(120 days)
No
The summary describes a device for disinfecting ultrasound probes and an accessory holder. There is no mention of AI or ML in the intended use, device description, or performance studies. The device is described as "software-controlled," which is common for many medical devices and does not inherently imply AI/ML.
No.
The device and its accessories are used for high-level disinfection of ultrasound transducers, not for treating any medical condition or directly interacting with the patient therapeutically.
No
The device is described as a system for High-Level Disinfection of ultrasound transducers, not for diagnosing medical conditions.
No
The device is described as a "trophon Wireless Ultrasound Probe Holder," which is an accessory to hardware devices (trophon EPR and trophon2). The description focuses on the physical holder and its function in facilitating the disinfection of wireless probes within the existing hardware systems. While the trophon EPR and trophon2 are mentioned as "software-controlled devices," the submitted device itself is a physical accessory, not a standalone software product.
Based on the provided information, the trophon Wireless Ultrasound Probe Holder is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use of the trophon Wireless Ultrasound Probe Holder, and the systems it's an accessory to (trophon EPR and trophon2), is for the High-Level Disinfection of ultrasound transducers. This is a process related to the sterilization and preparation of medical devices for use, not for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description confirms the device's function is to facilitate the disinfection of ultrasound probes.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Measuring analytes
- Using reagents for testing
The device is clearly intended for the reprocessing of medical equipment, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The trophon Wireless Ultrasound Probe Holder is an accessory to be added to the trophon EPR and trophon2 to allow wireless ultrasound probes to be disinfected.
trophon EPR:
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% Minimum Disinfectant Dose: 1.0 g Minimum Chamber Temperature: 56℃
trophon2:
The trophon2 is designed to provide High-Level Disinfection (HLD) of validated ultrasound transducers. High-Level Disinfection is achieved by surface exposure to a controlled dose of hydrogen peroxide mist delivered to a disinfection chamber contain 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
Product codes (comma separated list FDA assigned to the subject device)
OUJ
Device Description
The trophon Wireless Ultrasound Probe Holder is an accessory to be added to the trophon EPR and trophon2 to allow wireless ultrasound probes to be disinfected.
The Nanosonics trophon EPR and trophon2 are software-controlled devices which provide 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, supplied as an accessory to the device. Precleaned and dried ultrasound transducers are placed within the trophon EPR/trophon2 chamber and disinfected by means of an automated disinfection and aeration cycle. The disinfected ultrasound transducer is removed from the chamber 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
The trophon EPR and trophon2 are suitable for use in 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)
Efficacy Validation: High-level disinfection efficacy was evaluated by simulated use test using Mycobacterium terrae. Inoculation sites included Probe touchpoints, Probe scanning windows, Probe button, and 3 sites on the Probe Holder including touchpoints. Meets the recommendations of Section III. H.4 of Content and Format Premarket Notification [510(k)] Submission for Liquid Chemical Sterilants/ High Level Disinfectants. Results: Pass.
Dimensional: Dimensional assessment. The Probe Holder shall have physical dimensions that are accommodated by the trophon2 & EPR chambers. Results: Pass.
Residual Testing: Residual H2O2 assessment. Meets the recommendations of Section III. I.3 of Content and Format Premarket Notification [510(k)] Submission for Liquid Chemical Sterilants/ High Level Disinfectants. Results: Pass.
Material Compatibility: Life-time material compatibility assessment (5000 cycles). Meets the recommendations of Section III. J.2 of Content and Format Premarket Notification [510(k)] Submission for Liquid Chemical Sterilants/ High Level Disinfectants. Results: Pass.
Temperature Measurement: Temperature assessment. Probe Holder remains below operating temperature (60°C). Results: Pass.
Leak Test: System leak test performed. Meets the recommendations of Section III. J.2 of Content and Format Premarket Notification [510(k)] Submission for Liquid Chemical Sterilants/ High Level Disinfectants. Results: Pass.
Cleaning Validation: Cleaning test performed per AAMI TIR30:2016 and AAMI ST98:2022 and ISO 15883-5:2021 (E). Meets standards. Results: Pass.
Compatibility Test: The Wireless Ultrasound Probe Holder shall withstand 1000 wipe cycles when used with the trophon Companion Cleaning Wipes. Meets the recommendations of Section III. J.2a of Content and Format Premarket Notification [510(k)] Submission for Liquid Chemical Sterilants/ High Level Disinfectants. Results: Pass.
Transportation: Simulated transportation testing performed to ensure that packaging and device will not be compromised during shipping. Meets standard ASTM D4169-16. Results: Pass.
Lifetime Loading: Lifetime loading of Wireless Ultrasound Probe Holder into wireless ultrasound probe. Meets the recommendations of Section III. J.2 of Content and Format Premarket Notification [510(k)] Submission for Liquid Chemical Sterilants/ High Level Disinfectants. Results: Pass.
Drop Test: Drop test from 1 m height performed per Section 8.3.2 of IEC 61010-1: 2010 + AMD 2016. Ed. 3.1. Meets standard. Results: Pass.
Human Factors: A human factors validation study was conducted to ensure that the user interface and workflow are not impacted by the introduction of the subject device. Meets standards ANSI AAMI IEC 62366-1:2015+AMD1:2020, ANSI/AAMI HE75:2009/(R)2013, EN ISO 14971:2019. Results: Pass.
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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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.
September 27, 2024
Nanosonics Limited Nancy Kaiser Regulatory Affairs Manager 7-11 Talavera Road Macquarie Park, NSW 2113 Australia
Re: K241536
Trade/Device Name: trophon® Wireless Ultrasound Probe Holder Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasonic Transducer Regulatory Class: Class II Product Code: OUJ Dated: May 30, 2024 Received: August 29, 2024
Dear Nancy Kaiser:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Image /page/2/Picture/3 description: The image shows the name "Katharine Segars" followed by "-S". The text is in a large, clear font, making it easily readable. The background is plain, which helps the text stand out.
Katharine Segars, Ph.D. Assistant Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241536
Device Name
trophon® Wireless Ultrasound Probe Holder
Indications for Use (Describe)
The trophon Wireless Ultrasound Probe Holder is an accessory to be added to the trophon EPR and trophon2 to allow wireless ultrasound probes to be disinfected.
trophon EPR:
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% Minimum Disinfectant Dose: 1.0 g Minimum Chamber Temperature: 56℃
trophon2:
The trophon2 is designed to provide High-Level Disinfection (HLD) of validated ultrasound transducers. High-Level Disinfection is achieved by surface exposure to a controlled dose of hydrogen peroxide mist delivered to a disinfection chamber contain 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 Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
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Image /page/5/Picture/0 description: The image shows the logo for Nanosonics. The word "nanosonics" is written in a sans-serif 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." in a smaller font.
510(k) SUMMARY - trophon® Wireless Ultrasound Probe Holder
I. DATE PREPARED September 24, 2024
II. 510(k) NUMBER K241536
III. 510(k) SUBMITTER
Nanosonics Limited 7-11 Talavera Road Macquarie Park NSW 2113 Australia
Contact Person:
Nancy Kaiser, Regulatory Affairs Manager Address: 7-11 Talavera Road Macquarie Park, NSW 2113 Australia Email: n.kaiser@nanosonics.com Telephone: (317) 854-7625
IV. DEVICE
| Trade Name of Device: | trophon® Wireless Ultrasound Probe Holder. |
|---|---|
| Common or Usual Name: | High Level Disinfection Reprocessing Instrument for Ultrasonic Transducers, Mist |
| Classification: | II |
| Regulation Number: | 21 CFR 892.1570 |
| Product Code: | OUJ |
V. PREDICATE DEVICE
| Predicate Device | |
|---|---|
| Trade Name: | trophon2 |
| 510(k) Number: | K173865 |
| Company Name: | Nanosonics Ltd. |
Reference Device
| Trade Name: | trophon EPR |
|---|---|
| 510(k) Number: | K103059 |
| Company Name: | Nanosonics Ltd. |
VI. DEVICE DESCRIPTION
The trophon Wireless Ultrasound Probe Holder is an accessory to be added to the trophon EPR and trophon2 to allow wireless ultrasound probes to be disinfected.
The Nanosonics trophon EPR and trophon2 are software-controlled devices which provide 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, supplied as an accessory to the device. Precleaned and dried ultrasound transducers are placed within the trophon EPR/trophon2
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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 word "nano" is in blue, and the word "sonics" is in gray. Below the word "nanosonics" is the phrase "Infection Prevention. For Life." in a smaller font.
chamber and disinfected by means of an automated disinfection and aeration cycle. The disinfected ultrasound transducer is removed from the chamber and is ready for immediate use.
VII. INDICATIONS FOR USE
The trophon Wireless Ultrasound Probe Holder is an accessory to be added to the trophon EPR and trophon2 to allow wireless ultrasound probes to be disinfected.
trophon EPR:
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% Minimum Disinfectant Dose: 1.0 g Minimum Chamber Temperature: 56°C
trophon2:
The trophon2 is designed to provide High-Level Disinfection (HLD) of validated ultrasound transducers. High-Level Disinfection is achieved by surface exposure to a controlled dose of hydrogen peroxide mist delivered to a disinfection chamber contain 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
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Image /page/7/Picture/0 description: The image shows the logo for Nanosonics. The word "nanosonics" is written in a sans-serif font, with "nano" in blue and "sonics" in gray. Below the word "nanosonics" is the phrase "Infection Prevention. For Life." in a smaller, sans-serif font. A blue arc is above the word "nanosonics".
VIII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The trophon2 and the trophon EPR with the proposed Ultrasound Probe Holder are as safe and as effective in terms of technological characteristics and principles of operation to the predicate device, trophon2 and reference device, trophon EPR without the Ultrasound Probe Holder.
Like the predicate and reference devices, the trophon2 and trophon EPR still achieve HLD by having the probe suspended in their chamber, the Probe Holder is held in place by the cable clamp during high level disinfection to achieve this positioning for a wireless ultrasound probe. During each disinfection cycle, a controlled quantity of hydrogen peroxide mist is generated by a nebulizer and is delivered to the trophon EPR/trophon2 chamber. In the chamber, the mist directly contacts the wired or wireless ultrasound probe covering its surface. Contact occurs for a specified time, temperature, and liquid/mist dosage which determines the germicidal efficacy. The disinfected wired or wireless ultrasound transducer is removed from the chamber and is ready for immediate use. Design verification testing demonstrates that the proposed Wireless Ultrasound Probe Holder meets the product specifications and validation testing confirmed, intended use and user needs continue to be met.
| Feature | Table 1. A Comparison between the Subject and Predicate Device
Subject Device:
trophon2 (K241536) | Predicate Device:
trophon2 (K173865) | Comparison |
|-------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Nanosonics Limited | Nanosonics Limited | Same |
| Regulation Number | 21 CFR 892.1570 | 21 CFR 892.1570 | Same |
| Product Code | OUJ | OUJ | Same |
| Indication for
Use/Intended Use | The trophon Wireless Ultrasound
Probe Holder is an accessory to be
added to the trophon EPR and
trophon2 to allow wireless ultrasound
probes to be disinfected.
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 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: | The trophon2 is designed to provide
High-Level Disinfection (HLD) of
validated ultrasound transducers. High-
Level Disinfection is achieved by
surface exposure to a controlled dose of
hydrogen peroxide mist delivered to a
disinfection chamber contain 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 |
| Operating Principle | Software controlled systems
that deliver measured doses of
hydrogen peroxide disinfectant
to achieve High -Level
Disinfection (HLD) | Software controlled systems that
deliver measured doses of
hydrogen peroxide disinfectant to
achieve High -Level Disinfection
(HLD) | Same |
| Disinfectant | trophon Sonex-HL (35%
hydrogen peroxide in
cartridge) | trophon Sonex-HL (35%
hydrogen peroxide in cartridge) | Same |
| Disinfectant Delivery | Liquid Aerosol Mist | Liquid Aerosol Mist | Same |
| Disinfectant Removal
Process | Automate Aeration | Automate Aeration | Same |
| Process Monitoring | Automated process monitoring
in the device | Automated process monitoring in
the device | Same |
| Chemical Indicator
Required? | Yes, trophon chemical
indicator (cleared in K103126) | Yes, trophon chemical indicator
(cleared in K103126) | Same |
| Microbiology/Efficacy
AOAC Performance
Standards | Meets AOAC Methods | Meets AOAC Methods | Same |
| Device Performance
Standards | IEC 601010-1
IEC 61010-2-040
IEC 61326
IEC 62304
ISO 62366 -1 and -2
ISO 10993-1
ISO 14971 | IEC 601010-1
IEC 61010-2-040
IEC 61326
IEC 62304
ISO 62366 -1 and -2
ISO 10993-1
ISO 14971 | Same |
| Residue Testing | Effectively removes residues
from disinfected transducers | Effectively removes residues
from disinfected transducers | Same |
| Chamber Design | Regular shaped chamber | Irregular shaped chamber | Same |
| Chamber Temperature | Set point 65°C | Set point 75°C | Same |
| Door Lock | Motor and hook assembly | Motor and hook assembly | Same |
| Probe Clamp | Spring loaded cleats | Spring loaded cleats | Same |
| All in One Catalytic
Destruct | An integrated catalytic
destruct system | An integrated catalytic destruct
system | Same |
| Touch Screen | Color touch screen panel | Color touch screen panel | Same |
| Software/Firmware | Multiple software/firmware
components which are
deployed on two PCBAs | Multiple software/firmware
components which are deployed
on two PCBAs | Same |
| Traceability | An integrated RFID module
allowing automated
traceability features in the
device.
Patient information is not
received or recorded by the
device; therefore, it cannot be
accessed via RFID. | An integrated RFID module
allowing automated traceability
features in the device.
Patient information is not
received or recorded by the
device; therefore, it cannot be
accessed via RFID. | Same |
| Communication Ports | 3 USB ports to connect to
external device (i.e. printer)
1 Ethernet port
The trophon2 will be able to
connect externally to a | 3 USB ports to connect to
external device (i.e. printer)
1 Ethernet port
The trophon2 will be able to
connect externally to a network | Same |
| | network via the Ethernet port | via the Ethernet port | |
| Key Accessories | trophon AcuTrace Operator
Card
trophon AcuTrace Medical
Instrument Tag
trophon AcuTrace PLUS
activation Card | trophon AcuTrace Operator Card
trophon AcuTrace Medical
Instrument Tag
trophon AcuTrace PLUS
activation Card
trophon Sonex-HL | Same
An optional
Wireless
Ultrasound
Probe Holder |
| Image: Infection Prevention. For Life. | trophon Sonex-HL | | (provided
separately) to
provide high
level
disinfection for
wireless GE
ultrasound
probe (model:
Vscan Air CL) |
| Intended to provide high
level disinfection to
Wired Probes | Yes | Yes | Same
Wired Probes
and Validated
Wireless GE
Probe (model:
Vscan Air CL) |
Table 1. A Comparison between the Subject and Predicate Device
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Image /page/8/Picture/0 description: The image shows the logo for Nanosonics. The word "nanosonics" is written in a combination of blue and gray colors. A blue arc is above the word. Below the word "nanosonics" is the phrase "Infection Prevention. For Life."
9
Image /page/9/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 "nanosonics" is the phrase "Infection Prevention. For Life."
Table 2. A Comparison between the Subject and Reference Device
| Feature | Subject Device:
trophon EPR (K241536) | Reference Device:
trophon EPR (K103059) | Comparison |
|-------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Nanosonics Limited | Nanosonics Limited | Nanosonics Limited | Same |
| Regulation Number | 21 CFR 892.1570 | 21 CFR 892.1570 | Same |
| Product Code | OUJ | OUJ | Same |
| Indication for
Use/Intended Use | The trophon Wireless Ultrasound
Probe Holder is an accessory to be
added to the trophon EPR and
trophon2 to allow wireless
ultrasound probes to be disinfected.
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%
Minimum Disinfectant Dose: 1.0 g
Minimum Chamber Temperature:
56°C | 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%
Minimum Disinfectant Dose: 1.0 g
Minimum Chamber Temperature: 56°C | Same |
| Operating Principle | Software controlled systems
that deliver measured doses of
hydrogen peroxide
disinfectant to achieve High -
Level Disinfection (HLD) | Software controlled systems that
deliver measured doses of
hydrogen peroxide disinfectant to
achieve High -Level Disinfection
(HLD) | Same |
| Disinfectant | trophon Sonex-HL (35%
hydrogen peroxide in
cartridge) | trophon Sonex-HL (35%
hydrogen peroxide in cartridge) | Same |
| Disinfectant Delivery | Liquid Aerosol Mist | Liquid Aerosol Mist | Same |
| Disinfectant Removal
Process | Automate Aeration | Automate Aeration | Same |
| Process Monitoring | Automated process monitoring
in the device | Automated process monitoring in
the device | Same |
| Chemical Indicator
Required? | Yes, trophon chemical
indicator (cleared in K103126) | Yes, trophon chemical indicator
(cleared in K103126) | Same |
| Microbiology/Efficacy | Meets AOAC Methods | Meets AOAC Methods | Same |
| AOAC Performance
Standards | | | |
| Device Performance
Standards | IEC 601010-1
IEC 61010-2-040
IEC 61326
IEC 62304
ISO 62366 -1 and -2
ISO 10993-1
ISO 14971 | IEC 601010-1
IEC 61010-2-040
IEC 61326
IEC 62304
ISO 62366 -1 and -2
ISO 10993-1
ISO 14971 | Same |
| Residue Testing | Effectively removes residues
from disinfected transducers | Effectively removes residues
from disinfected transducers | Same |
| Chamber Design | Irregular shaped chamber | Irregular shaped chamber | Same |
| Chamber Temperature | Set point 75°C | Set point 75°C | Same |
| Door Lock | Solenoid | Solenoid | Same |
| Probe Clamp | Spring clip | Spring clip | Same |
| All in One Catalytic
Destruct | Contains a mist catalytic
destruct and liquid catalytic
destruct system | Contains a mist catalytic destruct
and liquid catalytic destruct
system | Same |
| Touch Screen | A character LCD | A character LCD | Same |
| Software/Firmware | Single firmware component
deployed on the main board
PCBA | Single firmware component
deployed on the main board
PCBA | Same |
| Traceability | Manually implemented by
downloading the trophon EPR
device logs during device
service or by using the system
accessories: trophon Connect,
trophon printer and trophon
Logbook | Manually implemented by
downloading the trophon EPR
device logs during device service
or by using the system
accessories: trophon Connect,
trophon printer and trophon
Logbook | Same |
| Communication Ports | 1 serial port to connect with
external device (trophon
printer)
No network connectivity in
trophon EPR
Integration to hospital network
is not available | 1 serial port to connect with
external device (trophon printer)
No network connectivity in
trophon EPR
Integration to hospital network is
not available | Same |
| Key Accessories | trophon Curved Probe
Positioner | trophon Curved Probe Positioner
trophon Sonex-HL | Same |
| | trophon Sonex-HL | | An optional
Wireless |
| | | | |
| | | | Ultrasound Probe
Holder (provided
separately) to
provide high level
disinfection for
wireless GE
ultrasound probe
(model: Vscan Air
CL) |
| Intended to provide high
level disinfection to
Wired Probes | Yes | Yes | Same
Wired Probes and
Validated Wireless
GE Probe (model:
Vscan Air CL) |
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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. The first part of the word, "nano," is in blue, while the second part, "sonics," is in gray. Below the word "nanosonics," there is a tagline that reads "Infection Prevention. For Life." in smaller font size.
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Image /page/11/Picture/0 description: The image shows the logo for Nanosonics. The word "nanosonics" is written in a combination of blue and gray colors. The first part of the word, "nano," is in blue, while the second part, "sonics," is in gray. Below the word "nanosonics" is the text "Infection Prevention. For Life." in a smaller font size and gray color.
SUMMARY OF NON-CLINICAL TESTING IX.
In support of the substantial equivalence determination, the following non-clinical tests were performed:
| Test | Brief Description | Applicable Standard | Acceptance Criteria | Results (Pass/Fail) |
|---|---|---|---|---|
| Efficacy | ||||
| Validation | High-level disinfection | |||
| efficacy was evaluated by | ||||
| simulated use test using | ||||
| Mycobacterium terrae. | ||||
| Inoculation sites included: | ||||
| • Probe touchpoints | ||||
| • Probe scanning | ||||
| windows | ||||
| • Probe button | ||||
| • 3 sites on the Probe | ||||
| Holder including | ||||
| touchpoints | ||||
| (same test methods and | ||||
| acceptance criteria as | ||||
| K103059 and K173865) | N/A | Meets the | ||
| recommendations of | ||||
| Section III. H.4 of Content | ||||
| and Format Premarket | ||||
| Notification [510(k)] | ||||
| Submission for Liquid | ||||
| Chemical Sterilants/ High | ||||
| Level Disinfectants | Pass | |||
| Dimensional | Dimensional assessment | |||
| (same test methods and | ||||
| acceptance criteria as | ||||
| K103059 and K173865 | N/A | The Probe Holder shall | ||
| have physical dimensions | ||||
| that are accommodated by | ||||
| the trophon2 & EPR | ||||
| chambers. | Pass | |||
| Residual | ||||
| Testing | Residual H2O2 assessment | |||
| (same test methods and | ||||
| acceptance criteria as | ||||
| K103059 and K173865 | N/A | Meets the | ||
| recommendations of | ||||
| Section III. I.3 of Content | ||||
| and Format Premarket | ||||
| Notification [510(k)] | ||||
| Submission for Liquid | ||||
| Chemical Sterilants/ High | ||||
| Level Disinfectants | Pass | |||
| Material | ||||
| Compatibility | Life-time material | |||
| compatibility assessment | ||||
| (5000 cycles) | ||||
| (same test methods and | N/A | Meets the | ||
| recommendations of | ||||
| Section III. J.2 of Content | ||||
| and Format Premarket | Pass | |||
| acceptance criteria as | ||||
| K103059 and K173865) | Notification [510(k)] | |||
| Submission for Liquid | ||||
| Chemical Sterilants/ High | ||||
| Level Disinfectants | ||||
| Temperature | ||||
| Measurement | Temperature assessment | |||
| (same test methods and | ||||
| acceptance criteria as | ||||
| K103059 and K173865) | N/A | Probe Holder remains | ||
| below operating | ||||
| temperature (60°C) | Pass | |||
| Leak Test | System leak test performed | |||
| (same test methods and | ||||
| acceptance criteria as | ||||
| K103059 and K173865) | N/A | Meets the | ||
| recommendations of | ||||
| Section III. J.2 of Content | ||||
| and Format Premarket | ||||
| Notification [510(k)] | ||||
| Submission for Liquid | ||||
| Chemical Sterilants/ High | ||||
| Level Disinfectants | Pass | |||
| Cleaning | ||||
| Validation | Cleaning test performed per | |||
| AAMI TIR30:2016 and | ||||
| AAMI ST98:2022 and ISO | ||||
| 15883-5:2021 (E) | AAMI TIR30:2016 | |||
| and AAMI | ||||
| ST98:2022 | ||||
| and ISO 15883- | ||||
| 5:2021 (E) | Meets standards | Pass | ||
| Compatibility | ||||
| Test | The Wireless Ultrasound | |||
| Probe Holder shall | ||||
| withstand 1000 wipe cycles | ||||
| when used with the trophon | ||||
| Companion Cleaning | ||||
| Wipes. | N/A | Meets the | ||
| recommendations of | ||||
| Section III. J.2a of | ||||
| Content and Format | ||||
| Premarket Notification | ||||
| [510(k)] Submission for | ||||
| Liquid Chemical | ||||
| Sterilants/ High Level | ||||
| Disinfectants | Pass | |||
| Transportation | Simulated transportation | |||
| testing performed to ensure | ||||
| that packaging and device | ||||
| will not be compromised | ||||
| during shipping. | ASTM D4169-16 | Meets standard | Pass | |
| Lifetime | ||||
| Loading | Lifetime loading of Wireless | |||
| Ultrasound Probe Holder | ||||
| into wireless ultrasound | ||||
| probe | N/A | Meets the | ||
| recommendations of | ||||
| Section III. J.2 of Content | ||||
| and Format Premarket | ||||
| Notification [510(k)] | ||||
| Submission for Liquid | ||||
| Chemical Sterilants/ High | ||||
| Level Disinfectants | Pass | |||
| Drop Test | Drop test from 1 m height | |||
| performed per Section 8.3.2 | ||||
| of IEC 61010-1: 2010 + | ||||
| AMD 2016. Ed. 3.1 | IEC 61010-1: 2010 |
- AMD 2016. Ed.
3.1 | Meets standard | Pass |
| Human Factors | A human factors validation
study was conducted to
ensure that the user interface
and workflow are not
impacted by the introduction
of the subject device. | ANSI AAMI IEC
62366-
1:2015+AMD1:2020
ANSI/AAMI
HE75:2009/
(R)2013
EN ISO 14971:2019 | Meets standards | Pass |
Table 3. Summary of Non-clinical Testing
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Image /page/12/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, there is a tagline that reads "Infection Prevention. For Life."
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Image /page/13/Picture/0 description: The image shows the logo for Nanosonics. The word "nanosonics" is written in a combination of blue and gray colors. The word "nano" is in blue, and the word "sonics" is in gray. Below the word "nanosonics" is the phrase "Infection Prevention. For Life." in a smaller font.
CLINICAL TESTING X. N/A
CONCLUSION XI.
Based on the intended use, technological characteristics and non-clinical testing, the subject device is as safe and as effective and performs at least as safely and effectively as the predicate device.