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510(k) Data Aggregation
(179 days)
A chemical indicator for monitoring all cycles within the STERIS® V-PRO™ 60 (Flexible, Lumen & The VH2O2 Indicators are intended to be used by health care providers with Non-lumen). 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 External Indicators are single use process indicators, intended 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, V-PRO® maX and Sterilucent™ PSD-85 sterilizers. For purposes of this submission testing has been performed to validate the SPSmedical VH2O2 External Indicators for use in the Steris® V-PRO® 60 sterilizer.
Indicators will identify if an item has seen vaporized hydrogen peroxide during the Steris® V-PRO® 60 sterilization processes by changing from a pink to a blue signal color. They provide a visual indication to help distinguish between processed and unprocessed items.
Physical Properties: The SPSmedical VH2O2 External Indicators consist of two (2) devices, an indicator label and an indicator card. These devices have minor physical differences. The label has an adhesive backing while the card does not. They use the same manufacturing process and are printed on the same substrate.
Technical Characteristics: The chemical indicator ink utilized on the SPSmedical VH2O2 External Indicators has been formulated to meet the performance requirements ANSVAAMI/ISO 11140-1 for Process Indicators.
Functional Characteristics: The SPSmedical VH2O2 External Indicators are designed to monitor sterilization cycles in low temperature vaporized hydrogen peroxide sterilizers. They are a reliable tool used for the monitoring of vaporized hydrogen peroxide sterilization processes and provide a visual indication that hydrogen peroxide (H2O2), an essential ingredient in the vaporized hydrogen peroxide sterilization process has been introduced into the sterilizer's chamber. Indicators will identify if an item has seen H2O2 during the sterilization process. Indicators change from an initial color of pink to a final signal color of blue.
Here's an analysis of the provided text regarding the acceptance criteria and study for the SPSmedical VH2O2 External Indicators:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the SPSmedical VH2O2 External Indicators are primarily focused on their color change performance and adherence to standards.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use | Equivalent to predicate (Process Indicator) |
| Indications for Use | Chemical indicator for monitoring all cycles within the STERIS® V-PRO™ 60 (Flexible, Lumen & Non-lumen) to distinguish between processed and unprocessed units. Colors other than blue (e.g., yellow/green) indicate a process failure. |
| Endpoint Color | Signal Color of Blue (Equivalent to predicate) |
| Indicator Agent | H2O2 Indicator Ink (Equivalent to predicate) |
| Sterilization Method | Vaporized Hydrogen Peroxide (Equivalent to predicate) |
| Device Materials | Synthetic Substrate (Equivalent to predicate) |
| Performance - ISO 11140-1 (Complete Reaction Cycle) | Indicators turn to a complete reaction color of blue (Equivalent to predicate) |
| Performance - ISO 11140-1 (Incomplete Reaction Cycle) | Indicators do not turn blue and are markedly different than the color achieved under the complete reaction cycle testing (Equivalent to predicate) |
| Biocompatibility | Non-toxic (Equivalent to predicate), made with nontoxic inks and substrates, safe for human contact, and disposable in general waste. |
| Non-clinical Performance - Steris® V-PRO® 60 (Flexible, Lumen & Non-Lumen cycles) | Turns blue in a half cycle under worst-case conditions. Confirmed via simulated use testing using three lots of product at or beyond their real-time shelf-life, with end-of-shelf-life sterilant and a fully loaded chamber. All testing performed in triplicate in lumen and flexible cycles of the Steris® V-PRO® 60 sterilizer. |
| Shelf-life | Up to 2 years from the date of manufacture. Post-processing indicator stability verified to maintain color change results for a minimum of six months. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Three (3) lots of product were used for the simulated use testing. These lots were "at or beyond their real time shelf life expiration of twenty four (24) months."
- Data Provenance: The simulated use testing was performed "at Steris® by Steris® technicians." This implies the data originated from the manufacturer of the sterilizer (STERIS®), which is a U.S.-based company. The data is prospective, generated specifically for this submission to validate the device's performance with the new sterilizer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: The document states that the simulated use testing was performed "by Steris® technicians." It does not specify the number of individual technicians involved.
- Qualifications of Experts: The qualifications are broadly stated as "Steris® technicians." No specific details are provided regarding their professional certifications, years of experience, or specialization.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The "Steris® technicians" performed the testing and observed the color change. The acceptance was based on the indicators turning blue.
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 device is a chemical indicator, not an AI-powered diagnostic tool, so such a study would not be applicable. The performance is assessed by a direct pass/fail observation of color change.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to a non-AI device. The "standalone performance" is the indicator's ability to change color correctly when exposed to H2O2. This was directly assessed in the simulated use testing by observing the color change.
7. The Type of Ground Truth Used
The ground truth for the test set was the actual exposure to the specified vaporized hydrogen peroxide sterilization process within the Steris® V-PRO™ 60 sterilizer, under "half cycle with end of shelf life sterilant with a fully loaded chamber" and observation of the expected color change (pink to blue).
8. The Sample Size for the Training Set
This device does not involve an AI algorithm, so there is no "training set." The performance is based on the inherent chemical properties of the indicator and its physical design.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this chemical indicator.
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