FUJIFILM Endoscope Models EG-760R and EG-760Z are intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

FUJIFILM Endoscope Models EC-760R-V/L and EC-760ZP-V/L are intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.

FUJIFILM Water Tank Model WT-603 has following indications for use.

This product is intended for use in combination with FUJIFILM 700 system scopes to deliver air and water through the endoscope under the management of a physician in medical facilities. Do not use this product for any other purpose.

Device Description

FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L are comprised of three general sections: a control portion, an insertion and an umbilicus. The control portion controls the angulation of the endoscopes. This portion also controls the flexibility of the distal end in the endoscopes. The insertion contains glass fiber bundles, several channels and a complementary metal-oxide- semiconductor (CMOS) image sensor in its distal end. The channels in the insertion portion assist in delivering air/suction as well as endoscope accessories, such as forceps. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion portion to illuminate the body cavity. This provides enough light to the CMOS image sensor to capture an image and display it on the monitor. The umbilicus consists of electronic components needed to operate the endoscope when plugged in to the video processor and the light source.

FUJIFILM Water Tank Model WT-603 consists of a container which holds the sterile water and a tank cover which provides delivery of water through the channel tube to the distal end of an Endoscope.

The subject devices are used in combination with FUJIFILM's video processors, light sources and peripheral devices such as monitor, printer, foot switch, and cart. All of these combinations were previously cleared in K132210, K162622 and K163675.

AI/ML Overview

This document describes the regulatory submission for several models of FUJIFILM Endoscopes (EG-760R, EG-760Z, EC-760R-V/L, EC-760ZP-V/L) and the FUJIFILM Water Tank Model WT-603. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily the Fujifilm 600 Series Endoscope Model EG-600WR and Water Tank Model WT-4 (K132210), and the Fujifilm Video Colonoscope Model EC-600WL v2 (K160196).

Based on the provided text, the acceptance criteria and study details are primarily focused on bench performance testing and compliance with established consensus standards, rather than clinical studies with human readers or specific statistical performance metrics (like sensitivity, specificity, AUC) against a ground truth.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various tests performed and states that the devices met pre-determined acceptance criteria and performance specifications. However, the document does not explicitly state the numerical acceptance criteria or specific quantitative performance values for each test. It broadly states that the devices met "pre-determined acceptance criteria" and demonstrated "substantially equivalent performance" to predicate devices.

Acceptance Criterion Category	Reported Device Performance	Comments
Electrical Safety	Met pre-determined acceptance criteria; evaluated using ANSI/AAMI ES 60601-1:2012, IEC 60601-1-2:2007, IEC 60601-1-6:2013, and IEC 60601-2-18:2009.	No specific numerical criteria or results provided.
Biocompatibility	Met pre-determined acceptance criteria; evaluated using ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.	No specific numerical criteria or results provided.
Endoscope Specific Testing	Met performance specifications for: Field of view, Bending capability, Rate of suction, Working length, Diameter of forceps channel, Viewing direction, LG output, Flexibility adjustment mechanism. Evaluated using ISO 8600-1:2015, ISO 8600-3:1997, and ISO 8600-4:2014.	No specific numerical criteria or results provided.
Cleaning, Disinfection, Sterilization	Met pre-determined acceptance criteria; evaluated according to AAMI TIR12:2010, AAMI TIR30:2011, and FDA's guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (March 17, 2015).	No specific numerical criteria or results provided.
Backflow Prevention (AW-603 valve)	Met pre-determined acceptance criteria; evaluated in compliance with FDA's Guidance "Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes" (January 20, 2015).	No specific numerical criteria or results provided.
Overall Equivalence	Bench testing data demonstrated substantially equivalent performance and safety to respective predicate devices. New functions (optical zoom, flexibility adjustment, Scope Connector) do not raise new safety/effectiveness concerns, supported by reference devices and prior clearances.	No specific numerical performance metrics are provided for this equivalence.

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

The document describes bench performance testing of physical devices/components, not a test set of data (e.g., images for an AI algorithm).

Sample Size: Not explicitly stated. The testing would have involved a number of manufactured devices/components rather than a "test set" in the context of data.
Data Provenance: Not applicable in the context of data provenance for an AI algorithm. The tests were performed on the physical devices themselves.

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

This information is not applicable as the submission describes testing of endoscope hardware and reprocessing procedures, not an AI or diagnostic device that requires expert-established ground truth for a test set.

4. Adjudication Method for the Test Set:

This information is not applicable for the reasons stated above.

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:

No, an MRMC comparative effectiveness study was not done. This submission pertains to the hardware and reprocessing of endoscopes, not an AI-assisted diagnostic tool.

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

No, a standalone algorithm performance study was not done. This submission is for endoscope hardware and related accessories, not an AI algorithm.

7. The Type of Ground Truth Used:

For the performance testing described, the "ground truth" would be established by the compliance with the specified international and national consensus standards (e.g., ISO, IEC, AAMI) and the device's own pre-determined engineering specifications. This is distinct from pathology, expert consensus on images, or outcomes data. The tests are designed to objectively measure physical characteristics and safety in comparison to these standards and the predicate device.

8. The Sample Size for the Training Set:

This information is not applicable as this submission is for endoscope hardware, not an AI algorithm requiring a training set.

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

This information is not applicable for the reasons stated above.

Summary

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March 1, 2018

Fujifilm Corporation Shraddha More Specialist, Regulatory Affairs FUJIFILM Medical Systems U.S.A., Inc 10 High Point Drive Wayne, New Jersey 07470

Re: K172916

Trade/Device Name: FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L, and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FDS, FDF Dated: January 26, 2018 Received: January 29, 2018

Dear Shraddha More:

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

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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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page

510(k) Number (if known)

K172916

Device Name

FUJIFILM Endoscope Models EG-760Z, EC-760R-V/L and EC-760ZP-V/L and FUJIFILM Water Tank Model WT-603 Indications for Use (Describe)

FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760ZP-V/L have following indications for use.

FUJIFILM Endoscope Models EG-760Z are upper gastrointestinal endoscopes intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

FUJIFILM Endoscope Models EC-760R-V/L are lower gastrointestinal endoscopes intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the recturn and large intestine. .

FUJIFILM Water Tank Model WT-603 has following indications for use.

The Water Tank Model WT-603 is intended for use in combination with FUJIFILM 700 system scopes to deliver air and water through the endoscope under the management of a physician in medical facilities. Do not use this product for any other purpose.

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:

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510(k) SUMMARY

FUJIFILM Medical Systems U.S.A., Inc.'s FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L

Date: March 1, 2018

Submitter's Information

FUJIFILM Medical Systems U.S.A., Inc., Endoscopy Division 10 High Point Drive Wayne, NJ 07470 USA FDA Establishment Registration Number: 2431293

Contact Person

Jeffrey Wan Specialist, Regulatory Affairs Telephone: (973) 709-2219 Facsimile: (201) 995-2452 E-Mail: jeffrey.wan@fujifilm.com

ldentification of the Proposed Device

Proprietary/Trade Name:	FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L, EC-760ZP-V/L and Water Tank Model WT-603
Common Name:	Endoscopes
Device Class:	Class II
Review Panel:	Gastroenterology/Urology

Classification Information

Classification Name	CFR Section	Product Codes
Gastroscope And Accessories, Flexible/Rigid	21 CFR 876.1500	FDS
Colonoscope And Accessories, Flexible/Rigid	21 CFR 876.1500	FDF

Predicate Devices

. Fujifilm 600 Series Endoscope Model EG-600WR and Water Tank Model WT-4 (K132210)
Fujifilm Video Colonoscope Model EC-600WL v2 (K160196) .

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Intended Use / Indications for Use

FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L, and EC-760ZP-V/L have following indications for use.

FUJIFILM Water Tank Model WT-603 has following indications for use.

Device Description

FUJIFILM Water Tank Model WT-603 consists of a container which holds the sterile water and a tank cover which provides delivery of water through the channel tube to the distal end of an Endoscope.

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The main differences between the subject and predicate devices are provided below.

Comparison of Technological Characteristics

For FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, main differences from predicate device endoscopes are as follows:

. Introduction of optical zoom function for EG-760Z and EC-760ZP-V/L
. Introduction of flexibility adjustment mechanism for EC-760R-V/L and EC-760ZP-V/L
Introduction of Scope Connector with contactless connecting technology and software and . CPU installation for in the subject endoscopes to accommodate this functionality.
. Minor material changes in insertion, instrument channel, Air/Water channel, and water jet channel due to supplier availability.

For FUJIFILM Water Tank Model WT-603, main differences from the predicate Water Tank WT-4 are materials and compatible endoscope models.

Performance Data

FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L have been subjected to the bench performance testing as below. The devices met pre-determined acceptance criteria in compliance with the relevant standards

Electrical safety of the subject device was evaluated using following standards: ANSI/AAMI ES 60601-1:2012, IEC 60601-1-2:2007, IEC 60601-1-6:2013, and IEC 60601-2-18:2009.

Biocompatibility of the subject devices was evaluated using the following consensus standards: ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.

Endoscope specific testing was conducted using the following consensus standards: ISO 8600-1:2015, ISO 8600-3:1997, and ISO 8600-4:2014.

The endoscopes met performance specifications in the following additional testing:

. Field of view
Bending capability .
Rate of suction ●
Working length
Diameter of forceps channel ●
Viewing direction
LG output
Flexibility adjustment mechanism ●

FUJIFILM Water Tank Model WT-603 has been subjected to the bench performance testing as below. The device met pre-determined acceptance criteria in compliance with the relevant standards

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Biocompatibility of the subject devices was evaluated using the following consensus standards: ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.

Cleaning, disinfection, and sterilization of subject devices were evaluated according to the following consensus standards: AAMI TIR12:2010, AAMI TIR30:2011. Validation of the cleaning, disinfection, and sterilization instructions was performed in accordance with FDA's quidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," published March 17, 2015.

The endoscope valve AW-603 which controls the supply of Air/Water from Water Tank to the endoscope, has been validated for its efficiency in preventing the backflow of the fluids from the endoscope to the Water Tank. The valve met pre-determined acceptance criteria in compliance with the FDA's Guidance "Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes, published on January 20, 2015".

Substantial Equivalence

FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L, EC-760ZP-V/L and Water Tank WT-603 have the same intended use, indications for use and substantially technological characteristics, and principles of operation as their respective predicate devices. The key differences between the predicate and subject endoscope models are new functionalities, known as optical zoom function and flexibility adjustment mechanism, which are not present in their respective predicate devices, but have been supported by substantially similar zoom magnification function in Olympus EVIS EXERA Gastrointestinal Videoscopes GIF-Q160Z (K011151) and flexibility adjustment function in Olympus EVIS EXERA III Gastrointestinal Videoscopes PCF-H190L (K112680), which are cited as reference devices. Additionally, the subject devices are installed with Scope Connector, which utilizes wireless contact, electromagnetic induction for power supply and optical communication. The same integrated connector technology has been submitted as "contacting technology" under pre-sub Q151022 in "Section I: Device Description, Subsection A: Technological Characteristics" and subsequently cleared under premarket notification K163675 for Processor VP-7000 and Light Source BL-7000, which are used in combination with the subject endoscope models. More information is provided in substantial equivalence section.

The main differences between the predicate and subject Water Tank Model are compatibility with different endoscope models and materials.

Bench testing data demonstrated that the subject endoscope models have substantially equivalent performance and safety to their respective predicate devices. The materials of the Water Tank have been changed due to supplier availability.

In summary, these minor differences between FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L, EC-760ZP-V/L and Water Tank WT-603 and their respective predicate devices were made for the purpose of overall product enhancement and general technological advancement, and raise no new issues of safety or effectiveness. The material changes in the subject device do not raise new concerns regarding biocompatibility as discussed in section XVII. Performance data demonstrated that FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L, EC-760ZP-V/L and Water Tank WT-603 have substantially equivalent performance to their respective predicate

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devices. The subject devices are successfully validated for the electrical safety and reprocessing instructions, supporting their safety equivalent to the predicate devices.

Conclusions

The subject devices FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L, EC-760ZP-V/L and Water Tank WT-603 are substantially equivalent to their respective predicate devices based on the same intended use, substantially similar indications for use and technological characteristics. The differences in the indications for use and technological characteristics and materials between the subject devices and their respective predicate devices raise no new issues of safety or effectiveness. Bench testing data demonstrated that the subject devices have substantially equivalent performance to their respective predicates. Additional performance testing has demonstrated that new functions included in the subject devices do not raise concerns regarding safety and efficacy of the subject devices. Thus, the subject devices FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L, EC-760ZP-V/L and Water Tank WT-603 are substantially equivalent to their respective predicate devices, Fujifilm 600 Series Endoscope Model EG-600WR and Water Tank WT-4 (K132210) and Fujifilm Video Colonoscope EC-600WL v2 (K160196).

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.