The PENTAX Medical ED-3490TK Video Duodenoscope is intended to provide optical visualization (via a video monitor) of, and therapeutic access to the Biliary Tract via the Upper GI Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Common Bile, Hepatic, and Cystic Ducts. This instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric populations.

Device Description

The PENTAX Medical ED-3490TK Video Duodenoscope is used with a PENTAX compatible Video Processor (software controlled device). The duodenoscope has a flexible insertion tube, a control body and umbilicus The umbilicus provides connection to the video processor. The control body includes controls for up/down/left/right angulation, air/water delivery, suction and an accessory inlet port. The devices contain light carrying bundles to illuminate the body cavity and a charge couple device (CCD) to collect image data. The instruments contain a working channel through which biopsy devices or other devices may be introduced.

AI/ML Overview

This appears to be an FDA 510(k) clearance letter and summary for a medical device, specifically a duodenoscope. The core of this submission is not about an AI/ML-driven device's performance in terms of diagnostic accuracy or effect on human readers, but rather about an updated version of an existing device, primarily focusing on revisions to its reprocessing instructions for use (RIFU) based on human factors testing.

Therefore, many of the standard questions regarding AI/ML device performance (like MRMC studies, standalone algorithm performance, training set details, ground truth establishment for diagnostic tasks) are not applicable to this document. The "device performance" here refers to the device's physical and functional characteristics, and the "study" is a human factors study on the RIFU, not a clinical trial assessing medical outcomes or AI diagnostic accuracy.

Given the document provided, here's an attempt to address the relevant points and explain why others are not applicable:

Acceptance Criteria and Study for PENTAX Medical ED-3490TK Video Duodenoscope (K192280)

This 510(k) submission primarily focuses on improved "Reprocessing Instructions for Use (RIFU)" for the PENTAX Medical ED-3490TK Video Duodenoscope, not on the diagnostic/imaging performance of an AI/ML component. The "study" mentioned is a human factors study to ensure the RIFU are clear and lead to proper reprocessing, thereby enhancing safety and effectiveness in that aspect.

1. Table of Acceptance Criteria and Reported Device Performance

For this specific submission, the "performance" is related to the usability and clarity of the Reprocessing Instructions for Use (RIFU), assessed through human factors testing.

Acceptance Criteria (related to RIFU clarity/usability)	Reported Device Performance (based on Human Factors Study)
Primary Goal: More readily support user comprehension of and adherence to the reprocessing instructions.	The revision to the RIFU was based upon human factors testing conducted by PENTAX Medical, demonstrating that the revision does not raise new issues of safety or effectiveness. (Implies satisfactory user comprehension and adherence, though specific metrics are not detailed in this summary).
Underlying Principle: Ensure the RIFU revision does not negatively affect device safety or effectiveness.	The revision to the RIFU does not affect biocompatibility, electrical safety, electromagnetic compatibility, software verification and validation, or performance testing for the scope.

2. Sample Size Used for the Test Set and Data Provenance

The document states a "Human Factors study" was conducted to revise the RIFU.

Sample Size: The specific sample size for the human factors test set is not provided in this 510(k) summary. Human factors studies typically involve a defined number of representative users.
Data Provenance: The data provenance (e.g., country of origin, retrospective/prospective) is not specified in this summary. Human factors studies are inherently prospective, as they involve users interacting with the instructions and device in a controlled setting.

3. Number of Experts Used to Establish Ground Truth for the Test Set & Qualifications

This question is not applicable in the traditional sense of diagnostic ground truth for an AI model.

The "ground truth" here would be the correct/intended reprocessing steps. The human factors study evaluates whether users can correctly follow those steps based on the RIFU. This involves observing user performance. The "experts" would be the designers of the RIFU and the human factors specialists who designed and analyzed the study, not annotators for image data. The document does not specify the number or qualifications of these internal experts.

4. Adjudication Method for the Test Set

This question is not applicable as there is no diagnostic "ground truth" being adjudicated between multiple human readers or an AI. The human factors study involved evaluating user performance based on whether they correctly followed the revised RIFU. The evaluation method would be specified in the human factors study protocol but is not detailed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size of AI vs. Without AI Assistance

Not applicable. This submission is for a physical medical device (duodenoscope) and revised instructions for its reprocessing, not for an Artificial Intelligence (AI) or Machine Learning (ML) driven diagnostic or assistive device. Therefore, no MRMC study comparing human readers with and without AI assistance was performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

Not applicable. See point 5. There is no standalone algorithm being evaluated.

7. The Type of Ground Truth Used

The "ground truth" in the context of this human factors study is the correct and complete set of reprocessing steps as defined by the manufacturer and relevant standards. The study sought to confirm that the revised RIFU enabled users to achieve this "ground truth" through their actions. It is not an expert consensus, pathology, or outcomes data in the medical diagnostic sense.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device where a "training set" of data is used to train an algorithm. The "training" here refers to the user's ability to learn and follow the instructions, which is what the human factors study assesses.

9. How the Ground Truth for the Training Set was Established

Not applicable. See point 8.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

October 21, 2019

Pentax Medical William Goeller Vice President, Ouality Assurance and Regulatory Affairs 3 Paragon Drive Montvale, NJ 07645

Re: K192280

Trade/Device Name: PENTAX Medical ED-3490TK Video Duodenoscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: FDT Dated: August 21, 2019 Received: August 22, 2019

Dear William Goeller:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

{1}------------------------------------------------

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,

Martha 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

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K192280

Device Name PENTAX Medical ED-3490TK Video Duodenoscope

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)

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."

PSC Publishing Services (301) 443-6740 EF

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

Confidential

{3}------------------------------------------------

PENTAX Medical ED-3490TK Video Duodenoscope Traditional 510(k) Premarket Notification

510(k) SUMMARY

PENTAX Medical ED-3490TK Video Duodenoscope

1. Submitter

PENTAX Medical 3 Paragon Drive Montvale, NJ 07645

Phone: 201-571-2318 Facsimile: 201-571-2340 Contact Person: William Goeller Date Prepared: October 16, 2019

2. Device

Name of Device:	PENTAX Medical ED-3490TK Video Duodenoscope
Common or Usual Name:	Duodenoscope And Accessories, Flexible/Rigid
Classification Name:	Endoscope and accessories
Classification Number:	21 C.F.R. § 876.1500
Regulatory Class:	II
Product Code:	FDT

3. Predicate Device

PENTAX Medical ED-3490TK Video Duodenoscope (K181522)

4. Device Description

Confidential

{4}------------------------------------------------

PENTAX Medical ED-3490TK Video Duodenoscope Traditional 510(k) Premarket Notification

The subject device is identical to the predicate device. There are no changes to the design, specifications, or technological characteristics of the PENTAX Medical ED-3490TK Video Duodenoscope as described in the predicate device 510(k) Premarket Notification, K181522.

5. Indications for Use

The PENTAX Medical ED-3490TK Video Duodenoscope is intended to provide optical visualization (via a video monitor) of, and therapeutic access to the Biliary Tract via the Upper GI Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Common Bile, Hepatic, and Cystic Ducts. This instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric populations.

The indications for use of the subject and predicate devices are identical. There have been no changes to the indications for use for the PENTAX Medical ED-3490TK Video Duodenoscope as described in the predicate device 510(k) Premarket Notification, K181522.

6. Comparison of Technological Characteristics with the Predicate Device

The technological characteristics of the subject and predicate device are identical with the exception of improvements to the RIFU resulting from completion of a Human Factors study. The reprocessing manual was revised to promote user adherence and comprehension of the reprocessing instructions. The subject device has the same fundamental technology and operating principles of the predicate device. There are no differences in specifications, design, materials, or manufacture.

7. Performance Data

The purpose of this 510(k) Premarket Notification is to obtain clearance of revised reprocessing instructions for use (RIFU) for the PENTAX Medical ED-3490TK Video Duodenoscope. The RIFU has been modified from the previously cleared version to more readily support user comprehension of and adherence to the reprocessing instructions. The revision to the RIFU was based upon human factors testing conducted by PENTAX Medical.

The revision to the RIFU does not affect the biocompatibility, electrical safety, electromagnetic compatibility, software verification and validation, or performance testing for the scope. No additional performance testing has been performed and no performance standards or special controls applicable to this device have been adopted under Section 513or 514 of the Federal Food, Drug, and Cosmetic Act.

{5}------------------------------------------------

PENTAX Medical ED-3490TK Video Duodenoscope Traditional 510(k) Premarket Notification

8. Conclusions

The subject PENTAX Medical ED-3490TK Video Duodenoscope is identical to the predicate PENTAX Medical ED-3490TK Video Duodenoscope. The intended use and indications for use, technological characteristics, and principles of operation are the same for both devices. The sole difference between the subject and predicate device is that the RIFU has been revised to more readily support user comprehension of and adherence to the reprocessing instructions. This has been supported by Human Factors testing which demonstrates that the revision to the RIFU does not raise new issues of safety or effectiveness and thus, the data provided in this 510(k) Premarket Notification support the equivalence of the subject and predicate devices.

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.