(96 days)
The Verify® V-PRO Chemical Indicator (Version 1) and the Verify® V-PRO Chemical Indicator Adhesive Label (Version 2) are Class 1 vaporized hydrogen peroxide sterilization process indicators. They are designed to distinguish between processed and unprocessed units when placed within (Version 1) or affixed to (Version 2) sterilization wraps, trays or pouches to indicate, through a visible change from magenta to yellow, when the device (Version 1) or pack (Version 2) has been exposed to a V-PRO 1 sterilization process. This product is designed for use exclusively in the Amsco V-PRO 1 Low Temperature Sterilization system at 50 °C using Vaprox™ HC Sterilant.
The Verify® V-PRO Chemical Indicator is used in each processing cycle to indicate exposure to an Amsco V-PRO 1 Low Temperature Sterilizer cycle. When exposed, the indicator exhibits a visible color change from magenta to yellow.
The Verify® V-PRO Chemical Indicator is provided as two formats:
- Version 1: Verify® V-PRO Chemical Indicator .
- Version 2: Verify® V-PRO Chemical Indicator Adhesive Label .
The Version 1: Verify® V-PRO Chemical Indicator is a Class 1 process indicator in accordance with 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 2: Verify® V-PRO Chemical Indicator Adhesive Label is a Class 1 process indicator in accordance with 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 an analysis of the acceptance criteria and study information for the STERIS® Verify® V-PRO Chemical Indicator, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meets requirements for Class 1 vaporized hydrogen peroxide sterilization indicators as defined in ANSI/AAMI ISO 11140-1:2005. | "Performance testing was conducted to verify that the proposed Verify® V-PRO Chemical Indicator meets the requirements for Class 1 vaporized hydrogen peroxide sterilization indicators as defined in ANSVAAMI ISO 11140-1:2005." (The document states that it meets these requirements, implying successful performance.) |
| Exhibits a visible color change from magenta to yellow when exposed to an Amsco V-PRO 1 Low Temperature Sterilizer cycle. | "When exposed, the indicator exhibits a visible color change from magenta to yellow." and "indicate, through a visible change from magenta to yellow, when the device (Version 1) or pack (Version 2) has been exposed to a V-PRO 1 sterilization process." (The description of the device's function directly states this is its performance.) |
| Performance in typical in-use applications. | "Additional testing was completed to simulate typical in-use applications." (The document states this testing was done but does not provide specific performance metrics beyond the implication that it was successful.) |
| Resistance to effects of exposure to UV, visible light, and aggressive chemicals. | "testing was also performed to investigate the effects of exposure to UV, visible light and aggressive chemicals to the performance of the Verify® V-PRO Chemical Indicator." (The document states this testing was done but does not provide specific performance metrics beyond the implication that it was successful.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the sample size used for the performance tests. It mentions "Performance testing was conducted to verify..." but does not quantify the number of indicators or cycles tested.
- Data Provenance: The document does not explicitly state the country of origin of the data. Given it's a submission to the FDA (U.S. Department of Health and Human Services), it's highly likely the testing was either conducted in the USA or under protocols accepted by US regulatory standards. The data provenance is retrospective, as the testing was completed prior to the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide this information. Chemical indicators are typically assessed objectively based on a chemical reaction producing a color change, rather than subjective expert interpretation requiring a "ground truth" established by multiple human experts. The color change is a physical/chemical phenomenon.
4. Adjudication Method for the Test Set
Not applicable for this device. The assessment of a chemical indicator's performance (color change) is objective and typically determined by visual inspection against a reference, not through a human reader adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and AI assistance can potentially improve their performance. This chemical indicator is an objective indicator of sterilization process exposure, not a diagnostic tool requiring human interpretation improvement.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This device is a passive chemical indicator, not an algorithm. Its performance is inherent in its chemical properties and design, observed directly by a human. There is no "algorithm only" performance to evaluate.
7. Type of Ground Truth Used
The ground truth for the chemical indicator's performance is the objective outcome of exposure to the specified sterilization cycle parameters. That is, whether the indicator was actually exposed to a V-PRO 1 sterilization process that met certain conditions (temperature, sterilant concentration, time). The expected outcome (color change to yellow) is then compared to this objective 'ground truth' of actual exposure.
8. Sample Size for the Training Set
Not applicable. This device is a chemical indicator, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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).