(132 days)
Not Found
No
The device is a simple chemical indicator that changes color based on exposure to a chemical, with no mention of AI or ML in the description or intended use.
No
The device is a chemical indicator used to monitor the disinfectant concentration in another device, not to treat a patient.
No
The device is a chemical indicator used to confirm the concentration of a disinfectant, not to diagnose a medical condition in a patient.
No
The device description clearly states it is a physical disc with chemical indicating ink applied to a substrate, which are hardware components.
Based on the provided information, the Trophon Chemical Indicator is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Trophon Chemical Indicator is used to monitor the concentration of a disinfectant within a medical device (the Trophon EPR chamber). It does not interact with or analyze any biological samples from a patient.
- The intended use is to confirm the concentration of a disinfectant. This is a quality control measure for a medical device's disinfection process, not a diagnostic test performed on a patient sample.
- The device description confirms it's a chemical indicator for hydrogen peroxide. This is a chemical reaction used for monitoring, not a diagnostic assay.
Therefore, the Trophon Chemical Indicator falls under the category of a sterilization/disinfection process indicator, which is a different type of medical device than an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
JOJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care providers
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Serim D-CIDE GTA 1.5% Test Strip. (K092346)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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% Test | ||
| Strip. (K092346) | Trophon Chemical Indicator | |
| Description | Chemical indicator based on | |
| proprietary ink technology which | ||
| changes color on exposure to | ||
| sterilant | Chemical indicator based on | |
| proprietary ink technology which | ||
| changes color on exposure to | ||
| sterilant | ||
| Usage | As indicator to confirm that | |
| glutaraldehyde exceeds the | ||
| validated minimum effective | ||
| concentration. | As indicator to confirm that | |
| hydrogen peroxide exceeds the | ||
| validated minimum effective | ||
| concentration. | ||
| Indicator | ||
| Technology | Reacting Chemicals and | |
| background dye | Reacting Chemicals and | |
| background dve | ||
| Nature of | ||
| Indication | Qualitative - color change | Qualitative - color change |
| Single Use | Single Use disposable | Single Use disposable |
| Technical | ||
| Characteristics | Glutaraldehyde reacts with sodium | |
| sulfite to form a colorless addition | ||
| product and a base. The base | ||
| then reacts with a pH indicator | ||
| producing a purple color. The | ||
| indicator pad also contains sodium | ||
| bisulfite, which reacts with both | ||
| glutaraldehyde and with the base. | Hydrogen peroxide reacts with | |
| components within the proprietary | ||
| ink formulation to cause a pH shift, | ||
| resulting in a color change from an | ||
| initial red color to a yellow signal | ||
| color. | ||
| User | Trained Health Care Professionals | Trained Health Care Professionals |
Conclusion:
2
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.
3
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
4
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: