(188 days)
The Verify® V-PRO Chemical Indicator (Version 1A) and the Verify® V-PRO Chemical Indicator Adhesive Label (Version 2A) are Class 1 vaporized hydrogen peroxide sterilization process indicators that conform to ANSI/AAMI/ISO 11140-1: 2005. They are designed to distinguish between processed and unprocessed units when placed within (Version 1A) or affixed to (Version 2A) sterilization wraps, trays or pouches to indicate, through a visible change from magenta to yellow, when the device (Version 1A) or pack (Version 2A) has been exposed to a V-PRO 1 Low Temperature sterilization process (Lumen Cycle) or V-PRO 1 Plus Low Temperature sterilization process (Lumen or Non-Lumen cycle). This product is designed for use exclusively in the Amsco V-PRO 1 Low Temperature Sterilization System and Amsco V-PRO 1 Plus Low Temperature Sterilization System at 50 °C using Vaprox™ HC Sterilant.
The Verify® V-PRO Chemical Indicator (Version 1A) and the Verify® V-PRO Chemical Indicator Adhesive Label (Version 2A) intended for use in vaporized hydrogen peroxide sterilization processes. The Verify® V-PRO Chemical Indicator (Version 1A) and the Verify® V-PRO Chemical Indicator Adhesive Label (Version 2A) change color from magenta to yellow when exposed to the appropriate cycle conditions of temperature, sterilant concentration and duration, as shown in the table below:
| Model | Temperature | Sterilant
Concentration | Cycle Type | Exposure
Time |
|----------------------|-------------|------------------------------|------------|------------------|
| Verify
Version 1A | 50 °C | 2.1 g H2O2 x 4
injections | Lumen | 32 minutes |
| Verify
Version 2A | 50 °C | 2.1 g H2O2 x 4
injections | Lumen | 32 minutes |
| Verify
Version 1A | 50 °C | 2.1 g H2O2 x 4
injections | Non-Lumen | 12 minutes |
| Verify
Version 2A | 50 °C | 2.1 g H2O2 x 4
injections | Non-Lumen | 12 minutes |
The Verify® V-PRO Chemical Indicator is provided as two formats:
- Version 1A: Verify® V-PRO Chemical Indicator .
- Version 2A: Verify® V-PRO Chemical Indicator Adhesive Label .
The Version 1A: Verify® V-PRO Chemical Indicator is a Class 1 process indicator in accordance with ANSI/AAMI/ISO 11140-1:2005 which consists of the chemical indicator applied to an inert polymeric substrate; the indicator spot is laminated with a transparent laminate.
The Version 2A: Verify® V-PRO Chemical Indicator Adhesive Label is a Class 1 process indicator in accordance with ANSI/AAMI/ISO 11140-1:2005 which consists of the chemical indicator applied to a spun bonded polyolefin substrate with an adhesive supplied on a backing paper.
Here's a summary of the acceptance criteria and the study details for the STERIS Verify® V-PRO Chemical Indicators, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Verify® V-PRO Chemical Indicator – Version 1A and Version 2A are based on their classification as Class 1 process indicators conforming to ANSI/AAMI/ISO 11140-1:2005. The primary performance metric is a visible color change from magenta to yellow when exposed to appropriate cycle conditions and no color change when not sufficiently exposed.
| Performance Metric / Acceptance Criteria | Reported Device Performance |
|---|---|
| Color Change after Exposure to Sterilization Conditions: | The device (CI) changes color from magenta to yellow when exposed to the appropriate cycle conditions. |
| - Lumen Cycle: | Change from magenta to yellow after exposure to 50 °C, 2.1 g H2O2 x 4 injections, for 32 minutes. |
| - Non-Lumen Cycle: | Change from magenta to yellow after exposure to 50 °C, 2.1 g H2O2 x 4 injections, for 12 minutes. |
| No Color Change (or insufficient change) in Ineffective Exposure: | (Not explicitly detailed in the provided text, but implied by the function of a chemical indicator to distinguish between processed and unprocessed units.) |
| Conformance to ANSI/AAMI/ISO 11140-1:2005 (Class 1 indicator): | The device meets the requirements for Class 1 vaporized hydrogen peroxide sterilization indicators as defined in ANSI/AAMI/ISO 11140-1:2005. |
| Durability / Stability: | Testing was performed to investigate the effects of exposure to UV, visible light, and aggressive chemicals. (Results not detailed in the summary.) |
| Simulated In-Use Applications: | Additional testing was completed to simulate typical in-use applications. (Results not detailed in the summary.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The exact sample size (number of indicators or runs) used for performance testing is not specified in the provided 510(k) summary. The document generally states "Performance testing was conducted."
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) submission to the FDA, it's highly probable the testing was conducted in a controlled lab environment (likely in the US or a country with recognized standards), but details are absent.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- This information is not applicable / not provided in the context of this device. Chemical indicators rely on a physical, observable color change, not subjective expert interpretation like diagnostic imaging. The "ground truth" is typically established by physical parameters of the sterilization cycle (temperature, sterilant concentration, exposure time) and a reference standard (e.g., biological indicator or validated sterilization cycle).
4. Adjudication Method for the Test Set
- This information is not applicable / not provided. Adjudication typically refers to resolving discrepancies between multiple human readers or interpretations. For a chemical indicator with a clear color change, the "adjudication" is inherent in the objective chemical reaction.
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 relevant for diagnostic devices where human readers interpret results, often with and without AI assistance. This device is a chemical indicator that provides a direct visual change, not interpreted by multiple readers in an MRMC setting.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This concept is not applicable to a chemical indicator. The device is the "standalone" indicator; its performance is based on its chemical reaction and visible color change, not an algorithm.
7. The Type of Ground Truth Used
- The ground truth for this device's performance is established by controlled sterilization cycle parameters (temperature, sterilant concentration, and duration as specified in the table on page 2), in adherence to the requirements of the ANSI/AAMI/ISO 11140-1:2005 standard for chemical indicators. The expected outcome is a specific color change (magenta to yellow) under these defined conditions, and either no change or an insufficient change under inadequate conditions.
8. The Sample Size for the Training Set
- This information is not applicable / not provided. Chemical indicators are not "trained" in the way AI algorithms are. Their performance is inherent in their chemical composition and manufacturing.
9. How the Ground Truth for the Training Set was Established
- This information is not applicable / not provided for the same reasons as point 8.
§ 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).