(120 days)
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
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.
The provided text from the FDA 510(k) submission for the "trophon® Wireless Ultrasound Probe Holder" details the acceptance criteria and study results for non-clinical testing. However, it does not contain information about clinical studies, MRMC studies, or AI/algorithm-only performance. This device is an accessory for an existing high-level disinfection system and not a diagnostic AI device. Therefore, many of the requested categories related to AI development and clinical study methodologies are not applicable or present in this document.
Here's the breakdown of the information that is available, formatted as requested:
Device: trophon® Wireless Ultrasound Probe Holder (Accessory for trophon EPR and trophon2 High-Level Disinfection systems)
Purpose: To allow wireless ultrasound probes to be disinfected in existing trophon systems.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Brief Description | Applicable Standard | Acceptance Criteria | Results (Pass/Fail) |
|---|---|---|---|---|
| Efficacy Validation | High-level disinfection efficacy 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 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 |
| 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 |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a numerical count for each test. The descriptions refer to "simulated use," "assessments," and testing "the Wireless Ultrasound Probe Holder." Given the nature of mechanical/material testing for an accessory, the sample sizes would typically be determined by engineering standards (e.g., number of units tested, number of cycles).
- Data Provenance: The document does not specify the country of origin for the test data for the non-clinical tests. The tests are described as "simulated use," "assessments," and compatibility/durability tests directly on the device accessory. It implies these were performed as part of the device's development and regulatory submission. The document is a 510(k) submission, not a clinical trial report.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable and not provided. The "ground truth" for this device accessory's performance is based on engineering and microbiology standards (e.g., disinfection efficacy, material compatibility, dimensional accuracy), not on expert clinical interpretation or consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 refer to agreement among multiple readers (e.g., radiologists) for clinical ground truth establishment, which is not relevant for this type of non-clinical device testing.
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. This is a medical device accessory for high-level disinfection, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device accessory and does not involve AI algorithms or standalone software performance in the context of diagnostic interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is established by engineering and microbiological standards and specifications. For example:
- Efficacy: Reduction of Mycobacterium terrae to specified log levels (as per FDA guidance for HLD devices).
- Dimensional: Conforming to design specifications to fit existing trophon systems.
- Material Compatibility: No degradation after a specified number of cycles.
- Human Factors: Conformance to usability standards ensuring safe and effective use.
8. The sample size for the training set:
- Not applicable. This device does not use machine learning or AI that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.
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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"
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(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).
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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
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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.
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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 DeviceSubject 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 forUse/Intended Use | The trophon Wireless UltrasoundProbe Holder is an accessory to beadded to the trophon EPR andtrophon2 to allow wireless ultrasoundprobes to be disinfected.The trophon2 is designed to provideHigh-level Disinfection (HLD) ofvalidated ultrasound probes, High-Level Disinfection is achieved bysurface exposure to a controlled doseof hydrogen peroxide mist delivered toa disinfection chamber containing theultrasound probe.The trophon2 is suitable for use ingeneral hospital and health carefacilities by trained personnel.The trophon Sonex-HL should beused with the following contactconditions:Minimum Operational Cycle Time: 7minutesMinimum Concentration: 31.5%Minimum Disinfectant Dose: 1.0 gMinimum Chamber Temperature: | The trophon2 is designed to provideHigh-Level Disinfection (HLD) ofvalidated ultrasound transducers. High-Level Disinfection is achieved bysurface exposure to a controlled dose ofhydrogen peroxide mist delivered to adisinfection chamber contain theultrasound probe.The trophon2 system consists of amultiple use instrument combined with asingle use disinfectant "trophon Sonex-HL", delivered from a multi-dosecartridge.The trophon2 is suitable for use ingeneral hospital and health care facilitiesby trained personnel.The trophon Sonex-HL should be usedwith the following contact conditions:Minimum Operational Cycle Time: 7minutesMinimum Concentration: 31.5%Minimum Disinfectant Dose: 1.0 gMinimum Chamber Temperature: 56°C | Same |
| Operating Principle | Software controlled systemsthat deliver measured doses ofhydrogen peroxide disinfectantto achieve High -LevelDisinfection (HLD) | Software controlled systems thatdeliver measured doses ofhydrogen peroxide disinfectant toachieve High -Level Disinfection(HLD) | Same |
| Disinfectant | trophon Sonex-HL (35%hydrogen peroxide incartridge) | trophon Sonex-HL (35%hydrogen peroxide in cartridge) | Same |
| Disinfectant Delivery | Liquid Aerosol Mist | Liquid Aerosol Mist | Same |
| Disinfectant RemovalProcess | Automate Aeration | Automate Aeration | Same |
| Process Monitoring | Automated process monitoringin the device | Automated process monitoring inthe device | Same |
| Chemical IndicatorRequired? | Yes, trophon chemicalindicator (cleared in K103126) | Yes, trophon chemical indicator(cleared in K103126) | Same |
| Microbiology/EfficacyAOAC PerformanceStandards | Meets AOAC Methods | Meets AOAC Methods | Same |
| Device PerformanceStandards | IEC 601010-1IEC 61010-2-040IEC 61326IEC 62304ISO 62366 -1 and -2ISO 10993-1ISO 14971 | IEC 601010-1IEC 61010-2-040IEC 61326IEC 62304ISO 62366 -1 and -2ISO 10993-1ISO 14971 | Same |
| Residue Testing | Effectively removes residuesfrom disinfected transducers | Effectively removes residuesfrom 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 CatalyticDestruct | An integrated catalyticdestruct system | An integrated catalytic destructsystem | Same |
| Touch Screen | Color touch screen panel | Color touch screen panel | Same |
| Software/Firmware | Multiple software/firmwarecomponents which aredeployed on two PCBAs | Multiple software/firmwarecomponents which are deployedon two PCBAs | Same |
| Traceability | An integrated RFID moduleallowing automatedtraceability features in thedevice.Patient information is notreceived or recorded by thedevice; therefore, it cannot beaccessed via RFID. | An integrated RFID moduleallowing automated traceabilityfeatures in the device.Patient information is notreceived or recorded by thedevice; therefore, it cannot beaccessed via RFID. | Same |
| Communication Ports | 3 USB ports to connect toexternal device (i.e. printer)1 Ethernet portThe trophon2 will be able toconnect externally to a | 3 USB ports to connect toexternal device (i.e. printer)1 Ethernet portThe trophon2 will be able toconnect externally to a network | Same |
| network via the Ethernet port | via the Ethernet port | ||
| Key Accessories | trophon AcuTrace OperatorCardtrophon AcuTrace MedicalInstrument Tagtrophon AcuTrace PLUSactivation Card | trophon AcuTrace Operator Cardtrophon AcuTrace MedicalInstrument Tagtrophon AcuTrace PLUSactivation Cardtrophon Sonex-HL | SameAn optionalWirelessUltrasoundProbe Holder |
| Image: Infection Prevention. For Life. | trophon Sonex-HL | (providedseparately) toprovide highleveldisinfection forwireless GEultrasoundprobe (model:Vscan Air CL) | |
| Intended to provide highlevel disinfection toWired Probes | Yes | Yes | SameWired Probesand ValidatedWireless GEProbe (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."
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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 forUse/Intended Use | The trophon Wireless UltrasoundProbe Holder is an accessory to beadded to the trophon EPR andtrophon2 to allow wirelessultrasound probes to be disinfected.The trophon EPR is designed toprovide High-Level Disinfection ofultrasound transducers. The systemuses the trophon Disinfectant whichis intended to be used exclusivelywith the trophon EPR device.The trophon Disinfectant is intendedfor use as a High-Level Disinfectantto be used exclusively with thetrophon EPR for the High-LevelDisinfection of ultrasoundtransducers.The trophon EPR is suitable for usein general hospital and health carefacilities by trained personnel.The trophon EPR system consists ofa multiple use instrument combinedwith a single use disinfectant,delivered from a multi-dosecartridge.The trophon Disinfectant should beused with the following contactconditions:Minimum Operational Cycle Time:7 minutesMinimum Concentration: 31.5%Minimum Disinfectant Dose: 1.0 gMinimum Chamber Temperature:56°C | The trophon EPR is designed to provideHigh-Level Disinfection of ultrasoundtransducers. The system uses the trophonDisinfectant which is intended to beused exclusively with the trophon EPRdevice.The trophon Disinfectant is intended foruse as a High-Level Disinfectant to beused exclusively with the trophon EPRfor the High-Level Disinfection ofultrasound transducers.The trophon EPR is suitable for use ingeneral hospital and health care facilitiesby trained personnel.The trophon EPR system consists of amultiple use instrument combined with asingle use disinfectant, delivered from amulti-dose cartridge.The trophon Disinfectant should be usedwith the following contact conditions:Minimum Operational Cycle Time: 7minutesMinimum Concentration: 31.5%Minimum Disinfectant Dose: 1.0 gMinimum Chamber Temperature: 56°C | Same |
| Operating Principle | Software controlled systemsthat deliver measured doses ofhydrogen peroxidedisinfectant to achieve High -Level Disinfection (HLD) | Software controlled systems thatdeliver measured doses ofhydrogen peroxide disinfectant toachieve High -Level Disinfection(HLD) | Same |
| Disinfectant | trophon Sonex-HL (35%hydrogen peroxide incartridge) | trophon Sonex-HL (35%hydrogen peroxide in cartridge) | Same |
| Disinfectant Delivery | Liquid Aerosol Mist | Liquid Aerosol Mist | Same |
| Disinfectant RemovalProcess | Automate Aeration | Automate Aeration | Same |
| Process Monitoring | Automated process monitoringin the device | Automated process monitoring inthe device | Same |
| Chemical IndicatorRequired? | Yes, trophon chemicalindicator (cleared in K103126) | Yes, trophon chemical indicator(cleared in K103126) | Same |
| Microbiology/Efficacy | Meets AOAC Methods | Meets AOAC Methods | Same |
| AOAC PerformanceStandards | |||
| Device PerformanceStandards | IEC 601010-1IEC 61010-2-040IEC 61326IEC 62304ISO 62366 -1 and -2ISO 10993-1ISO 14971 | IEC 601010-1IEC 61010-2-040IEC 61326IEC 62304ISO 62366 -1 and -2ISO 10993-1ISO 14971 | Same |
| Residue Testing | Effectively removes residuesfrom disinfected transducers | Effectively removes residuesfrom 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 CatalyticDestruct | Contains a mist catalyticdestruct and liquid catalyticdestruct system | Contains a mist catalytic destructand liquid catalytic destructsystem | Same |
| Touch Screen | A character LCD | A character LCD | Same |
| Software/Firmware | Single firmware componentdeployed on the main boardPCBA | Single firmware componentdeployed on the main boardPCBA | Same |
| Traceability | Manually implemented bydownloading the trophon EPRdevice logs during deviceservice or by using the systemaccessories: trophon Connect,trophon printer and trophonLogbook | Manually implemented bydownloading the trophon EPRdevice logs during device serviceor by using the systemaccessories: trophon Connect,trophon printer and trophonLogbook | Same |
| Communication Ports | 1 serial port to connect withexternal device (trophonprinter)No network connectivity introphon EPRIntegration to hospital networkis not available | 1 serial port to connect withexternal device (trophon printer)No network connectivity introphon EPRIntegration to hospital network isnot available | Same |
| Key Accessories | trophon Curved ProbePositioner | trophon Curved Probe Positionertrophon Sonex-HL | Same |
| trophon Sonex-HL | An optionalWireless | ||
| Ultrasound ProbeHolder (providedseparately) toprovide high leveldisinfection forwireless GEultrasound probe(model: Vscan AirCL) | |||
| Intended to provide highlevel disinfection toWired Probes | Yes | Yes | SameWired Probes andValidated WirelessGE 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) |
|---|---|---|---|---|
| EfficacyValidation | High-level disinfectionefficacy was evaluated bysimulated use test usingMycobacterium terrae.Inoculation sites included:• Probe touchpoints• Probe scanningwindows• Probe button• 3 sites on the ProbeHolder includingtouchpoints(same test methods andacceptance criteria asK103059 and K173865) | N/A | Meets therecommendations ofSection III. H.4 of Contentand Format PremarketNotification [510(k)]Submission for LiquidChemical Sterilants/ HighLevel Disinfectants | Pass |
| Dimensional | Dimensional assessment(same test methods andacceptance criteria asK103059 and K173865 | N/A | The Probe Holder shallhave physical dimensionsthat are accommodated bythe trophon2 & EPRchambers. | Pass |
| ResidualTesting | Residual H2O2 assessment(same test methods andacceptance criteria asK103059 and K173865 | N/A | Meets therecommendations ofSection III. I.3 of Contentand Format PremarketNotification [510(k)]Submission for LiquidChemical Sterilants/ HighLevel Disinfectants | Pass |
| MaterialCompatibility | Life-time materialcompatibility assessment(5000 cycles)(same test methods and | N/A | Meets therecommendations ofSection III. J.2 of Contentand Format Premarket | Pass |
| acceptance criteria asK103059 and K173865) | Notification [510(k)]Submission for LiquidChemical Sterilants/ HighLevel Disinfectants | |||
| TemperatureMeasurement | Temperature assessment(same test methods andacceptance criteria asK103059 and K173865) | N/A | Probe Holder remainsbelow operatingtemperature (60°C) | Pass |
| Leak Test | System leak test performed(same test methods andacceptance criteria asK103059 and K173865) | N/A | Meets therecommendations ofSection III. J.2 of Contentand Format PremarketNotification [510(k)]Submission for LiquidChemical Sterilants/ HighLevel Disinfectants | Pass |
| CleaningValidation | Cleaning test performed perAAMI TIR30:2016 andAAMI ST98:2022 and ISO15883-5:2021 (E) | AAMI TIR30:2016and AAMIST98:2022and ISO 15883-5:2021 (E) | Meets standards | Pass |
| CompatibilityTest | The Wireless UltrasoundProbe Holder shallwithstand 1000 wipe cycleswhen used with the trophonCompanion CleaningWipes. | N/A | Meets therecommendations ofSection III. J.2a ofContent and FormatPremarket Notification[510(k)] Submission forLiquid ChemicalSterilants/ High LevelDisinfectants | Pass |
| Transportation | Simulated transportationtesting performed to ensurethat packaging and devicewill not be compromisedduring shipping. | ASTM D4169-16 | Meets standard | Pass |
| LifetimeLoading | Lifetime loading of WirelessUltrasound Probe Holderinto wireless ultrasoundprobe | N/A | Meets therecommendations ofSection III. J.2 of Contentand Format PremarketNotification [510(k)]Submission for LiquidChemical Sterilants/ HighLevel Disinfectants | Pass |
| Drop Test | Drop test from 1 m heightperformed per Section 8.3.2of 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 validationstudy was conducted toensure that the user interfaceand workflow are notimpacted by the introductionof the subject device. | ANSI AAMI IEC62366-1:2015+AMD1:2020ANSI/AAMIHE75:2009/(R)2013EN 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.
§ 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.