FUJIFILM Endoscope Models EC-600HL and EC-600LS

K180405 · Fujifilm Corporation · FDF · Mar 15, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K180405
• Device Name: FUJIFILM Endoscope Models EC-600HL and EC-600LS
• Applicant: Fujifilm Corporation
• Product Code: FDF · Gastroenterology, Urology
• Decision Date: Mar 15, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

These devices 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 Story

Lower gastrointestinal endoscopes (EC-600HL, EC-600LS) capture images of the rectum and large intestine. Light from an external source travels through fiber bundles to illuminate the body cavity; a CMOS sensor at the distal tip captures images for display on a monitor. Used by clinicians in clinical settings for diagnostic and therapeutic procedures. Output allows real-time visualization of the lower digestive tract to guide clinical decision-making and endoscopic interventions. Benefits include direct visualization for diagnosis and treatment of colorectal conditions.

Clinical Evidence

Bench testing only. Performance testing included field of view, bending capability, air/water supply rates, suction rate, working length, forceps channel diameter, viewing direction, resolution, and light guide output. All tests met pre-defined acceptance criteria.

Technological Characteristics

Video endoscopes with CMOS image sensors, 170-degree field of view, and 0-degree forward viewing direction. Materials include glass fiber bundles for illumination. Connectivity via 500 Series video/light guide connectors to compatible processors (VP-7000, VP-4440HD/FN) and light sources (BL-7000, XL-4450/FN). Electrical safety complies with ANSI AAMI ES 60601-1 Edition 3.1.

Indications for Use

Indicated for visualization, observation, diagnosis, and endoscopic treatment of the rectum and large intestine in the lower digestive tract.

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 Endoscope Models EC-600HL and EC-600LS (K162622)

Submission Summary (Full Text)

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March 15, 2018

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

Re: K180405

Trade/Device Name: FUJIFILM Endoscope Models EC-600HL and EC-600LS Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FDF Dated: February 5, 2018 Received: February 14, 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 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.

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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); good manufacturing practice requirements as set forth in the quality systems (QS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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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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#### VI. INDICATIONS FOR USE STATEMENT

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Druq 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) K180405

Device Name

FUJIFILM Endoscope Models EC-600HL and EC-600LS

Indications for Use (Describe)

These devices are intended for the lower digestive tract, specifically for the observation, diagnosis,

and endoscopic treatment of the rectum and large intestine.

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

区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.

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#### VII. 510(K) SUMMARY

# 510(k) SUMMARY

# FUJIFILM Endoscope Models EC-600HL and EC-600LS

#### 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 Fujifilm Medical Systems U.S.A., Inc. Endoscopy Division Telephone: [phone] Facsimile: [phone] E-Mail: [e-mail]

Date Prepared: February 5, 2018

### Identification of the Proposed Device:

| Proprietary/Trade Name: | FUJIFILM Endoscope Models EC-600HL and EC-600LS |
|-------------------------|-------------------------------------------------|
| Common Name: | Video Endoscope |
| Device Class: | Class II |
| Review Panel: | Gastroenterology/Urology |
| Classification: | Endoscope and accessories, 21 C.F.R. § 876.1500 |
| Product Code: | FDF |

### Predicate Device:

Fujifilm Endoscope Models EC-600HL and EC-600LS, Fujifilm Medical Systems U.S.A, K162622

### Intended Use / Indications for Use:

These devices are intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.

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# Device Description:

FUJIFILM Endoscope Models EC-600HL and EC-600LS are lower gastrointestinal endoscopes that capture images when used in combination with a video processor and light source. Light travels from the light source, through the glass fiber bundles in the endoscopes, and out 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.

# Technological Characteristics:

A comparison of the technological characteristics between the modified and predicate devices is provided in the table below.

| | Proposed Device | Predicate Device | |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | EC-600HL | EC-600HL | |
| Common name | Endoscope and accessories | Endoscope and accessories | |
| Manufacturer | FUJIFILM Corporation | FUJIFILM Corporation | |
| 510(k) number | To be assigned | K162622 | |
| Intended | | The device is intended for the visualization of the lower | |
| Use/Indications | Same as K162622 | digestive tract, specifically for the observation, diagnosis, and | |
| for Use | | endoscopic treatment of the rectum and large intestine. | |
| Appearance | Same as K162622 | Image: Endoscope | |
| Viewing direction | Same as K162622 | Forward / 0 degrees | |
| Observation<br>range | Same as K162622 | 2-100mm | |
| Field of view | Same as K162622 | 170 degrees | |
| F# of the objective<br>lens | Same as K162622 | 7 | |
| Resolution | Same as K162622 | At 5mm of working distance: 0.056mm of line pair on the<br>square wave chart is readable.<br>At 100mm of working distance: 1.25mm of line pair on the<br>square wave chart is readable. | |
| Distortion<br>characteristics | Same as K162622 | Orthogonal Projection | |
| Magnification of<br>lens(es) | Same as K162622 | 0.3-0.01 | |
| Focal length | Same as K162622 | 0.9mm | |
| Image sensors | Same as K162622 | CMOS | |
| # of Light Guide<br>Fiber Bundles | Same as K162622 | 2800 | |
| | | Proposed Device | Predicate Device |
| Distal end diameter | | Same as K162622 | 12.8mm |
| Flexible portion diameter | | Same as K162622 | 12.8mm |
| Maximum insertion diameter | | Same as K162622 | 14.3mm |
| Bending capability | Up | Same as K162622 | 180 degrees |
| | Down | Same as K162622 | 180 degrees |
| | Left | Same as K162622 | 160 degrees |
| | Right | Same as K162622 | 160 degrees |
| Forceps channel diameter | | Same as K162622 | 4.2mm |
| Working length | | Same as K162622 | 1690mm |
| Total length | | Same as K162622 | 1990mm |
| WJ Function | | Same as K162622 | available |
| Location of WJ inlet | | Same as K162622 | On the light guide connector |
| | | Light source: BL-7000<br>Processor: VP-7000 | |
| Video Processor | | EPX-4440HD<br>Light source: XL-4450<br>Processor: VP-4440HD<br><br>EPX-4440FN<br>Light source: XL-4450FN<br>Processor: VP-4440FN | EPX-4440HD<br>Light source: XL-4450<br>Processor: VP-4440HD |
| Video/Light guide connector | | Same as K162622 | 500 Series |
| Peripherals | | Same as K162622 | Water Tank WT-2<br>Water Tank WT-4<br>Endoscopic Accessory (i.e. Forceps)<br>Monitor<br>Printer<br>Electrosurgical Instruments<br>Foot Switch<br>Cart |
| Accessories | | Same as K162622 | Cleaning Brush (WB11002FW2)<br>Cleaning Brush (WB5021FW2)<br>Cleaning Adapter Kit (CA-510/A)<br>Forceps Valve (FOV-DV7)<br>Ventilation Adapter (AD-7)<br>J Tube (JT-500)<br>Air/Water button (AW-500)<br>Suction button (SB-500)<br>Water Jet Inlet cap |
| Optional Items | | Same as K162622 | Air leak tester LT-7F |
| Electrical Safety Compliance | | ANSI AAMI ES 60601-1<br>Edition 3.1 | ANSI AAMI ES 60601-1 Edition 3.0 |
| | | Proposed Device | Predicate Device |
| Device name | | EC-600LS | EC-600LS |
| Common name | | Endoscope and accessories | Endoscope and accessories |
| Manufacturer | | FUJIFILM Corporation | FUJIFILM Corporation |
| 510(k) number | | To be assigned | K162622 |
| Intended<br>Use/Indications<br>for Use | | Same as K162622 | The device is intended for the visualization of the lower<br>digestive tract, specifically for the observation, diagnosis, and<br>endoscopic treatment of the rectum and large intestine. |
| Appearance | | Same as K162622 | Image: Endoscope |
| Viewing direction | | Same as K162622 | Forward / 0 degrees |
| Observation<br>range | | Same as K162622 | 2-100mm |
| Field of view | | Same as K162622 | 170 degrees |
| F# of the objective<br>lens | | Same as K162622 | 7 |
| Resolution | | Same as K162622 | At 5mm of working distance: 0.056mm of line pair on the<br>square wave chart is readable.<br>At 100mm of working distance: 1.25mm of line pair on the<br>square wave chart is readable. |
| Distortion<br>characteristics | | Same as K162622 | Orthogonal Projection |
| Magnification of<br>lens(es) | | Same as K162622 | 0.3-0.01 |
| Focal length | | Same as K162622 | 0.9mm |
| Image sensors | | Same as K162622 | CMOS |
| # of Light Guide<br>Fiber Bundles | | Same as K162622 | 2800 |
| Distal end<br>diameter | | Same as K162622 | 11.5mm |
| Flexible portion<br>diameter | | Same as K162622 | 11.5mm |
| Maximum<br>insertion diameter | | Same as K162622 | 13.1mm |
| | Up | Same as K162622 | 180 degrees |
| Bending<br>capability | Down | Same as K162622 | 180 degrees |
| | Left | Same as K162622 | 160 degrees |
| | Right | Same as K162622 | 160 degrees |
| Forceps channel<br>diameter | | Same as K162622 | 3.8mm |
| Working length | | Same as K162622 | 1690mm |
| Total length | | Same as K162622 | 1990mm |
| WJ Function | Same as K162622 | available | |
| Location of WJ inlet | Same as K162622 | On the light guide connector | |
| Video Processor | Light source: BL-7000<br>Processor: VP-7000<br><br>EPX-4440HD<br>Light source: XL-4450<br>Processor: VP-4440HD<br><br>EPX-4440FN<br>Light source: XL-4450FN<br>Processor: VP-4440FN | EPX-4440HD<br>Light source: XL-4450<br>Processor: VP-4440HD | |
| Video/Light guide connector | Same as K162622 | 500 Series | |
| Peripherals | Same as K162622 | Water Tank WT-2<br>Water Tank WT-4<br>Endoscopic Accessory (i.e. Forceps)<br>Monitor<br>Printer<br>Electrosurgical Instruments<br>Foot Switch<br>Cart | |
| Accessories | Same as K162622 | Cleaning Brush (WB11002FW2)<br>Cleaning Brush (WB5021FW2)<br>Cleaning Adapter Kit (CA-510/A)<br>Forceps Valve (FOV-DV7)<br>Ventilation Adapter (AD-7)<br>J Tube (JT-500)<br>Air/Water button (AW-500)<br>Suction button (SB-500)<br>Water Jet Inlet cap | |
| Optional Items | Same as K162622 | Air leak tester LT-7F | |
| Electrical Safety Compliance | ANSI AAMI ES 60601-1 Edition 3.1 | ANSI AAMI ES 60601-1 Edition 3.0 | |

# Table 7.1 - Comparison Chart for EC-600HL

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# Table 7.2 – Comparison Chart for EC-600LS

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# Performance Data:

Fujifilm conducted the following performance testing on the proposed devices EC-600HL and EC-600LS to ensure that the modified devices perform equivalently to the predicate devices:

- Field of view .
- Bending capability ●
- Air supply rate .
- Water supply rate .
- Suction rate ●
- Working length ●
- Forceps channel diameter .
- . Viewing direction

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- Resolution ●
- . LG output

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

# Substantial Equivalence:

The company's EC-600HL and EC-600LS has the same intended use, indications for use, technological characteristics, and principles of operation as the previously cleared predicate EC-600HL and EC-600LS (K162622). 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 EC-600HL and EC-600LS are substantially equivalent to their predicate devices.

# Conclusions:

The modified EC-600HL and EC-600LS are substantially equivalent to the predicate EC-600HL and EC-600LS and conform to applicable medical device safety and performance standards.