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 Description

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.

AI/ML Overview

The provided document is a 510(k) Pre-Market Notification for the trophon2 device, establishing its substantial equivalence to a predicate device (Trophon EPR) for High-Level Disinfection (HLD) of ultrasound transducers. It focuses on the device's technical specifications, comparisons to the predicate, and non-clinical testing performed to demonstrate its safety and effectiveness.

Based on the provided document, here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance:

The document doesn't provide specific quantitative acceptance criteria or detailed reported performance values for each test. Instead, it makes a general statement:

Acceptance Criteria (Implied)	Reported Device Performance
Device meets requirements for Electromechanical and EMC testing.	The results demonstrated that the subject device met the acceptance criteria for each non-clinical test.
Device meets requirements for Biocompatibility.	The results demonstrated that the subject device met the acceptance criteria for each non-clinical test.
Device meets requirements for Microbiological Efficacy Testing.	The results demonstrated that the subject device met the acceptance criteria for each non-clinical test.
Device meets requirements for Validation testing of process parameters.	The results demonstrated that the subject device met the acceptance criteria for each non-clinical test.
Device meets requirements for Materials Compatibility.	The results demonstrated that the subject device met the acceptance criteria for each non-clinical test.
Device meets requirements for Stability testing of Sonex-HL.	The results demonstrated that the subject device met the acceptance criteria for each non-clinical test.
Device meets requirements for Verification Testing of the Chemical Indicator.	The results demonstrated that the subject device met the acceptance criteria for each non-clinical test.
Critical operational parameters for HLD are maintained.	The trophon2 maintains the same minimum operational cycle time (7 minutes), minimum concentration of hydrogen peroxide (31.5%), minimum disinfectant dose (1.0g), and minimum chamber temperature (56°C) as the predicate device.
Device effectively removes residues from disinfected transducers.	"Effectively removes residues from disinfected transducers" (stated as a "Same" characteristic as the predicate).
Device meets relevant performance standards (IEC 61010-1, IEC61010-2-040, IEC 61326, IEC 62304, ISO 62366 -1 and -2, ISO10993, ISO14971).	Listed as "Same" as predicate, implying adherence to these standards.

2. Sample size used for the test set and the data provenance:

The document refers to "Non-clinical Testing" but does not specify the sample sizes used for any of the tests, nor does it explicitly state the data provenance (e.g., country of origin, retrospective or prospective). The testing appears to be primarily laboratory-based to validate the device's functional and biological performance rather than clinical studies with human subjects or medical images.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The type of testing described (electromechanical, biocompatibility, microbiological, etc.) typically relies on established scientific protocols and instrumentation rather than expert human interpretation for ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided in the document. Adjudication methods are typically relevant for studies involving human interpretation (e.g., image reading), which is not the primary focus of the non-clinical testing described here.

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:

No, an MRMC comparative effectiveness study was not conducted or described in this document. This device is an automated high-level disinfection system, not an AI-assisted diagnostic tool that aids human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

The core of the device is an automated, standalone system for high-level disinfection. The "Non-clinical Testing" section describes validation of the device's automated functions: "Microbiological Efficacy Testing," "Validation testing of process parameters," and "Verification Testing of the Chemical Indicator." This implies that the device's performance in achieving HLD is evaluated independently of human intervention during the disinfection cycle.

7. The type of ground truth used:

The "ground truth" for the non-clinical tests would be established by:

Microbiological Standards: For microbiological efficacy, ground truth would be determined by established standards for killing specified microorganisms (e.g., AOAC methods mentioned on page 6).
Physical/Chemical Measurements: For process parameters (temperature, concentration, dose, time), ground truth would be established by precise measurements using calibrated instruments.
Engineering Specifications: For electromechanical and material compatibility, ground truth would be established by compliance with engineering design specifications and relevant international standards (e.g., IEC, ISO standards listed).

8. The sample size for the training set:

This information is not applicable and not provided. This device is a hardware system for disinfection and the document does not describe the use of machine learning or AI models that would require a "training set."

9. How the ground truth for the training set was established:

This information is not applicable and not provided for the same reason as above. There is no mention of a training set for an AI/ML model.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 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.

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 Limited14 Mars RoadLane Cove, NSW, 2066AustraliaPh: +61 2 8063 1600Fax: +61 2 9317 5010
Contact Person:	Dr. Frederic BustosHead of Regulatory AffairsNanosonics Limited14 Mars RoadLane Cove, NSW 2066Ph: +61 2 8063 1600Fax: +61 2 9317 5010
Brand Name:	trophon2
Common Name:	Hydrogen Peroxide High-Level Disinfection system forultrasound transducers
Classification Name:	21CFR 892.1570 – High Level Disinfection ReprocessingInstrument for Ultrasonic Transducers, Mist
Product Code:	OUJ
Regulatory Class:	II
Predicate Devices:	Trophon EPR (K103059)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:

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 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 CriticalParameters for HLD	Trophon EPR(predicate)	trophon 2	Same/Modified
Operational CycleTime	Minimum 7 minutes	Minimum 7 minutes	Same
Concentration ofhydrogen peroxide	Minimum of 31.5%hydrogen peroxide	Minimum of 31.5%hydrogen peroxide	Same
Dosage of hydrogenperoxide	Minimum of 1g	Minimum of 1g	Same
ChamberTemperature	Minimum of 56°C	Minimum of 56°C	Same
Device Design	Trophon EPR(predicate)	trophon 2	Same /Modified
Indications foruse	The Trophon EPR isdesigned to provideHigh-Level Disinfectionof ultrasoundtransducers. Thesystem uses theTrophon Disinfectantwhich is intended to beused exclusively withthe Trophon EPRdevice.The TrophonDisinfectant is intendedfor use as a High-LevelDisinfectant to be usedexclusively with theTrophon EPR for theHigh-Level Disinfectionof ultrasoundtransducers.The Trophon EPR issuitable for use ingeneral hospital andhealth care facilities bytrained personnel.The Trophon EPRsystem consists of amultiple use instrumentcombined with a singleuse disinfectant,delivered from a multi-dose cartridge.The TrophonDisinfectant should beused with the followingcontact conditions:Minimum OperationalCycle Time: 7 minutesMinimumConcentration: 31.5%	The trophon2 isdesigned to provideHigh-Level Disinfection(HLD) of validatedultrasound probes.High-Level Disinfectionis achieved by surfaceexposure to acontrolled dose ofhydrogen peroxide mistdelivered to adisinfection chambercontaining theultrasound probe.The trophon2 systemconsists of a multipleuse instrumentcombined with a singleuse disinfectant"trophon Sonex-HL",delivered from a multi-dose cartridge.The trophon2 issuitable for use ingeneral hospital andhealth care facilities bytrained personnel.The trophon Sonex-HLshould be used with thefollowing contactconditions:Minimum OperationalCycle Time: 7 minutesMinimumConcentration: 31.5%Minimum DisinfectantDose: 1.0 gMinimum ChamberTemperature: 56°C	Same
	Minimum Disinfectant Dose: 1.0 g
	Minimum Chamber Temperature: 56°C
OperatingPrinciple	Software controlledsystems that delivermeasured doses ofhydrogen peroxidedisinfectant to achieveHLD	Software controlledsystems that delivermeasured doses ofhydrogen peroxidedisinfectant to achieveHLD	Same
CriticalParameters forHLD	As per Table 1 above–minimum operatingconditions	As per Table 1 above–minimum operatingconditions	Same
Disinfectant	35% hydrogen peroxidein cartridge	35% hydrogen peroxidein cartridge	Same
Disinfectantdelivery	Liquid Aerosol Mist	Liquid Aerosol Mist	Same
DisinfectantRemoval Process	Automated aeration	Automated aeration	Same
ProcessMonitoring	Automated processmonitoring in the device	Automated processmonitoring in the device	Same
ChemicalIndicator	Trophon ChemicalIndicator (K103126)	Trophon ChemicalIndicator (K103126)	Same
MicrobiologyEfficacy /AOACPerformanceStandards	Meets the requirementsof Section III.H.5 ofContent and FormatPremarket Notification[510(k)] Submission forLiquid ChemicalSterilants/ High LevelDisinfectantsAOAC Methods	Meets the requirementsof Section III.H.5 ofContent and FormatPremarket Notification[510(k)] Submission forLiquid ChemicalSterilants/ High LevelDisinfectantsAOAC Methods	Same
DevicePerformanceStandards	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 removesresidues fromdisinfected transducers	Effectively removesresidues fromdisinfected transducers	Same
Device/ MaterialCompatibility	Meets the requirementsof Section III. J.2 ofContent and FormatPremarket Notification[510(k)] Submission forLiquid ChemicalSterilants/ High LevelDisinfectants	Meets the requirementsof Section III. J.2 ofContent and FormatPremarket Notification[510(k)] Submission forLiquid ChemicalSterilants/ High LevelDisinfectants	Same
Chamber design	Irregular shapedchamber	The trophon 2 chamberhas a more regularizedshape - the volume,height and depthremains the same.	Modified
Chambertemperature	Set point 75°C (167°F)in trophon EPR	Set point 65°C (149°F)in trophon2	Modified
Door lock	Solenoid	Motor and hookassembly	Modified
Probe clamp	Spring clip	Spring loaded cleats	Modified
All in OneCatalytic Destruct	Contains a MistCatalytic Destruct andLiquid CatalyticDestruct system.	An integrated catalyticdestruct system isintroduced as animprovement to themanufacturing process	Modified
Touch screen	A character LCD	A color touch screenpanel	Modified
Software/Firmware	Software controlledsystem- The TrophonEPR has a singlefirmware component	Software controlledsystem - trophon2 iscomprised of multiplesoftware/firmwarecomponents	Modified
Traceability	Traceability can bemanually implementedby downloading theTrophon EPR devicelogs during deviceservice or by using thesystem accessories:	An integrated RFIDmodule is introduced,allowing automatedtraceability features inthe device.Patient information isnot received orrecorded by the device,	NewFeature
	Trophon ConnectTrophon PrinterTrophon Logbook	therefore it cannot beaccessed via RFID.
Communicationports	Trophon EPR has 1serial port to connectwith external device i.etrophon printer	3 USB ports to connectto external device i.eprinter1 Ethernet port	Modified
	No network connectivityin trophon EPR	The trophon2 will beable to connectexternally to a networkvia the Ethernet port.

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Image /page/7/Picture/0 description: The image shows the logo for "nanosonics". The word "nano" is in blue, and the word "sonics" is in gray. There is a blue arc above the word "nano". Below the word "sonics" is the phrase "Infection Prevention. For Life.", with the words "Infection Prevention" in gray and the words "For Life" in blue.

Table 2: Comparison of Trophon EPR v trophon 2

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Image /page/8/Picture/0 description: The image shows the logo for Nanosonics. The word "nanosonics" is written in a stylized font, with the "nano" portion in blue and the "sonics" portion in gray. A blue arc is above the word "nanosonics". Below the word "nanosonics" is the phrase "Infection Prevention For Life."

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Image /page/9/Picture/0 description: The image shows the logo for Nanosonics. The word "nanosonics" is written in a stylized font, with "nano" in blue and "sonics" in gray. A blue arc is above the word "nano". Below the word "nanosonics" is the phrase "Infection Prevention. For Life."

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Image /page/10/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 text "Infection Prevention. For Life."

Summary of Non-Clinical Testing:

Non-clinical Testing was performed with the trophon2. The testing that was performed with the trophon2 device included Electromechanical and EMC testing, Biocompatibility, Microbiological Efficacy Testing, Validation testing of process parameters, Materials Compatibility, Stability testing of Sonex-HL and Verification Testing of the Chemical Indicator. The results from these tests demonstrated that the subject device met the acceptance criteria for each non-clinical test.

Conclusion Statement:

The information summarized above demonstrates that trophon2 is substantially equivalent to and is as safe and as effective as the legally marketed predicate device Trophon EPR (K103059), Class II (21CFR892.1570, Product code OUJ).

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
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.(b)
Classification. Class II.