Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)

K250701 · Olympus Medical Systems Corp. · FDT · Jun 5, 2025 · Gastroenterology, Urology

Device Facts

• Record ID: K250701
• Device Name: Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)
• Applicant: Olympus Medical Systems Corp.
• Product Code: FDT · Gastroenterology, Urology
• Decision Date: Jun 5, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V has been designed to be used with a video system center, light source, documentation equipment, monitor, endo therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

Device Story

Flexible duodenoscope for visualization and surgical intervention in the duodenum. Device features flexible insertion section, control section, and connector section with integrated CCD chip for image capture. Light source provides white light and narrow band imaging (NBI) via light guide. Instrument channel allows passage of EndoTherapy accessories; distal forceps elevator facilitates accessory positioning. Used in clinical settings by trained physicians. Device connects to video system centers (CV-190, CV-1500) and light sources (CLV-190) to display images on monitors. Output enables real-time visualization for diagnosis and guidance of therapeutic instruments. Modifications involve adhesive materials in insertion/distal sections to enhance durability against reprocessing chemicals.

Clinical Evidence

No clinical data were collected. Substantial equivalence is supported by bench performance testing, biocompatibility evaluation, and sterilization/shelf-life testing regarding residual toxicity of reprocessing chemicals.

Technological Characteristics

Flexible endoscope with CCD imaging sensor. Compatible with CV-190 and CV-1500 video processors. Features include forceps elevator and instrument channel. Adhesive materials modified for improved chemical durability. Reprocessing-compatible design. No changes to optical or electrical performance specifications.

Indications for Use

Indicated for endoscopy and endoscopic surgery within the duodenum in patients requiring diagnostic or therapeutic procedures using compatible video systems and ancillary equipment.

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.

Predicate Devices

• EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (K202661)

Reference Devices

• Video System Center OLYMPUS CV-190 (K112680)
• XENON LIGHT SOURCE OLYMPUS CLV-190 (K112680)
• EVIS X1 Video System Center OLYMPUS CV-1500 (K222584)
• Distal cover MAJ-2315 (K193182, K202661, K220587)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

June 5, 2025

Olympus Medical Systems Corp.
% Darlene Hull
Program Manager, Regulatory Affairs
Olympus Surgical Technologies of the Americas
800 West Park Drive
Westborough, Massachusetts 01581

Re: K250701
Trade/Device Name: Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: FDT
Dated: March 7, 2025
Received: March 7, 2025

Dear Darlene Hull:

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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K250701 - Darlene Hull
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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" (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-

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K250701 - Darlene Hull
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

SIVAKAMI VENKATACHALAM -S

for
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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EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
Page 10 of 41

| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K250701 | ? |
| Please provide the device trade name(s). | | ? |
| EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V) | | |
| Please provide your Indications for Use below. | | ? |
| The EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V has been designed to be used with a video system center, light source, documentation equipment, monitor, endo therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum. | | |
| Please select the types of uses (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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OLYMPUS
K250701
Page 1 of 4
Traditional 510(k) Notification
Product Name: Evis Exera III Duodenoscope TJF-Q190V
Adhesive Modifications

# 510(k) Summary

## 1. Company Information

- Applicant: OLYMPUS MEDICAL SYSTEMS CORP.
2951 Ishikawa-cho, Hachioji-shi,
Tokyo, Japan 192-8507
Establishment Registration No: 8010047

- Official Correspondent: Darlene Hull
c/o Olympus Corporation of the Americas
3500 Corporate Parkway
P.O. Box 610
Center Valley, PA 18034-0610
Phone: [phone]
E-mail: [e-mail]

- Manufacturing site: Aizu Olympus Co., Ltd.,
3-1-1 Niiderakita, Aizuwakamatsu-shi, Fukushima
965-8520, Japan

- Date Prepared: 7-Mar-25

## 2. Product Information

- Trade Name: EVIS EXERA III DUODENOVIDEOSCOPE
OLYMPUS TJF-Q190V

- Common Name: Duodenoscope and accessories

- Classification Name: Endoscope and Accessories

- Regulation Number: 876.1500

- Regulation Name: Endoscope and Accessories

CONFIDENTIAL
510(k) Summary

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OLYMPUS
K250701
Page 2 of 4

- Regulatory Class: II
- Product Code(s): FDT (Duodenoscope, Accessories, Flexible/Rigid)
- Classification Panel: Gastroenterology/Urology

# 3. Predicate Device

The subject device is equivalent to the predicate device listed below in Table 1.

Table 1: Predicate device on TJF-Q190V
| Device name | 510(k) Submitter | 510(k) No. |
| --- | --- | --- |
| EVIS EXERA III | OLYMPUS MEDICAL SYSTEMS CORP. | K202661 |
| DUODENOVIDEOSCOPE | | |
| OLYMPUS TJF-Q190V | | |

# 4. Device Description

The EVIS EXERA III DUODENOSCOPE TJF-Q190V has been designed to be used with an video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum. The TJF-Q190V is compatible with Olympus system “Video System Center OLYMPUS CV-190 and XENON LIGHT SOURCE OLYMPUS CLV-190 (K112680).” TJF-Q190V is also compatible with Olympus system “EVIS X1 Video System Center OLYMPUS CV-1500 (K222584).”

The subject device consists of a flexible insertion section, control section and endoscope connector section with equipped charge-coupled device (CCD) chip which delivers images.

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 white light for normal observation and narrow band imaging (NBI). The CCD chip transduces the incident light from the objective lens to electrical signal. The video processor transduces the electrical signal to video signal.

There is an instrument channel located inside of the flexible insertion section. EndoTherapy accessories can be inserted through the instrument channel. A forceps

CONFIDENTIAL
510(k) Summary

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OLYMPUS
K250701
Page 3 of 4
Traditional 510(k) Notification
Product Name: Evis Exera III Duodenoscope TJF-Q190V
Adhesive Modifications

elevator is located at the distal end of the insertion section to elevate endo therapy accessories for endoscopic treatment.

A sterile, single-use distal cover (MAJ-2315) has been designed to be attached to the OLYMPUS TJF-Q190V to cover the distal end of the insertion tube and fit around the forceps elevator. MAJ-2315 is to be discarded after clinical use. MAJ-2315 and TJF-Q190V were previously cleared under 510(k)s K193182, K202661 and K220587.

# 5. Indications for Use

The EVIS EXERA III DUODENOSCOPE OLYMPUS TJF-Q190V has been designed to be used with a video system center, light source, documentation equipment, monitor, endo therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

# 6. Comparison of Technological Characteristics

Compared to the predicate device, the changes are limited to design modifications to the adhesive used in the insertion section and distal end of the device to improve material durability against reprocessing chemical stress. In addition, minor labeling changes were applied including update in indications for use to include the subject device name.

There are no changes in contents of the indications for use, conditions of use, compatible components or accessories to be marketed/used with the device, or device specifications for TJF-Q190V, including optical or electrical performance.

# 7. Summary of Non-clinical Performance Data

Verification/validation activities were performed subsequent to a risk assessment evaluation of the device modifications per the Olympus Quality Management System. Results of the following testing demonstrate that the changes to the device do not adversely affect device performance:

- Performance Testing - Bench
- Sterilization and Shelf-Life - Residual Toxicity of Reprocessing Chemicals
- Biocompatibility Evaluation

# 8. Summary of Clinical Performance Data

No clinical data were collected.

# 9. Conclusion

CONFIDENTIAL
510(k) Summary

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OLYMPUS
K250701
Page 4 of 4
Traditional 510(k) Notification
Product Name: Evis Exera III Duodenoscope TJF-Q190V
Adhesive Modifications

Based on the results of the comparison of the indications for use, technological characteristics, and performance testing of the subject and predicate device, the change does raise no new issues of safety and effectiveness and the device is substantially equivalent to the predicate device and is as safe, as effective, and performs as well as or better than the predicate device.

CONFIDENTIAL
510(k) Summary