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

The FUJIFILM Endoscope Models EC-600HL and EC-600LS are comprised of three main sections: an operation section, an insertion portion, and an umbilicus. The operation controls the angulation (up/down/left/right) of the distal end of the endoscope. The insertion contains glass fiber bundles, several channels and a complementary metal-oxide-semiconductor (CMOS) image sensor. The qlass 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 CMOS image sensor to capture an image and display it on the monitor. The endoscope also contains several channels to deliver air/water and provide suction, as well as a forceps channel. The forceps channel is used to introduce endoscope accessories such as biopsy forceps during the procedure. The umbilicus section consists of electronic components needed to operate the endoscope when plugged in to the video processor and the light source.

The subject device is used in combination with FUJIFILM's video processor, light source and peripheral devices such as water tank, endoscope accessories, monitor, printer, electrosurgical instruments, foot switch, and cart. All of these were previously cleared in K132210.

AI/ML Overview

This document is a 510(k) summary for the Fujifilm Endoscope Models EC-600HL and EC-600LS. It primarily focuses on demonstrating substantial equivalence to a predicate device (FUJIFILM 600 Series Endoscope EC-600WL) rather than establishing novel acceptance criteria or a comprehensive study proving a device meets specific performance metrics for image interpretation by an AI.

Therefore, many of the requested categories for AI-related performance studies cannot be filled as this document concerns a physical endoscope device and its safety/effectiveness, not an AI algorithm for image analysis.

Here's an attempt to address the requested information based only on the provided text, recognizing that much of it is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not specify discrete acceptance criteria in terms of numerical performance metrics for clinical outcomes (e.g., diagnostic accuracy, sensitivity, specificity) for the endoscope's visualization capabilities. Instead, the "acceptance criteria" are implied by adherence to recognized consensus standards for safety and performance of medical devices. The reported device performance is that it meets these standards and is substantially equivalent to the predicate.

Acceptance Criteria Category	Specific Standard/Requirement	Reported Device Performance
Electromagnetic Compatibility & Electrical Safety	ANSI/AAMI ES60601-1:2005; IEC 60601-1-2:2007; IEC 60601-1-6:2010; IEC 60601-2-18:2009	Evaluated using these standards.
Biocompatibility	ISO 10993-1:2009; ISO 10993-5:2009; ISO 10993-10:2010	Evaluated using these standards.
Cleaning, Disinfection, Sterilization	AAMI TIR30:2011; AAMI TIR12:2010; AAMI/ANSI/ISO 11135-1:2007; AAMI/ANSI/ISO 17665-1:2006	Evaluated according to these standards.
Endoscope Specific Testing	ISO 8600-1:2013; ISO 8600-3:1997; ISO 8600-4:1997	Conducted using these standards.
Overall Equivalence	"As safe and effective as the predicate device" (K132210)	"Performance data demonstrate that the Endoscope Models EC-600HL and EC-600LS are as safe and effective as the Endoscope EC-600WL."

Regarding AI-specific questions:

Since this document describes a physical endoscope, not an AI-powered diagnostic device or software, the following information is not present in the provided text:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. The "performance data" refers to technical bench testing against consensus standards, not a clinical study with patient data used for AI evaluation.
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): Not applicable. Ground truth for clinical diagnostic performance is not established as this is a hardware submission, not an AI diagnostic tool.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the context of AI diagnostic performance. The "ground truth" for the endoscope itself is its demonstrable adherence to safety and performance standards through engineering and biocompatibility testing.
The sample size for the training set: Not applicable. There is no AI training set mentioned.
How the ground truth for the training set was established: Not applicable. There is no AI training set mentioned.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 6, 2015

Fujifilm Medical Systems U.S.A., Inc. Mary Moore Senior Director, Regulatory Affairs and Quality Assurance 10 High Point Drive Wayne, NJ 07470

K143732 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: May 29, 2015 Received: May 29, 2015

Dear Mary Moore,

Re:

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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Herbert P. Lerner -
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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Indications for Use

510(k) Number (if known) K143732

Device Name

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

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 Medical Systems U.S.A., Inc.'s FUJIFILM Endoscope Models EC-600HL and EC-600LS

Date: May 29, 2015

Submitter's Information

FUJIFILM Medical Systems U.S.A., Inc., Endoscopy Division 10 High Point Drive Wayne, NJ 07470 USA FDA Establishment Registration Number: 2431293

Contact Person:

Mary K. Moore Senior Director, Regulatory Affairs and Quality Assurance Telephone: (973) 686-2498 Facsimile: (973) 686-2616 E-Mail: mkmoore@fujifilm.com

ldentification of the Subject 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 Information:

Colonoscope and Accessories (Flexible/Rigid), 21 CFR 876.1500 Product Code: FDF

Predicate Device

FUJIFILM 600 Series Endoscope EC-600WL (K132210)

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Intended Use / Indications for Use

Technological Characteristics

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

Device Description	EC-600WL(Predicate Device)	EC-600HL(Subject Device)	EC-600LS(Subject Device)
Indications for Use	This device is intended forthe visualization of the lowerdigestive tract, specificallyfor the observation,diagnosis, and endoscopictreatment of the rectum andlarge intestine.	This device is intended forthe visualization of thelower digestive tract,specifically for theobservation, diagnosis,and endoscopic treatmentof the rectum and largeintestine.	This device is intended forthe visualization of thelower digestive tract,specifically for theobservation, diagnosis,and endoscopic treatmentof the rectum and largeintestine.
Insertion route	Retrograde	Retrograde	Retrograde
Viewing direction	Forward/ 0 degree	Forward/ 0 degree	Forward/ 0 degree
Observation range	2-100 nm	2-100 nm	2-100 nm
Field of view	140 degrees	170 degrees	170 degrees
Distal end diameter	12.0 millimeters	12.8 millimeters	11.5 millimeters
Flexible portion diameter	12.0 millimeters	12.8 millimeters	11.5 millimeters
Maximum diameter of insertionportion	13.2 millimeters	14.3 millimeters	13. 1 millimeters
Forceps channel diameter	3.8 millimeters	4.2 millimeters	Same as predicate
Working length	1690 millimeters	Same as predicate	Same as predicate
Total length	1990 millimeters	Same as predicate	Same as predicate

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Processors and light sources	EPX-4440HD videoprocessor systems (VP-4440HD Video Processorand XL-4450 Light Source,K102466) or EPX-4440HDwith FICE systems (VP-4440HD Video Processorwith FICE and XL-4450Light Source, K140149),	EPX-4440HD videoprocessor systems (VP-4440HD Video Processorand XL-4450 LightSource, K102466) orEPX-4440HD with FICEsystems (VP-4440HDVideo Processor withFICE and XL-4450 LightSource, K140149),	EPX-4440HD videoprocessor systems (VP-4440HD Video Processorand XL-4450 LightSource, K102466) orEPX-4440HD with FICEsystems (VP-4440HDVideo Processor withFICE and XL-4450 LightSource, K140149),
Accessories	Channel Cleaning BrushWB4321FW2	Channel Cleaning BrushWB5021FW2	Channel Cleaning BrushWB5021FW2

Performance Data

EMC and electrical safety of the subject devices were evaluated using the following consensus standards: ANSI/AAMI ES60601-1:2005; IEC 60601-1-2:2007; IEC 60601-1-6:2010; and IEC 60601-2-18:2009.

Biocompatibility of the subject devices was evaluated using the following consensus standards: ISO 10993-1:2009; ISO 10993-5:2009; and ISO 10993-10:2010.

Cleaning, disinfection, and sterilization were evaluated according to the following consensus standards: AAMI TIR30:2011; AAMI TIR12:2010; AAMI/ANSI/ISO 11135-1:2007; and AAMI/ANSI/ISO 17665-1:2006.

Endoscope specific testing was conducted using the following consensus standards: ISO 8600-1:2013; ISO 8600-3:1997; and ISO 8600-4:1997.

Substantial Equivalence

The Endoscope Models EC-600HL and EC-600LS are as safe and effective as the FUJIFILM 600 Series Endoscope EC-600WL. Endoscope Models EC-600HL and EC-600LS have the same intended uses and similar indications, technological characteristics, and principles of operation as their predicate device. The minor technological differences between the Endoscope Models EC-600HL and EC-600LS and their predicate device were made for the purpose of overall product enhancement and general technological advancement, and raise no new issues of safety or effectiveness. Performance data demonstrate that the Endoscope Models EC-600HL and EC-600LS are as safe and effective as the Endoscope EC-600WL. Thus, the devices are substantially equivalent.

Conclusions

The Endoscope Models EC-600HL and EC-600LS are substantially equivalent to the cleared predicate based on intended use/indications for use and technological characteristics. The minor technological differences between the subject endoscopes and its predicate devices raise no new issues of safety or effectiveness. Bench testing data demonstrated that the subject endoscopes have substantially equivalent performance to the predicate. Thus, the devices are as safe and effective as the predicate.

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.