This instrument has been designed to be used with an Olympus 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.

Device Description

The TJF-Q190V has been designed to be used with an Olympus 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-0190V is compatible with Olympus system "Video System Center OLYMPUS CV-190 and XENON LIGHT SOURCE OLYMPUS CLV-190 (K112680)".

The subject device consists of flexible insertion section, control section and endoscope connector section with equipped 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 the white light for the normal observation and the narrow band imaging (NBI). The CCD chip transduces the incident light from the objective lens to electrical signal. The video processor transduces electrical signal to video signal.

There is an instrument channel entirely inside of the flexible insertion section. Endo Therapy accessories can be inserted through the instrument channel. A forceps elevator is located at the distal end of the insertion to elevate EndoTherapy accessories for endoscopic treatment.

The TJF-Q190V consists of a single-use distal cover, MAJ-2315 which has been designed to be attached to OLYMPUS TJF-O190V to cover the distal end of the insertion tube and around the forceps elevator. MAJ-2315 is to be discarded after clinical use. MAJ-2315 and TJF-Q190V were previously 510(k) cleared via premarket notification, K193182.

The following new reprocessing accessory has also been designed for use with TJF-O190V:

CONNECTING TUBE MAJ-2358

The MAJ-2358 has been designed to be used when reprocessing TJF-Q190V using the Olympus endoscope reprocessor.

The MAJ-2358 is a connecting tube to connect Olympus endoscope reprocessor and TJF-O190V. The endoscope side connector is attached to the distal end of the endoscope to directly deliver fluid to the elevator area.

AI/ML Overview

This document (K202661) is a 510(k) premarket notification for a medical device, the Evis Exera III Duodenovideoscope Olympus TJF-Q190V, and its associated reprocessing accessory, the Connecting Tube MAJ-2358. The core of the submission is to demonstrate that the redesigned duodenoscope and new reprocessing accessory are substantially equivalent to a previously cleared predicate device.

The provided text does not contain information about a study that proves the device meets specific performance acceptance criteria in terms of clinical performance (e.g., diagnostic accuracy, sensitivity, specificity, or human expert performance improvement with AI). Instead, the performance data provided focuses on:

Reprocessing validation testing: Ensuring the device can be properly reprocessed for safe reuse.
Bench testing: Verifying the device and its accessories meet design specifications and perform as intended.
Risk analysis: Assessing potential risks associated with the new connecting tube.

Therefore, many of the requested details, particularly those related to AI/human reader performance studies, ground truth establishment for clinical data, and effect sizes of AI assistance, are not applicable to this document as it describes a conventional medical device rather than an AI-powered one.

However, based on the provided text, I can extract information related to the device's technical acceptance criteria and the type of studies performed for regulatory clearance.

Acceptance Criteria and Device Performance (Based on provided text)

Since this is not an AI/diagnostic device, the acceptance criteria are related to cleaning, functionality, and safety.

Acceptance Criteria Category	Reported Device Performance (Summary from text)
Reprocessing Validation	Reprocessing instructions and validation testing for TJF-Q190V using OER-Pro and MAJ-2358 were conducted as recommended by FDA guidance ("Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling").
Bench Testing	Bench testing for TJF-Q190V and accessories (including MAJ-2358) was conducted to ensure the device performs as intended and meets design specifications. This included process verification, design verification, and design validation.
Connecting Tube MAJ-2358 Functionality	The MAJ-2358 is designed to connect the endoscope reprocessor to the TJF-Q190V to deliver fluid directly to the elevator area during reprocessing. Bench testing supports this functionality.
Risk Analysis	Risk analysis for MAJ-2358 when used with TJF-Q190V was conducted in accordance with ISO 14971:2007 established in-house acceptance criteria.
Human Factors Validation	Human factors validation for the MAJ-2358 and TJF-Q190V was conducted in accordance with FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices."
Substantial Equivalence	Based on indications for use, technological characteristics, performance testing, and technological comparison to predicate devices, the TJF-Q190V makes "no new issue of safety and effectiveness" and is "substantially equivalent" to predicate devices in terms of safety, efficacy, and performance. This is the overarching "acceptance criterion" for 510(k) clearance.

Study Details (Applicable to this type of device and submission)

Sample sizes used for the test set and the data provenance:
- The document does not specify sample sizes for the reprocessing validation, bench testing, risk analysis, or human factors studies. These would typically be detailed in the full test reports referenced by the submission, not in the summary document.
- Data Provenance: Not explicitly stated for specific tests, but the manufacturing site is Aizu Olympus Co., Ltd., Japan, implying tests likely occurred within Olympus's development and testing infrastructure, which could be global. The submission is to the U.S. FDA. The design and validation studies generally reflect prospective testing of the device against its specifications and reprocessing protocols.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of clinical expert review for diagnostic accuracy. For reprocessing validation, experts would be microbiologists or reprocessing specialists. For human factors, they would be end-users (e.g., nurses, technicians, physicians) representative of the target user population. The specific number and qualifications are not disclosed in this summary but would be part of the underlying test reports.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for clinical diagnostic adjudication. For technical validation (reprocessing, bench tests), "adjudication" wouldn't be in the sense of resolving differing clinical interpretations. Pass/fail criteria are established based on engineering specifications, regulatory standards (e.g., AAMI TIR30 for reprocessing), and risk analysis results. Human factors studies would assess usability and potential for error, which might involve qualitative and quantitative data but not a clinical adjudication model.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is a duodenoscope, an imaging and interventional tool. It is not an AI-powered diagnostic device, nor does it claim to assist human readers in image interpretation or diagnostic performance in the way an AI algorithm would.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a hardware device.
The type of ground truth used:
- Not a clinical ground truth (e.g., pathology, outcomes data). The "ground truth" for these tests would be:
  - Reprocessing: Sterility, absence of bioburden, and functional integrity after multiple reprocessing cycles, confirmed by laboratory methods.
  - Bench Testing: Engineering specifications (e.g., dimensional accuracy, image quality parameters, durability, fluid flow rates in channels), confirmed by measurements and functional checks.
  - Risk Analysis/Human Factors: Identification of potential hazards and user errors, and confirmation that controls mitigate risks to an acceptable level.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that uses a "training set."
How the ground truth for the training set was established:
- Not applicable. (See point 7)

In summary: The provided document is a regulatory clearance for a medical device (a duodenoscope) and a reprocessing accessory. The acceptance criteria and supporting studies are focused on the device's physical and functional performance, reprocessing efficacy, safety, and human factors, rather than clinical diagnostic performance enhancements or AI assistance.

Summary

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December 8, 2020

Olympus Medical Systems Corp. % Sheri Musgnung Regulatory Affairs Manager Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, Pennsylvania 18034-0610

Re: K202661

Trade/Device Name: Evis Exera III Duodenovideoscope Olympus TJF-Q190V Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FDT, NWB, FEB Dated: September 11, 2020 Received: September 14, 2020

Dear Sheri Musgnung:

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 (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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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.

For comprehensive regulatory information about medical devices and radiation-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,

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

510(k) Number (if known)

K202661

Device Name

EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TIF-Q190V

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, dark blue letters. The letters are closely spaced together, creating a solid block of text. Below the word "OLYMPUS" is a horizontal gold bar. The gold bar is slightly wider than the word "OLYMPUS" above it.

1. General Information

OLYMPUS MEDICAL SYSTEMS CORP. ■ Applicant: 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047
Official Correspondent: Sheri L. Musgnung Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-788-3258 Email: sheri.musgnung@olympus.com
Manufacturing site: Aizu Olympus Co., Ltd., 500 Muranishi, Niidera, Monden-machi, Aizuwakamatsu-shi, Fukushima 965-8520, Japan

2. Device Identification

■ Device Name	EVIS EXERA III DUODENOVIDEOSCOPEOLYMPUS TJF-Q190V
■ Common Name	Duodenoscope and accessories
■ Regulation Number	876.1500
■ Regulation Name	Endoscope and Accessories
■ Regulatory Class	II
■ Product Code	FDT; Duodenoscope, Accessories, Flexible/RigidNWB; Endoscope, accessories, narrow band spectrumFEB; Accessories, Cleaning, For Endoscope
■ Classification Panel	Gastroenterology/Urology

510(k) Summary Page 1 of 4

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3. PREDICATE DEVICE

Device name	510(k) Submitter	510(k) No.
EVIS EXERA IIIDUODENOVIDEOSCOPEOLYMPUS TJF TYPE Q190V	OLYMPUS MEDICALSYSTEMS CORP.	K193182

Table 1 Predicate device on TJF-O190V

4. DEVICE DESCRIPTION

EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V

The subject device consists of flexible insertion section, control section and endoscope connector section with equipped CCD chip which delivers images.

The following new reprocessing accessory has also been designed for use with TJF-O190V:

CONNECTING TUBE MAJ-2358

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The MAJ-2358 has been designed to be used when reprocessing TJF-Q190V using the Olympus endoscope reprocessor.

5. Indications for Use

6. Comparison of Technological Characteristics

Compared to the predicate device, HLD reprocessing method using OER-Pro and MAJ-2358 is compatible with the subject device. In addition, compatibility with OER-Elite has been submitted to FDA via an addendum-to-file K190969/A001.

There are no other major differences and the technological characteristics of the subject device TJF-Q190V are functionally equivalent to the predicate device.

5.7 PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

1) Reprocessing validation testing

Reprocessing instruction and reprocessing method validation testing for the TJF-Q190V using OER-Pro and MAJ-2358 were conducted and documentation was provided as recommended by Guidance for Industry and Food and Drug Administration Staff, "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling".

2) Performance testing - Bench

Bench testing for the TJF-Q190V and its accessories as listed below was conducted to ensure that the subject device performs as intended and meet design specifications. Device performance assessed the design requirements, and included process verification, design verification, and design validation.

Connecting Tube Validation (MAJ-2358)

3) Risk analysis

Risk analysis for the MAJ-2358 when used with the TJF-Q190V was conducted in

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accordance with established in-house acceptance criteria based on ISO 14971:2007 and the human factors validation was conducted in accordance with the FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices".

8. CONCLUSIONS

Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate devices, the TJF-Q190V raised no new issue of safety and effectiveness and are substantially equivalent to the predicate devices in terms of safety, efficacy and performance.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
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.(b)
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.