(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.
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Trophon Chemical Indicator
510(k) Summarv
K103126 p 1 of 2
MAR - 3 2011
Date Prepared: Submitter:
October 20, 2010 Nanosonics Ltd Unit 24 566, Gardeners Rd Alexandria, NSW. 2015 Australia Ph: +61 2 8063 1600 Fax: +61 2 9317 5010
Trophon Chemical Indicator
Contact Information:
Mr. Ron Weinberger General Manager - Innovation and Technology Nanosonics Ltd Unit 24, 566 Gardeners Road Alexandria, NSW 2015 Ph: +61 2 8063 1600 Fax: +61 2 9317 5010
Device Trade Name: Common or Usual Name: Device Classification Name:
Product Code:
Class:
Regulation Number:
Substantial Equivalence:
Device Description:
Intended Use:
Chemical Indicator for Liquid Chemical Germicide Physical/Chemical Sterilization Process Indicator المارك المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتق
ll
21 CFR 880.2800
Chemical Indicator
The Trophon Chemical Indicator is substantially equivalent to Serim D-CIDE GTA 1.5% Test Strip. (K092346)
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.
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.
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Trophon Chemical Indicator
The color of the Trophon Chemical Indicator cha 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.
The Trophon Chemical Indicator and the predicate device are both single use indicators used to monitor the active ingredient/critical process parameters in a specific solution/process. There are no significant technological risks and no new risks are presented by the design of the Trophon Chemical Indicator.
| Product Comparison | ||
|---|---|---|
| Technological Characteristics | ||
| Predicate Device | Subject Device | |
| Serim D-CIDE GTA 1.5% TestStrip. (K092346) | Trophon Chemical Indicator | |
| Description | Chemical indicator based onproprietary ink technology whichchanges color on exposure tosterilant | Chemical indicator based onproprietary ink technology whichchanges color on exposure tosterilant |
| Usage | As indicator to confirm thatglutaraldehyde exceeds thevalidated minimum effectiveconcentration. | As indicator to confirm thathydrogen peroxide exceeds thevalidated minimum effectiveconcentration. |
| IndicatorTechnology | Reacting Chemicals andbackground dye | Reacting Chemicals andbackground dve |
| Nature ofIndication | Qualitative - color change | Qualitative - color change |
| Single Use | Single Use disposable | Single Use disposable |
| TechnicalCharacteristics | Glutaraldehyde reacts with sodiumsulfite to form a colorless additionproduct and a base. The basethen reacts with a pH indicatorproducing a purple color. Theindicator pad also contains sodiumbisulfite, which reacts with bothglutaraldehyde and with the base. | Hydrogen peroxide reacts withcomponents within the proprietaryink formulation to cause a pH shift,resulting in a color change from aninitial red color to a yellow signalcolor. |
| User | Trained Health Care Professionals | Trained Health Care Professionals |
Conclusion:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines suggesting movement or connection. The seal is black and white and appears to be a scanned or printed image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Ron Weinberger General Manager-Innovation and Technology Nanosonics, Limited Unit 24 566, Gardeners Road Alexandria, NSW, 2015 Australia
MAR - 3 2011
Re: K103126
Trade/Device Name: Trophon Chemical Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: February 16, 2011 Received: February 18, 2011
Dear Mr. Weinberger:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2- Mr. Weinberger
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.goy/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
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510(k) Number (if known):
Device Name:
Trophon Chemical Indicator
Indications for Use:
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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use_ X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sivar Punare
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Anesthesions of Anestics
510(k) Number:
§ 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).