The PENTAX Duodenoscope ED34-i10T is intended to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Common Bile, Hepatic and Cystic Ducts. These instruments are introduced via the mouth when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.

Device Description

The ED34-i10T, Video Duodenoscope is used with a compatible Video Processor. The ED34-i10T is composed of the following main parts: an insertion portion, control body and PVE connector. The insertion portion is inserted into the body cavity of patient. The insertion includes the distal end and bending section. The objective lens, light guide, instrument channel, cannula/forceps elevator, and air/water nozzle are located on the distal end of the insertion portion. The control body is held by the user's hand. The control body includes the angulation control knob, angulation lock knob/lever, cannula/forceps elevator control lever, air/water cylinder, suction cylinder, remote button, and instrument channel inlet. The air/water feeding valve is attached to the air/water cylinder, and the suction control valve is attached to the suction cylinder. The inlet seal is attached to the instrument channel inlet. The PVE connected to the video processor via electrical contacts. The bending section is bent by the angulation control knob to operate the endoscope angulation. The angulation lock knob/lever is used to adjust the rotation torque of the angulation control knob. The cannula/forceps elevator mechanism is used to control for position of cannula which is inserted through the Instrument Channel. The cannula/forceps elevator control lever is used to operate the cannula/forceps elevator. The air/water feeding system is used to deliver the air and water to the objective lens from the air/water nozzle. When the hole at the top of air/water feeding valve is covered, the air is delivered. When the air/water feeding valve is pushed, the water is delivered. The suction control system is used to suction the fluid and air in body cavity from the instrument channel. When the suction control valve is pushed, the fluid and air are suctioned. The remote button is used to operate the function of video processor and external device from the control body, as necessary. The detachable and disposable distal cap of ED34-i10T is intended for single use, and is processed with steam sterilization prior to use. It is discarded after use. Endoscopic devices such as biopsy forceps are inserted from the instrument channel Inlet into the body cavity through the instrument channel. The light guide of the distal end is used to illuminate the body cavity by light which is carried through the light carrying bundle. The light carrying bundle guide plug which is connected to the light source inside the Video Processor. The CCD built into the distal end receives reflected light (image data) from the body cavity, and sends the image data to the Video Processor through the video cable. The image data are converted into the image signal by the Video Processor, and the body cavity is displayed on the monitor.

AI/ML Overview

This document is a 510(k) summary for the PENTAX Medical ED34-i10T Video Duodenoscope, which is a medical device and not an AI or software-only product. Therefore, much of the requested information regarding AI-specific criteria (like training set size, ground truth for training data, MRMC studies, or standalone algorithm performance) is not applicable or available in this document.

However, I can extract and describe the acceptance criteria and performance data provided for the device as a whole.

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria/Methodology	Reported Device Performance
Detachable Distal Cap	Durability, chemical resistance, autoclave, ultrasonic wave cleaning resistance, operating environment, thermal shock, and vibration resistance.	Results of all testing were within the acceptance criteria.
O-Ring Analysis	Design change to achieve a recommended minimum compression of 10% for sealing the Elevator Channel.	Design change created to achieve the recommended minimum compression of 10%.
Optical Testing	Measurement of signal-to-noise ratio, spatial resolution (MTF), distribution, and spectral F-distribution for the ED34-i10T in conjunction with the EPK-i5010 video processor.	All results show no differences between the subject device (ED34-i10T) and the predicate device (ED-3490TK). The ED34-i10T has more pixels for optical visualization, but overall optical properties are equivalent.
Reprocessing Validation	Simulated use testing, cleaning, high-level disinfection (HLD) validation studies conforming to FDA's 2015 Reprocessing Guidance. Acceptance criteria established per AAMI TIR 30:2011 for residual soil accumulation and extraction efficiency.	Acceptance criteria were met after each phase of reprocessing. The effectiveness of reprocessing procedures was confirmed. A human factors study for reprocessing instructions was also conducted.
Biocompatibility	Assessment of cytotoxicity, sensitization, and intracutaneous reactivity of surface device materials (limited contact < 24 hours with mucosal membrane) per ISO 10993-1, 5, and 10. Assessment of carbon black and titanium oxide in patient contact parts.	All biocompatibility assessments confirmed. Risk level for toxicity of colorant (carbon black and titanium oxide) determined as "Very Low," and risk level of local toxicity determined as "Acceptable" by applying risk evaluation criteria.
Software	Software verification and validation testing as recommended by FDA guidance ("Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"). Software classified as Class B per IEC 62304:2006. Level of concern "Moderate".	Documentation provided. Software is classified as CLASS B under IEC 62304:2006, and the software level of concern is "Moderate" based on FDA guidance.
EMC and Electrical Safety	Compliance with IEC 60601-1-2:2001, A1:2004; IEC 60601-1:2005+CORR 1:2006+CORR 2:2007+AM 1:2012; and IEC 60601-2-18:2009.	The acceptable level of electromagnetic compatibility (EMC) and electrical safety (ES) for the PENTAX ED34-iT10 Video Duodenoscope were confirmed by these standards.

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

Sample Size: Not explicitly stated for most tests. For reprocessing validation, "simulated use testing" was conducted, but the number of cycles or units is not specified.
Data Provenance: Not specified, but generally, such tests are conducted internally by the manufacturer (PENTAX Medical) or by certified testing laboratories commissioned by the manufacturer. The document doesn't mention specific countries of origin for the data; it's a submission to the U.S. FDA. The testing conducted is prospective for the new device design.

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

This information is not provided in the document. The tests described are primarily engineering performance and safety tests, not clinical performance studies requiring expert interpretation of results in the traditional sense of AI ground truth. For example, biocompatibility is assessed against ISO standards, and optical properties are measured objectively.

4. Adjudication method for the test set:

Not applicable as this is not a study involving human interpretation of clinical data that would require an adjudication method. The testing described involves objective measurements and compliance with standards.

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:

No, an MRMC study was not done. This device is a video duodenoscope, which is an imaging and therapeutic access instrument, not an AI-assisted diagnostic tool for which an MRMC study would typically be conducted. This document makes no mention of AI integration.

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

Not applicable. This device is an endoscope that requires human operation and interpretation. There is no standalone algorithm being evaluated.

7. The type of ground truth used:

For the engineering and safety tests, the "ground truth" is defined by the technical specifications, standards (e.g., ISO, IEC, AAMI TIR), and regulatory guidances (e.g., FDA's reprocessing guidance). For instance, for optical testing, the predicate device's performance provides a benchmark for equivalence, and for biocompatibility, the ISO standards define acceptable limits.

8. The sample size for the training set:

Not applicable. This document describes the validation of a physical medical device (duodenoscope), not an AI algorithm that requires a training set.

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

Not applicable, as there is no AI algorithm training set mentioned in this document.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of three human profiles facing right, arranged in a stacked formation. The profiles are rendered in a dark color, creating a silhouette effect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

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

September 20, 2017

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

Re: K163614 Trade/Device Name: PENTAX Medical ED34-i10T, Video Duodenoscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FDT Dated: August 9, 2017 Received: August 11, 2017

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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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

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 contact the Division of Industry and Consumer Education 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. 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

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 Industry and Consumer Education 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.

Benjamin R. Fisher -S

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

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

Indications for Use

510(k) Number (if known) K163614

Device Name

PENTAX Medical ED34-i10T 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."

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

Image /page/3/Picture/0 description: The image shows the logo for Pentax Medical. The word "PENTAX" is written in large, red, bold letters. Below "PENTAX" is a gray line, and below that is the word "MEDICAL" in gray, bold letters.

ED34-i10T Traditional 510(k) Submission

510(k) Summary

Submitter:	PENTAX of America, Inc.,HOYA Corporation PENTAX Division3 Paragon DriveMontvale, New Jersey 07645-1782
Contact:	William GoellerVice President, QA/RAPENTAX of America, Inc.3 Paragon DriveMontvale, New Jersey 07645-1782Phone: 800-431-5880 x 5170, 201-251-2300 x5170Fax: 201-799-4117Email: William.Goeller@pentaxmedical.com
Date Prepared:	September 18, 2017
Trade/Device Name:	PENTAX Medical ED34-i10T
Common/Usual Name:	Video Duodenoscope
Regulation Number:	21 CFR Part 876.1500
Regulation Name:	Endoscope and accessories
Regulatory Class:	Class II
Product Code:	FDT
Predicate Device:	PENTAX ED-3490TK Video Duodenoscope (K092710, clearance received onDecember 2, 2009)

Device Description:

The ED34-i10T, Video Duodenoscope is used with a compatible Video Processor.

The ED34-i10T is composed of the following main parts: an insertion portion, control body and PVE connector. The insertion portion is inserted into the body cavity of patient. The insertion includes the distal end and bending section. The objective lens, light guide, instrument channel, cannula/forceps elevator, and air/water nozzle are located on the distal end of the insertion portion. The control body is held by the user's hand. The control body includes the angulation control knob, angulation lock knob/lever, cannula/forceps elevator control lever, air/water cylinder, suction cylinder, remote button, and instrument channel inlet. The air/water feeding valve is attached to the air/water cylinder, and the suction control valve is attached to the suction cylinder. The inlet seal is attached to the instrument channel inlet. The PVE connected to the video processor via electrical contacts.

The bending section is bent by the angulation control knob to operate the endoscope angulation. The angulation lock knob/lever is used to adjust the rotation torque of the angulation control knob. The cannula/forceps elevator mechanism is used to control for position of cannula which is inserted through the Instrument Channel.

The cannula/forceps elevator control lever is used to operate the cannula/forceps elevator. The air/water feeding system is used to deliver the air and water to the objective lens from the air/water nozzle. When the hole at the top of air/water feeding valve is covered, the air is delivered. When the air/water feeding valve is pushed, the water is delivered. The suction control system is used to suction the fluid and air in body cavity from the instrument channel. When the suction control valve is pushed, the fluid and air are suctioned.

The remote button is used to operate the function of video processor and external device from the control body,

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

ED34-i10T Traditional 510(k) Submission

Image /page/4/Picture/1 description: The image contains the logo for Pentax Medical. The word "PENTAX" is written in red, bold letters on the top line. Below it is a gray line, and below that is the word "MEDICAL" in gray, bold letters.

as necessary.

The detachable and disposable distal cap of ED34-i10T is intended for single use, and is processed with steam sterilization prior to use. It is discarded after use.

Endoscopic devices such as biopsy forceps are inserted from the instrument channel Inlet into the body cavity through the instrument channel.

The light guide of the distal end is used to illuminate the body cavity by light which is carried through the light carrying bundle. The light carrying bundle guide plug which is connected to the light source inside the Video Processor. The CCD built into the distal end receives reflected light (image data) from the body cavity, and sends the image data to the Video Processor through the video cable. The image data are converted into the image signal by the Video Processor, and the body cavity is displayed on the monitor.

Intended Use/Indications for Use:

"The PENTAX Duodenoscope ED34-i10T is intended to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Common Bile, Hepatic and Cystic Ducts.

This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in adult and pediatric patient populations."

Summary of Technology Characteristics:

The technological characteristics of the ED34-i10T are functionally equivalent to the ED-3490TK.

While there are some differences in the materials that comprise the distal cap, the air/water channel system, and the control body of the ED-34i10T, those materials that are direct contact with the human body were assessed for biocompatibility in accordance with ISO 10993-1, 5, and 10: Biological Evaluation of Medical Devices.

The sealed elevator mechanism can be accessed after removal of the single and disposable distal cap compared with the permanently fixed cap of ED-3490TK. The detachable and disposable distal cap of ED34i10T allows the user to access the back side of the elevator for reprocessing.

The ED34-i10T has smaller distance between the control buttons, the shape of the RL knob is changed to from five spokes to six spokes, and the elevator knob surface is wider.

The ED34-i10T has more pixels for optical visualization.

The total overall length of ED34-i10T is slightly shorter than the length of ED-3490TK. As a result of the length reduction, the dimensions of the suction, air and water channels were changed accordingly.

PENTAX has submitted performance testing for the above referenced design differences with this 510(k) that demonstrate that the ED34-i10T is as safe and effective as the predicate device.

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

Image /page/5/Picture/0 description: The image shows the logo for Pentax Medical. The word "PENTAX" is in red, bold, sans-serif font. Below "PENTAX" is a gray line, and below that is the word "MEDICAL" in gray, bold, sans-serif font.

Performance Data:

No performance standards or special controls applicable to this device have been adopted under Section 513 or 514 of the Federal Food, Drug, and Cosmetic Act. The following performance data are provided in support of the substantial equivalence determination.

Detachable Distal Cap

The following performance testing was done for the detachable distal cap: durability, chemical resistance, autoclave, ultrasonic wave cleaning resistance, operating environment, thermal shock, and vibration resistance. PENTAX determined that the results of all testing was within the acceptance criteria.

O-Ring Analysis

The O Ring design providing sealing of the Elevator Channel has been analyzed, and a design change created to achieve the recommended minimum compression of 10%.

Optical Testing

Optical properties including signal to noise ratio, spatial resolution (MTF), distribution, and spectral distribution were measured for the ED34-i10T in conjunction with the EPK-i5010 video processor. All results show that there are no differences between the subject device, ED34-10T, and the predicate device, ED-3490TK.

Reprocessing Validation

Simulated use testing, cleaning, high level dising (after cleaning and after HLD) validation studies of the ED34-i10T Video Duodenoscope and its detachable distal cap were conducted and confirmed the effectiveness of reprocessing procedures with FDA's 2015 Final Guidance, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling ("FDA's 2015 Reprocessing Guidance"). Acceptance criteria were established in accordance with AAMI TIR 30:2011 for amount of residual soil accumulation and extraction efficiency. Acceptance criteria were met after each phase of reprocessing.

Reprocessing and Processing Instructions for Use are provided for the scope and for the singleuse detachable distal cap, respectively.

An assessment of the ability of reprocessing staff to carry out the reprocessing instructions (a human factors study for reprocessing instructions) was conducted.

Sterilization and Shelf Life

PENTAX Medical coordinated with STERIS Corporation to validate the use of System 1E liquid chemical sterilization for the sterilization of the ED34-i10T. The device is not provided sterile, therefore, shelf-life is not applicable.

Maintenance

Annual maintenance of the duodenoscope is recommended. This allows PENTAX to inspect the forceps elevator mechanism for wear and required maintenance.

Biocompatibility

Biocompatibility of direct and indirect contact materials was confirmed by assessing the cytotoxicity, sensitization, and intracutaneous reactivity of the surface device with limited (less than 24 hours) contact with mucosal membrane in accordance with ISO 10993-1, 5, and 10: Biological Evaluation of Medical Devices.

A biocompatibility assessment of the amount of carbon black and titanium oxide contained in the patient contact

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for Pentax Medical. The word "PENTAX" is in red, bold, sans-serif font. Below it is a gray line, and below that is the word "MEDICAL" in gray, bold, sans-serif font. The logo is simple and modern.

parts of the device as well as the tolerable exposure (TE) value was conducted. The risk lev determined as "Very Low" based on the low concern for toxicity of colorant. The risk level of local toxicity was determined as "Acceptable" as a result of applying the risk level of local toxicity to the risk evaluation criteria.

Software

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software is classified as CLASS B under the Software Safety Classification per IEC 62304:2006, Medical device software life cycle processes) and the software level of concern is "Moderate" based on the FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

EMC and Electrical Safety

The acceptable level of electromagnetic compatibility (EMC) and electrical safety (ES) for the PENTAX ED34-iT10 Video Duodenoscope were confirmed by the following standards: IEC 60601-1-2:2001, A1:2004; IEC 60601 1:2005+CORR 1:2006+CORR 2:2007+AM 1:2012; and IEC 60601-2-18:2009.

Substantial Equivalence Discussion:

After analyzing the intended use, indications for use, technological characteristics (including fundamental operating principle, energy source, scientific technology, functional characteristics, design features, performance characteristics, and constituent materials), labeling, and sterilization method, we conclude that the subject device ED34-i10T Video Duodenoscope is substantially equivalent to the predicate ED-3490TK Video Duodenoscope. While there are some differences in technological characteristics, the ED-34i10T is as safe and effective as the predicate device and none of the differences raise new questions of safety or effectiveness.

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.