(140 days)
This ultrasound center is intended to be used with Olympus ultrasound endoscopes, Olympus ultrasound probes or Olympus esophageal ultrasound probes to observe and to store real-time ultrasound images and indicated for use within the gastrointestinal (GI) tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree, and urinary tract.
The subject system EU-Y0006 ENDOSCOPIC ULTRASOUND CENTER combines with Ultrasound videoscopes or Ultrasound probes to make an endoscopic ultrasound imaging system that can acquire and display high-resolution and high-penetration, real-time ultrasound images of the target organs. The subject system has modes of B, PWD, Color Doppler, Combined and Other (3-D Imaging and Harmonic Imaging). The subject system provides measurements and calculations of distance, area, circumference, volume, time and blood velocity, providing for the storage and retrieval of images for review and printing. The subject system enables the user to print images and record images to external recording devices. The subject system can identify and recognize the compatible Olympus transducers and display endoscopic images in addition to ultrasound images.
The document provided is a 510(k) summary for the Olympus Endoscopic Ultrasound Center EU-Y0006, submitted to the FDA. It declares the device's substantial equivalence to previously cleared predicate devices.
Acceptance Criteria and Device Performance:
The document primarily focuses on establishing substantial equivalence to predicate devices rather than defining specific performance-based acceptance criteria for diagnostic accuracy metrics. The acceptance criteria for this type of submission are typically based on demonstrating that the new device is as safe and effective as the predicate device(s) and meets relevant electrical, thermal, EMC safety, and acoustic output standards.
The "device performance" reported is its ability to perform the same functions as the predicate devices, with some additions in operating modes (Tissue Harmonic Imaging and Pulse Wave Doppler).
Here's a table summarizing the modes of operation and clinical applications for the EU-Y0006 system and its various transducers, showing which aspects are "new" (N) or "previously cleared" (P) relative to prior submissions/predicate devices. This serves as the 'performance' characteristics presented.
| Clinical Application (Specific) | Mode of Operation: B | Mode of Operation: M | Mode of Operation: PWD | Mode of Operation: CWD | Mode of Operation: Color Doppler (*2) | Combined (*3) | Other (*4) |
|---|---|---|---|---|---|---|---|
| Trans-rectal (for EU-Y0006 with no specific transducer, UM-DP12-25R, UM-DP20-25R, UM-DG20-31R) | N / P | N / P | N | N | N (*3) | ||
| Trans-urethral (for EU-Y0006 with no specific transducer, UM-DP12-25R, UM-DP20-25R, UM-DG20-31R) | N / P | N / P | N | N | N (*3) | ||
| Trans-esoph. (non-Card.) (for EU-Y0006 with no specific transducer, UM-DP12-25R, UM-DP20-25R, UM-DG20-31R, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM160) | N / P | N / P | N | N (*3) | N (*4) | ||
| Other (Specification: Gastrointestinal tract, biliary, pancreatic duct and surrounding organs, airways and tracheobronchial tree) (Various Transducers) | N / P | N / P | N | N (*3) | N (*4) | ||
| (Selected Transducers: ULTRASONIC PROBE UM-S20-20R, UM-G20-29R, UM-S20-17S, UM-S30-20R, UM-S30-25R) | P | P | P | ||||
| EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE UC180F & ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UE160-AL5 | P | P (for UC180F) | P | P | N (*3) | N (*4) | |
| ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UC140P-AL5 & UCT140-AL5 & UCT180 | P | P | P | N (*3) / N (*3) N (*4) |
Notes:
- 2: Includes Power Doppler
- 3: Combination of each operating mode, B, PWD, Color Doppler and Other
- 4: 3-D Imaging, Harmonic Imaging (for some transducers); Harmonic Imaging (for others)
- N = new indication; P = previously cleared by FDA; E = added under this appendix.
Details of the Study:
The provided document is a 510(k) summary, which outlines the regulatory submission for the device. It states explicitly that no clinical studies were required to support the determination of substantial equivalence (Section 8, page 26). The device's approval is based on non-clinical testing and comparison to predicate devices.
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Sample size used for the test set and data provenance:
- No clinical test set was used for the determination of substantial equivalence, as clinical studies were not required. Non-clinical testing was performed.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical test set was used.
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Adjudication method for the test set:
- Not applicable as no clinical test set was used.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. The document explicitly states that clinical studies were not required.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is an ultrasound system intended to be used by a human operator, not an algorithm operating independently. The testing focused on technical performance, safety, and substantial equivalence to predicate devices, not AI performance.
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The type of ground truth used:
- For the non-clinical testing, the "ground truth" would be established engineering specifications, relevant consensus standards (e.g., IEC, ISO, NEMA), and the performance characteristics of the identified predicate devices.
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The sample size for the training set:
- Not applicable. This is not an AI/algorithm-driven device requiring a training set in the context of machine learning.
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How the ground truth for the training set was established:
- Not applicable.
Summary of Non-Clinical Testing (from Section 7, page 26):
The device was evaluated for:
- Electrical, Thermal, and EMC Safety: Compliance with standards like IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-2-18.
- Acoustic Output: Measured, calculated, and derated following the Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment. The acoustic output did not exceed derated ISPTA of 720 mW/cm² and MI of 1.9. Compliance with NEMA UD3-2004 and NEMA UD2-2004.
- Risk Analysis: Carried out in accordance with ISO 14971:2007, leading to identified and performed design verification tests and acceptance criteria.
- Software Validation: Performed in accordance with FDA Guidance for "Moderate Level of Concern" software in medical devices.
The conclusion (Section 9, page 26) states that the device does not incorporate any significant changes in intended use, method of operation, or design that could affect safety or effectiveness when compared to the predicate device. The new modes (Tissue Harmonic Imaging and Pulse Wave Doppler) are explicitly stated to be present in one of the predicate devices (Hitachi HI VISION Preirus, K093466).
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.