EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 is intended to be used with Olympus ultrasound endoscopes and Olympus ultrasound probes to observe real-time ultrasound images and is indicated for use within the gastrointestinal (GI) tract, biliary and pancreatic ducts and surrounding organs, intraluminal ultrasound for airways, tracheobronchial tree, trans-rectal, trans-urethral, and trans-esophageal (non-cardiac).

Device Description

The EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 system (including KEYBOARD MAJ-2380), when combined with compatible ultrasound video scopes or ultrasound probes, makes an endoscopic ultrasound imaging system that can acquire and display and record real-time ultrasound images of the target tissue or organs. It supplies the driving voltage to the ultrasound transducers to generate ultrasound waves. Using these transducers, the Subject system can display endoscopic and ultrasound images to provide measurements and calculations of distance, area, circumference, time, blood velocity, strain ratio, strain histogram and shear wave speed of the targeted areas. It also allows the storage and retrieval of images for reviewing and printing. The Subject system enables the user to print and record images to an external recording device. Additionally, the Subject system enables the user to record movies to internal memory. The accessories submitted for clearance with the EU-ME3 that may be purchased separately include three (3) Software Options, which unlock software that is pre-installed on the EU-ME3 (for Contrast Harmonic Echo [MAJ-2381], Elastography [MAJ-2382] and Shear Wave Quantification [MAJ-2383]).

AI/ML Overview

The provided FDA 510(k) summary (K243502 for the OLYMPUS EU-ME3) does not contain the detailed information necessary to answer all the questions regarding acceptance criteria and a study proving the device meets those criteria, particularly concerning AI/software performance in a clinical context.

This document describes a premarket notification for a medical imaging device that primarily focuses on hardware and basic software functionalities of an endoscopic ultrasound system, rather than an AI/ML-driven device that requires performance metrics against a defined ground truth.

Specifically, the document states: "No clinical data were collected to support performance of the Subject device." This explicitly indicates that no clinical study, whether involving human readers, standalone AI, or comparative effectiveness, was performed or presented in this submission to establish performance against acceptance criteria for an AI/ML component.

Therefore, the following points can be directly addressed based on the provided text, while others cannot.

Acceptance Criteria and Device Performance Study Analysis (Based on Provided Document K243502)

The provided document describes the Olympus EU-ME3 (EVIS EUS Endoscopic Ultrasound Center), an ultrasound imaging system. The 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device (OLYMPUS EU-ME2 Premier Plus, K203128) based on technological characteristics and non-clinical performance data, not a study of an AI/ML algorithm's clinical performance.

Therefore, it is crucial to note that the document explicitly states: "No clinical data were collected to support performance of the Subject device." This means there is no clinical study described within this submission that proves the device meets specific performance acceptance criteria for an AI-driven functionality.

The "acceptance criteria" discussed in this document are primarily related to non-clinical bench testing, safety, electrical compatibility, and compliance with regulatory standards for an ultrasound imaging system.

1. A table of acceptance criteria and the reported device performance

Based on the "SUMMARY OF NON-CLINICAL PERFORMANCE DATA" section (Page 8), the following non-clinical tests were completed and demonstrated compliance, implying these are the "acceptance criteria" for the non-AI/ML aspects of the device demonstrated in this submission:

Acceptance Criteria (Non-Clinical)	Reported Device Performance
Acoustic Output	Tested and compliant. (Specific values not provided but implied to be <720mW/cm² as stated on page 7 as a shared characteristic with the predicate).
Clinical Measurement Accuracy (Strain Ratio, Distance, Circumference, Area, Velocity in SWQ, Time, Velocity)	Tested and compliant. (Specific accuracy metrics/tolerances not provided but implied to meet internal specifications for medical device functionality).
Strain Ratio Function (Elastography)	Tested and compliant. (Details on performance metrics not provided).
Visualization of Strain (Elastography)	Tested and compliant. (Details on performance metrics not provided).
Contrast Harmonic Echo (CHE)	Tested and compliant. (Details on performance metrics not provided).
Human Factors Evaluation	Compliance with ANSI AAMI IEC 62366-1 demonstrated.
Cleaning/Disinfection Validation	Compliance with ISO 17664-1 demonstrated.
Software and Cybersecurity Testing	Compliance with ANSI AAMI ISO 14971 (Risk Management), ANSI AAMI IEC 62304 (Medical Device Software Lifecycle Processes) demonstrated.
Electrical Safety and EMC Testing	Compliance with IEC 60601-1, ANSI AAMI IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-18, IEC 60601-2-37, IEC 60601-4-2 demonstrated.
Overall Conclusion	"The nonclinical testing demonstrated that the device is as safe, as effective, and performs as well or better than the legally marketed Predicate." This is the overarching acceptance criterion for a 510(k) submission: demonstrating substantial equivalence based on a comparison of indications for use, technological characteristics, and performance testing (non-clinical in this case for the core device functionalities).

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 explicitly states "No clinical data were collected to support performance of the Subject device." The testing described is non-clinical bench testing, not a clinical study involving a test set of patient data.

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. Since no clinical data or clinical study was conducted for performance evaluation in this submission, there was no need for experts to establish ground truth for a clinical test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Not provided. No clinical test set.

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. The document explicitly states, "No clinical data were collected to support performance of the Subject device." Therefore, no MRMC study, especially one involving AI assistance, was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. The document describes a full ultrasound imaging system. While it mentions features like "Elastography and Shear Wave Speed Measurement (Shear Wave Quantification)" and "Strain Ratio/Strain Histogram," these are described as modes or measurement functions of the imaging device itself, rather than a separate AI algorithm that performs standalone analysis and requires independent performance validation. The submission focuses on the inherent physical and software capabilities of the ultrasound machine for these measurements.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable for clinical performance. For the non-clinical bench testing, the "ground truth" would be the known physical properties of the phantoms or test objects used (e.g., known distances, known material properties for elasticity measurements).

8. The sample size for the training set

Not applicable. This submission does not describe an AI/ML algorithm that requires a training set. The device is an ultrasound imaging system with various modes and measurement capabilities.

9. How the ground truth for the training set was established

Not applicable. No training set was involved as this is not an AI/ML device submission requiring such.

Summary

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January 17, 2025

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".

Olympus Medical Systems Corporation % Wendy Perreault Regulatory Affairs SME Consultant Olympus Surgical Technologies of the Americas 800 West Park Drive Westborough, MA 01581

Re: K243502

Trade/Device Name: EVIS EUS Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN. IYO. ITX. ODG Dated: November 11, 2024 Received: November 12, 2024

Dear Wendy Perreault:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Marjan Nabili -S for

Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K243502

Device Name

EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3)

Indications for Use (Describe)

B mode, PWD (Pulsed Wave Doppler) mode, Color Doppler (including Power Doppler) mode, combinations of each mode of operation (B mode, PWD mode, Color Doppler mode) and Other (Harmonic Imaging, Elastography and Shear Wave Speed Measurement (Shear Wave Quantification]).

Appropriately trained healthcare professionals.

Hospital or Patient care facility.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary: K243502

1. COMPANY INFORMATION

• Applicant

OLYMPUS MEDICAL SYSTEMS CORPORATION 2951 Ishikawa-cho, Hachioji-shi Tokyo 192-8507, Japan FDA Establishment Registration #: 8010047

Official Correspondent .

Wendy Perreault c/o Olympus Surgical Technologies of the Americas 800 West Park Drive Westborough, MA 01581 Cell: 404.542.5854 Email: wendy.perreault@olympus.com

. Manufacturing Site

SHIRAKAWA OLYMPUS CO., LTD. 3-1 Okamiyama, Odakura NISHIGO-MURA NISHISHIRAKAWA-GUN Fukushima, JAPAN 961-8061

Date Prepared: .

2. PRODUCT INFORMATION

Trade Name: EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3)

Common Name: Ultrasonic Pulsed Doppler Imaging System

Classification Name: System, Imaging, Pulsed Doppler, Ultrasonic

Regulation Number: 892.1550

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Regulatory Class: II

Product Code(s): IYN, IYO, ITX, ODG

Classification Panel: Radiology

3. PREDICATE DEVICE

The Subject device is equivalent to the Predicate device listed below in Table 1.

Table 1: Predicate Device

Device name	510(k) Submitter	510(k) No
OLYMPUS EU-ME2 Premier Plus	OLYMPUS MEDICAL SYSTEMS CORP.	K203128

A Reference device (shown in Table 2) was included in the submission to support the Subject device Strain Ratio, Strain Histogram, Shear Wave Quantification and Contrast Hamonic Echo functions/modes:

Table 2: Reference Device

Device name	510(k) Submitter	510(k) No.
Hitachi ALOKA ARIETTA 850	Hitachi, Ltd.	K183456

4. DEVICE DESCRIPTION

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OLYMPUS

ട്. INDICATIONS FOR USE

Appropriately trained healthcare professionals.

Hospital or Patient care facility.

COMPARISON OF INDICATIONS FOR USE 6.

The Indications for Use for the Subject and Predicate device are similar but not identical. The Subject device Indication for Use references "intraluminal ultrasound for airways and tracheobronchial tree and trans-rectal, trans-urethral, and trans-esophageal (non-cardiac) clinical applications" - this description was not specifically in the Indications for Use for the Predicate but were listed as clinical applications for the Predicate device in K203128. The Subject device includes Shear Wave Speed Measurement (Shear Wave Quantification) as a listed Mode of Operation which was not included with the Predicate device, and the Predicate device included 3-D imaging, which is not provided for the Subject device. Note that although Elastography was a Mode of Operation included with the Predicate device, it was not listed in the Indications for Use as such in K203128 because Elastography was considered an Image Function at the time of submission of the Predicate, rather than a Mode of Operation. The Subject Indications for Use includes a Patient Care Facility as a specified Device Use Setting, in addition to the Hospital Setting which is common to both the Subject and the Predicate. The differences between the Subject and Predicate device Indications for Use do not constitute a new intended use for the Subject device.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS 7.

The Subject and Predicate device share technological characteristics (i.e., design,

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material, principle of operation, and energy source). Acoustic output of both devices is <720mW/cm²; both offer Measurement and Calculation functions, Time-intensity-curve (TIC) Analysis function, Electronic and Mechanical scanning, and image storage and review and printing and recording capabilities. The Subject device also provides Strain Ratio/Strain Histogram and Shear Wave Quantification (Shear Wave Speed Measurement), as provided by the Reference device. Both the Subject and Predicate devices provide B, Pulsed Wave Doppler, Color Flow (Color Doppler), Power Flow (Power Doppler), Combined, and Tissue Harmonic Echo (THE) (Harmonic Imaging) modes. The Subject device also provides Contrast Harmonic Echo (Harmonic Imaging) mode, as provided by the Reference device.

SUMMARY OF NON-CLINICAL PERFORMANCE DATA 8.

The following non-clinical testing was completed for the Subject device:

. Bench testing, including Acoustic Output; Clinical Measurement Accuracy of Strain Ratio Measurement, Distance, Circumference and Area, Velocity Measurement in SWQ Function, Time, and Velocity; Strain Ratio Function on Elastography (ELST); Visualization of the Amount of Strain on ELST; and Contrast Harmonic Echo (CHE).
Human Factors Evaluation in compliance with ANSI AAMI IEC 62366-1 ●
Cleaning/disinfection validation in compliance with ISO 17664-1 ●
Software and Cybersecurity testing in compliance with .
- o ANSI AAMI ISO 14971
- o ANSI AAMI IEC 62304
Electrical Safety and EMC testing in compliance with ●
- IEC 60601-1 O
- o ANSI AAMI IEC 60601-1-2
- o IEC 60601-1-6
- IEC 60601-2-18 O
- o IEC 60601-2-37
- o IEC 60601-4-2

Completed nonclinical testing supports compliance of the Subject device with FDA Guidance Document Marketing Clearance of Diagnostic Ultrasound Systems and Transducers - Guidance for Industry and Food and Drug Administration Staff (issued February 21, 2023).

The nonclinical testing demonstrated that the device is as safe, as effective, and performs as well or better than the legally marketed Predicate.

9. SUMMARY OF CLINICAL PERFORMANCE DATA

No clinical data were collected to support performance of the Subject device.

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CONCLUSION 10.

Based on the results of the comparison of the indications for use, technological characteristics, and performance testing of the Subject and Predicate device, the Subject EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 raises no new issues of safety and effectiveness, and the device is substantially equivalent to the Predicate device.

Regulation Number and Section

§ 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.