Search Results
Found 1 results
510(k) Data Aggregation
(100 days)
The VERIFY™ VH2O2 Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change from the start color (pink) to peach, yellow or lighter.
The tape may be used in the following sterilization cycles:
- · Non Lumen, Flexible and Lumen Cycles of the V-PRO 1, 1 Plus, maX and 60 Low Temperature Sterilizers
- · Standard Cycle of the STERRAD® 100S Sterilizer
- · Standard and Advanced Cycles of the STERRAD® NX Sterilizer
- · Express, Flex Scope, Duo and Standard Cycles of the STERRAD® 100 NX Sterilizer
The VERIFY VH2O2 Indicator Tape consists of a special coated crepe paper with diagonal lines of a chemical indicator specific for hydrogen peroxide sterilization. It meets the performance specifications for a Type 1 process indicator as defined in ANSI/AAMI/ISO 11140-1:2014.
The VERIFY | VH2O2 Indicator Tape and its packaging are manufactured in the absence of lead, heavy metals, natural rubber latex and dry natural rubber.
The medical device is the VERIFY™ VH2O2 Indicator Tape, which is a chemical sterilization process indicator.
Here's an analysis of the provided information, addressing your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Reported Device Performance (Result) |
|---|---|
| ANSI/AAMI/ISO 11140-1:2014 Vaporized Hydrogen Peroxide Process Indicator Performance Testing | Pass |
| Simulated Use: Pass Performance Testing (in V-Pro and STERRAD sterilizers with loads) | Pass |
| Simulated Use: Fail Performance Testing (in V-Pro and STERRAD sterilizers with loads) | Pass |
| Endpoint Stability (color of processed tape at various time points) | Pass |
| Light Stability after Removal from Packaging (before exposure to sterilization) | Pass |
| Adhesion Evaluation (ASTM adhesion standard and simulated use) | Pass |
| Shelf Life Evaluation (CI performance and tape adhesion) | Pass |
| Hydrogen Peroxide Residual Testing | Pass |
| Off-set (transference) Performance Testing | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test in the test set. It mentions tests being conducted "in an ANSI/AAMI/ISO 18472:2006-conforming resistometer" and "in hydrogen peroxide sterilizers (V-Pro and STERRAD) with loads under simulated use conditions." The provenance of the data is not explicitly stated as country of origin, but it is implied to be from the manufacturer's (STERIS Corporation) testing, which is based in Mentor, Ohio, USA. The testing appears to be prospective as it was conducted to demonstrate the performance of the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For chemical indicators like this, ground truth is typically established by physical/chemical properties and standardized tests, not by human expert interpretation in the same way an imaging AI might be evaluated. The "Pass" results are against established standards (ANSI/AAMI/ISO).
4. Adjudication Method for the Test Set
This information is not applicable in the traditional sense for a chemical indicator. The "Pass" or "Fail" of the tests is determined by adherence to predefined measurable criteria set forth in the ISO standards and internal performance specifications, rather than by a panel of human adjudicators reviewing outputs.
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 type of study is typically conducted for diagnostic devices where human interpretation of results is involved, and the AI's impact on human performance is being assessed. The VERIFY™ VH2O2 Indicator Tape is a chemical indicator that provides a direct visual color change, not an interpretive diagnostic.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, the testing performed can be considered "standalone" in the sense that the device's performance (color change, adhesion, stability) was evaluated directly against scientific and industry standards without a human-in-the-loop component for the device's core function. The device itself is designed to provide a clear, unambiguous signal (color change) that indicates processing. The evaluation focuses on whether this signal occurs accurately and reliably under specified conditions.
7. The Type of Ground Truth Used
The ground truth used is based on established industry standards and physical/chemical properties. This includes:
- ANSI/AAMI/ISO 11140-1:2014: This standard defines the requirements for chemical indicators for sterilization.
- ANSI/AAMI/ISO 18472:2006: This standard relates to resistometers, which are used to evaluate sterilization processes and indicators.
- ASTM adhesion standard: Used for evaluating tape adhesion.
- Measurable parameters for color change (from pink to peach/yellow or lighter) under defined sterilization conditions (pass conditions) and no change under fail conditions.
- Shelf-life stability of the indicator.
- Residual chemical levels (hydrogen peroxide).
8. The Sample Size for the Training Set
This document describes a physical device, a chemical indicator tape, not an algorithm that requires a "training set" in the context of machine learning or AI. Therefore, the concept of a training set sample size does not apply.
9. How the Ground Truth for the Training Set Was Established
As explained above, this device does not utilize a training set in the AI sense. Ground truth relates to the performance standards and physical/chemical characteristics of the indicator itself, established by international and industry standards, and verified through laboratory and simulated-use testing.
Ask a specific question about this device
Page 1 of 1