FUJIFILM Endoscope Model EG-740N is intended for the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum. The device can be inserted orally or transnasally.

Device Description

FUJIFILM Endoscope Model EG-740N is comprised of three general sections: a control portion, an insertion portion and an umbilicus. The control portion 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 a complementary Charge-Coupled Device (CCD) 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 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 in to the video processor and the light source. The endoscope is used in combination with FUJIFILM's video processors, light sources and peripheral devices such as monitor, printer, foot switch, and cart.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, the FUJIFILM Endoscope Model EG-740N. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy or superiority through extensive clinical studies, especially those involving AI algorithms or human reader performance.

Therefore, much of the requested information regarding AI algorithm performance, multi-reader multi-case studies, and detailed ground truth establishment methods for large datasets is not applicable to this specific submission. The document primarily reports on bench testing, electrical safety, and biocompatibility to demonstrate that the new device performs similarly and is as safe as the predicate devices.

Here's a breakdown of the requested information based on the provided text, highlighting what is and is not present:

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

The document states that the subject device met performance specifications in various tests. While it lists the categories, it does not provide specific numerical acceptance criteria or reported performance values in a table format. It simply states that the device "met performance specifications" or that "bench testing data demonstrated that the subject device is substantially equivalent in performance to the predicate devices."

Acceptance Criteria Category	Reported Device Performance
Electrical safety	Met specifications (eval. using ANSI/AAM ES 60601-1:2012, IEC 60601-1-2:2007, IEC 60601-1-6:2013, and IEC 60601-2-18:2009)
Biocompatibility	Met specifications (eval. using ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010; in accordance with FDA guidance, June 16, 2016)
Endoscope specific testing	Met specifications (eval. using ISO 8600-1:2015, ISO 8600-3:1997, and ISO 8600-4:2014)
Software specific testing	Met specifications (eval. using ANSI/AAM//EC 62304:2006; in accordance with FDA Guidance, May 11, 2005)
Cleaning, high-level disinfection, and sterilization	Met specifications (eval. using AAMI TIR12:2010, AAMI TIR30:2011; in accordance with FDA guidance, March 17, 2015)
Field of view	Met performance specifications
Bending capability	Met performance specifications
Rate of air supply	Met performance specifications
Rate of water supply	Met performance specifications
Rate of suction	Met performance specifications (Comparative bench testing with primary predicate device conducted)
Working length	Met performance specifications
Diameter of forceps channel	Met performance specifications
Viewing direction	Met performance specifications
Resolution	Met performance specifications
LG output	Met performance specifications

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

The document refers to "bench testing" and "comparative bench testing" without specifying a sample size in terms of number of patients or images. These tests would involve physical testing of the device prototypes. Data provenance and whether it's retrospective or prospective are not relevant for this type of physical device testing.

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)

This is not applicable. The "ground truth" for this device's testing relates to engineering specifications (e.g., does the endoscope bend to the correct angle, is the resolution within specification, does it pass the electrical safety tests). It does not involve human expert interpretation of medical images or clinical outcomes data.

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

This is not applicable. Adjudication methods are used to establish ground truth in clinical data interpretation, typically in studies involving human readers or AI algorithms assessing medical conditions. This submission focuses on engineering and safety performance.

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

This is not applicable. This submission is for a physical endoscope, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or reported.

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

This is not applicable. This device is a physical endoscope, not a standalone algorithm.

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

The "ground truth" for this submission are the engineering specifications, consensus standards (e.g., ISO, IEC, AAMI), and regulatory guidance documents used for electrical safety, biocompatibility, software validation, and reprocessing validation. For example, the device must meet the specified lumens for light output or specific angles for bending capability, which are objective engineering parameters.

8. The sample size for the training set

This is not applicable. This is a 510(k) for a physical endoscope, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of data used for algorithm development.

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

This is not applicable for the same reasons as #8.

Summary

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April 2, 2019

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

Re: K182836

Trade/Device Name: FUJIFILM Endoscope Model EG-740N Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FDS Dated: February 28, 2019 Received: March 1, 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 mav, 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 avare 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 statutes and regulations administered by other Federal agencies.

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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 and Part 809; 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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,

Mark J. Antonino -S

for

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

510(k) Number (if known) K182836

Device Name

FUJIFILM Endoscope Model EG-740N

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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510(k) SUMMARY

FUJIFILM Corporation's FUJIFILM Endoscope Model EG-740N

Date: March 29, 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 Specialist, Regulatory Affairs Telephone: (201) 675-8947 E-Mail: jeffrey.wan@fujifilm.com

Identification of the Proposed Device:

Proprietary/Trade Name:	FUJIFILM Endoscope Model EG-740N
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

Predicate Devices:

Primary - FUJIFILM Endoscope Model EG-530N (K063316)
. Secondary - FUJIFILM Endoscope Model EG-760R (K172916)

Intended Use / Indications for Use

FUJIFILM Endoscope Model EG-740N is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophaqus, stomach, and duodenum. The device can be inserted orally or transnasally.

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Device Description

FUJIFILM Endoscope Model EG-740N differs from the primary predicate device EG-530N in terms of technological characteristics and materials. The secondary predicate device EG-760R supports substantial equivalence with respect to several of these differences. Furthermore, the subject device and predicate devices share the same mode of operation and intended use.

Comparison of Technological Characteristics

A summary of major differences between the subject device EG-740N and the primary predicate device EG-530N is provided as follows:

. The Scope Connector has updated technological characteristics for power supply and optical communication. These technological characteristics have been previously cleared by the secondary predicate device.
CPU software has been installed in the subject device to support the modified scope connector. Similar software has been previously cleared by the secondary predicate device.
. Compatibility with different video processors, light sources, and other accessories
. Minor material changes to the insertion portion, instrument channel and air/water channel due to supplier availability.

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 Mav 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.

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 ●

Comparative bench testing was conducted on the subject and primary predicate device to evaluate the rate of suction.

Substantial Equivalence

The subject device FUJIFILM Endoscope Model EG-740N is substantially equivalent to the predicate devices, FUJIFILM Endoscope Model EG-530N (K063316) and FUJIFILM Endoscope Model EG-760R (K172916). The subject device has the same intended use and substantially similar indications, technological characteristics, and principles of operation as that of the previously cleared predicate devices.

Technological changes to the primary predicate device EG-530N have previously been cleared for the secondary predicate device EG-760R. Material changes to the primary predicate device have been validated through biocompatibility testing. Thus, the subject device EG-740N is substantially equivalent to the predicate devices.

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Conclusions

The subject device FUJIFILM Endoscope Model EG-740N is substantially equivalent to the predicate devices based on the same intended use, indications for use, similar technological characteristics and materials. The differences in technological characteristics and materials between the subject device and the predicate devices raise no new issues of safety or effectiveness. Bench testing data demonstrated that the subject device is 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 device FUJIFILM Endoscope Model EG-740N is substantially equivalent to the predicate devices, FUJIFILM Endoscope Model EG-530N (K063316) and FUJIFILM Endoscope Model EG-760R (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.