(66 days)
No
The summary describes standard ultrasound imaging and measurement capabilities without mentioning AI or ML algorithms for image analysis, interpretation, or prediction.
No.
The device is used for acquiring and displaying real-time ultrasound images for diagnostic observation and measurement, not for treatment.
Yes
The device acquires and displays real-time ultrasound images to provide measurements and calculations of distance, area, circumference, time, blood velocity, strain ratio, strain histogram and shear wave speed of targeted areas within the body, which are used for diagnostic purposes.
No
The device description explicitly states it is a "system" that includes hardware components like a keyboard and supplies driving voltage to ultrasound transducers. While it has software options, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 is an imaging system that uses ultrasound to visualize internal structures in vivo (within the living body). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it is for observing real-time ultrasound images within various anatomical sites within the patient.
Therefore, this device falls under the category of medical imaging equipment used for diagnostic purposes in vivo, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX, ODG
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]).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
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).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Appropriately trained healthcare professionals.
Hospital or Patient care facility.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- ANSI AAMI ISO 14971
- ANSI AAMI IEC 62304
- Electrical Safety and EMC testing in 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
The nonclinical testing demonstrated that the device is as safe, as effective, and performs as well or better than the legally marketed Predicate.
No clinical data were collected to support performance of the Subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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"
1
(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.
2
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
3
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)
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, transurethral, and trans-esophageal (non-cardiac).
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. There is a registered trademark symbol to the right of the letter "S".
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
5
Image /page/5/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, dark blue letters. The font is sans-serif and the letters are closely spaced together. A small registration mark is visible to the upper right of the letter "S".
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
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]).
6
OLYMPUS
ട്. INDICATIONS FOR USE
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).
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.
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,
7
Image /page/7/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are closely spaced together, creating a solid block of text. There is a thin, horizontal, yellow line below the word, adding a subtle accent to the logo.
material, principle of operation, and energy source). Acoustic output of both devices is