TROPHON CHEMICAL INDICATOR

K103126 · Nanosonics Limited · JOJ · Mar 3, 2011 · General Hospital

Device Facts

• Record ID: K103126
• Device Name: TROPHON CHEMICAL INDICATOR
• Applicant: Nanosonics Limited
• Product Code: JOJ · General Hospital
• Decision Date: Mar 3, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended 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.

Device Story

Trophon Chemical Indicator is a single-use, 26 mm diameter disc consisting of a Tyvek substrate coated with hydrogen peroxide-sensitive ink. Used by healthcare professionals to verify that the Trophon EPR disinfector delivers disinfectant at or above the minimum effective concentration (MEC). During the disinfection cycle, the indicator is placed within the Trophon EPR chamber; exposure to hydrogen peroxide triggers a chemical reaction causing the ink to transition from red to yellow. This visual color change provides a qualitative confirmation to the clinician that the disinfectant concentration is sufficient for effective high-level disinfection. The device ensures the integrity of the disinfection process, directly impacting clinical decision-making regarding the readiness of disinfected equipment for patient use.

Clinical Evidence

Bench testing only. The device performance was validated by demonstrating the color transition from red to yellow specifically when exposed to hydrogen peroxide concentrations at or above the established minimum effective concentration (MEC) of the Trophon EPR-C40 disinfectant.

Technological Characteristics

Single-use qualitative chemical indicator; 26 mm diameter disc; Tyvek substrate; proprietary hydrogen peroxide-sensitive ink; colorimetric reaction (red to yellow) triggered by pH shift upon exposure to hydrogen peroxide; non-electronic; standalone.

Indications for Use

Indicated for use by healthcare providers to monitor the high-level disinfection process within the Trophon EPR chamber by confirming that the hydrogen peroxide concentration in the Trophon EPR-C40 disinfectant is above the established minimum effective concentration (MEC).

Regulatory Classification

Identification

Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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.

Predicate Devices

• Serim D-CIDE GTA 1.5% Test Strip (K092346)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

Trophon Chemical Indicator

Contact Information:

Mr. Ron Weinberger General Manager - Innovation and Technology Nanosonics Ltd Unit 24, 566 Gardeners Road Alexandria, NSW 2015 Ph: [phone] Fax: [phone]

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

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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% Test<br>Strip. (K092346) | Trophon Chemical Indicator |
| Description | Chemical indicator based on<br>proprietary ink technology which<br>changes color on exposure to<br>sterilant | Chemical indicator based on<br>proprietary ink technology which<br>changes color on exposure to<br>sterilant |
| Usage | As indicator to confirm that<br>glutaraldehyde exceeds the<br>validated minimum effective<br>concentration. | As indicator to confirm that<br>hydrogen peroxide exceeds the<br>validated minimum effective<br>concentration. |
| Indicator<br>Technology | Reacting Chemicals and<br>background dye | Reacting Chemicals and<br>background dve |
| Nature of<br>Indication | Qualitative - color change | Qualitative - color change |
| Single Use | Single Use disposable | Single Use disposable |
| Technical<br>Characteristics | Glutaraldehyde reacts with sodium<br>sulfite to form a colorless addition<br>product and a base. The base<br>then reacts with a pH indicator<br>producing a purple color. The<br>indicator pad also contains sodium<br>bisulfite, which reacts with both<br>glutaraldehyde and with the base. | Hydrogen peroxide reacts with<br>components within the proprietary<br>ink formulation to cause a pH shift,<br>resulting in a color change from an<br>initial red color to a yellow signal<br>color. |
| User | Trained Health Care Professionals | Trained Health Care Professionals |

## Conclusion:

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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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 [phone] or [phone] 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: