(132 days)
The Trophon Chemical Indicator is intended by Nanosonics for use by health care providers for confirming that the disinfectant delivered into the Chamber of the Nanosonics Trophon EPR disinfector device is above the minimum effective concentration (MEC) required to achieve the stated performance of the Trophon EPR.
The Trophon Chemical Indicator is used exclusively for monitoring the High Level Disinfection process when placed within the Trophon EPR chamber.
The color of the Trophon Chemical Indicator changes from red to yellow when exposed to hydrogen peroxide, the active ingredient in Trophon EPR-C40 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. 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.
Chemical indicator based on proprietary ink technology which changes color on exposure to sterilant.
The Trophon Chemical Indicator is a qualitative, single-use disc with a hydrogen peroxide-sensitive chemical indicating ink designed to transition from red to yellow when exposed to hydrogen peroxide. It is intended for use by healthcare providers to confirm that the disinfectant delivered into the Nanosonics Trophon EPR disinfector device chamber is above the minimum effective concentration (MEC).
1. Acceptance Criteria and Reported Device Performance:
The document describes the device's function: "The color of the Trophon Chemical Indicator changes from red to yellow when exposed to hydrogen peroxide, the active ingredient in Trophon EPR-C40 disinfectant. This color change occurs above the minimum effective concentration (MEC) established for this solution."
While specific numerical acceptance criteria (e.g., sensitivity, specificity percentage) are not provided in the given text, the implicit acceptance criterion is that the chemical indicator must reliably and accurately change color from red to yellow when the hydrogen peroxide concentration is at or above the MEC. The document states that the device is "substantially equivalent" to a predicate device, meaning it performs comparably.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Color change from red to yellow | 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 color of the Trophon Chemical Indicator changes from red to yellow when exposed to hydrogen peroxide, the active ingredient in Trophon EPR-C40 disinfectant. |
| Color change occurs above MEC | This color change occurs above the minimum effective concentration (MEC) established for this solution. The Trophon Chemical Indicator is intended...for confirming that the disinfectant delivered into the Chamber of the Nanosonics Trophon EPR disinfector device is above the minimum effective concentration (MEC). |
| Substantial equivalence to predicate device | The Trophon Chemical Indicator is substantially equivalent to Serim D-CIDE GTA 1.5% Test Strip (K092346). Both are chemical indicators based on proprietary ink technology which changes color on exposure to a sterilant, with qualitative color change, are single-use disposable, and are used by trained healthcare professionals to confirm the active ingredient exceeds the validated minimum effective concentration (glutaraldehyde for the predicate, hydrogen peroxide for the subject device). |
2. Sample size used for the test set and the data provenance:
The provided 510(k) summary does not explicitly state the sample size used for a test set, nor does it detail the specific data provenance (e.g., country of origin, retrospective or prospective nature of studies). Instead, it relies on a comparison to a predicate device and a general description of the device's functional design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not mention the use of experts to establish ground truth for a test set. The validation described is based on the chemical properties and performance comparison to a predicate device.
4. Adjudication method for the test set:
No adjudication method is described, as the evaluation is based on the chemical reaction and color change of the indicator within the specified concentration range.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is a chemical indicator, not an AI or imaging device that would typically involve human readers or MRMC studies. Therefore, no MRMC study was done, and no effect size for human reader improvement with AI assistance is applicable or reported.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The Trophon Chemical Indicator is a standalone device in the sense that it performs its function (color change) without human intervention in the chemical reaction itself. However, it's not an algorithm, and its performance is based on chemical principles, not computational ones. Its interpretation (reading the color change) does involve a human-in-the-loop, but this is a simple visual assessment.
7. The type of ground truth used:
The ground truth is established by the known chemical concentrations of hydrogen peroxide. The device is designed to visually indicate when the hydrogen peroxide concentration is at or above the Minimum Effective Concentration (MEC). The "ground truth" therefore would be the actual measured concentration of hydrogen peroxide, against which the indicator's color change is correlated.
8. The sample size for the training set:
The document does not describe a "training set" in the context of machine learning or AI. The development of this chemical indicator would involve experiments to optimize the ink formulation and its response to hydrogen peroxide. The sample size for these developmental experiments is not specified.
9. How the ground truth for the training set was established:
As this is a chemical indicator and not an AI/ML device, the concept of a "training set" and its "ground truth" as typically understood in AI development does not directly apply. The "ground truth" during development would be established through controlled laboratory experiments using precisely measured concentrations of hydrogen peroxide at and around the MEC. The chemical formulation would be refined until it consistently and accurately exhibits the desired color change only when the hydrogen peroxide concentration is at or above the MEC.
§ 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).