(132 days)
Not Found
No
The summary describes a software-controlled device for high-level disinfection of ultrasound transducers using a chemical process. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the chemical disinfection process and its efficacy.
No.
The device is designed for high-level disinfection of ultrasound transducers, not for treating any medical condition in a patient.
No
The Trophon EPR is a high-level disinfection device for ultrasound transducers, not a diagnostic device.
No
The device description explicitly states it is a "software controlled device" but also describes physical components like a "sealed disinfection chamber" and operates in conjunction with a "multi-dose cartridge of concentrated hydrogen peroxide disinfectant." This indicates it is a hardware device with integrated software control, not a software-only medical device.
Based on the provided text, the Trophon EPR is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is clearly stated as providing High-Level Disinfection of ultrasound transducers. This is a process for sterilizing or disinfecting medical devices, not for performing diagnostic tests on biological samples.
- Device Description: The description details a system for disinfecting transducers using hydrogen peroxide, not for analyzing biological specimens.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
- Performance Studies: The performance studies focus on the efficacy of disinfection, material compatibility, and disinfectant stability, which are relevant to a device sterilizer/disinfector, not an IVD.
- Predicate Devices: The listed predicate devices (CS Medical TD-100 and Reckitt & Colman Sporox™) are also devices used for disinfection/sterilization, not IVDs.
In summary, the Trophon EPR is a device designed for disinfecting medical equipment (ultrasound transducers), which falls under the category of a sterilizer or disinfectant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Trophon EPR is designed to provide High-Level Disinfection of ultrasound transducers. The system uses the Trophon Disinfectant which is intended to be used exclusively with the Trophon EPR device.
The Trophon Disinfectant is intended for use as a High-Level Disinfectant to be used exclusively with the Trophon EPR for the High-Level Disinfection of ultrasound transducers.
The Trophon EPR is suitable for use in general hospital and health care facilities by trained personnel.
The Trophon EPR system consists of a multiple use instrument combined with a single use disinfectant, delivered from a multi-dose cartridge.
The Trophon Disinfectant should be used with the following contact conditions:
Minimum Operational Cycle Time: 7 minute:
Minimum Concentration: 31.5%
Minimum Disinfectant Dose: 1.0 g
Minimum Chamber Temperature: 56°C
Product codes
FEX
Device Description
The Nanosonics Trophon EPR is a software controlled device which provides High-Level Disinfection of ultrasound transducers. The device consists of a sealed disinfection chamber and operates in conjunction with a multi-dose cartridge of concentrated hydrogen peroxide disinfectant, supplied as an accessory to the device. Pre-cleaned and dried ultrasound transducers are placed within the Trophon EPR 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
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Indicated Patient Age Range
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Intended User / Care Setting
The Trophon EPR is 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
Potency testing conducted on the Trophon Disinfectant delivered through the Trophon EPR was performed according to relevant AOAC and EPA methods.
High-Level Disinfection efficacy of the Trophon EPR was validated in a simulated use environment.
Ultrasound transducers used in a clinical setting were disinfected with the Trophon EPR. Bioburden testing was conducted pre- and post disinfection cycle and High-Level Disinfection was achieved in all cases.
A range of materials and transducers were exposed to the Trophon EPR disinfection cycle and were shown to be compatible.
Stability testing showed that the disinfectant retained effective concentration for the duration of the labeled shelf life.
Key Metrics
Not Found
Predicate Device(s)
CS Medical TD-100 (K051305), Reckitt & Colman Sporox™ (K970230)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the text "K.103059" at the top. Below that is the text "nanosonics" with a circular graphic around the "o". To the right of "nanosonics" is the text "p 1 of 3".
510(k) Summary
FEB 2 4 2011
11 1
| 510(k) Owner: | Nanosonics Ltd
Unit 24 566, Gardeners Rd
Alexandria, NSW, 2015
Australia
Ph: +61 2 8063 1600
Fax: +61 2 9317 5010 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Ron Weinberger
General Manager - Innovation and Technology
Nanosonics
Unit 24, 566 Gardeners Road
Alexandria, NSW 2015
Ph: +61 2 8063 1600
Fax: +61 2 9317 5010 |
| Brand Name: | Nanosonics Trophon EPR
Nanosonics Trophon Disinfectant |
| Common Name: | Hydrogen Peroxide High-Level Disinfection system for ultrasound
transducers |
| Classification Name: | 21 CFR Sec. 892.1570 Diagnostic ultrasonic transducer (accessory to) |
| Product Code: | FEX OUJ |
| Regulatory Class: | II |
| Predicate Devices: | CS Medical TD-100 (K051305)
Reckitt & Colman Sporox™ (K970230) |
| Date Prepared: | February 16, 2011 |
Description of the Device:
The Nanosonics Trophon EPR is a software controlled device which provides High-Level Disinfection of ultrasound transducers. The device consists of a sealed disinfection chamber and operates in conjunction with a multi-dose cartridge of concentrated hydrogen peroxide disinfectant, supplied as an accessory to the device. Pre-cleaned and dried ultrasound transducers are placed within the Trophon EPR chamber and disinfected by means of an
1
p2of3
nanosonics
automated disinfection and aeration cycle. The disinfected ultrasound transducer is removed from the chamber and is ready for immediate use.
Indications for Use:
The Trophon EPR is designed to provide High-Level Disinfection of ultrasound transducers. The system uses the Trophon Disinfectant which is intended to be used exclusively with the Trophon EPR device.
The Trophon Disinfectant is intended for use as a High-Level Disinfectant to be used exclusively with the Trophon EPR for the High-Level Disinfection of ultrasound transducers.
The Trophon EPR is suitable for use in general hospital and health care facilities by trained personnel.
The Trophon EPR system consists of a multiple use instrument combined with a single use disinfectant, delivered from a multi-dose cartridge.
The Trophon Disinfectant should be used with the following contact conditions:
| Minimum Operational Cycle Time: | 7 minute: |
|---|---|
| Minimum Concentration: | 31.5% |
| Minimum Disinfectant Dose: | 1.0 g |
| Minimum Chamber Temperature: | 56°C |
Summary of Equivalence:
The Nanosonics Trophon EPR is substantially equivalent to the CS Medical TD-100 (K051305). The Trophon Disinfectant Cartridge is substantially equivalent to Sporox™ (K970230).
Both the Trophon EPR and predicates are intended to be used in general hospital and health care facilities to achieve High-Level Disinfection of ultrasound transducers.
The Nanosonics Trophon EPR device and the K051305 predicate use a validated and controlled automated cycle to deliver measured doses of disinfectant to a chamber which contains the pre-cleaned and dried ultrasound transducer requiring disinfection. Both the EPR and the K051305 predicate device include a means to verify for each cycle, the correct delivery of the disinfectant.
A risk assessment concluded that there were no significant new safety concerns raised by the design of Nanosonics' Trophon EPR and associated disinfectant
Performance Testing:
Potency testing conducted on the Trophon Disinfectant delivered through the Trophon EPR was performed according to relevant AOAC and EPA methods.
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Image /page/2/Picture/0 description: The image shows the word "nanosonics" in a stylized font, with a curved line above and below the word. Above the word "nanosonics" is the text "K103059" and "p 3 of 3" in handwriting. The word "nanosonics" is in all lowercase letters.
High-Level Disinfection efficacy of the Trophon EPR was validated in a simulated use environment.
Ultrasound transducers used in a clinical setting were disinfected with the Trophon EPR. Bioburden testing was conducted pre- and post disinfection cycle and High-Level Disinfection was achieved in all cases.
A range of materials and transducers were exposed to the Trophon EPR disinfection cycle and were shown to be compatible.
Stability testing showed that the disinfectant retained effective concentration for the duration of the labeled shelf life.
Conclusion:
The information summarized above demonstrates that Nanosonics' Trophon EPR is substantially equivalent to the predicate devices in that it:
- achieves validated High-Level Disinfection; and .
- provides equivalent or improved safety, in that it uses smaller quantities of disinfectant, . produces no significant residues or hazardous wastes, and has no significant adverse effects on ultrasound transducers.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The logo is black and white and appears to be a simple, clean design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20993-0002
Mr. Ron Weinberger General Manager Nanosonics, Limited Unit 24 566, Gardeners Road Alexandria, NSW 2015 AUSTRALIA
FEB 2 4 2011
Re: K103059
Trade/Device Name: Nanosonics Trophon EPR Regulation Number: 21 CFR 892.7570 Regulation Name: Diagnostic Ultrasonic Transducer Regulatory Class: II Product Code: OUJ Dated: February 7, 2011 Received: February 9, 2011
Dear Mr. Weinberger:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/ default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known):
Device Name:
Nanosonics Trophon EPR
Indications for Use:
The Trophon EPR is designed to provide High-Level Disinfection of ultrasound transducers. The system uses the Trophon Disinfectant which is intended to be used exclusively with the Trophon EPR device.
The Trophon Disinfectant is intended for use as a High-Level Disinfectant to be used exclusively with the Trophon EPR for the High-Level Disinfection of ultrasound transducers.
The Trophon EPR is suitable for use in general hospital and health care facilities by trained personnel.
The Trophon EPR system consists of a multiple use instrument combined with a single use disinfectant, delivered from a multi-dose cartridge.
The Trophon Disinfectant should be used with the following contact conditions:
| Minimum Operational Cycle Time: | 7 minutes |
|---|---|
| Minimum Concentration: | 31.5% |
| Minimum Disinfectant Dose: | 1.0 g |
| Minimum Chamber Temperature: | 56°C |
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use × (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth T. Clavie-Will
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K103059