FUJIFILM Ultrasonic Endoscope

K181763 · Fujifilm Corporation · FDS · Jul 27, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K181763
• Device Name: FUJIFILM Ultrasonic Endoscope
• Applicant: Fujifilm Corporation
• Product Code: FDS · Gastroenterology, Urology
• Decision Date: Jul 27, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

EG-530UT2 and EG-530UR2 are intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis, and endoscopic treatment. The product is intended to be used with a Fujifilm ultrasonic processor. This product is not intended for use on children and infants.

Device Story

Upper gastrointestinal endoscopes; emit ultrasound waves; scan reflected signals to generate ultrasonic images. Used with Fujifilm ultrasonic processor, video processor, and light source. Operated by physicians in clinical settings for observation, diagnosis, and endoscopic treatment of submucosal and peripheral organs. Output displayed for real-time clinical decision-making during endoscopic procedures. Benefits include enhanced visualization of gastrointestinal structures.

Clinical Evidence

Bench testing only. Performance evaluated via field of view, viewing direction, bending capability, resolution, air/water supply rates, suction rate, working length, axial/lateral resolution, penetration depth, and forceps channel diameter. Biocompatibility testing (ISO 10993-1, -5, -10) leveraged data from reference device EC-600WL v2. Electrical safety verified per ANSI/AAMI ES 60601-1 and IEC 60601 series. Storage/transport conditions validated through environmental testing.

Technological Characteristics

Upper GI endoscope with integrated ultrasonic transducer. Materials include new epoxy resin. Compliant with IEC 60601-1 (ed 3.1) and IEC 60601-2-37 (ed 2.1). Compatible with Fujifilm VP-7000, BL-7000, and SU-1 processors. Storage/transport range: -20°C to 60°C, 10-85% RH.

Indications for Use

Indicated for adults requiring ultrasonic imaging of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis, and endoscopic treatment. Contraindicated 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 Endoscopes EG-530UT2 and EG-530UR2 (K120446)

Reference Devices

• Fujifilm Video Colonoscope Model EC-600WL v2 (K160196)
• Video Processor VP-7000 and Light Source BL-7000 (K163675)
• Ultrasonic Processor SU-1 (K153206)

Submission Summary (Full Text)

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July 27, 2018

FUJIFILM Corporation % Jeffrey Wan Specialist, Regulatory Affairs FUJIFILM Medical Systems U.S.A., Inc. 10 High Point Drive Wayne, NJ 07470

Re: K181763

> Trade/Device Name: FUJIFILM Ultrasonic Endoscopes EG-530UT2 and EG-530UR2 Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FDS, ITX Dated: July 2, 2018 Received: July 3, 2018

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); 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Image /page/1/Picture/7 description: The image shows the FDA logo on the left side. On the right side, the text "Jeffrey W. Co" is present, followed by the date "2018.07.27 1" and the time zone "-04'00'".

Jeffrey W. Cooper -S 2018.07.27 18:59:10

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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# Indications for Use

510(k) Number (if known) K181763

Device Name

FUJIFILM Ultrasonic Endoscopes EG-530UT2 and EG-530UR2

Indications for Use (Describe)

EG-530UT2 and EG-530UR2 are intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis, and endoscopic treatment. The 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) | |
|-----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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### 510(k) SUMMARY

### FUJIFILM Ultrasonic Endoscopes EG-530UT2 and EG-530UR2

Date: July 2, 2018

#### 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: [phone] Facsimile: [phone] E-Mail: [e-mail]

### Identification of the Proposed Device:

| Proprietary/Trade Name: | FUJIFILM Ultrasonic Endoscopes EG-530UT2 and EG-530UR2 |
|-------------------------|-----------------------------------------------------------------------------------------------------------|
| Common Name: | Video Endoscope |
| Device Class: | Class II |
| Review Panel: | Gastroenterology/Urology |
| Classification: | Endoscope and accessories, 21 C.F.R. § 876.1500<br>Diagnostic ultrasonic transducer, 21 C.F.R. § 892.1570 |
| Product Code: | FDS, ITX |

#### Predicate Device:

Fujifilm Ultrasonic Endoscopes EG-530UT2 and EG-530UR2 (K120446)

#### Reference Device:

Fujifilm Video Colonoscope Model EC-600WL v2 (K160196)

#### Intended Use / Indications for Use:

EG-530UT2 and EG-530UR2 are intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis, and endoscopic treatment. The product is intended to be used with a Fujifilm ultrasonic processor. This product is not intended for use on children and infants.

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## Device Description:

FUJIFILM Ultrasonic Endoscopes EG-530UT2 and EG-530UR2 are upper gastrointestinal endoscopes that emit ultrasound waves and scan the reflected signals to provide ultrasonic images when used in combination with an ultrasonic processor.

## Technoloqical Characteristics:

The proposed devices EG-530UT2 and EG-530UR2 differ from the predicate devices in the following minor modifications:

- . Compatibility with Video Processor VP-7000 and Light Source BL-7000 (K163675).
- Compatibility with Ultrasonic Processor SU-1 (K153206). ●
- Compliance to IEC60601-1 edition 3.1 and IEC60601-2-37 edition 2.1 to support . compatibility with VP-7000, BL-7000, and SU-1.
- . Expansion of transport and storage conditions to a temperature range of -20°C to 60°C and a humidity range of 10 to 85% RH.
- . Use of a new epoxy resin in the manufacturing process. Both the new and original epoxy resins can be used for repair.
- Other minor material changes .

### Performance Data:

Electrical safety of the proposed devices was evaluated using following standards: ANSI/AAMI ES 60601-1:2012, IEC 60601-1-2:2007, IEC 60601-1-6:2013, IEC 60601-2-18:2009, and IEC 60601-2-37:2015.

The proposed devices EG-530UR2 and EG-530UR2 were adopted into biocompatibility testing conducted on reference device EC-600WL v2 using the following consensus standards: ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.

Storage and transportation testing was conducted on the proposed devices EG-530UT2 and EG-530UR2 to validate the expanded storage and transportation conditions.

Fujifilm conducted the following performance testing on the proposed devices EG-530UT2 and EG-530UR2 to ensure that the modified devices perform equivalently to the predicate devices:

- Field of view
- Viewing direction ●
- . Bending capability
- Resolution .

●

- . Air supply rate
- . Water supply rate
- Axial resolution ●

LG output

- . Suction rate
- Working length
- Lateral resolution .
- ●
- . Penetration depth
- Forceps channel diameter ●

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In all cases, the devices met the pre-defined acceptance criteria for the test.

### Substantial Equivalence:

The company's EG-530UT2 and EG-530UR2 has the same intended use and indications for use as the previously cleared predicates EG-530UT2 and EG-530UR2 (K120446). In addition, the proposed devices have similar technological characteristics and principles of operation as their predicates. The minor differences between the proposed devices and their predicate devices do not raise new or additional questions of safety or effectiveness of the proposed devices. Thus, the proposed devices EG-530UT2 and EG-530UR2 are substantially equivalent to their predicate devices.

### Conclusions:

The modified EG-530UT2 and EG-530UR2 are substantially equivalent to the predicate EG-530UT2 and EG-530UR2 and conform to applicable medical device safety and performance standards.

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K181763
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