Fujifilm 600 Series Endoscope EC-600WL: This device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.

Fujifilm 600 Series Endoscope EG-600WR: The device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

Fujifilm 600 Series (Water Tank, WT-4): This product is intended for use in combination with Fujinon/Fujifilm Endoscopes to deliver air and water through the Endoscope under the management of a physician in medical facilities. Do not use this product for any other purpose.

Device Description

Fujifilm 600 Series Endoscopes, EC-600WL and EG-600WR, are modified versions of the legally marketed Fujinon Colonoscopes EC-530HL2 and EC-530LS2 in K112391, and Fujinon G5 Gastroscope EG-450WR5 in K042043 respectively. Just like K112391, the proposed EC-600WL is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine. The proposed EG-600WR is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum, this is similar to K042043.

The endoscopes are comprised of three general sections: an operation section, an insertion portion and an umbilicus. The operation section controls the angulation (up/down/left/right) of the distal end of the endoscope. The insertion portion contains glass fiber bundles, several channels, and a complementary metal-oxide-semiconductor (CMOS) image sensor. The glass 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, provide suction, and 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 to the video processor and light source.

The proposed models are used in combination with Fujifilm's video processor, light source and peripheral devices (water tank, endoscopic accessories, monitor, printer, DVD recorder, electrosurgical instruments, foot switch, cart).

The intended use, scientific fundamental technology and operating principle of the Water Tank WT-4 accessory, remains the same as the legally marketed Water Tank WT-2.

The minor modifications to the proposed devices were made for the purpose of overall product enhancement and general technological advancement.

AI/ML Overview

The provided document describes the 510(k) premarket notification for Fujifilm 600 Series Endoscopes and the Water Tank WT-4, seeking substantial equivalence to previously cleared devices. It outlines the device description, indications for use, and the studies conducted to demonstrate safety and performance. However, this document does not contain information about a study that proves the device meets specific acceptance criteria related to a diagnostic algorithm or a specific performance metric like sensitivity or specificity. Instead, the studies presented are focused on demonstrating safety and compliance with recognized standards for medical devices.

Here's a breakdown of the requested information based on the provided text, with explanations where information is not present:

Acceptance Criteria and Device Performance Study for Fujifilm 600 Series Endoscopes and Water Tank WT-4

1. Table of acceptance criteria and the reported device performance

The document does not specify performance-based acceptance criteria (e.g., specific diagnostic accuracy thresholds, image quality metrics with acceptance levels) for the endoscopes or water tank. Instead, it lists safety and performance requirements (standards) to which the devices were evaluated and passed. The "reported device performance" is implicitly that the devices met these safety and performance standards.

Acceptance Criteria (Standards Met)	Reported Device Performance (Passed/Evaluated)
ANSI/AAMI ES60601-1 (General reqs. for basic safety & essential performance)	Passed evaluation
IEC60601-1-2 (Electromagnetic Compatibility)	Passed evaluation
IEC60601-2-18 (Safety of endoscopic equipment)	Passed evaluation
ISO10993-1 (Biological evaluation - general)	Passed evaluation (tested per ISO10993-5 and ISO10993-10)
ISO10993-5 (In vitro cytotoxicity)	Passed evaluation
ISO10993-10 (Irritation and skin sensitization)	Passed evaluation
ISO8600-1 (Optics & photonics - Medical endoscopes)	Passed evaluation (tested per ISO8600-3 and ISO8600-4)
ISO8600-3 (Field of view and direction of view)	Passed evaluation
ISO8600-4 (Maximum width of insertion portion)	Passed evaluation
Reprocessing instructions validated	Reprocessing instructions updated and validated

2. Sample size used for the test set and the data provenance

The document clearly states: "No clinical testing was conducted." Therefore, there was no "test set" in the context of clinical or diagnostic performance evaluation with a sample size or data provenance. The evaluations were based on engineering, bench, and biocompatibility testing against recognized standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

As no clinical testing was conducted and no "test set" for diagnostic performance was used, there were no experts involved in establishing ground truth for such a purpose. The ground truth for the engineering and safety tests would have been the specifications of the standards themselves, verified by testing laboratories and engineers.

4. Adjudication method for the test set

Not applicable, as no clinical test set requiring adjudication was used.

5. 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. No MRMC study was mentioned, nor is this device an AI-assisted diagnostic tool. It is an endoscope and water tank.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is not an algorithm or an AI system; it is a medical hardware device (endoscope and accessory).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the evaluations conducted (safety, biocompatibility, performance against technical specifications), the "ground truth" was defined by the requirements and methodologies outlined in the referenced international standards (e.g., IEC, ISO, ANSI/AAMI) that the device was tested against. For example, for biocompatibility testing, the ground truth would be the defined acceptable levels of cytotoxicity or irritation according to ISO 10993. For mechanical and electrical tests, it would be the published limits and methodologies in the respective IEC/ANSI/AAMI standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established

Not applicable. As above, this is not an AI/ML device.

Summary of the Study and Device Justification:

The studies performed for the Fujifilm 600 Series Endoscopes and Water Tank WT-4 were primarily bench testing, engineering verification, and biocompatibility evaluations to demonstrate compliance with recognized international and national safety and performance standards (e.g., IEC 60601 series, ISO 10993 series, ISO 8600 series).

The primary method for "proving the device meets acceptance criteria" in this context was demonstrating substantial equivalence to existing legally marketed predicate devices (Fujinon Colonoscopes EC-530HL2 and EC-530LS2, Fujinon G5 Gastroscope EG-450WR5, and Water Tank WT-2). The modifications were described as "minor modifications... for the purpose of overall product enhancement and general technological advancement." The lack of clinical testing further supports that the modifications were considered minor enough not to raise new questions of safety or effectiveness from a performance standpoint, allowing reliance on the predicate devices' established performance.

Summary

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FUJ!FILM

Date: January 9, 2014

Submitter's Information:

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

Contact Persons:

Gina Walljasper Director, Quality and Requlatory Compliance Telephone: (973) 686-2636 Facsimile: (973) 686-2616 E-Mail: qwalliasper@fujifilm.com

Identification of the Proposed Devices:

Proprietary/Trade Name: Fujifilm 600 Series Endoscopes EC-600WL and · EG-600WR Water Tank WT-4 Common Name: Video Endoscope Device Class: Class II Review Panel: Gastroenterology/Urology Classification Information:

Classification Name	CFR Section	Product Codes
Colonoscope and Accessories (Flexible/Rigid)	21 CFR 876.1500	FDF
Gastroscope and Accessories (Flexible/Rigid)	21 CFR 876.1500	FDS

I. INDICATIONS FOR USE

JAN 1 0 2014

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FUJIFILM

Fujifilm 600 Series (Water Tank, WT-4): The device is intended for use in combination with Fuiinon/Fujifilm Endoscopes to deliver air and water through the Endoscope under the management of a physician in medical facilities. Do not use this product for any other purpose.

II. DEVICE DESCRIPTION

Fuiifilm 600 Series Endoscopes, EC-600WL and EG-600WR, are modified versions of the legally marketed Fujinon Colonoscopes EC-530HL2 and EC-530LS2 in K112391, and Fujinon G5 Gastroscope EG-450WR5 in K042043 respectively. Just like K112391, the proposed EC-600WL is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine. The proposed EG-600WR is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum, this is similar to K042043.

The endoscopes are comprised of three general sections: an operation section, an insertion portion and an umbilicus. The operation section controls the anqulation (up/down/left/right) of the distal end of the endoscope. The insertion portion contains glass fiber bundles, several channels, and a complementary metal-oxide-semiconductor (CMOS) image sensor. The glass 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, provide suction, and 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 to the video processor and light source.

The intended use, scientific fundamental technology and operating principle of the Water Tank WT-4 accessory, remains the same as the legally marketed Water Tank WT-2.

The minor modifications to the proposed devices were made for the purpose of overall product enhancement and general technological advancement.

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FUJIFILM

SUMMARY OF STUDIES III.

The proposed devices have been subjected to and passed electrical safety and EMC test requirements.

Fuiifilm 600 Series Endoscopes, EC-600WL and EG-600WR, and Water Tank WT-4 were evaluated in accordance with the following safety and performance requirements in addition to the applicable quality regulations:

ANSI/AAMI ES60601-1***	Medical electrical equipment - Part 1: Generalrequirements for basic safety and essentialperformance
IEC60601-1-2***	Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essentialperformance - Collateral standard: ElectromagneticCompatibility - Requirements and tests
IEC60601-2-18***	Medical electrical equipment - Part 2-18: Particularrequirements for the safety of endoscopic equipment
ISO10993-1*	Biological evaluation of medical devices
ISO10993-5	Biological evaluation of medical devices - Part 5:Tests for in vitro cytotoxicity
ISO10993-10	Biological evaluation of medical devices - Part 10:Tests for irritation and skin sensitization
ISO8600-1**	Optics and photonics - Medical endoscopes andendotherapy devices
ISO8600-3	Optics and Optical instruments - Medical endoscopesand endoscopic accessories - Part 3: Determinationof field of view and direction of view of endoscopeswith optics
ISO8600-4	Optics and Optical instruments - Medical endoscopesand certain accessories - Part 4: Determination ofmaximum width of insertion portion

*Evaluation to ISO 10993-1 (Tested per ISO10993-5 and ISO-10993-10) was conducted for patient contact materials for 600 Series Endoscopes (direct and indirect) and Water Tank WT-4 (indirect only).

**Evaluation to ISO 8600-1 (Tested per ISO 8600-3 and ISO 8600-4) was conducted for 600 Series Endoscopes.

***Evaluation to ANSI/AAMI ES60601-1, IEC60601-1-2 and IEC60601-2-18 were conducted for 600 Series Endoscopes.

The reprocessing instructions were updated and validated. No clinical testing was conducted.

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FUJIFILM

IV. SUBSTANTIAL EQUIVALENCE

Fujifilm 600 Series Endoscopes, EC-600WL and EG-600WR, and Water Tank WT-4 are substantially equivalent to the following devices:

Proposed Device	Legally Marketed Device(s)	510(k) #
Fujifilm 600 SeriesEndoscope EC-600WL	Fujinon Colonoscopes, EC-530HL2and EC-530LS2	K112391
Fujifilm 600 SeriesEndoscope EG-600WR	Fujinon G5 Gastroscope EG-450WR5	K042043
Water Tank WT-4	Water Tank WT-2	K944620

V. CONCLUSION

Fujifilm 600 Series Endoscopes, EC-600WL and EG-600WR, and Water Tank WT-4 are substantially equivalent to the legally marketed devices and conform to applicable medical device safety and performance standards.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three overlapping, curved lines, which is the official symbol of the department.

Public Health Service

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

January 10, 2014

FUJIFILM Medical Systems U.S.A., Inc. Gina Walliasper Director, Quality and Regulatory Compliance 10 High Point Drive Wayne, NJ 07470

Re: K132210
Trade/Device Name: Fujifilm 600 Series Endoscopes EC-600WL and EG-600WR Fujifilm 600 Series (Water Tank, WT-4) Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF, FDS Dated: December 20, 2013 Received: December 23, 2013

Dear Gina Walljasper,

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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Page 2 - Gina Walljasper

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

Image /page/5/Picture/7 description: The image shows the name "Herbert P. Lerner -S" in a bold, sans-serif font. The letters "Herbert" and "Lerner" are clear and distinct. The "P." is smaller and has a slightly pixelated appearance. The "-S" is also in bold and is separated from "Lerner" by a space and a hyphen.

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K132210

Device Name Fujifilm 600 Series (Water Tank, WT-4)

Indications for Use (Describe)

This product is intended for use in combination with Fujinon/Fujifilm Endoscopes to deliver air and water through the Endoscope under the management of a physician in medical facilities.

Do not use this product for any other purpose.

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

[X] 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 Radiclogical Health (CDRH) (Signature)

Herbert P. Le 2014.01.10 12: 00'

FORM FDA 3881 (9/13)

Page Lotz

CONFIDENTIAL and PROPRIETARY

K132210 - FUJIFILM 600 Series Endoscopes

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Indications for Use

510(k) Number (if known): K 132210

Device Name: Fujifilm 600 Series Endoscopes EC-600WL and EG-600WR

Indications for Use:

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert P. Lerner -S 2014.01.10 10:26:44 -05'00'

FUJIFILM 600 Series Endoscopes (EC-600WL and EG-600WR)

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.