Distal Cap Models DH-32EN and DH-17EN2 are intended to be used in combination with the dedicated endoscope to maintain the field of view during endoscopic procedures.

Device Description

Distal Cap Models DH-32EN and DH-17EN2 are pre-sterilized, single-use accessories that are attached to the tip of an applicable FUJIFILM double balloon endoscope to maintain a clear, unobstructed field of view during endoscopic procedures.

AI/ML Overview

The provided document is a 510(k) premarket notification for Distal Cap Models DH-32EN and DH-17EN2. This document is a regulatory submission for medical devices that demonstrates substantial equivalence to a legally marketed predicate device.

The document primarily focuses on demonstrating the safety and effectiveness of the new devices by comparing their technological characteristics and performance data to a predicate device (Distal Cap Model DH-39CZ). It does not describe a study involving an AI algorithm or human readers for diagnostic purposes. Therefore, most of the requested information regarding AI acceptance criteria, sample sizes for test/training sets, expert involvement, adjudication, MRMC studies, standalone algorithm performance, or the exact nature of ground truth as typically understood for AI/diagnostic studies, is not applicable to this type of medical device submission.

The "acceptance criteria" and "study" described in this document pertain to the physical properties, sterility, biocompatibility, and secure attachment of the distal caps, rather than the diagnostic performance of an AI system.

Here's a breakdown of the relevant information from the document in relation to your request, with an emphasis on what is not applicable:

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

The document mentions "pre-defined acceptance criteria" for "Additional performance specifications" and states that "Bench testing was conducted to demonstrate that the subject devices are attached securely such that they will not detach during use." However, it does not provide a specific table detailing these acceptance criteria and the exact reported performance results. It only generally states that these evaluations were conducted and demonstrated equivalence.

For the aspects that are detailed, here's a summary of the performance evaluations conducted:

Performance Evaluation Type	Acceptance Criteria (Implied/Stated)	Reported Device Performance
Sterility	Compliance with consensus standards: ISO 11135:2014, ISO 11607-1:2019, ASTM F1980-16	Evaluated using these standards. (Implied successful demonstration of sterility to meet these standards for market clearance)
Biocompatibility	Compliance with consensus standards and FDA guidance: ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010, FDA guidance "Use of International Standard ISO 10993-1" (Sept 4, 2020)	Performed in accordance with these standards and guidance. (Implied successful demonstration of biocompatibility)
Secure Attachment	Devices must be attached securely such that they will not detach during use.	Bench testing conducted to demonstrate this. (Claimed successful demonstration)
Additional Performance Specifications	Pre-defined acceptance criteria (not specified in detail)	Evaluated against pre-defined acceptance criteria. (Implied successful evaluation)

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

Not applicable in the context of an AI/diagnostic algorithm. The "testing" here refers to physical, chemical, and mechanical tests on the device itself.
The document implies that multiple units of the device were tested for sterility, biocompatibility, and secure attachment, but it does not specify the sample sizes of devices (e.g., how many distal caps were tested for secure attachment).
Data Provenance: The studies were conducted by FUJIFILM Corporation, a Japanese manufacturer, but the specific location of the testing laboratories is not provided. These are likely internal or contracted laboratory tests, not clinical data sets from specific countries. The studies are by nature prospective as they are conducted specifically for this regulatory submission.

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

Not applicable in the context of an AI/diagnostic algorithm. "Ground truth" here refers to objective measurements and compliance with scientific testing standards (e.g., a sterile product passes a sterility test, a material is biocompatible if it does not induce a toxic response). This does not involve expert readers reviewing images or clinical cases.

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

Not applicable. This concept typically applies to discrepancies in human reader interpretations of diagnostic data, which is not what this document describes.

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. This document describes a medical device (a distal cap for endoscopes), not an AI diagnostic algorithm. There is no mention of human readers, AI assistance, or diagnostic performance evaluation in this context.

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

Not applicable. This device is a physical accessory, not an algorithm.

7. The type of ground truth used:

Objective Test Results / Compliance with Standards: The "ground truth" for this device's performance is established by scientific and engineering principles, and compliance with recognized consensus standards (e.g., ISO for sterility and biocompatibility, ASTM for material testing). It is not pathology, outcomes data, or expert consensus in the diagnostic sense. For example, the ground truth for biocompatibility is whether the material elicits a biological response above acceptable limits, as measured by standard laboratory tests.

8. The sample size for the training set:

Not applicable. This is not an AI algorithm. There is no concept of a "training set" for this type of device.

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

Not applicable. As above, no training set or AI algorithm is involved.

In summary: The provided document is relevant to the regulatory clearance of a physical medical device. It demonstrates the device's safety and effectiveness through engineering specifications, sterility testing, and biocompatibility studies, asserting its "substantial equivalence" to a predicate device. It does not provide any information about the development or validation of an Artificial Intelligence (AI) diagnostic system, which is what most of your questions are geared toward.

Summary

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August 19, 2021

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

Re: K212296

Trade/Device Name: Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FDF, FDS Dated: July 21, 2021 Received: July 22, 2021

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 control's 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,

for

Shanil P. Haugen, Ph.D. 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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Indications for Use

510(k) Number (if known) K212296

Device Name

Distal Cap Models DH-32EN and DH-17EN2

Indications for Use (Describe)

Distal Cap Models DH-32EN and DH-17EN2 are intended to be used in combination with the dedicated endoscope to maintain the field of view during endoscopic procedures.

Type of Use (Select one or both, as applicable)
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☒ Production/Use for 21 CFR 511.1 Subject Drugs
□ Compounding/Manufacturing for 21 CFR 511.4 Subject Drugs

X 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 Corporation Distal Cap Models DH-32EN and DH-17EN2

Date: July 21, 2021

Submitter's Information:

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

Contact Person:

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

Identification of the Proposed Device:

Device Name:	Distal Cap Models DH-32EN and DH-17EN2
Common Name:	Endoscopic Accessory
Device Class:	Class II
Classification Number:	21 C.F.R. § 876.1500
Classification Name:	Endoscope and accessories
Device Panel:	Gastroentereology/Urology
Product Code:	FDS, FDF

Predicate Devices:

. Distal Cap Model DH-39CZ (K193123)

Intended Use / Indications for Use

Distal Cap Models DH-32EN and DH-17EN2 are intended to be used in combination with the dedicated endoscope to maintain the field of view during endoscopic procedures.

Device Description

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Comparison of Technological Characteristics

A comparison of technological characteristics between DH-32EN and DH-17EN2 and the predicate DH-39CZ is provided below:

	Subject Device #1DH-32EN	Subject Device #2DH-17EN2	Predicate DeviceDH-39CZ
510(k) number	To be assigned	To be assigned	K193123
Product code	FDF, FDS	FDF, FDS	FDF, FDS
Manufacturer	FUJIFILM Corporation	FUJIFILM Corporation	FUJIFILM Corporation
Intended Use	Distal Cap Models DH-32EN and DH-17EN2are intended to be usedin combination with thededicated endoscope tomaintain the field of viewduring endoscopicprocedures.	Distal Cap Models DH-32EN and DH-17EN2are intended to be usedin combination with thededicated endoscope tomaintain the field of viewduring endoscopicprocedures.	This hood is intended tobe used in combinationwith compatibleendoscopes to maintainthe field of view duringobservation of thedigestive tract
Outerdiameter	9.7±0.2mm	11.5±0.2mm	14.2±0.5mm
Maximumdiameter ofcompatibleendoscope	13.3mm	17.8mm	18.2mm
Total length	9.1mm	8.0mm	12.0mm
Distance fromthe tip	1.3mm	1.5mm	2.0mm
Compatibleendoscopes	EN-580TEl-580BT	EN-580TEI-580BT	EC-600HL
Sterile method	EO	EO	EO
Single use	Yes	Yes	Yes

Performance Data

Sterility of the subject devices was evaluated using the following consensus standards: ISO 11135:2014, ISO 11607-1:2019, ASTM F1980-16.

Biocompatibility of the subject device was evaluated using the following consensus standards: ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-7:2008, 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 September 4, 2020.

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Bench testing was conducted to demonstrate that the subject devices are attached securely such that they will not detach during use.

Additional performance specifications were evaluated against pre-defined acceptance criteria.

Conclusions

The subject devices Distal Cap Models DH-32EN and DH-17EN2 share the same intended use and similar indications to the predicate device. Bench testing demonstrates that the subject devices are as safe and effective as the predicate device. Thus, Distal Cap Models DH-32EN and DH-17EN2 are 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.