(120 days)
The ULTRASONIC PROBE UM-S20-17S has been designed to be used with an endoscopic ultrasound center, a probe driving unit, and an endoscope for intraluminal ultrasonic imaging of the upper airways and tracheobronchial tree.
The ULTRASONIC PROBE UM-S20-20R has been designed to be used with an endoscopic ultrasound center, a probe driving unit, and an endoscope for intraluminal ultrasonic imaging of the upper airways and tracheobronchial tree.
The Ultrasonic Probes have been designed to be used with an Olympus Endoscopic Ultrasound Center, a Probe Driving Unit, other ancillary equipment and an endoscope for intraluminal ultrasonic imaging of the of the upper airways and tracheobronchial tree and surrounding organs.
Ultrasonic Probes UM-S20-17S and UM-S20-20R are designed to be used in conjunction with bronchoscopes. The Probes are inserted into the patient through a channel of the endoscope.
The Ultrasonic Probes consist of an insertion tube and a connector section. The connector section is connected to the Probe Driving Unit and the Probe Driving Unit is connected to the Ultrasound Center.
The Ultrasonic Probe sends and receives electrical signals to and from the Ultrasound Center through the Probe Driving Unit. The Probes use a 20MHz frequency piezoelectric transducer and produce B-mode scan. They produce 360-degree mechanical/radial sonograms.
The transducer is built into the insertion tube at the tip of the Probe. The transducer is rotated by the Probe Driving Unit within the insertion tube.
The transducer converts the electrical signal to the ultrasound wave, sends it to the object, receives the reflected wave from the object and converts it to the electrical signal. The electrical signal is input to the Endoscopic Ultrasound Center and the ultrasound image is generated by the Endoscopic Ultrasound Center.
UM-S20-17S and UM-S20-20R use direct contact method only.
The Subject devices submitted for clearance each include one (1) major component: the Ultrasonic Probe, which is packaged with a Probe Holder (MH-245) and a Water-resistant Cap (MH-244).
The provided FDA 510(k) clearance letter for the Olympus Ultrasonic Probes (UM-S20-17S and UM-S20-20R) details the acceptance criteria and the study that proves the device meets those criteria. However, it's crucial to note that this document pertains to ultrasonic probes (hardware) and does not involve Artificial Intelligence (AI). Therefore, many of the typical elements related to AI/ML device testing (e.g., training set, ground truth experts, MRMC studies, standalone algorithm performance) are not applicable or described in this type of submission.
The "studies" described here are non-clinical performance tests (bench testing), demonstrating the safety and effectiveness of the physical medical device by comparing its characteristics and performance to a legally marketed predicate device.
Acceptance Criteria and Device Performance for Olympus Ultrasonic Probes
The acceptance criteria for these ultrasonic probes are predominantly based on meeting the performance specifications of the predicate and reference devices, and complying with established medical device standards for safety and functionality. The "reported device performance" indicates that the subject devices met all the acceptance criteria through various non-clinical tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Category | Acceptance Criteria (Based on Predicate/Reference & Standards) | Reported Device Performance |
|---|---|---|
| Acoustic Output | Compliance with IEC 60601-2-37, IEC 62359, IEC 62127-1, and FDA Guidance: Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (Feb. 21, 2023). This includes parameters like: |
- Frequency: 20 MHz (matching Reference Device UM-3R)
- Axial Resolution: 2mm or less (matching Reference Device UM-3R)
- Lateral Resolution: 2mm or less (matching Reference Device UM-3R)
- Frame Rate: 6.67rps (matching Reference Device UM-3R)
- Scanning Field of View: 360° (matching Reference Device UM-3R)
- Display Mode: B-mode (matching Predicate and Reference Devices) | All acoustic output parameters passed/met the specified criteria and standards. |
| Durability | Demonstrated adequate operational lifespan and resistance to wear and tear. Specific quantitative thresholds are not detailed but are implied by "Durability" testing. | Testing passed/met acceptance criteria. |
| Measurement Accuracy | Verified the accuracy of measurements obtained using the ultrasonic probes. Specific accuracy metrics are not detailed but are implied by "Measurement Accuracy" testing. | Testing passed/met acceptance criteria. |
| Human Use Factors | Compliance with FDA Guidance Documents: Applying Human Factors and Usability Engineering to Medical Devices (Feb 3, 2016). Ensures safe and effective use by healthcare professionals. | Testing passed/met acceptance criteria. |
| Biocompatibility | Compliance with ISO 10993 series (ISO 10993-1, -5, -10, -12, -17, -18, -23). Ensures materials are safe for patient contact. | Testing passed/met acceptance criteria. |
| Reprocessing Validation | Compliance with ISO 17664-1, AAMI TIR12, ANSI AAMI ST98, ANSI AAMI ST58, ISO 11135, ISO 11138-2. Ensures safe and effective cleaning and sterilization through methods like ETO. | Testing passed/met acceptance criteria. |
| Electrical Safety/EMC | Compliance with IEC 60601-1, IEC ES60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 60601-2-37, IEC TR 60601-4-2. Ensures electrical safety and electromagnetic compatibility. | Testing passed/met acceptance criteria. |
Study Details (Applicable to Non-AI Hardware Verification)
As this is a hardware device 510(k) submission, the study methodology focuses on non-clinical performance data and bench testing rather than clinical trials with human subjects or AI-specific assessment methods.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify a "sample size" in terms of cases or patients, as the testing was non-clinical (bench testing). The "test set" in this context refers to the manufactured probes themselves and the conditions under which they were tested (e.g., phantom models for acoustic output, simulated use for durability, material samples for biocompatibility).
- Data Provenance: The tests were conducted internally by Olympus Medical Systems Corporation and its manufacturing site, SHIRAKAWA OLYMPUS CO., LTD. in Japan. The data is from bench testing and in-house validation, not from real-world patient data (retrospective or prospective). The manufacturing site is in Japan.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This concept is not applicable to this type of hardware 510(k) submission. "Ground truth" for these tests is established by adhering to widely accepted international standards (ISO, IEC, AAMI) and FDA guidance documents for medical device performance, safety, and manufacturing. These standards define the measurable physical and electrical properties that the device must meet. The experts involved would be engineers, quality control specialists, and regulatory affairs personnel responsible for designing, manufacturing, and testing the probes to these standards.
4. Adjudication Method for the Test Set:
- This concept is not applicable. Adjudication typically refers to resolving discrepancies in expert interpretations of medical images or data, which is relevant for AI image analysis or clinical trials. For hardware testing, "adjudication" is replaced by adherence to established test protocols, measurement equipment calibration, and standard-defined pass/fail criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not performed. MRMC studies are used to assess the impact of AI on human reader performance, which is not relevant for this non-AI hardware device. The equivalence claim for this device is based on technical specifications and non-clinical performance data compared to a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance test was not done. This device is a physical diagnostic ultrasonic transducer, not a software algorithm. Its "performance" refers to its ability to generate images when connected to an ultrasound center, which is then interpreted by a human operator.
7. The Type of Ground Truth Used:
- The "ground truth" for this hardware device is defined by engineering specifications, physical measurements, and compliance with national and international medical device standards. For example, acoustic output parameters are measured against specific limits defined in IEC standards, and biocompatibility is confirmed by testing against ISO 10993. There is no "expert consensus" on imaging findings, pathology, or outcomes data used as ground truth for this device's clearance.
8. The Sample Size for the Training Set:
- This concept is not applicable. There is no "training set" as this is not an AI/ML device that requires machine learning.
9. How the Ground Truth for the Training Set was Established:
- This concept is not applicable as there is no training set.
In summary, the FDA 510(k) clearance for the Olympus Ultrasonic Probes is based on a comprehensive set of non-clinical, bench-level performance tests demonstrating technical equivalence to a predicate device and compliance with relevant safety and performance standards for diagnostic ultrasonic transducers. It does not involve AI/ML components or associated clinical study designs like MRMC or standalone algorithm performance assessment.
§ 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.