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510(k) Data Aggregation
(264 days)
Ultraphon Chemical Indicator (TRO-T and TRO-B)
The Ultraphon Chemical Indicator is used exclusively for monitoring the High Level Disinfection process when placed within the Nanosonics trophon® 2 chambers. The color of the Ultraphon Chemical Indicator changes from red to yellow when exposed to hydrogen peroxide, the active ingredient used in trophon® 2 disinfectant. This occurs above the minimum effective concentration (MEC) established for this solution.
The Ultraphon Chemical Indicator is used exclusively for monitoring the High Level Disinfection process when placed within the Nanosonics trophon® EPR and trophon® 2 chambers. The color of the Ultraphon Chemical Indicator changes from red to yellow when exposed to hydrogen peroxide, the active ingredient used in trophon® EPR and trophon® 2 disinfectant. This occurs above the minimum effective concentration (MEC) established for this solution.
The device is a qualitative, single use, disc (26 mm in diameter) that has a hydrogen peroxide sensitive chemical indicating ink applied to a Tyvek® substrate (Product Code: TRO-T) or polypropylene substrate (Product Code: TRO-B). The hydrogen peroxide sensitive chemical indicating ink has been designed to transition from an initial red color to a signal yellow color when subjected to sources of hydrogen peroxide.
The provided text describes the acceptance criteria and a summary of non-clinical testing for the Ultraphon Chemical Indicator (TRO-T and TRO-B). Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Name of Test | Acceptance Criteria | Subject Device Result |
|---|---|---|
| Performance Testing | Pass result when hydrogen peroxide solution is above the MEC (signal color achieved for all product codes) and fail color when hydrogen peroxide solution is at MEC achieved when exposed to the HLD cycle in combination of a worst-case load: trophon® EPR and trophon® 2 HLD Systems | PASS |
| End Point Stability | 1 month | PASS |
| Offset/Transference | The chemical indicators shall not offset or bleed, penetrate the substrate to which it is applied, or materials in which it is in contact before, during or after the sterilization cycles for which it is designed. | PASS |
| Chemical Indicator Performance Testing in the Presence of Contaminated Ultrasound Probes | Hydrogen Peroxide 31.5% (1.8g): More yellow than MEC | |
| Hydrogen Peroxide 31.5% (1.0g): Equal to MEC or more red | PASS | |
| Color Analysis (X-Rite Spectrophotometer) | More yellow than the MEC using 31.5%, 1.8 grams | |
| Equal to or more red than MEC using 31.5%, 1.0 gram | ||
| More red than MEC using 31.5%, 0.8 grams | ||
| More Yellow than MEC using 31.5%, 1.2 grams | PASS | |
| Sensitivity, Specificity, Accuracy, and Precision of Performance Data | Comparative Sensitivity: > 0.95 | |
| Analytic Sensitivity (31.5% H2O2): | ||
| 1.8 g H2O2 solution: 0.56 - 0.58 g H2O2 | ||
| 1.2 g H2O2 solution: 0.37 - 0.39 g H2O2 | ||
| 1.0 g H2O2 solution: 0.31 – 0.33 g H2O2 | ||
| 0.8 g H2O2 solution: 0.25 - 0.27 g H2O2 | ||
| Comparative Specificity: > 0.95 | ||
| Accuracy: > 0.95 | ||
| Precision: |
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