(183 days)
Diagnostic ultrasound imaging or fluid flow analysis or the human body as follows: the urinary tract.
The Olympus UM-S30-25R Ultrasonic Probe has been designed to be used with an Olympus Endoscopic Ultrasound center, Probe Driving Unit and an endoscope for intraluminal ultrasonic imaging of the urinary tract.
The probe is connected to the endoscopic ultrasound center through the probe driving unit. The probe is attached to the endoscope which allows the user to use probe. The probe is inserted into the patient through a channel of the endoscope. A probe driving unit controls the rotation of the transducer.
UM-S30-25R Ultrasound Probe produces a B-mode scans using the de-aerated water immersion method and balloon method. The probeoffers 360 degree mechanical /radial scanning of the tissue under observation. The outer diameter of the insertion tube is 2.4mm and the length is 2050mm.
The provided text is a 510(k) summary for the Olympus UM-S30-25R Ultrasonic Probe and associated equipment. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria were met for a new AI/software-based medical device.
Therefore, many of the requested elements are not applicable to the information contained within this 510(k) summary. This document describes the device, its intended use, and argues for substantial equivalence based on design, materials, and compliance with standards, not performance against specific clinical acceptance criteria through a dedicated study.
Here's an breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not applicable / Not provided. This 510(k) summary does not define specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) for the device. Instead, it relies on demonstrating that the device meets safety and effectiveness standards through design compliance and material equivalence to a predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The document does not describe a performance study with a test set of data. The non-clinical tests mentioned are related to design compliance (IEC 60601-1, IEC 60601-1-2) and material equivalence, not performance on a dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not provided. As no test set performance study is described, there's no mention of experts establishing ground truth for such a study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No test set performance study is described.
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
- Not applicable / Not provided. This document concerns a physical ultrasonic probe and its associated hardware, not an AI or software component that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable / Not provided. This device is an ultrasonic probe, a hardware component, which requires human operation. It is not an algorithm that can perform standalone.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. No ground truth for device performance is described in a study context.
8. The sample size for the training set
- Not applicable / Not provided. The device is a hardware probe, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable / Not provided. Not a machine learning device.
Summary of the study/evidence presented in the document:
The provided document describes non-clinical tests focused on design compliance and material equivalence to demonstrate substantial equivalence to a legally marketed predicate device (K982610 for the probe and associated units, K982734 for the balloon sheath).
- Design Tests:
- Endoscopic Ultrasound Center EU-M30 and Probe Driving Unit MH-240 were tested for compliance with IEC 60601-1 and the Revised 510(k) Diagnostics ultrasound Guidance for 1993, 1995.
- Ultrasonic Probe UM-S30-25R was tested for electromagnetic compatibility (EMC) with IEC 60601-1-2.
- Results: The devices "meet the requirements" of these standards.
- Materials Test:
- The patient contacting materials are stated to be "identical to predicate device."
Conclusion: The summary concludes that, "When compared to the predicate device, the Olympus UM-S30-25R Ultrasonic probe and associated ancillary equipment do not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness." This statement forms the basis for the FDA's finding of substantial equivalence.
§ 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.