FUJIFILM Ultrasonic Endoscope EG-740UT

K221238 · Fujifilm Corporation · ODG · Aug 19, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K221238
• Device Name: FUJIFILM Ultrasonic Endoscope EG-740UT
• Applicant: Fujifilm Corporation
• Product Code: ODG · Gastroenterology, Urology
• Decision Date: Aug 19, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

FUJIFILM Ultrasonic Endoscope EG-740UT is intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis, and endoscopic treatment. This product is intended to be used with a FUJIFILM ultrasonic processor.

Device Story

The FUJIFILM Ultrasonic Endoscope EG-740UT is a flexible endoscope used by physicians in clinical settings to visualize and perform ultrasonic imaging of the upper gastrointestinal tract. The device features an insertion portion with a CCD image sensor, light-emitting glass fiber bundles, and an instrument channel for accessories like forceps. It connects to a FUJIFILM video processor, light source, and ultrasonic processor. The physician controls distal end angulation and flexibility via the control portion. The device captures optical images and ultrasonic data, which are processed and displayed on a monitor. This output assists clinicians in diagnosing lesions and guiding endoscopic treatments, potentially improving patient outcomes through minimally invasive visualization and intervention.

Clinical Evidence

Bench testing only. Performance validated against specifications including field of view, bending capability, air/water/suction rates, resolution, and penetration depth. Biocompatibility evaluated per ISO 10993 standards. Electrical safety and EMC tested per ANSI/AAMI ES 60601-1 and IEC 60601 series. Usability testing conducted per IEC 62366-1.

Technological Characteristics

Flexible endoscope with CCD sensor, glass fiber illumination, and 4.0mm instrument channel. Distal end diameter 14.5mm. Compatible with FUJIFILM ultrasonic processors (SU-1, SU-1 PLATINUM) and video systems. Complies with ISO 10993 (biocompatibility), IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), and ISO 8600-1 (endoscope performance).

Indications for Use

Indicated for observation, diagnosis, and endoscopic treatment of submucosal and peripheral organs of the upper gastrointestinal tract in adults. Not intended for use on children and infants.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• FUJIFILM Ultrasonic Endoscope EG-580UT (K183433)

Reference Devices

• Olympus GF Type UCT180 (K093395)
• FUJIFILM Endoscope Model EG-740N (K182836)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 19, 2022

FUJIFILM Corporation % Kotei Aoki Senior Regulatory Affairs Specialist FUJIFILM Healthcare Americas Corporation 81 Hartwell Avenue, Suite 300 Lexington, MA 02421

Re: K221238

Trade/Device Name: FUJIFILM Ultrasonic Endoscope EG-740UT Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: ODG, FDS, ITX Dated: July 20, 2022 Received: July 20, 2022

Dear Kotei Aoki:

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.

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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 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 ([e-mail]) or phone [phone] 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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# Indications for Use

510(k) Number (if known)

#### K221238

Device Name FUJIFILM Ultrasonic Endoscope EG-740UT

#### Indications for Use (Describe)

FUJIFILM Ultrasonic Endoscope EG-740UT is intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis, and endoscopic treatment. This product is intended to be used with a FUJIFILM ultrasonic processor.

This product is not intended for use on children and infants.

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

| <div> <span> <span style="font-size: 10px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|---------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 10px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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### 510(k) Summary

#### FUJIFILM Corporation

#### FUJIFILM Ultrasonic Endoscope EG-740UT

Date: April 28, 2022

#### Submitter's Information:

FUJIFILM Corporation 798 MIYANODAI KAISEI-MACHI ASHIGARAKAMI-GUN, KANAGAWA 258-8538 JAPAN

#### Contact Person:

Kotei Aoki Senior Regulatory Affairs Specialist E-Mail: [e-mail] Telephone: [phone]

#### Identification of the Proposed Device:

| Device Name: | FUJIFILM Ultrasonic Endoscope EG-740UT |
|-------------------------|-------------------------------------------------------------|
| Common Name: | Ultrasonic Endoscope |
| Product Code: | ODG; FDS, ITX |
| Device Class: | II |
| Regulation Number: | 21 CFR 876.1500; 21 CFR 892.1570 |
| Regulation Description: | Endoscope and accessories; Diagnostic ultrasonic transducer |
| Review Panel: | Gastroenterology/Urology |

#### Predicate Device:

- . FUJIFILM Ultrasonic Endoscope EG-580UT (K183433)
#### Reference Devices:

- Olympus GF Type UCT180 (K093395) .
- FUJIFILM Endoscope Model EG-740N (K182836)

#### Intended Use / Indications for Use:

FUJIFILM Ultrasonic Endoscope EG-740UT is intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis, and endoscopic treatment. This product is intended to be used with a FUJIFILM ultrasonic processor.

This product is not intended for use on children and infants.

#### Device Description:

FUJIFILM Ultrasonic Endoscope EG-740UT 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 contains glass fiber bundles, several channels and a 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

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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 into the video processor, light source, and ultrasonic processor. The endoscopes are used in combination with FUJIFILM's video processors, light sources, ultrasonic processors, and peripheral devices such as monitor, printer, foot switch, and cart.

## Comparison of Technological Characteristics:

The comparison is presented in Table 1.

### Table 1

| | Proposed device<br>(to be assigned) | Predicate device<br>(K183433) | Reference 1<br>(K182836) | Reference 2<br>(K093395) | |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|-------------------------------------------------------|--------------------------------|--------------------------|
| Device name | Ultrasonic Endoscope<br>EG-740UT | Ultrasonic Endoscope<br>EG-580UT | GF Type<br>UCT180 | Endoscope<br>Model EG-<br>740N | |
| Indications for use | [This product is] intended to provide ultrasonic<br>images of submucosal and peripheral organs of the<br>upper gastrointestinal tract for observation, diagnosis,<br>and endoscopic treatment. This product is intended<br>to be used with a FUJIFILM ultrasonic processor.<br>This product is not intended for use on children and<br>infants. | | | | |
| Endoscopic specification | | | | | |
| Viewing direction | 40 degrees | | | | |
| Observation range | 3-100 mm | | | | |
| Field of view | 140 degrees | | | | |
| F# of the objective<br>lens | 4.9 | | | | |
| Resolution<br>(Acceptance<br>Criteria) | At 5mm of working distance: 0.08mm of line pair on<br>the square wave chart is readable.<br>At 100mm of working distance: 1.4mm of line pair on<br>the square wave chart is readable. | | | | |
| Distortion<br>characteristics | Orthogonal Projection | | | | |
| Magnification of<br>lens(es) | 0.2-0.01 | | | | |
| Focal length | 0.7 mm | | | | |
| Image sensors | CCD | | | | |
| Distal end diameter | 14.5 mm | 13.9 mm | 14.6 mm | | |
| Insertion portion<br>diameter | 12.6 mm | 12.4 mm | 12.6 mm | | |
| | | Proposed device<br>(to be assigned) | Predicate device<br>(K183433) | Reference 1<br>(K093395) | Reference 2<br>(K182836) |
| Instrument channel<br>diameter | | 4.0 mm | 3.8 mm | | |
| Maximum insertion<br>diameter | | 15.6 mm | 15.0 mm | 15.85 mm | |
| Working length | | | 1250mm | | |
| | Up | 150 degrees | | | |
| Bending | Down | 100 degrees | 150 degrees | 90 degrees | |
| capability | Left | 100 degrees | 120 degrees | 90 degrees | |
| | Right | 100 degrees | 120 degrees | 90 degrees | |
| | Control portion | | G7 | | |
| Scope Connector | | One Step Connector | LG Connector; Video<br>Connector | | |
| CPU/Software (for<br>contact-free Scope<br>Connector) | | Installed | N/A | | Installed |
| Ultrasound specification | | | | | |
| Scanning method | | | Electrical convex scanning method | | |
| Scanning direction | | | Same as the insertion direction of the endoscope | | |
| | | Compatible Peripherals and Standard Accessories | | | |
| | | Video processing system<br>(VP-7000, BL-7000) | Video processing system<br>(EPX-4440HD, EPX-<br>7000) | | |
| | | Water Tank (WT-603) | Water Tank (WT-2, WT-4) | | |
| | | Balloon (BS-102) | Balloon (B20UT) | | |
| Compatible | | Ultrasonic cable (UC-01) | Not included | | |
| Peripherals | | | Air leak tester (LT-7F) | | |
| | | | Suction Unit[1] | | |
| | | Mouthpiece (MPC-ST) | | | |
| | | Foot Switch (FS1) | | | |
| | | Electrosurgical instruments | | | |
| | | Monitor, Printer, Cart | | | |
| | | Ultrasonic processors (SU-1, SU-1 PLATINUM) | | | |
| | | Forceps valve (FV-002) | Forceps valve (FOV-LL2) | | |
| | | Built in the scope | US waterproof cap (WA- | | |
| | | connector | 7000) | | |
| | | Balloon attachment tool | Balloon attachment tool | | |
| | | (BA-03) | (BA-1) | | |
| | | Balloon channel brush<br>(WB2517DC) | Balloon channel brush<br>(WB2221FW2) | | |
| Standard | | | | | |
| Accessories | | | | | |
| | | Air/Water valve (AW-602)<br>Suction valve (SB-604) | | | |
| | | Air/Water channel cleaning adapter (CA-609) | | | |
| | | Cleaning adapter (CA-608) | | | |
| | | Ventilation adapter (AD-7) | | | |
| | | Cleaning brushes | | | |
| | | (WB11003DV, WB7025DC, WB1318DE) | | | |

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# Table 1 (continued)

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## Performance Data:

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.

Biocompatibility of the proposed device was evaluated using the following consensus standards: ISO 10993-1:2018, 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 September 4, 2020.

Electrical safety and EMC of the proposed device was evaluated using following standards: ANSI/AAMI ES 60601-1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2010/AMD1:2013, IEC 60601-2-18:2009, and IEC 60601-2-37:2015.

Laser safety and photobiological safety of the proposed device was evaluated using the following standards: IEC 60825-1:2007 and IEC 62471:2006.

Endoscope specific testing was conducted according to ISO 8600-1: 2015.

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

- Field of view
- Bending capability ●
- Bonuing Supability Rate of air supply ●
- Rate of water supply ●
- Rate of balloon water supply ●
- . Rate of suction
- Rate of Suction
Rate of balloon suction .
- .
- Diameter of forceps channel ●
- Viewing direction .
- Resolution ●
- LG output
- Axial resolution ●
- Lateral resolution ●
- Penetration depth .

Usability testing was conducted according to IEC 62366-1:2015 and the FDA guidance, Applying Human Factors and Usability Engineering to Medical Devices, issued February 3, 2016.

## Conclusion:

The proposed device, FUJIFILM Ultrasonic Endoscope EG-740UT, share intended use and indications for use as, similar technological characteristics to, the same principles of operation as, and similar materials to the predicate device and the reference devices. The differences in technological characteristics and materials have been validated through the biocompatibility, the electrical safety, the EMC testing, and the bench testing. The testing demonstrates that the proposed device remains as safe and effective as the predicate device and there remains no new concern regarding the safety and effectiveness. FUJIFILM Ultrasonic Endoscope EG-740UT is substantially equivalent to the predicate device, FUJIFILM Ultrasonic Endoscope EG-580UT (K183433).