(172 days)
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: 4 minutes
- Minimum Concentration: 31.5%
- Minimum Disinfectant Dose: 1.0 g
- Minimum Chamber Temperature: 56°C
The trophon2 is a software-controlled device which provides High- Level Disinfection of validated ultrasound probes. 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. Pre-cleaned and dried ultrasound transducers are placed within the trophon2 chamber and disinfected by means of an automated disinfection and aeration cycle.
The provided text is a 510(k) clearance letter for a medical device called "trophon2". It focuses on proving the new version of trophon2 is substantially equivalent to a previously cleared version, primarily through non-clinical testing. This document does not describe a study involving an AI model for medical image analysis, nor does it detail a multi-reader multi-case (MRMC) study or expert adjudication for ground truth related to medical imaging.
The device, trophon2, is a High-Level Disinfection (HLD) system for ultrasound transducers, a piece of equipment for cleaning medical devices, not an AI diagnostic tool. Therefore, many of the requested categories (e.g., number of experts for ground truth, MRMC study, training set ground truth) are not applicable to the information provided in this regulatory document.
However, based on the non-clinical testing section, I can extract and present the acceptance criteria and reported device performance related to its disinfection capabilities.
Analysis of Acceptance Criteria and Device Performance for trophon2 (K250434)
The trophon2 device, as described in the 510(k) submission K250434, is a High-Level Disinfection (HLD) system for ultrasound transducers. The evaluation presented in the document is primarily a demonstration of its substantial equivalence to a previously cleared version of the trophon2 (K173865) by fulfilling specified non-clinical performance and safety standards.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the trophon2 are based on its ability to perform High-Level Disinfection effectively and safely, as well as adherence to relevant industry standards.
| Test Category | Test / Parameter | Applicable Standard / Guidance | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|---|
| Efficacy | Mycobactericidal Efficacy Test | AOAC 6.3.06:2012; FDA Guidance "Content and Format Premarket Notification [510(k)] Submission for Liquid Chemical Sterilants/ High Level Disinfectants" Jan 2000, Section III. H.5a | Meets recommendations of Section III. H.5a | Pass |
| Efficacy | Fungicidal Efficacy Test | AOAC 6.3.02:2006 | Not explicitly stated, implied by standard compliance | Pass |
| Efficacy | Bactericidal Efficacy Test | AOAC 6.2.02:2006, AOAC 6.2.03:2006, AOAC 6.2.05:2006 | Not explicitly stated, implied by standard compliance | Pass |
| Efficacy | Virucidal Efficacy Test (Poliovirus type 1) | N/A (Internal protocol implied) | Not explicitly stated, implied by Pass result | Pass |
| Efficacy | Virucidal Efficacy Test (Herpes simplex virus type 1) | N/A (Internal protocol implied) | Not explicitly stated, implied by Pass result | Pass |
| Simulated Use | Simulated Use Test | ASTM E1837-96(2014); FDA Guidance "Content and Format Premarket Notification [510(k)] Submission for Liquid Chemical Sterilants/ High Level Disinfectants" Jan 2000, Section III. H.4 | Meets recommendations of Section III. H.4 | Pass |
| Critical Process Parameters | 1. Temperature Sensor | N/A (Internal protocol, same as K173865) | The verification sensor temperature is equal to or greater than the lower verification sensor temperature limit at any time during all disinfection cycles at temperature setpoint. | Pass |
| Critical Process Parameters | 2. Dose Sensor vs Consumption Assessment | N/A (Internal protocol, same as K173865) | The dose limits for a disinfection cycle shall correspond to the defined operational range of the device. | Pass |
| Critical Process Parameters | 3. Dosage Measurement | N/A (Internal protocol, same as K173865) | Within the upper and lower limits of the dosage sensors corresponding to the defined operational range of the device. | Pass |
| Critical Process Parameters | 4. Flow Rate Measurement | N/A (Internal protocol, same as K173865) | A statistically linear relationship (R² ≥ 0.99) exists between the flow rate and the max nebuliser fan rpm. | Pass |
| Safety / Residues | Chamber Venting Assessment | N/A (Internal protocol, same as K173865); FDA Guidance "Content and Format Premarket Notification [510(k)] Submission for Liquid Chemical Sterilants/ High Level Disinfectants" Jan 2000, Section III.I.2 and III. J.2 | Meets recommendations of Section III.I.2 and III. J.2 | Pass |
| Safety / Residues | Chemical Indicator (CI) Assessment | N/A (Internal protocol, same as K173865); FDA Guidance "Content and Format Premarket Notification [510(k)] Submission for Liquid Chemical Sterilants/ High Level Disinfectants" Jan 2000, Section III.J.3 | Meets recommendations of Section III.J.3 | Pass |
| Safety / Residues | Ultrasound Probe Residual H2O2 Assessment | N/A (Internal protocol, same as K173865); FDA Guidance "Content and Format Premarket Notification [510(k)] Submission for Liquid Chemical Sterilants/ High Level Disinfectants" Jan 2000, Section III. I.2 | Meets recommendations of Section III. I.2 | Pass |
| Safety / Residues | Chemical Indicator Residual H2O2 Assessment | N/A (Internal protocol, same as K173865); Implied by guidance. | Not explicitly stated, implied by Pass result | Pass |
| Safety / Leakage | Leak Test | N/A (Internal protocol, same as K173865); FDA Guidance "Content and Format Premarket Notification [510(k)] Submission for Liquid Chemical Sterilants/ High Level Disinfectants" Jan 2000, Section III. J.2 | Meets recommendations of Section III. J.2 | Pass |
2. Sample size used for the test set and the data provenance
The document states that "Potency tests were conducted under worst case conditions" and "Simulated use testing was conducted under worst case conditions." However, specific sample sizes (e.g., number of tested devices, number of disinfection cycles, number of contaminated probes) for these non-clinical tests are not provided in the provided 510(k) summary. The data provenance is implied to be from Nanosonics Limited's internal testing in Australia, as the company is based in Macquarie Park, NSW, Australia. The document does not specify if the data was retrospective or prospective, though it pertains to performance testing of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to the provided document. The trophon2 is a disinfection device, not an AI model that interprets medical images. Therefore, the concept of "ground truth" established by medical experts for a test set, as is common in AI/ML medical devices, does not apply here. The "ground truth" for this device's performance is objective measurements of microbial kill, chemical residue levels, and functional parameters, validated against established standards (e.g., AOAC, ASTM, FDA guidance).
4. Adjudication method for the test set
This question is not applicable to the provided document, as it does not describe studies involving human readers or interpretation requiring adjudication.
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
This question is not applicable to the provided document. The trophon2 is not an AI diagnostic tool, and no MRMC study or AI assistance for human readers is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to the provided document. While the trophon2 is a software-controlled system, it is a physical device performing disinfection, not an algorithm providing diagnostic output. The "software verification and validation testing" mentioned refers to the functional correctness of the device's control software, not diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the trophon2's performance is based on microbiological standards (e.g., complete kill of specific microorganisms), chemical concentration measurements, temperature parameters, and physical operational limits. This is established by well-defined laboratory testing protocols outlined in standards like AOAC and ASTM, and FDA guidance for liquid chemical sterilants/high-level disinfectants. It is a deterministic, objective ground truth based on the device's physical and chemical disinfection capabilities, not interpretive expert consensus or patient outcomes data for diagnosis.
8. The sample size for the training set
This question is not applicable to the provided document. The trophon2 is a hardware device with controlling software; it does not involve machine learning or a "training set" in the context of AI model development for diagnostic purposes. Its software is developed and validated through traditional software engineering principles.
9. How the ground truth for the training set was established
This question is not applicable for the reasons stated in point 8.
FDA 510(k) Clearance Letter - trophon2
Page 1
August 5, 2025
Nanosonics
Nancy Kaiser
n.kaiser@nanosonics.com
7-11 Talavera Road
Macquarie Park, NSW 2113
Australia
Re: K250434
Trade/Device Name: trophon2
Regulation Number: 21 CFR 892.1570
Regulation Name: Diagnostic Ultrasonic Transducer
Regulatory Class: Class II
Product Code: OUJ
Dated: July 3, 2025
Received: July 3, 2025
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.
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K250434 - Nancy Kaiser Page 2
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" (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 QS 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 (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-reporting-combination-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 Rule"). 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-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K250434 - Nancy Kaiser Page 3
assistance/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).
Sincerely,
Dolly M. Singh -S
Digitally signed by Dolly M. Singh -S
Date: 2025.08.05 09:46:16 -04'00'
For: Katharine Segars
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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K250434
Device Name: trophon2
Indications for Use (Describe)
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: 4 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)
☒ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 5
510(k) SUMMARY – trophon2
Page 1 of 8
I. DATE PREPARED
August 5, 2025
II. 510(k) NUMBER
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: trophon2
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.
VI. DEVICE DESCRIPTION
The trophon2 is a software-controlled device which provides High- Level Disinfection of validated ultrasound probes. 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. Pre-cleaned and dried ultrasound transducers are placed within the trophon2 chamber and disinfected by means of an automated disinfection and aeration cycle.
Page 6
Page 2 of 8
VII. INDICATIONS FOR USE
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 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: 4 minutes
- Minimum Concentration: 31.5%
- Minimum Disinfectant Dose: 1.0 g
- Minimum Chamber Temperature: 56°C
VIII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The trophon2 with the proposed software 1.8 is substantially equivalent in terms of technological characteristics, software architecture, and principle of operation to the cleared trophon2.
Like the predicate device, the trophon2 achieves high level disinfection (HLD) by having the probe suspended directly in the chamber (for a wired ultrasound probe) or the Probe Holder is held in place by the cable clamp and suspended in the chamber containing a wireless ultrasound probe during high level disinfection. During each disinfection cycle, a controlled quantity of hydrogen peroxide mist is generated by a nebulizer and is delivered to the 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 prepared for either storage or use as per the trophon2 User Manual.
Software verification and validation testing has been successfully completed using previously identified test methods and the same acceptance criteria as in the predicate device.
Page 7
Page 3 of 8
Table 1. A Comparison between the Subject and Predicate Device
| Feature | Subject Device: trophon2 | 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 |
| Intended Use | To provide high level disinfection (HLD) of ultrasound probes. HLD is achieved by surface exposure to a controlled dose of hydrogen peroxide mist delivered to a disinfection chamber containing the ultrasound probe. | To provide high level disinfection (HLD) of ultrasound probes. HLD is achieved by surface exposure to a controlled dose of hydrogen peroxide mist delivered to a disinfection chamber containing the ultrasound probe. | Same |
| Indication for Use | 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: 4 minutesMinimum Concentration: 31.5%Minimum Disinfectant Dose: 1.0 gMinimum Chamber Temperature: 56°C | 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 minutesMinimum Concentration: 31.5%Minimum Disinfectant Dose: 1.0 gMinimum Chamber Temperature: 56°C | Substantially Equivalent |
| 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 | Automate Aeration | Automate Aeration | Same |
Page 8
Page 4 of 8
| Feature | Subject Device: trophon2 | Predicate Device: trophon2 (K173865) | Comparison |
|---|---|---|---|
| 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 61010-1IEC 61010-2-040IEC 61326IEC 62304ISO 62366 -1 and -2ISO 10993-1ISO 14971IEC 60601-1-2IEC 60601-1-2 Edition 4.1 2020-09 Consolidated VersionIEC 61010-1 Edition 3.1 2017-01 Consolidated VersionIEC 61010-2-040:2021IEC 62304:2006+AMD1:2015ISO 27001:2002ANSI/AAMI SW96:2023AAMI/ANSI/IEC TIR 80001-2-2:2012 | IEC 61010-1IEC 61010-2-040IEC 61326IEC 62304ISO 62366 -1 and -2ISO 10993-1ISO 14971 | Same |
| Residue Testing | Effectively removes residues from disinfected transducers | Effectively removes residues from disinfected transducers | Same |
| Chamber Design | Regular shaped chamber | Regular shaped chamber | Same |
| Minimum Chamber Temperature | 56 °C | 56 °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 portThe trophon2 will be able to connect externally to a network via the Ethernet port | 3 USB ports to connect to external device (i.e. printer)1 Ethernet portThe trophon2 will be able to connect externally to a network via the Ethernet port | Same |
| Key Accessories | trophon AcuTrace Operator Cardtrophon AcuTrace Medical Instrument Tagtrophon AcuTrace PLUS activation Cardtrophon Sonex-HLAn optional Wireless Ultrasound Probe Holder (provided separately) to provide high level disinfection for wireless GE ultrasound probe (model no. Vscan Air CL) – cleared in K241536 | trophon AcuTrace Operator Cardtrophon AcuTrace Medical Instrument Tagtrophon AcuTrace PLUS activation Cardtrophon Sonex-HLAn optional Wireless Ultrasound Probe Holder (provided separately) to provide high level disinfection for wireless GE ultrasound probe (model no. Vscan Air CL) – cleared in K241536 | Same |
| Intended to provide high level disinfection to Wired and Wireless Ultrasound Probes | Yes | Yes | Same |
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Page 5 of 8
IX. SUMMARY OF NON-CLINICAL TESTING
In support of the substantial equivalence determination, the following non-clinical tests were performed:
Table 2. Summary of Non-clinical Testing
| Test | Brief Description | Applicable Standard | Acceptance Criteria | Results (Pass/Fail) |
|---|---|---|---|---|
| Mycobactericidal Efficacy Test | Potency tests were conducted under worst case conditions per the FDA Guidance "Content and Format Premarket Notification [510(k)] Submission for Liquid Chemical Sterilants/ High Level Disinfectants" January 3, 2000 | AOAC 6.3.06:2012 | Meets the recommendations of Section III. H.5a of Content and Format Premarket Notification [510(k)] Submission for Liquid Chemical Sterilants/ High Level Disinfectants | Pass |
| Fungicidal efficacy Test | AOAC 6.3.02:2006 | Pass | ||
| Bactericidal Efficacy Test | AOAC 6.2.02:2006AOAC 6.2.03:2006AOAC 6.2.05:2006 | Pass | ||
| Virucidal Efficacy Test (Poliovirus type 1) | N/A | Pass | ||
| Virucidal Efficacy Test (Herpes simplex virus type 1) | N/A | Pass | ||
| Simulated Use Test | Simulated use testing was conducted under worst case conditions per the FDA Guidance "Content and Format Premarket Notification [510(k)] Submission for Liquid Chemical Sterilants/ High Level Disinfectants" January 3, 2000 | ASTM E1837-96(2014) | 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 |
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Page 6 of 8
| Test | Brief Description | Applicable Standard | Acceptance Criteria | Results (Pass/Fail) |
|---|---|---|---|---|
| Critical Process Parameters Validation | ||||
| 1. Temperature Sensor (same test methods and acceptance criteria as K173865) | N/A | The verification sensor temperature is equal to or greater than the lower verification sensor temperature limit at any time during all disinfection cycles at temperature setpoint. | Pass | |
| 2. Dose Sensor vs Consumption Assessment (same test methods and acceptance criteria as K173865) | N/A | The dose limits for a disinfection cycle shall correspond to the defined operational range of the device. | Pass | |
| 3. Dosage Measurement (same test methods and acceptance criteria as K173865) | N/A | Within the upper and lower limits of the dosage sensors corresponding to the defined operational range of the device | Pass | |
| 4. Flow Rate Measurement (same test methods and acceptance criteria as K173865) | N/A | A statistically linear relationship (R² ≥ 0.99) exists between the flow rate and the max nebuliser fan rpm. | Pass | |
| Chamber Venting Assessment | Testing was conducted to verify that venting of the hydrogen peroxide disinfectant from the disinfection chamber prior to the user opening the door. (same test methods and acceptance criteria as K173865) | N/A | Meets the recommendations of Section III.I.2 and III. J.2 of Content and Format Premarket Notification [510(k)] Submission for Liquid Chemical Sterilants/ High Level Disinfectants | Pass |
| Chemical Indicator (CI) Assessment | Performance of Chemical Indicator Assessment (same test methods and acceptance criteria as K173865) | N/A | Meets the recommendations of Section III.J.3 of Content and Format Premarket Notification [510(k)] Submission for Liquid Chemical Sterilants/ High Level Disinfectants | Pass |
| Residual Testing | Ultrasound Probe Residual H2O2 Assessment (same test methods and acceptance criteria as K173865) | N/A | Meets the recommendations of Section III. I.2 of Content and Format Premarket Notification [510(k)] Submission for Liquid Chemical Sterilants/ High Level Disinfectants | Pass |
| Chemical Indicator Residual H2O2 Assessment (same test methods and acceptance criteria as K173865) | Pass |
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| Test | Brief Description | Applicable Standard | Acceptance Criteria | Results (Pass/Fail) |
|---|---|---|---|---|
| Leak Test | System leak test performed (same test methods and acceptance criteria as 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 |
X. CLINICAL TESTING
N/A
Page 12
Page 8 of 8
XI. CONCLUSION
Based on the intended use, technological characteristics, and conclusions drawn from the non-clinical tests, proposed device is determined to be Substantially Equivalent (SE) to predicate device cleared under K173865.
§ 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.