(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.
§ 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.