included in testing." No specific number is provided, but it implies a sufficient number of indicators for robust testing across different manufacturing batches and ages.
- Data Provenance: The testing was "performed as a result of a Failure Mode and Effects Analysis (FMEA)" and included "simulated use in the Sterilization processes." This indicates laboratory-based, controlled testing simulating real-world conditions, likely in the US (where the submitter is based and FDA is located). It is retrospective in the sense that the testing was performed on manufactured devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- No external human experts were explicitly mentioned for interpreting the results of the chemical indicator itself. The ground truth for a chemical indicator is its visual color change according to a known chemical reaction. The "ground truth" for the test set is established by running controlled sterilization cycles (complete vs. incomplete/failure conditions) and observing if the indicator changes color as expected. This involves standard laboratory practices and instrument calibration.
- The "experts" would be the scientists or engineers performing the testing and confirming compliance with ISO standards and expected color changes. Qualifications are not specified but would include expertise in sterilization processes and chemical indicator testing.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable in the conventional sense for image interpretation or diagnosis. The endpoint is a distinct, observable color change (initial color to blue, or other colors for failure). This is a direct chemical reaction, not a subjective interpretation requiring adjudication.
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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:
- No. This is a physical chemical indicator, not an AI-powered diagnostic device. Therefore, no MRMC study, human reader improvement with AI, or effect size is relevant or reported.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in concept. The "device" in this context is the physical chemical indicator, which performs its function autonomously by reacting to chemical exposure (without human interaction to "run" the function). Its "performance" is its inherent color change. Humans then interpret this change. The testing validates this standalone performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the chemical indicators, the ground truth for testing performance is derived from:
- Controlled Sterilization Conditions: Exposure to known complete and incomplete vaporized hydrogen peroxide sterilization cycles, as defined by the sterilizer's parameters and industry standards (e.g., partial cycles simulating failure).
- Standard Reference: Compliance with requirements of ANSI/AAMI/ISO 11140-1 for Process Indicators. The expected color change (e.g., initial pink/yellow to blue) is the predefined correct response.
- For the chemical indicators, the ground truth for testing performance is derived from:
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. (See answer to #7).
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).