FUJIFILM Endoscope Model EG-760CT is intended for the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

FUJIFILM Endoscope Models EC-760P-V/L and EC-740T/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.

Device Description

FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L are comprised of three general sections: a control portion, an insertion portion and an umbilicus. The controls the angulation of the endoscope. This portion also controls the flexibility of the distal end in the endoscope. The insertion portion contains glass fiber bundles, several channels and either a complementary metal-oxide-semiconductor (CMOS, in 760 series models) or charged-coupled device (CCD, in EC-740T/L) 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 or CCD 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 into the video processor and the light source. The endoscopes 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 K172916.

AI/ML Overview

This document is a 510(k) summary for FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L, and EC-740T/L. It does not describe a study proving the device meets acceptance criteria related to AI or algorithm performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices through various non-clinical performance tests and adherence to regulatory standards.

Therefore, many of the requested details about acceptance criteria for AI algorithms, sample sizes for test sets, expert involvement, and MRMC studies are not applicable to the information provided.

However, I can extract the information related to the performance data presented to support substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific quantitative acceptance criteria or reported device performance for clinical outcomes. Instead, it lists various types of engineering and safety tests and states that the device "met performance specifications" or "are substantially equivalent in performance."

Category of Testing	Acceptance Criteria (Implied)	Reported Device Performance
Electrical Safety	Compliance with ANSI/AAM ES 60601-1:2012, IEC 60601-1-2:2007, IEC 60601-1-6:2013, and IEC 60601-2-18:2009.	Evaluated and met these standards.
Biocompatibility	Compliance with ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010, and FDA guidance on ISO 10993-1.	Evaluated and successfully conducted in accordance with standards and guidance. Differences in materials from predicate were validated.
Endoscope Specific Testing	Compliance with ISO 8600-1:2015, ISO 8600-3:1997, and ISO 8600-4:2014.	Evaluated and met these standards.
Software Specific Testing	Compliance with ANSI/AAM//EC 62304:2006 and FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.	Software validation activities performed in accordance with standards and guidance.
Cleaning, High-level Disinfection, and Sterilization	Compliance with AAMI TIR12:2010, AAMI TIR30:2011, and FDA guidance "Reprocessing Medical Devices in Health Care Settings."	Validation of cleaning, disinfection, and sterilization instructions according to standards and guidance.
Bench Testing (Features)	Validation of "Advanced Force Transmission" and "Adaptive Bending" features.	Conducted and features were validated.
Bench Testing (Comparison)	Substantial equivalence in the "rate of suction" compared to the predicate device.	Comparative bench testing conducted, showing substantial equivalence in the rate of suction.
Additional Performance Testing	Meeting performance specifications for: Field of view, Bending capability, Rate of air supply, Rate of water supply, Working length, Diameter of forceps channel, Viewing direction, Resolution, LG output.	Device met performance specifications for all listed items.

2. Sample size used for the test set and the data provenance

Not applicable. The document describes engineering and bench testing, not clinical studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This document pertains to device engineering and safety testing, not clinical evaluation requiring expert ground truth for a test set.

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

Not applicable. Adjudication methods are typically for clinical study outcomes and expert consensus, which are not described here.

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. This document does not mention any MRMC studies or AI assistance. The devices are endoscopes, and the evaluation focuses on their physical and functional characteristics.

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

No. The devices are physical endoscopes, not standalone algorithms.

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

For the bench and engineering tests, the "ground truth" was established by technical specifications, consensus standards (e.g., ISO, AAMI, IEC, ANSI/AAMI), and established testing protocols. For comparative tests, the predicate device's performance served as a reference for substantial equivalence.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI-driven device being evaluated for a machine learning model.

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

Not applicable. As there is no training set mentioned, this question is not relevant.

Summary

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July 16, 2019

FUJIFILM Corporation % Jeffrey Wan Specialist. Regulatory Affairs FUJIFILM Medical Systems U.S.A., Inc. 419 West Ave Stamford, CT 06902

Re: K183572

Trade/Device Name: FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: FDF, FDS Dated: June 20, 2019 Received: June 21, 2019

Dear Jeffrey Wan:

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,

for

Shanil Haugen, Ph.D. Acting 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183572

Device Name

FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L

Indications for Use (Describe)

FUJIFILM Endoscope Model EG-760CT is intended for the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

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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510(k) SUMMARY

FUJIFILM Corporation's FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L, and EC-740T/L

Date: July 15, 2019

Submitter's Information:

FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-Gun, Kanagawa, 258-8538, Japan FDA Establishment Registration Number: 3001722928

Contact Person:

Jeffrey Wan Senior Regulatory Affairs Specialist Telephone: (201) 675-8947 E-Mail: jeffrey.wan@fujifilm.com

ldentification of the Proposed Devices:

Proprietary/Trade Name:	FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and
	EC-740T/L
Common Name:	Endoscope
Device Class:	Class II
Review Panel:	Gastroenterology/Urology

Classification Information:

Classification Name	CFR Section	Product Codes
Endoscope and accessories	21 CFR 876.1500	FDS, FDF

Predicate Devices:

. FUJIFILM Endoscope Models EG-760R and EC-760R-V/L (K172916)

Intended Use / Indications for Use

FUJIFILM Endoscope Model EG-760CT is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

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Device Description

Comparison of Technological Characteristics

FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L differ from the predicate devices EG-760R and EC-760R-V/L in terms of technological characteristics and materials. The subject and predicate devices share mode of operation and intended use.

A summary of differences between the subject devices EG-760CT, EC-760P-V/L and EC-740T/L and the predicate devices EG-760R and EC-760R-V/L is provided as follows:

. Introduction of new features, "Advanced Force Transmission" and "Adaptive Bending" for EC-760P-V/L and EC-740T/L
. Dimensional changes to the insertion portion and instrument channel
. Material changes to the insertion portion, instrument channel, and water jet channel

Performance Data

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

Biocompatibility of the subject device was evaluated using the following consensus standards: ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010. Biocompatibility testing was conducted in accordance with the FDA guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", issued June 16, 2016.

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

Software specific testing was conducted using the following consensus standard: ANSI/AAM//EC 62304:2006. 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, issued on May 11, 2005.

Cleaning, high-level disinfection, and sterilization of the subject device 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 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," published March 17, 2015.

Bench testing was conducted on EC-760P-V/L and EC-740T/L to validate the Advanced Force Transmission and Adaptive Bending features. Comparative bench testing was conducted on the subject device EG-760CT and the predicate device EG-760R to evaluate the rate of suction.

The subject device met performance specifications in the following additional testing:

Field of view
Bending capability ●
. Rate of air supply
Rate of water supply
Rate of suction
Working length ●
Diameter of forceps channel
Viewing direction
Resolution
LG output

Substantial Equivalence

The subject devices FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L are substantially equivalent to the predicate devices, FUJIFILM Endoscope Models EG-760R and EC-760R-V/L (K172916). The subject devices have the same intended use/indications for use and substantially similar technological characteristics and principles of operation as that of the predicate devices. Material changes to the predicate devices have been validated through biocompatibility testing. Thus, the subject devices FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L are substantially equivalent to the predicate devices.

Conclusions

The subject devices FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L are substantially equivalent to the predicate devices based on the same intended use, indications for

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use, similar technological characteristics and materials. The differences in technological characteristics and materials between the subject and predicate devices raise no new issues of safety or effectiveness. Bench testing data demonstrated that the subject devices are substantially equivalent in performance to the predicate devices. The difference in materials between subject and predicate devices has been validated through biocompatibility testing. Thus, the subject devices FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L are substantially equivalent to the predicate devices, FUJIFILM Endoscope Models EG-760R and EC-760R-V/L (K172916).

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.