This product is a single use distal end cap required to be attached to certain FUJIFILM endoscopes during clinical use to assist in providing atraumatic passage of the endoscope tip during endoscopic procedures.

Do not use this product for any other purposes.

Device Description

FUJIFILM Distal End Cap DC-08D is a single use device that is supplied sterile, eliminating the need for reprocessing prior to use. This distal end cap is designed to the distal tip of a FUJIFILM ED-580XT duodenoscope. After an endoscopic procedure, the DC-08D is detached to facilitate easier access to the distal elevator during reprocessing of the ED-580XT.

AI/ML Overview

The available document is a 510(k) Summary for the FUJIFILM Distal End Cap DC-08D. It details the device's characteristics and compares it to a predicate device (FUJIFILM Distal End Cap DC-07D). However, it does not contain details about a clinical study involving human readers or an AI algorithm’s standalone performance, as the device is a medical accessory, not an AI diagnostic tool.

Therefore, many of the requested sections about acceptance criteria and study details for AI performance are not applicable and cannot be extracted from this document.

Here's the information that can be extracted, along with an explanation for the unavailable sections:

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

The document mentions that "Additional performance specifications were evaluated against pre-determined acceptance criteria" and that "Bench testing was conducted to demonstrate that the subject device is attached securely such that it will not detach during use." However, it does not explicitly list the specific acceptance criteria or quantitative performance results in a table format. It only states that the device was evaluated for conformance to ISO 8600-1:2015 and other standards.

Acceptance Criteria (Not explicitly stated in detail)	Reported Device Performance (Summary)
Sterility (Based on consensus standards)	Evaluated using ASTM F1980-16, ISO 11137-1:2006, ISO 11607-1:2019, ISO 11607-2:2019. (Implies successful evaluation).
Biocompatibility (Based on international standards)	Evaluated using ISO 10993-1:2018, ISO 10993-5:2009, and ISO 10993-10:2010 per FDA guidance. (Implies successful evaluation).
Secure attachment during use	Bench testing conducted to demonstrate secure attachment and no detachment during use. (Implies satisfactory performance).
Conformance to ISO 8600-1:2015	Evaluated for conformance to ISO 8600-1:2015. (Implies successful conformance).
Other performance specifications	Evaluated against pre-determined acceptance criteria. (Implies satisfactory performance, but criteria not detailed).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as the document describes the regulatory submission for a physical medical device (an end cap), not an AI algorithm requiring a test set of data. The "testing" mentioned refers to bench testing, sterility testing, and biocompatibility testing of the physical product, not data analysis.

3. 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)

This information is not applicable. Ground truth for data analysis is not relevant for this physical device submission. The "ground truth" for this device would be established by validated engineering and scientific methods and standards (e.g., successful sterilization, material safety, secure attachment), not by expert consensus on data interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for the reasons stated above.

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

This information is not applicable. The device is an end cap for an endoscope, not an AI system designed to assist human readers.

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

This information is not applicable. The device is a physical medical accessory, not an algorithm.

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

As mentioned, the concept of "ground truth" for data analysis is not applicable here. The verification of the device's properties relies on scientific and engineering testing methods, such as:

Sterility verification: Based on biological indicators and established sterilization cycles.
Biocompatibility verification: Based on in-vitro and/or in-vivo tests according to ISO standards.
Mechanical integrity: Based on bench testing to ensure secure attachment and durability during use.

8. The sample size for the training set

This information is not applicable as there is no AI algorithm and therefore no training set for data.

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

This information is not applicable as there is no AI algorithm and therefore no training set.

Summary

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Image /page/0/Picture/0 description: The image shows 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 in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.

October 30, 2020

Fujifilm Corporation % Jeffrey Wan Senior Regulatory Affairs Specialist FUJIFILM Medical Systems U.S.A., Inc. 81 Hartwell Avenue, Suite 300 Lexington, MA 02421

Re: K203028

Trade/Device Name: FUJIFILM Distal End Cap Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDT Dated: September 30, 2020 Received: October 2, 2020

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. 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.

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

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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 (OS) 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,

Shanil P. Haugen, PhD 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 SERVICES
Food and Drug Administration
Indications for Use		Form Approved: OMB No. 0910-0120
		Expiration Date: 06/30/2020
		See PRA Statement below.
510(k) Number (if known)	K203028
Device Name	FUJIFILM Distal End Cap DC-08D
Indications for Use (Describe)	This product is a single use distal end cap required to be attached to certain FUJIFILM endoscopes during clinical use to assist in providing atraumatic passage of the endoscope tip during endoscopic procedures.
	Do not use this product for any other purposes.
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)
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 Distal End Cap DC-08D

Date: September 30, 2020

Submitter's Information:

FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-Gun, Kanagawa, Japan 258-8538

Contact Person:

Jeffrey Wan Senior Regulatory Affairs Specialist Telephone: (201) 675-8947 E-Mail: jeffrey.wan@fujifilm.com

Identification of the Proposed Device:

Device Name:	FUJIFILM Distal End Cap DC-08D
Common Name:	Endoscopic accessory
Device Class:	Class II
Classification Number:	21 C.F.R. § 876.1500
Classification Name:	Endoscope and accessories
Device Panel:	Gastroenterology/Urology

Product Code Information:

Product Code Name:	Duodenoscope and accessories, flexible/rigid
CFR Section:	21 CFR 876.1500
Product Code:	FDT

Predicate Device:

FUJIFILM Distal End Cap DC-07D (K191747) .

Intended Use / Indications for Use

This product is a single use distal end cap required to certain FUJIFILM endoscopes during clinical use to assist in providing atraumatic passage of the endoscope tip during endoscopic procedures.

Do not use this product for any other purposes.

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Device Description

Comparison of Technological Characteristics

The subject device FUJIFILM Distal End Cap DC-08D differs from the predicate device in the following modifications:

DC-08D is supplied sterile, while DC-07D is supplied non-sterile and requires reprocessing . prior to use.
Packaging change from non-sterile bag to sterile pouch
. Material change

Performance Data

Sterility of the subject device was evaluated using the following consensus standards: ASTM F1980-16, ISO 11137-1:2006, ISO 11607-1:2019, ISO 11607-2:2019.

Biocompatibility of the subject device was evaluated using the following standards: ISO 10993-1:2018, ISO 10993-5:2009, and ISO 10993-10:2010. Biocompatibility testing was performed in accordance with FDA's quidance, "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.

Bench testing was conducted to demonstrate that the subject device is attached securely such that it will not detach during use.

The subject device was evaluated for conformance to ISO 8600-1:2015. Additional performance specifications were evaluated against pre-determined acceptance criteria.

Conclusions

The subject device DC-08D shares the same intended use and indications to the predicate device. Bench testing demonstrates that the subject device is as safe and effective as the predicate device. Thus, DC-08D is substantially equivalent to the listed predicate device.

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.