(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.
§ 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.