(125 days)
No
The description focuses on the automated disinfection process and mentions "software controlled" but does not indicate any AI/ML capabilities for decision-making or analysis.
No
Explanation: The device is designed to provide high-level disinfection of ultrasound probes, not to directly treat a medical condition or perform a medical procedure on a patient. It is a sterilization/disinfection device for medical equipment.
No
The device is described as providing high-level disinfection for ultrasound probes, which is a sterilization or cleaning function, not a diagnostic one.
No
The device description clearly states it is a "software controlled device" but also describes physical components like a "sealed disinfection chamber" and operates with a "multi-dose cartridge of concentrated hydrogen peroxide disinfectant". It is a hardware device with integrated software control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is "High-Level Disinfection (HLD) of validated ultrasound probes." This is a process for cleaning and sterilizing medical devices, not for performing diagnostic tests on patient samples.
- Device Description: The device description focuses on the mechanism of disinfection using hydrogen peroxide mist within a chamber. It does not describe any components or processes related to analyzing biological samples or generating diagnostic information.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing patient samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes (biomarkers, pathogens, etc.)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
- Predicate Device: The predicate device (K103059 Trophon EPR) is also a high-level disinfection system for ultrasound probes, further supporting that this device falls under the category of medical device disinfection rather than IVD.
In summary, the trophon2 is a medical device designed for the disinfection of other medical devices (ultrasound probes), not for performing diagnostic tests on patient samples.
N/A
Intended 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℃
Product codes (comma separated list FDA assigned to the subject device)
OUJ
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.
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
general hospital and health care facilities by trained personnel.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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);
1
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 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
14 Mars Road
Lane Cove, NSW, 2066
Australia
Ph: +61 2 8063 1600
Fax: +61 2 9317 5010 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dr. Frederic Bustos
Head of Regulatory Affairs
Nanosonics Limited
14 Mars Road
Lane Cove, NSW 2066
Ph: +61 2 8063 1600
Fax: +61 2 9317 5010 |
| Brand Name: | trophon2 |
| Common Name: | Hydrogen Peroxide High-Level Disinfection system for
ultrasound transducers |
| Classification Name: | 21CFR 892.1570 – High Level Disinfection Reprocessing
Instrument 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:
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
Parameters for HLD | Trophon EPR
(predicate) | trophon 2 | Same/
Modified |
|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Operational Cycle
Time | Minimum 7 minutes | Minimum 7 minutes | Same |
| Concentration of
hydrogen peroxide | Minimum of 31.5%
hydrogen peroxide | Minimum of 31.5%
hydrogen peroxide | Same |
| Dosage of hydrogen
peroxide | Minimum of 1g | Minimum of 1g | Same |
| Chamber
Temperature | Minimum of 56°C | Minimum of 56°C | Same |
| Device Design | Trophon EPR
(predicate) | trophon 2 | Same /
Modified |
| Indications for
use | The Trophon EPR is
designed to provide
High-Level Disinfection
of ultrasound
transducers. The
system uses the
Trophon Disinfectant
which is intended to be
used exclusively with
the Trophon EPR
device.
The Trophon
Disinfectant is intended
for use as a High-Level
Disinfectant to be used
exclusively with the
Trophon EPR for the
High-Level Disinfection
of ultrasound
transducers.
The Trophon EPR is
suitable for use in
general hospital and
health care facilities by
trained personnel.
The Trophon EPR
system consists of a
multiple use instrument
combined with a single
use disinfectant,
delivered from a multi-
dose cartridge.
The Trophon
Disinfectant should be
used with the following
contact conditions:
Minimum Operational
Cycle Time: 7 minutes
Minimum
Concentration: 31.5% | 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 | Same |
| | Minimum Disinfectant Dose: 1.0 g | | |
| | Minimum Chamber Temperature: 56°C | | |
| Operating
Principle | Software controlled
systems that deliver
measured doses of
hydrogen peroxide
disinfectant to achieve
HLD | Software controlled
systems that deliver
measured doses of
hydrogen peroxide
disinfectant to achieve
HLD | Same |
| Critical
Parameters for
HLD | As per Table 1 above–
minimum operating
conditions | As per Table 1 above–
minimum operating
conditions | Same |
| Disinfectant | 35% hydrogen peroxide
in cartridge | 35% hydrogen peroxide
in cartridge | Same |
| Disinfectant
delivery | Liquid Aerosol Mist | Liquid Aerosol Mist | Same |
| Disinfectant
Removal Process | Automated aeration | Automated aeration | Same |
| Process
Monitoring | Automated process
monitoring in the device | Automated process
monitoring in the device | Same |
| Chemical
Indicator | Trophon Chemical
Indicator (K103126) | Trophon Chemical
Indicator (K103126) | Same |
| Microbiology
Efficacy /
AOAC
Performance
Standards | Meets the requirements
of Section III.H.5 of
Content and Format
Premarket Notification
[510(k)] Submission for
Liquid Chemical
Sterilants/ High Level
Disinfectants
AOAC Methods | Meets the requirements
of Section III.H.5 of
Content and Format
Premarket Notification
[510(k)] Submission for
Liquid Chemical
Sterilants/ High Level
Disinfectants
AOAC Methods | Same |
| Device
Performance
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
residues from
disinfected transducers | Effectively removes
residues from
disinfected transducers | Same |
| Device/ Material
Compatibility | Meets the requirements
of Section III. J.2 of
Content and Format
Premarket Notification
[510(k)] Submission for
Liquid Chemical
Sterilants/ High Level
Disinfectants | Meets the requirements
of Section III. J.2 of
Content and Format
Premarket Notification
[510(k)] Submission for
Liquid Chemical
Sterilants/ High Level
Disinfectants | Same |
| Chamber design | Irregular shaped
chamber | The trophon 2 chamber
has a more regularized
shape - the volume,
height and depth
remains the same. | Modified |
| Chamber
temperature | Set point 75°C (167°F)
in trophon EPR | Set point 65°C (149°F)
in trophon2 | Modified |
| Door lock | Solenoid | Motor and hook
assembly | Modified |
| Probe clamp | Spring clip | Spring loaded cleats | Modified |
| All in One
Catalytic Destruct | Contains a Mist
Catalytic Destruct and
Liquid Catalytic
Destruct system. | An integrated catalytic
destruct system is
introduced as an
improvement to the
manufacturing process | Modified |
| Touch screen | A character LCD | A color touch screen
panel | Modified |
| Software/
Firmware | Software controlled
system- The Trophon
EPR has a single
firmware component | Software controlled
system - trophon2 is
comprised of multiple
software/firmware
components | Modified |
| Traceability | Traceability can be
manually implemented
by downloading the
Trophon EPR device
logs during device
service or by using the
system accessories: | An integrated RFID
module is introduced,
allowing automated
traceability features in
the device.
Patient information is
not received or
recorded by the device, | New
Feature |
| | Trophon Connect
Trophon Printer
Trophon Logbook | therefore it cannot be
accessed via RFID. | |
| Communication
ports | Trophon EPR has 1
serial port to connect
with external device i.e
trophon printer | 3 USB ports to connect
to external device i.e
printer
1 Ethernet port | Modified |
| | No network connectivity
in trophon EPR | The trophon2 will be
able to connect
externally to a network
via 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).