EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
K251859 · Olympus Medical Systems Corporation · ODG · Oct 3, 2025 · Gastroenterology, Urology
Device Facts
Record ID
K251859
Device Name
EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
Applicant
Olympus Medical Systems Corporation
Product Code
ODG · Gastroenterology, Urology
Decision Date
Oct 3, 2025
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE OLYMPUS GF-UE190 has been designed to be used with diagnostic ultrasound system, video system center, light source, documentation equipment, monitor, endoscopic therapy accessories and other ancillary equipment. The EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE OLYMPUS GF-UE190 is designed for endoscopic real-time ultrasound imaging, and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.
Device Story
The Olympus GF-UE190 is a flexible video endoscope with an integrated ultrasound transducer for real-time imaging of the upper gastrointestinal tract and surrounding organs. It functions by transmitting light from an external source to the distal end for visual observation and emitting/receiving ultrasound waves for internal imaging. The device features a control section for angulation, suction, and air/water delivery, and an insertion section containing an image sensor and ultrasound transducer. It connects to external video processors, light sources, and ultrasound systems (e.g., EU-ME3, Aplio i800). Healthcare professionals operate the device in a clinical setting to perform endoscopic procedures. The output is displayed on a monitor, allowing clinicians to visualize anatomy and perform ultrasound-guided procedures. It supports Shear Wave Elastography (SWE) for tissue stiffness measurement. The device benefits patients by enabling minimally invasive, real-time diagnostic imaging and therapeutic access to internal structures.
Clinical Evidence
Bench testing only. No clinical data provided. Testing included thermal safety, durability, dimensional analysis, fluid flow rates, photobiological safety, image quality metrics (FOV, resolution, latency, etc.), acoustic output, elastography function, and cleaning validation.
Technological Characteristics
Flexible video endoscope with electronic radial array ultrasound transducer. Materials: stainless steel distal end, ES-8SC rubber adhesive. Dimensions: 13.4mm distal end OD, 10.9mm insertion tube OD. Connectivity: proprietary connectors for video/light and ultrasound cable (MAJ-2056/UITC-AI800A). Sterilization: Ethylene oxide gas. Features: NBI observation, RFID tag for scope ID/reprocessor communication. Ultrasound output: MI ≤ 1.9, ISPTA.3 ≤ 720 mW/cm2.
Indications for Use
Indicated for endoscopic real-time ultrasound imaging and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs in patients requiring such diagnostic or therapeutic interventions. For use by appropriately trained healthcare professionals in a healthcare facility.
Regulatory Classification
Identification
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Special Controls
*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
Predicate Devices
OLYMPUS GF-UE160-AL5 Endoscope used with the Aloka SSD-5000 Diagnostic Ultrasound System (K051541)
Reference Devices
Gastrointestinal Videoscope OLYMPUS GIF TYPE HQ190 (K112680)
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FDA U.S. FOOD & DRUG ADMINISTRATION
October 3, 2025
Olympus Medical Systems Corporation
% Teffany Hutto
Project Manager, Regulatory Affairs
Olympus Corporation of the Americas
800 West Park Drive
Westborough, Massachusetts 01581
Re: K251859
Trade/Device Name: EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: ODG, ITX
Dated: September 4, 2025
Received: September 4, 2025
Dear Teffany Hutto:
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"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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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 QS 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 (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-reporting-combination-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 Rule"). 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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
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Sincerely,
**Shanil P. Haugen -S**
Shanil P. Haugen, Ph.D.
Assistant Director
DHT3A: Division of Renal, Gastrointestinal,
Obesity and Transplant Devices
OHT3: Office of Gastrorenal, ObGyn,
General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K251859
Device Name
EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE (OLYMPUS GF-UE190)
Indications for Use (Describe)
The EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE OLYMPUS GF-UE190 has been designed to be used with diagnostic ultrasound system, video system center, light source, documentation equipment, monitor, endoscopic therapy accessories and other ancillary equipment.
The EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE OLYMPUS GF-UE190 is designed for endoscopic real-time ultrasound imaging, and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.
Operator qualifications
Appropriately trained healthcare professionals.
Device use settings
Healthcare 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."
FORM FDA 3881 (8/23)
PEC Publishing Services (301) 443-6740
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K251859
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Traditional 510(k) Notification
EVIS EUS ULTRASOUND GASTROINTESTINAL
VIDEOSCOPE OLYMPUS GF-UE190
Date Prepared: September 30, 2025
# 510(k) Summary
## 1. GENERAL INFORMATION
- **510(k) Submitter:** OLYMPUS MEDICAL SYSTEMS CORP.
2951 Ishikawa-cho, Hachioji-shi, Tokyo 192-8507, Japan
- **Contact Person:** Teffany Hutto
Olympus Corporation of the Americas
3500 Corporate Parkway PO Box 610
Center Valley, PA 18034-0610, USA
Phone: 512-508-6550
Fax: 484-896-7128
Email: teffany.hutto@olympus.com
- **Manufacturing site:** Aizu Olympus Co., Ltd.,
3-1-1 Niiderakita, Aizuwakamatsu-shi, Fukushima 965-8520, Japan
## 2. DEVICE IDENTIFICATION
| Trade/Device Name | EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE OLYMPUS |
| --- | --- |
| Model Name | GF-UE190 |
| Common Name | Gastroscope and accessories, flexible/rigid |
| Regulation Number | 21 CFR 876.1500 |
| Regulation Name | Endoscope and accessories |
| Regulatory Class | II |
| Product Code | ODG (Endoscopic ultrasound system, gastroenterology-urology)
ITX (Transducer, ultrasonic, diagnostic) |
| Classification Panel | Radiology |
## 3. PREDICATE DEVICE / REFERENCE DEVICE
| Predicate Device Name | 510(k) Submitter | 510(k) No. |
| --- | --- | --- |
| OLYMPUS GF-UE160-AL5 Endoscope used with the Aloka SSD-5000 Diagnostic Ultrasound System | OLYMPUS MEDICAL SYSTEMS CORP. | K051541 |
510(k) Summary
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VIDEOSCOPE OLYMPUS GF-UE190
| Reference Device Name | 510(k) Submitter | 510(k) No. |
| --- | --- | --- |
| Gastrointestinal Videoscope
OLYMPUS GIF TYPE HQ190
(GIF-HQ190) | OLYMPUS MEDICAL SYSTEMS CORP. | K112680 |
## 4. DEVICE DESCRIPTION
The EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE OLYMPUS GF-UE190 has been designed to be used with diagnostic ultrasound system, video system center, light source, documentation equipment, monitor, endoscopic therapy accessories and other ancillary equipment.
The EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE OLYMPUS GF-UE190 is designed for endoscopic real-time ultrasound imaging, and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.
## 5. PRINCIPLE OF OPERATION
The GF-UE190 has been designed to be used with diagnostic ultrasound system, video system center, light source, documentation equipment, monitor and endoscopic therapy accessories and other ancillary equipment. This instrument is designed for endoscopic real-time ultrasound imaging, and other endoscopic procedures within the upper gastrointestinal tract, anus, rectum, and surrounding organs.
The GF-UE190 is a flexible video endoscope and modification of the GF-UE160-AL5 that was previously cleared under K051541. The subject device consists of three parts: the control section, the insertion section, and the connector section.
## The Control Section
The RIGHT/LEFT and UP/DOWN angulation control knob on the control section is connected to the tip of the tip of the bending section by a series of wires. By operating the RIGHT/LEFT and UP/DOWN angulation control knob, the bending section at the distal end bends vertically to guide the distal end for insertion and observation within the gastrointestinal tract.
The control section contains two cylinders: the suction cylinder and the air/water cylinder. The suction valve is attached to the suction cylinder and the air/water valve is attached to the air/water cylinder. When suction valve is depressed to the first stage to activate suction, the suction valve is operated to remove any fluids, debris, flatus, or air from the patient. The suction valve is depressed completely to activate suction of the water from the balloon through the balloon channel. The hole in the air/water valve is covered to insufflate air and the air/water valve is depressed to the first stage to feed water for lens washing. It also can be used to feed air to remove any
510(k) Summary
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EVIS EUS ULTRASOUND GASTROINTESTINAL
VIDEOSCOPE OLYMPUS GF-UE190
fluid or debris adhering to the objective lens. The air/water valve is depressed completely to fill the balloon with sterile water through the balloon channel.
## The Insertion Section
The insertion section has main parts including the image sensor, light guides that bring light from the light source through the endoscope, instrument channel where therapeutic tools can be pushed in and out (also the suction channel), and the ultrasound transducer that emits and receives ultrasound waves. The light from the light source travels through the light guide to the light guide lens at the distal end. The light source can offer both the white light for the normal observation and the narrow band imaging (NBI). The image sensor transduces the incident light from the objective lens to electrical signal. The video processor transduce electrical signal to video signal.
## The Endoscope Connector Section
The connector section has the endoscope connector that connects the endoscope with the light source (CLV-190 or CV-1500). The connector section also has the ultrasound cable connector. This ultrasound cable connector connects the endoscope with the Olympus ultrasound center through the ultrasound cable. The Ultrasound (US) Connector cap attached to the ultrasound cable connector protects the endoscope from water penetration during reprocessing.
The basic principle, including user interface and operation of the GF-UE190, are almost the same to the predicate GF-UE160-AL5.
The subject device has been designed to be used with the following systems:
- EU-ME3: K243502
- Aplio i800: K233195
- EVIS EXERA III 190 System: K112680, K121959
- EVIS X1 1500 System: K222584
## 6. INDICATIONS FOR USE
The EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE OLYMPUS GF-UE190 has been designed to be used with diagnostic ultrasound system, video system center, light source, documentation equipment, monitor, endoscopic therapy accessories and other ancillary equipment.
The EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE OLYMPUS GF-UE190 is designed for endoscopic real-time ultrasound imaging, and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.
510(k) Summary
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EVIS EUS ULTRASOUND GASTROINTESTINAL
VIDEOSCOPE OLYMPUS GF-UE190
**Operator qualifications**
Appropriately trained healthcare professionals.
**Device use settings**
Healthcare facility
# INDICATIONS FOR USE COMPARISON
The indications for use for the subject device, GF-UE190, is similar as the predicate device, GFUE160-AL5. The main difference is that the compatible ultrasound system cleared for use with the predicate device is different than the systems to be used with the subject device. Testing included in this application will show that these new ultrasound systems will not introduce new issues of safety or efficacy.
# 7. COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEVICE
The subject and predicate devices have the same design, materials, principle operation, and energy source. The subject and predicate devices do have different technological characteristics which are listed as follows:
1) Outer diameter of distal end
Outer diameter of distal end has been narrowed from $\Phi 13.8\mathrm{mm}$ to $\Phi 13.4\mathrm{mm}$. Compared to the Predicate Device; the outer diameter of the distal end is smaller. However, this difference does not affect the indications for use, device function or performance. Risk Analysis did not identify any new risks related to this difference. Therefore, this difference will not introduce new issues of safety or efficacy.
2) Maximum outer diameter of distal end
Maximum outer diameter of distal end has been narrowed from $\Phi 15.0\mathrm{mm}$ to $\Phi 14.7\mathrm{mm}$. Compared to the Predicate Device; the maximum outer diameter of the distal end is smaller. However, this difference does not affect the indications for use, device function or performance. Risk Analysis did not identify any new risks related to this difference. Therefore, this difference will not introduce new issues of safety or efficacy.
3) Outer diameter of insertion tube
Outer diameter of insertion tube has been narrowed from $\Phi 11.8\mathrm{mm}$ to $\Phi 10.9\mathrm{mm}$. Compared to the Predicate Device; the outer diameter of the insertion tube is smaller. However, this difference does not affect the indications for use, device function or performance. Risk Analysis did not identify any new risks related to this difference. Therefore, this difference will not introduce new issues of safety or efficacy.
510(k) Summary
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OLYMPUS
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VIDEOSCOPE OLYMPUS GF-UE190
4) Direction of view
Direction of view has been changed from 55° to 50°. Compared to the Predicate Device, the direction of view is closer to forward viewing. However, this difference does not affect the indication for use, device function or performance. Risk Analysis did not identify any new risks related to this difference. Therefore, this difference will not introduce new issues of safety or efficacy.
5) Electrical connector (transmit CCD image signal) and ultrasound connector (transmit ultrasound image signal)
Electrical connector and ultrasound connector are integrated with scope connector. Water-resistant cap for the electrical connector is no longer needed. On the other hand, ultrasound cable (MAJ-2056 or UITC-AI800A) is needed to communicate with ultrasound system. This is only mechanical structure change, and no modification is applied to its operation or communication with the video system center and ultrasound system. Therefore, this difference will not introduce new issues of safety or efficacy.
6) Shape of distal end
There is a D-cut at the distal end. This change aims to remove the band of balloon easily if the band of the balloon's distal end is left on the endoscope's balloon attachment groove. Insert a tool into the balloon attachment groove's notch and pull off the band to take it off. Cleaning validation was performed and confirmed that GF-UE190 can be cleaned effectively.
7) Outlet of the balloon suction channel
By changing the outlet shape of the balloon suction channel, the cleaning brush can be confirmed from the outlet of the balloon suction channel. This change aims to easily confirm that the cleaning brush has fully passed the whole length of the balloon suction channel. Cleaning validation was performed and confirmed that GF-UE190 can be cleaned effectively.
8) Structure of transducer cover
By changing the structure of the transducer cover, the edge of the acoustic lens can be covered. This change aims to prevent peeling of the edge of the acoustic lens. Cleaning validation was performed and confirmed that GF-UE190 can be cleaned effectively.
9) Shear Wave Elastography (SWE)
The GF-UE190 is compatible with Aplio i800 (K233195) and OLYMPUS EU-ME3 (K243502) which has Shear Wave Elastography (SWE) technology. SWE is an ultrasound applied technique used to measure tissue stiffness. In SWE, shear wave is transmitted from acoustic lens and the propagation velocity is measured when the wave passes the tissue. The ultrasound transmission in SWE is within the range of the IEC 60601-2-37 and the ultrasound output standard (MI ≤ 1.9, ISPTA.3 ≤ 720 mW/cm2) set by FDA. Therefore, this difference will not introduce new issues of safety or efficacy.
510(k) Summary
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VIDEOSCOPE OLYMPUS GF-UE190
A side-by-side comparison of the subject device and the predicate device is provided below.
| Item | Subject Device (SD) | Predicate Device (PD) |
| --- | --- | --- |
| General Information | | |
| Model | EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE OLYMPUS GF-UE190 | OLYMPUS GF-UE160-AL5 Endoscope used with the Aloka SSD-5000 Diagnostic Ultrasound System |
| Company | OLYMPUS MEDICAL SYSTEMS CORP. | OLYMPUS MEDICAL SYSTEMS CORP. |
| 510(k) Number | - | K051541 |
| Indications for use | The EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE OLYMPUS GF-UE190 has been designed to be used with diagnostic ultrasound system, video system center, light source, documentation equipment, monitor, endoscopic therapy accessories and other ancillary equipment.
The EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE OLYMPUS GF-UE190 is designed for endoscopic real-time ultrasound imaging, and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.
Operator qualifications
Appropriately trained healthcare professionals.
Device use settings
Healthcare facility | The Olympus GF-UE160-AL5 Ultrasonic Endoscope is intended to be used for endoscopic ultrasonic imaging of the gastrointestinal wall, bile and pancreatic ducts and surrounding organs. It is to be used with the Aloka SSD-5000 (K033311) Diagnostic Ultrasound system and various other video and light source accessories. |
| Regulation name | Endoscope and accessories | Endoscope and accessories, Diagnostic ultrasonic transducer |
510(k) Summary
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K251859
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Traditional 510(k) Notification
EVIS EUS ULTRASOUND GASTROINTESTINAL
VIDEOSCOPE OLYMPUS GF-UE190
| Item | Subject Device (SD) | Predicate Device (PD) |
| --- | --- | --- |
| Regulation number | 876.1500 | 876.1500 |
| Product Code | ODG, ITX | FDF, ITX |
| Ultrasound Specifications | | |
| Transducer Frequency | 7-10 MHz (Nominal ultrasound frequencies of the transducer assembly) | 7.5 MHz |
| Mode | Used with EU-ME3
B, PWD, Color Doppler, Combined, Other
Aplio i800
B, M, PWD, Color Doppler, Combined, Other | Used with the SSD-5000
B, M, PWD, Color Doppler, Combined |
| | | Used with EU-ME2 (combined in K203128) |
| | | B, PWD, Color Doppler, Combined |
| Applicable Ultrasound system | OLYMPUS ENDOSCOPIC
ULTRASOUND CENTER EU-ME3
Aplio i800 | Used with EU-ME2 PREMIER PLUS (combined in K203128)
B, PWD, Color Doppler, Combined, Other |
| | | Used with EU-ME3 (combined in K243502)
B, PWD, Color Doppler, Combined, Other |
| | | Used with ALOKA ARIETTA850 (combined in K183456)
B, M, PWD, Color Doppler, Combined, Other |
| Acoustic Output | I_{SPTA} :720 mW/cm² or less
MI :1.9 or less | I_{SPTA} :720 mW/cm² or less
MI :1.9 or less |
510(k) Summary
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K251859
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Traditional 510(k) Notification
EVIS EUS ULTRASOUND GASTROINTESTINAL
VIDEOSCOPE OLYMPUS GF-UE190
| Item | Subject Device (SD) | Predicate Device (PD) |
| --- | --- | --- |
| Scanning Direction | Perpendicular to the insertion direction | Perpendicular to the insertion direction |
| Scanning Field of View [deg] | 360 | 360 |
| Axial resolution | 1mm or less | 1mm or less |
| Lateral resolution | 3mm or less | 3mm or less |
| Depth of penetration | Used with EU-ME3: 90mm or moreUsed with Aplio i800: 85mm or more | Not Provided |
| Scanning Method | Electronic radial array | Electronic radial array |
| Contact Method | Balloon method, sterile de-aerated water immersion method | Balloon method, sterile de-aerated water immersion method |
| Endoscope Specifications | | |
| Field of View | 100° | 100° |
| Depth of Field | 3 – 100 mm | 3 – 100 mm |
| Direction of View | 50° (forward-oblique) | 55° (forward-oblique) |
| Optimum Working Distance | 14 mm | 14 mm |
| Type of CCD Chip | Color | Color |
| Total Number of Pixels | 182,484 | 84,633 |
| Pixels per square mm | 226,757 | — |
| Size of Pixel | 2.1μm(H) x 2.1μm(V) | 6.0μm(H) x 3.9μm(V) |
| Active Area of CCD Chip | 865μm(H) x 857μm(V) | 1414μm(H) x 1504μm(V) |
| Outer Diameter of Distal End | ø 13.4 mm | ø 13.8mm |
510(k) Summary
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K251859
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Traditional 510(k) Notification
EVIS EUS ULTRASOUND GASTROINTESTINAL
VIDEOSCOPE OLYMPUS GF-UE190
| Item | Subject Device (SD) | Predicate Device (PD) |
| --- | --- | --- |
| Maximum distal end outer diameter | ø 14.7 mm | ø 15.0 mm |
| Outer Diameter of Insertion Tube | ø 10.9 mm | ø 11.8mm |
| Angulation UP/DOWN /LEFT/RIGHT [deg] | 130/90/90/90 | 130/90/90/90 |
| Working Length | 1250 mm | 1250 mm |
| Inner Diameter of Instrument Channel | Φ2.2mm | Φ2.2mm |
| Combination use with Electrosurgical instruments | Not applicable | Not applicable |
| NBI observation | Available | Not available |
| Distal end | Stainless | Stainless |
| A rubber adhesive | ES-8SC | ES-8SC |
| Ultrasound Cable | The ultrasound cable (MAJ-2056 or UITC-AI800A) is separated from ultrasound connector. | The ultrasound cable is combined with the endoscope. |
| Scope connector | Electrical connector is integrated to scope connector. Ultrasound connector is separated. When combined with the water-resistant cap, ultrasound connector is water resistant. | Electrical connector (transmit CCD image signal) and ultrasound connector are separated. When combined with the water-resistant cap, both connectors are water resistant. |
| Protect water penetration during reprocessing. | The US connector cap (MAJ-2295) is attached to the ultrasound cable connector on the endoscope to protect the ultrasound cable connector and the endoscope from water penetration during reprocessing. | Water resistant cap (MH-553) is attached to the electrical connector on the endoscope to protect the electrical connector and the endoscope from water penetration during reprocessing. Water resistant cap (MAJ-896) is attached to the ultrasound connector to protect from water penetration during reprocessing. |
510(k) Summary
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K251859
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Traditional 510(k) Notification
EVIS EUS ULTRASOUND GASTROINTESTINAL
VIDEOSCOPE OLYMPUS GF-UE190
| Item | Subject Device (SD) | Predicate Device (PD) |
| --- | --- | --- |
| Sterilization methods for reprocessing endoscope | Ethylene oxide gas | Ethylene oxide gas |
| High-frequency accessories | Not available | Not available |
| RFID tag for communication with endoscope reprocessor | Available | Not available |
| Individual scope information (Scope ID) | Available | Not available |
# 8. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination for GF-UE190:
## 1) Performance testing - Bench
Bench testing as listed below was conducted to ensure that the subject device performs as intended and meet design specifications.
- Thermal Safety
- Durability
- Dimensional Analysis
- Rates of Air, Water and Suction
- Photobiological Safety
- Endoscopic Image Field of View
- Endoscopic Image Direction of View
- Endoscopic Image Depth of Field
- Endoscopic Image Resolution
- Endoscopic Image Dynamic Range
- Endoscopic Image Signal to Noise Ratio
- Endoscopic Image Color Performance
- Endoscopic Image Intensity Uniformity
- Endoscopic Image Video Latency
- Endoscopic Image Distortion
- Acoustic Output
- Clinical Accuracy
- Elastography Function
- Shear Wave Speed Quantification Measurement
- Transducer Element Check
510(k) Summary
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K251859
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Traditional 510(k) Notification
EVIS EUS ULTRASOUND GASTROINTESTINAL
VIDEOSCOPE OLYMPUS GF-UE190
- Transportation and Storage
2) Performance testing - Animal
Animal testing was not performed.
3) Risk management
Risk management was performed in accordance with ISO 14971:2019. The design verification tests and their acceptance criteria were performed and identified as a result of this risk management.
9. CONCLUSIONS
Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate device, EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE OLYMPUS GF-UE190 raises no new issue of safety and effectiveness and is substantially equivalent to the predicate device in terms of safety, effectiveness, and performance.
510(k) Summary
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Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
