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 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 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.

AI/ML Overview

The provided 510(k) clearance letter for the Olympus TJF-Q190V Duodenoscope indicates that the clearance is based on adhesive modifications to the device. This implies that the acceptance criteria and the study proving the device meets these criteria would primarily relate to the durability and safety of the new adhesive material and its impact on the overall performance of the endoscope, particularly concerning reprocessing and material integrity.

However, the provided text does not contain the detailed information typically found in a clinical study report or a summary of non-clinical performance data that would explicitly list acceptance criteria and device performance in the format requested. The document states:

"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."
"No clinical data were collected."

This means the clearance was based on non-clinical (bench) testing. Therefore, I cannot provide information on clinical performance metrics, multi-reader multi-case studies, or the establishment of ground truth by human experts, as these were not part of the submission for this particular change.

Given the limited information, I will infer the implied acceptance criteria based on the described non-clinical tests.

Implied Acceptance Criteria and Reported Device Performance

Based on the provided information, the acceptance criteria would be related to the non-clinical performance of the device with the new adhesive, ensuring it is equivalent or superior to the predicate device, especially concerning durability against reprocessing and biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance (Inferred)

Acceptance Criterion (Inferred)	Reported Device Performance (Inferred from "demonstrate that the changes... do not adversely affect device performance")
Material Durability/Mechanical Performance (Bench Testing): The modified device, including the new adhesive, must maintain its structural integrity and functionality after repeated reprocessing cycles, comparable to or better than the predicate device.	The changes to the device (adhesive modifications) were verified/validated, and results demonstrate that they "do not adversely affect device performance" in terms of mechanical integrity and functionality after testing. The device performs "as well as or better than the predicate device."
Sterilization and Shelf-Life - Residual Toxicity of Reprocessing Chemicals: The new adhesive must not retain toxic residues from reprocessing chemicals above acceptable limits, nor should it degrade in a way that compromises safety or effectiveness over its shelf-life.	Testing for residual toxicity of reprocessing chemicals was performed, and results indicate no adverse effect, confirming safety and chemical compatibility.
Biocompatibility: The new adhesive material must be biocompatible according to established standards, ensuring it does not elicit adverse biological responses when in contact with tissue.	Biocompatibility evaluation was performed, and results demonstrate no adverse effect, meaning the new adhesive material meets biocompatibility standards.
Overall Performance Equivalence: No adverse changes to optical or electrical performance, or other device specifications, compared to the predicate device.	"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." This implies equivalence was maintained.

Study Proving Device Meets Acceptance Criteria:

The study involved non-clinical, bench-level verification and validation activities.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated. For bench testing, this would typically involve a defined number of devices or components subjected to various tests (e.g., durability cycles, chemical exposure). The exact number of units or test replicates is not provided in the summary.
Data Provenance: The manufacturing site is Aizu Olympus Co., Ltd., Japan. The testing would have been conducted in a controlled lab environment. This was a retrospective evaluation of a design modification, and the data would be laboratory-generated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This question is not applicable as "No clinical data were collected." The "ground truth" for non-clinical bench testing would be defined by engineering specifications, material standards, and validated test methods, rather than expert human interpretation of medical images or patient outcomes.

4. Adjudication Method for the Test Set:

Not applicable. As no clinical data or human evaluations were involved for this specific submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a MRMC study was not done. The document explicitly states, "No clinical data were collected." Therefore, there is no information on how human readers might improve with or without AI assistance, as AI is not mentioned and no human reading study was conducted.

6. Standalone (Algorithm Only) Performance:

Not applicable. This device is a duodenoscope, a physical medical instrument, not an AI algorithm. There is no mention of a software algorithm or standalone performance in the context of AI.

7. Type of Ground Truth Used:

For the non-clinical testing, the "ground truth" would be based on:
- Engineering Specifications: Device design parameters, material specifications.
- Regulatory Standards: ISO standards for biocompatibility (e.g., ISO 10993), sterilization, and other relevant performance standards for endoscopes.
- Validated Test Methods: Established laboratory protocols for evaluating material durability, chemical resistance, and device functionality.
- Predicate Device Performance Baseline: The performance characteristics of the legally marketed predicate device (K202661) served as a benchmark for substantial equivalence.

8. Sample Size for the Training Set:

Not applicable. This submission focuses on a hardware modification (adhesive) to an existing device, not the development or training of a software algorithm.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there was no training set for a software algorithm.

Summary

FDA 510(k) Clearance Letter - Olympus TJF-Q190V Duodenoscope

Page 1

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

Doc ID # 04017.07.05

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.

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K250701 - Darlene Hull Page 2

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 Page 3

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).

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

Page 4

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.

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)

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

Page 5

Traditional 510(k) Notification

Product Name: Evis Exera III Duodenoscope TJF-Q190V
Adhesive Modifications

CONFIDENTIAL

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: 801-388-4558
E-mail: darlene.hull@olympus.com
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

K250701
Page 1 of 4

Page 6

Traditional 510(k) Notification

Product Name: Evis Exera III Duodenoscope TJF-Q190V
Adhesive Modifications

CONFIDENTIAL

510(k) Summary

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 DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V	OLYMPUS MEDICAL SYSTEMS CORP.	K202661

4. Device Description

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.

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

K250701
Page 2 of 4

Page 7

Traditional 510(k) Notification

Product Name: Evis Exera III Duodenoscope TJF-Q190V
Adhesive Modifications

CONFIDENTIAL

510(k) Summary

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

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

K250701
Page 3 of 4

Page 8

Traditional 510(k) Notification

Product Name: Evis Exera III Duodenoscope TJF-Q190V
Adhesive Modifications

CONFIDENTIAL

510(k) Summary

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.

K250701
Page 4 of 4

CONFIDENTIAL
510(k) Summary

Regulation Number and Section

N/A