trophon2

K173865 · Nanosonics Limited · OUJ · Apr 24, 2018 · Radiology

Device Facts

• Record ID: K173865
• Device Name: trophon2
• Applicant: Nanosonics Limited
• Product Code: OUJ · Radiology
• Decision Date: Apr 24, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The trophon2 is designed to provide High-Level Disinfection (HLD) of validated ultrasound probes. High-Level Disinfection is achieved by surface exposure to a controlled dose of hydrogen peroxide mist delivered to a disinfection chamber containing the ultrasound probe. The trophon2 system consists of a multiple use instrument combined with a single use disinfectant "trophon Sonex-HL", delivered from a multi-dose cartridge. The trophon2 is suitable for use in general hospital and health care facilities by trained personnel. The trophon Sonex-HL should be used with the following contact conditions: Minimum Operational Cycle Time: 7 minutes Minimum Concentration: 31.5% Minimum Disinfectant Dose: 1.0 g Minimum Chamber Temperature: 56℃

Device Story

The trophon2 is a software-controlled electromechanical system for high-level disinfection (HLD) of ultrasound transducers. It uses a multi-dose cartridge of hydrogen peroxide (trophon Sonex-HL) to generate a liquid aerosol mist within a sealed disinfection chamber. The device automates the disinfection and aeration cycle, monitoring time, temperature, and dose. It features a color touch screen, RFID for traceability, and Ethernet/USB connectivity for network integration. Used in hospitals and clinics by trained personnel, the device ensures probe safety via a chemical indicator (K103126) to verify disinfectant delivery. The system improves upon the predicate Trophon EPR by offering a more regularized chamber shape, enhanced user interface, and improved sub-assembly design, facilitating effective disinfection of irregular probes while maintaining established HLD efficacy standards.

Clinical Evidence

No clinical data. Bench testing only. Testing included electromechanical and EMC testing, biocompatibility, microbiological efficacy, process parameter validation, materials compatibility, disinfectant stability, and chemical indicator verification. Results met all acceptance criteria.

Technological Characteristics

Software-controlled electromechanical system. Uses 35% hydrogen peroxide in multi-dose cartridges. Disinfection via liquid aerosol mist and automated aeration. Features color touch screen, RFID module, 3 USB ports, and 1 Ethernet port. Standards: IEC 61010-1, IEC 61010-2-040, IEC 61326, IEC 62304, ISO 62366-1/-2, ISO 10993, ISO 14971.

Indications for Use

Indicated for high-level disinfection of validated ultrasound probes in general hospital and healthcare facilities by trained personnel.

Regulatory Classification

Identification

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

Predicate Devices

• Trophon EPR (K103059)

Reference Devices

• Trophon Chemical Indicator (K103126)

Submission Summary (Full Text)

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April 24, 2018

Nanosonics Limited Ruth Cremin, Ph.D. Head of Regulatory Affairs 14 Mars Road Lane Cove, NSW 2066 Australia

Re: K173865

Trade/Device Name: trophon2 Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: Class II Product Code: OUJ Dated: March 23, 2018 Received: March 26, 2018

Dear Ruth Cremin:

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.

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 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Geeta K. Pamidimukkala -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known) K173865

Device Name trophon2

Indications for Use (Describe)

The trophon2 is designed to provide High-Level Disinfection (HLD) of validated ultrasound probes. High-Level Disinfection is achieved by surface exposure to a controlled dose of hydrogen peroxide mist delivered to a disinfection chamber containing the ultrasound probe.

The trophon2 system consists of a multiple use instrument combined with a single use disinfectant "trophon Sonex-HL", delivered from a multi-dose cartridge.

The trophon2 is suitable for use in general hospital and health care facilities by trained personnel.

The trophon Sonex-HL should be used with the following contact conditions: Minimum Operational Cycle Time: 7 minutes Minimum Concentration: 31.5% Minimum Disinfectant Dose: 1.0 g Minimum Chamber Temperature: 56℃

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the Nanosonics logo. The word "nanosonics" is written in a combination of blue and gray letters. Below the word, the phrase "Infection Prevention. For Life." is written in a smaller font.

# 510(k) Summary: K173865

| 510(k) Owner: | Nanosonics Limited<br>14 Mars Road<br>Lane Cove, NSW, 2066<br>Australia<br>Ph: [phone]<br>Fax: [phone] |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dr. Frederic Bustos<br>Head of Regulatory Affairs<br>Nanosonics Limited<br>14 Mars Road<br>Lane Cove, NSW 2066<br>Ph: [phone]<br>Fax: [phone] |
| Brand Name: | trophon2 |
| Common Name: | Hydrogen Peroxide High-Level Disinfection system for<br>ultrasound transducers |
| Classification Name: | 21CFR 892.1570 – High Level Disinfection Reprocessing<br>Instrument for Ultrasonic Transducers, Mist |
| Product Code: | OUJ |
| Regulatory Class: | II |
| Predicate Devices: | Trophon EPR (K103059)<br>Nanosonics Limited |
| Date Prepared: | April 23, 2018 |

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Image /page/4/Picture/0 description: The image shows the logo for Nanosonics. The word "nanosonics" is written in a combination of blue and gray colors. Below the word "nanosonics" is the phrase "Infection Prevention. For Life." in a smaller font size.

#### Description of the Device:

The trophon2 is a software controlled device which provides High-Level Disinfection of ultrasound transducers. The device consists of a sealed disinfection chamber and operates in conjunction with a multi-dose cartridge of concentrated hydrogen peroxide disinfectant "trophon Sonex- HL".

Pre-cleaned and dried ultrasound transducers are placed within the trophon2 chamber and disinfected by means of an automated disinfection and aeration cycle.

The disinfected ultrasound transducer is removed from the chamber, wiped and is ready for immediate use.

#### Indications for Use:

The trophon2 is designed to provide High-Level Disinfection (HLD) of validated ultrasound probes. High-Level Disinfection is achieved by surface exposure to a controlled dose of hydrogen peroxide mist delivered to a disinfection chamber containing the ultrasound probe.

The trophon2 system consists of a multiple use instrument combined with a single use disinfectant "trophon Sonex-HL", delivered from a multi-dose cartridge.

The trophon2 is suitable for use in general hospital and health care facilities by trained personnel.

The trophon Sonex-HL should be used with the following contact conditions:

| Minimum Operational Cycle Time: | 7 minutes |
|---------------------------------|-----------|
| Minimum Concentration: | 31.5% |
| Minimum Disinfectant Dose: | 1.0 g |
| Minimum Chamber Temperature: | 56°C |

#### Detailed Predicate device comparison:

The trophon2 is similar to the legally marketed Trophon EPR manufactured by Nanosonics and cleared under 510(k) K103059.

The trophon Sonex-HL is the same disinfectant that is cleared under K103059.

The trophon2 device and the predicate Trophon EPR use a validated and controlled automated cycle to deliver measured doses of disinfectant to a chamber which contains the pre-cleaned and dried ultrasound transducer requiring disinfection.

Both the trophon EPR and the trophon2 require the use of the Trophon Chemical Indicator to verify for each cycle the correct delivery of the disinfectant.

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Image /page/5/Picture/0 description: The image shows the logo for "nanosonics". The word "nano" is in blue, and the word "sonics" is in gray. Underneath the word "sonics" is the phrase "Infection Prevention. For Life.", with the words "Infection Prevention." in gray and the words "For Life." in blue.

### Intended Use

The intended Use of the trophon2 is the same as the Trophon EPR, they are both intended for the High Level Disinfection of ultrasound probes under the same defined conditions.

## Similarities between trophon2 device and the predicate device

- Both the trophon2 device and the predicate Trophon EPR are High-Level Disinfecting systems for Ultrasound transducers.
- . Both devices are software controlled electromechanical devices which use a validated, automated cycle to deliver measured dose of hydrogen peroxide disinfectant to a chamber which contains the transducer to be disinfected.
- The trophon2 and predicate both monitor and control the disinfection parameters of time, temperature and dose delivery.
- Both devices are used in general hospital and health care facilities to achieve High-Level Disinfection of ultrasound transducers.
- . The same Trophon Chemical indicator (K103126) is used in both devices as a means to confirm delivery of the disinfectant.

## Differences between trophon2 device and the Trophon EPR

The difference between the trophon2 and Trophon EPR is the addition of new features and some device modifications to improve the usability of the device, mainly around:

- . The Chamber shape - to enable irreqular shaped probes to better fit in the chamber.
- RFID Functionality - provides a new traceability features when enabled.
- External Communication - allows integration with Hospital networks and Nanosonics Service database when enabled.
- . User Interface Improvements - introduction of a colored touch screen.
- Improved aesthetic.
- Design improvements to sub-assemblies. ●

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Image /page/6/Picture/0 description: The image shows the logo for Nanosonics. The word "nanosonics" is written in a combination of blue and gray letters. The first four letters, "nano", are in blue, while the rest of the word is in gray. There is a blue arc above the word. Below the word "nanosonics" is the phrase "Infection Prevention. For Life.", written in a smaller font size.

# Comparison Table

# Table 1: Device critical parameters for achieving High Level Disinfection

| Device Critical<br>Parameters for HLD | Trophon EPR<br>(predicate) | trophon 2 | Same/<br>Modified |
|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Operational Cycle<br>Time | Minimum 7 minutes | Minimum 7 minutes | Same |
| Concentration of<br>hydrogen peroxide | Minimum of 31.5%<br>hydrogen peroxide | Minimum of 31.5%<br>hydrogen peroxide | Same |
| Dosage of hydrogen<br>peroxide | Minimum of 1g | Minimum of 1g | Same |
| Chamber<br>Temperature | Minimum of 56°C | Minimum of 56°C | Same |
| Device Design | Trophon EPR<br>(predicate) | trophon 2 | Same /<br>Modified |
| Indications for<br>use | The Trophon EPR is<br>designed to provide<br>High-Level Disinfection<br>of ultrasound<br>transducers. The<br>system uses the<br>Trophon Disinfectant<br>which is intended to be<br>used exclusively with<br>the Trophon EPR<br>device.<br>The Trophon<br>Disinfectant is intended<br>for use as a High-Level<br>Disinfectant to be used<br>exclusively with the<br>Trophon EPR for the<br>High-Level Disinfection<br>of ultrasound<br>transducers.<br>The Trophon EPR is<br>suitable for use in<br>general hospital and<br>health care facilities by<br>trained personnel.<br>The Trophon EPR<br>system consists of a<br>multiple use instrument<br>combined with a single<br>use disinfectant,<br>delivered from a multi-<br>dose cartridge.<br>The Trophon<br>Disinfectant should be<br>used with the following<br>contact conditions:<br>Minimum Operational<br>Cycle Time: 7 minutes<br>Minimum<br>Concentration: 31.5% | The trophon2 is<br>designed to provide<br>High-Level Disinfection<br>(HLD) of validated<br>ultrasound probes.<br>High-Level Disinfection<br>is achieved by surface<br>exposure to a<br>controlled dose of<br>hydrogen peroxide mist<br>delivered to a<br>disinfection chamber<br>containing the<br>ultrasound probe.<br>The trophon2 system<br>consists of a multiple<br>use instrument<br>combined with a single<br>use disinfectant<br>"trophon Sonex-HL",<br>delivered from a multi-<br>dose cartridge.<br>The trophon2 is<br>suitable for use in<br>general hospital and<br>health care facilities by<br>trained personnel.<br>The trophon Sonex-HL<br>should be used with the<br>following contact<br>conditions:<br>Minimum Operational<br>Cycle Time: 7 minutes<br>Minimum<br>Concentration: 31.5%<br>Minimum Disinfectant<br>Dose: 1.0 g<br>Minimum Chamber<br>Temperature: 56°C | Same |
| | Minimum Disinfectant Dose: 1.0 g | | |
| | Minimum Chamber Temperature: 56°C | | |
| Operating<br>Principle | Software controlled<br>systems that deliver<br>measured doses of<br>hydrogen peroxide<br>disinfectant to achieve<br>HLD | Software controlled<br>systems that deliver<br>measured doses of<br>hydrogen peroxide<br>disinfectant to achieve<br>HLD | Same |
| Critical<br>Parameters for<br>HLD | As per Table 1 above–<br>minimum operating<br>conditions | As per Table 1 above–<br>minimum operating<br>conditions | Same |
| Disinfectant | 35% hydrogen peroxide<br>in cartridge | 35% hydrogen peroxide<br>in cartridge | Same |
| Disinfectant<br>delivery | Liquid Aerosol Mist | Liquid Aerosol Mist | Same |
| Disinfectant<br>Removal Process | Automated aeration | Automated aeration | Same |
| Process<br>Monitoring | Automated process<br>monitoring in the device | Automated process<br>monitoring in the device | Same |
| Chemical<br>Indicator | Trophon Chemical<br>Indicator (K103126) | Trophon Chemical<br>Indicator (K103126) | Same |
| Microbiology<br>Efficacy /<br>AOAC<br>Performance<br>Standards | Meets the requirements<br>of Section III.H.5 of<br>Content and Format<br>Premarket Notification<br>[510(k)] Submission for<br>Liquid Chemical<br>Sterilants/ High Level<br>Disinfectants<br>AOAC Methods | Meets the requirements<br>of Section III.H.5 of<br>Content and Format<br>Premarket Notification<br>[510(k)] Submission for<br>Liquid Chemical<br>Sterilants/ High Level<br>Disinfectants<br>AOAC Methods | Same |
| Device<br>Performance<br>Standards | IEC 61010-1 | IEC 61010-1 | Same |
| | IEC61010-2-040 | IEC61010-2-040 | |
| | | IEC 61326 | IEC 61326 |
| | | IEC 62304 | IEC 62304 |
| | | ISO 62366 -1 and -2 | ISO 62366 -1 and -2 |
| | | ISO10993 | ISO10993 |
| | | ISO14971 | ISO14971 |
| Residue Testing | Effectively removes<br>residues from<br>disinfected transducers | Effectively removes<br>residues from<br>disinfected transducers | Same |
| Device/ Material<br>Compatibility | Meets the requirements<br>of Section III. J.2 of<br>Content and Format<br>Premarket Notification<br>[510(k)] Submission for<br>Liquid Chemical<br>Sterilants/ High Level<br>Disinfectants | Meets the requirements<br>of Section III. J.2 of<br>Content and Format<br>Premarket Notification<br>[510(k)] Submission for<br>Liquid Chemical<br>Sterilants/ High Level<br>Disinfectants | Same |
| Chamber design | Irregular shaped<br>chamber | The trophon 2 chamber<br>has a more regularized<br>shape - the volume,<br>height and depth<br>remains the same. | Modified |
| Chamber<br>temperature | Set point 75°C (167°F)<br>in trophon EPR | Set point 65°C (149°F)<br>in trophon2 | Modified |
| Door lock | Solenoid | Motor and hook<br>assembly | Modified |
| Probe clamp | Spring clip | Spring loaded cleats | Modified |
| All in One<br>Catalytic Destruct | Contains a Mist<br>Catalytic Destruct and<br>Liquid Catalytic<br>Destruct system. | An integrated catalytic<br>destruct system is<br>introduced as an<br>improvement to the<br>manufacturing process | Modified |
| Touch screen | A character LCD | A color touch screen<br>panel | Modified |
| Software/<br>Firmware | Software controlled<br>system- The Trophon<br>EPR has a single<br>firmware component | Software controlled<br>system - trophon2 is<br>comprised of multiple<br>software/firmware<br>components | Modified |
| Traceability | Traceability can be<br>manually implemented<br>by downloading the<br>Trophon EPR device<br>logs during device<br>service or by using the<br>system accessories: | An integrated RFID<br>module is introduced,<br>allowing automated<br>traceability features in<br>the device.<br>Patient information is<br>not received or<br>recorded by the device, | New<br>Feature |
| | Trophon Connect<br>Trophon Printer<br>Trophon Logbook | therefore it cannot be<br>accessed via RFID. | |
| Communication<br>ports | Trophon EPR has 1<br>serial port to connect<br>with external device i.e<br>trophon printer…