This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

Device Description

FUJIFILM Duodenoscope Model ED-580XT is comprised of three general sections: a control portion, an insertion portion and an umbilicus. The control portion controls the angulation of the endoscope. This portion also controls the flexibility of the distal end in the endoscope. The insertion portion contains glass fiber bundles, several channels and a complementary Charge-Coupled Device (CCD) image sensor in its distal end. The channels in the insertion portion assist in delivering air/suction as well as endoscope accessories, such as forceps. 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 CCD image sensor to capture an image and display it on the monitor. The umbilicus consists of electronic components needed to operate the endoscope when plugged in to the video processor and the light source. The endoscope is used in combination with FUJIFILM's video processors, light sources and peripheral devices such as monitor, printer, foot switch, and cart.

AI/ML Overview

Based on the provided text, the document describes the substantial equivalence of the FUJIFILM Duodenoscope Model ED-580XT, not a study evaluating an AI-powered diagnostic device. Therefore, the requested information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML device studies, are not present in this document.

The document mainly focuses on the physical and functional aspects of the duodenoscope and its safety and performance standards.

Here's a breakdown of what can be extracted, and what cannot:

1. A table of acceptance criteria and the reported device performance

The document lists performance specifications that were tested and states the device met the "pre-defined acceptance criteria for the test." However, the specific numerical or descriptive acceptance criteria themselves are not provided, nor are the reported raw performance values.

Performance Characteristic	Acceptance Criteria (Not Specified)	Reported Device Performance
Electromagnetic compatibility	IEC 60601-1-2:2014 standards	Met all standards
Biocompatibility	ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010; FDA guidance "Use of International Standard ISO 10993-1..."	Met all standards and guidance
Sterilization	AAMI TIR12:2010, AAMI TIR30:2011; FDA guidance "Reprocessing Medical Devices in Health Care Settings..."	Met all standards and guidance
Field of view	Not specified	Met pre-defined acceptance criteria
Bending capability	Not specified	Met pre-defined acceptance criteria
Rate of air supply	Not specified	Met pre-defined acceptance criteria
Rate of water supply	Not specified	Met pre-defined acceptance criteria
Rate of suction	Not specified	Met pre-defined acceptance criteria
Working length	Not specified	Met pre-defined acceptance criteria
Forceps standing angle	Not specified	Met pre-defined acceptance criteria
Forceps standing tension	Not specified	Met pre-defined acceptance criteria
Diameter of forceps channel	Not specified	Met pre-defined acceptance criteria
Viewing direction	Not specified	Met pre-defined acceptance criteria
Resolution	Not specified	Met pre-defined acceptance criteria
LG output	Not specified	Met pre-defined acceptance criteria

Information NOT available in the document:

Sample sizes used for the test set and the data provenance: Not applicable as this is not an AI/ML study with a "test set" in that context. The "tests" refer to engineering performance validations.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML algorithm is not established for this type of device.
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, as this is not an AI-assisted device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary for a medical device (a duodenoscope) and details its engineering performance, biocompatibility, and sterilization, rather than the clinical performance of an AI/ML-powered diagnostic tool.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 27, 2019

FUJIFILM Corporation % Kamila Sak Specialist, Regulatory Affairs FUJIFILM Medical Systems U.S.A., Inc. 81 Hartwell Avenue, Suite 300 Lexington, MA 02421

Re: K191747

Trade/Device Name: FUJIFILM Duodenoscope Model ED-580XT Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDT Dated: June 28, 2019 Received: July 1, 2019

Dear Kamila Sak:

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. Although this letter refers to your product as a device, please be aware 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.

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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for

Martha W. Betz, Ph.D. Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal. ObGyn. General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below.
Indications for Use
510(k) Number (if known)	K191747
Device Name	FUJIFILM Duodenoscope Model ED-580XT
Indications for Use (Describe)	This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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 Drug 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."

FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

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510(k) SUMMARY

FUJIFILM Corporation's FUJIFILM Duodenoscope Model ED-580XT

Date: September 26, 2019

Submitter's Information:

FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-Gun, Kanagawa, 258-8538, Japan FDA Establishment Registration Number: 3001722928

Contact Person:

Kamila Sak Specialist, Regulatory Affairs Telephone: (347) 577-2309 E-Mail: kamila.sak@fujifilm.com

Identification of the Proposed Device:

Proprietary/Trade Name:	FUJIFILM Duodenoscope Model ED-580XT
Common Name:	Endoscope
Device Class:	Class II
Review Panel:	Gastroenterology/Urology
Classification:	Endoscope and accessories, 21 C.F.R. § 876.1500
Product Code:	FDT

Predicate Device:

FUJIFILM Duodenoscope Model ED-580XT (K181745)

Intended Use / Indications for Use

FUJIFILM Duodenoscope Model ED-580XT is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

Device Description

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glass fiber bundles, several channels and a complementary Charge-Coupled Device (CCD) image sensor in its distal end. The channels in the insertion portion assist in delivering air/suction as well as endoscope accessories, such as forceps. 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 CCD image sensor to capture an image and display it on the monitor. The umbilicus consists of electronic components needed to operate the endoscope when plugged in to the video processor and the light source. The endoscope is used in combination with FUJIFILM's video processors, light sources and peripheral devices such as monitor, printer, foot switch, and cart.

Comparison of Technological Characteristics

The proposed device ED-580XT differs from the predicate device in the following minor modifications:

Material changes to distal end section
Change to sterilization procedure .
Conformance to IEC 60601-1-2:2014

Performance Data

Electromagnetic compatibility of the subject device was evaluated using following standards: IEC 60601-1-2:2014.

Biocompatibility of the subject device was evaluated using the following consensus standards: ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010. Biocompatibility testing was performed in accordance with FDA's guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," published June 16, 2016.

Sterilization of the subject device were evaluated according to the following consensus standards: AAMI TIR12:2010, AAMI TIR30:2011. Validation of the sterilization instructions was performed in accordance with FDA's guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," published March 17, 2015.

The subject device met performance specifications in the following additional testing:

Field of view
. Bending capability
Rate of air supply ●
Rate of water supply ●
Rate of suction
Working length
Forceps standing angle ●
Forceps standing tension .

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K191747 Page 3 of 3

Diameter of forceps channel
. Viewing direction
Resolution ●
LG output o

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

Substantial Equivalence

The company's ED-580XT has the same intended use and indications for use as the previously cleared predicate ED-580XT (K181745). In addition, the proposed device has similar technological characteristics and principles of operation as the predicate. The minor differences between the proposed and predicate devices do not raise new or additional questions of safety or effectiveness of the proposed devices. Thus, the proposed device ED-580XT is substantially equivalent to the predicate device.

Conclusions

The modified ED-580XT is substantially equivalent to the predicate ED-580XT and conforms to applicable medical device safety and performance standards.

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.