Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the optical and mechanical aspects of the endoscope and image capture, with no mention of AI/ML processing or algorithms. The performance studies are based on physical and optical characteristics, not algorithmic performance.

Therapeutic

No
The device is described for observation, diagnosis, and endoscopic treatment, which implies interventional capabilities beyond just therapy.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is intended for "observation, diagnosis, and endoscopic treatment of the rectum and large intestine." The term "diagnosis" clearly indicates its use as a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the devices are lower gastrointestinal endoscopes that capture images using a CMOS image sensor and rely on physical components like glass fiber bundles, a video processor, and a light source. This indicates a hardware-based medical device, not a software-only one.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the "observation, diagnosis, and endoscopic treatment of the rectum and large intestine." This involves directly visualizing and potentially treating the internal anatomy of the patient.
Device Description: The device is described as a lower gastrointestinal endoscope that captures images using light and a CMOS sensor. This is a tool for direct visualization and intervention within the body.
Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health. This device operates inside the body.

Therefore, this device falls under the category of a medical device used for direct examination and treatment within the body, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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.

Product codes

FDF

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

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

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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
Resolution ●
. LG output
In all cases, the devices met the pre-defined acceptance criteria for the test.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K162622

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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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: (973) 709-2219 Facsimile: (201) 995-2452 E-Mail: jeffrey.wan@fujifilm.com

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
range	Same as K162622	2-100mm
Field of view	Same as K162622	170 degrees
F# of the objective
lens	Same as K162622	7
Resolution	Same as K162622	At 5mm of working distance: 0.056mm of line pair on the
square wave chart is readable.
At 100mm of working distance: 1.25mm of line pair on the
square wave chart is readable.
Distortion
characteristics	Same as K162622	Orthogonal Projection
Magnification of
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
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
Processor: VP-7000
Video Processor		EPX-4440HD
Light source: XL-4450
Processor: VP-4440HD

EPX-4440HD
Light source: XL-4450
Processor: VP-4440HD

EPX-4440FN
Light source: XL-4450FN
Processor: VP-4440FN | EPX-4440HD
Light source: XL-4450
Processor: VP-4440HD | |
| Video/Light guide connector | Same as K162622 | 500 Series | |
| Peripherals | Same as K162622 | Water Tank WT-2
Water Tank WT-4
Endoscopic Accessory (i.e. Forceps)
Monitor
Printer
Electrosurgical Instruments
Foot Switch
Cart | |
| Accessories | Same as K162622 | Cleaning Brush (WB11002FW2)
Cleaning Brush (WB5021FW2)
Cleaning Adapter Kit (CA-510/A)
Forceps Valve (FOV-DV7)
Ventilation Adapter (AD-7)
J Tube (JT-500)
Air/Water button (AW-500)
Suction button (SB-500)
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

8

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.