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 EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V is a flexible video endoscope used for endoscopic diagnosis and treatment within the duodenum. The device has a sealed elevator wire channel and a dual guidewire locking mechanism.

AI/ML Overview

This document, K143153 for the Olympus EVIS EXERA II Duodenovideoscope Olympus TJF Type Q180V, describes a 510(k) premarket notification. This type of submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study to prove the device meets specific performance acceptance criteria like an AI device would.

Therefore, the provided document does not contain the information requested in your prompt regarding acceptance criteria, a study proving device performance against those criteria, or details related to AI/algorithm performance. The non-clinical testing described is primarily focused on demonstrating the safety and effectiveness of the device's technological characteristics (e.g., sealed elevator wire channel, dual guidewire locking mechanism, reprocessing, biocompatibility, software validation, electromagnetic compatibility, electrical safety, thermal safety) through engineering tests and adherence to established standards and guidance documents.

Here's how the provided document aligns (or doesn't align) with your request:

1. A table of acceptance criteria and the reported device performance

Not Applicable. The document describes non-clinical engineering tests and adherence to standards (e.g., IEC, ISO, FDA guidance documents) to establish safety and effectiveness, and substantial equivalence to a predicate device. It does not provide a table of performance acceptance criteria and reported device performance in the manner typically seen for clinical or AI-based performance studies. For example, it states "Performance testing and design analysis was carried out to demonstrate the safety and effectiveness of the sealed elevator wire channel and the dual guidewire locking mechanism," implying that tests were done and passed, but specific quantitative acceptance criteria and results are not detailed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This information is generally for clinical or AI-based performance studies. The document describes engineering tests, not a study involving a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This pertains to clinical studies often involving AI. The document describes engineering and safety testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. This pertains to clinical studies often involving AI.

5. 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

Not Applicable. This device is a duodenovideoscope, not an AI or imaging interpretation system requiring an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This device is hardware; it does not have a standalone algorithm as described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable. For the engineering and safety tests performed, the "ground truth" would be established by engineering specifications, validated test methods, and adherence to regulatory standards, not by clinical or pathological diagnoses.

8. The sample size for the training set

Not Applicable. This pertains to AI/machine learning models.

9. How the ground truth for the training set was established

Not Applicable. This pertains to AI/machine learning models.

In summary, the provided document is a 510(k) clearance letter and summary for a medical device (a duodenovideoscope). It focuses on demonstrating substantial equivalence to a predicate device through engineering tests, adherence to standards, and verification of new features' safety and effectiveness. It does not involve AI, clinical performance studies with patient data, or the type of acceptance criteria and study designs you've asked about, which are common for AI/software as a medical device (SaMD) submissions.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 15, 2016

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

Re: K143153

Trade/Device Name: EVIS EXERA II Duodenovideoscope Olympus TJF Type Q180V Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FDT. NWB Dated: December 8, 2015 Received: December 11, 2015

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. 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 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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K143153

Device Name

EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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 Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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Image /page/3/Picture/1 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Underneath the word is a yellow line, and below that is the text "Your Vision, Our Future" in a smaller, blue font.

510(k) SUMMARY DUODENOVIDEOSCOPE EVIS MPUS TJF TYPE Q180

January 6, 2016

General Information I.

Applicant:	OLYMPUS MEDICAL SYSTEMS CORP.2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan192-8507Establishment Registration No: 8010047
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Sheri L. Musgnung Official Correspondent: . Manager, Regulatory Affairs Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-3147 FAX: 484-896-7128 Email: sheri.musgnung@olympus.com
AIZU OLYMPUS CO., LTD. . Manufacturer: 500 Aza Muranishi Ooaza-Iidera Monden-cho Aizuwakamatsu-Shi Fukushima, JAPAN 965-8520 Registration Number: 9610595

Device Identification II.

■	Device Trade Name:	EVIS EXERA II DUODENOVIDEOSCOPEOLYMPUS TJF TYPE Q180V
■	Common Name:	Duodenoscope
■	Regulation Number:	876.1500
■	Regulation Name:	Endoscope and Accessories
■	Regulatory Class:	II

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Image /page/4/Picture/0 description: The image displays the logo for Olympus, a company specializing in optics and imaging. The word "OLYMPUS" is written in large, bold, blue letters. A thin, horizontal, yellow line is underneath the company name. Below the line, the company's slogan, "Your Vision, Our Future," is written in a smaller font.

Classification Panel: Gastroenterology and urology . FDT; Duodenoscope, accessories, flexible/rigid ■ Product Code: NWB; Endoscope, accessories, narrow band spectrum

Predicate Device Information III.

Device Trade Name: XTJF Q160VF1 DUODENOVIDEOSCOPE
. 510(k) Number K080403
. Decision Date 05/20/2008
. Manufacturer AIZU OLYMPUS CO., LTD

Device Description IV.

V. Indications for Use

VI. Comparison of Technological Characteristics

The difference between the subject device and the predicate device is as follows:

Consists of a sealed elevator wire channel ●
Consists of a dual guidewire locking mechanism
. Modifications to the device's labeled reprocessing procedure
. Addition of recommended combination of equipment and accessories
. Physical dimensions of components at distal end tip

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Image /page/5/Picture/0 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a thin, yellow line. Under the line, the words "Your Vision, Our Future" are written in a smaller, blue font.

VII. Summary of non-clinical testing

The differences of technological characteristics between the predicate device and the subject device are confirmed that they are substantially equivalent through the following tests and standards.

Performance testing and design analysis was carried out to demonstrate the safety and effectiveness of the sealed elevator wire channel and the dual guidewire locking mechanism.
The validation test on the reprocessing is performed in accordance with the FDA guidance "Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance - April 1996". The FDA guidance "Draft Guidance for Industry and FDA Staff - Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling -May 2011" is also taken into consideration.
Biocompatibility testing is performed in accordance with the FDA Guidance, Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" dated on May 1 1995.
The software validation activities were performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Electromagnetic compatibility, electric safety, and thermal safety had been confirmed.
Risk analysis was carried out in accordance with established in-house acceptance . criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
The following standards have been applied to the TJF-Q180V.
- IEC 60601-1 -
- IEC 60601-1-2 -
- IEC 60601-2-18 -
- ISO 11135-1 -
- -ISO 10993-7
- ISO 10993-1 -
- ISO 10993-5 -
- ISO 10993-10 -
- ISO 14971 -

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Image /page/6/Picture/0 description: The image shows the Olympus logo. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a yellow line. Underneath the line is the text "Your Vision, Our Future".

VIII. Conclusion

Based on the 510(k) submission data, Olympus believes that the subject device and the predicate device selected are substantially equivalent and do not change the fundamental scientific technology and indications for use.

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.