(125 days)
The trophon2 is 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 minutes Minimum Concentration: 31.5% Minimum Disinfectant Dose: 1.0 g Minimum Chamber Temperature: 56℃
The trophon2 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 "trophon Sonex- HL".
Pre-cleaned and dried ultrasound transducers are placed within the trophon2 chamber and disinfected by means of an automated disinfection and aeration cycle.
The disinfected ultrasound transducer is removed from the chamber, wiped and is ready for immediate use.
The provided document is a 510(k) Pre-Market Notification for the trophon2 device, establishing its substantial equivalence to a predicate device (Trophon EPR) for High-Level Disinfection (HLD) of ultrasound transducers. It focuses on the device's technical specifications, comparisons to the predicate, and non-clinical testing performed to demonstrate its safety and effectiveness.
Based on the provided document, here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide specific quantitative acceptance criteria or detailed reported performance values for each test. Instead, it makes a general statement:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device meets requirements for Electromechanical and EMC testing. | The results demonstrated that the subject device met the acceptance criteria for each non-clinical test. |
| Device meets requirements for Biocompatibility. | The results demonstrated that the subject device met the acceptance criteria for each non-clinical test. |
| Device meets requirements for Microbiological Efficacy Testing. | The results demonstrated that the subject device met the acceptance criteria for each non-clinical test. |
| Device meets requirements for Validation testing of process parameters. | The results demonstrated that the subject device met the acceptance criteria for each non-clinical test. |
| Device meets requirements for Materials Compatibility. | The results demonstrated that the subject device met the acceptance criteria for each non-clinical test. |
| Device meets requirements for Stability testing of Sonex-HL. | The results demonstrated that the subject device met the acceptance criteria for each non-clinical test. |
| Device meets requirements for Verification Testing of the Chemical Indicator. | The results demonstrated that the subject device met the acceptance criteria for each non-clinical test. |
| Critical operational parameters for HLD are maintained. | The trophon2 maintains the same minimum operational cycle time (7 minutes), minimum concentration of hydrogen peroxide (31.5%), minimum disinfectant dose (1.0g), and minimum chamber temperature (56°C) as the predicate device. |
| Device effectively removes residues from disinfected transducers. | "Effectively removes residues from disinfected transducers" (stated as a "Same" characteristic as the predicate). |
| Device meets relevant performance standards (IEC 61010-1, IEC61010-2-040, IEC 61326, IEC 62304, ISO 62366 -1 and -2, ISO10993, ISO14971). | Listed as "Same" as predicate, implying adherence to these standards. |
2. Sample size used for the test set and the data provenance:
The document refers to "Non-clinical Testing" but does not specify the sample sizes used for any of the tests, nor does it explicitly state the data provenance (e.g., country of origin, retrospective or prospective). The testing appears to be primarily laboratory-based to validate the device's functional and biological performance rather than clinical studies with human subjects or medical images.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The type of testing described (electromechanical, biocompatibility, microbiological, etc.) typically relies on established scientific protocols and instrumentation rather than expert human interpretation for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the document. Adjudication methods are typically relevant for studies involving human interpretation (e.g., image reading), which is not the primary focus of the non-clinical testing described here.
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, an MRMC comparative effectiveness study was not conducted or described in this document. This device is an automated high-level disinfection system, not an AI-assisted diagnostic tool that aids human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The core of the device is an automated, standalone system for high-level disinfection. The "Non-clinical Testing" section describes validation of the device's automated functions: "Microbiological Efficacy Testing," "Validation testing of process parameters," and "Verification Testing of the Chemical Indicator." This implies that the device's performance in achieving HLD is evaluated independently of human intervention during the disinfection cycle.
7. The type of ground truth used:
The "ground truth" for the non-clinical tests would be established by:
- Microbiological Standards: For microbiological efficacy, ground truth would be determined by established standards for killing specified microorganisms (e.g., AOAC methods mentioned on page 6).
- Physical/Chemical Measurements: For process parameters (temperature, concentration, dose, time), ground truth would be established by precise measurements using calibrated instruments.
- Engineering Specifications: For electromechanical and material compatibility, ground truth would be established by compliance with engineering design specifications and relevant international standards (e.g., IEC, ISO standards listed).
8. The sample size for the training set:
This information is not applicable and not provided. This device is a hardware system for disinfection and the document does not describe the use of machine learning or AI models that would require a "training set."
9. How the ground truth for the training set was established:
This information is not applicable and not provided for the same reason as above. There is no mention of a training set for an AI/ML model.
§ 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.