The PENTAX Medical Video Duodenoscope ED34-110T2 is intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to, Billary 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.

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

Device Description

The PENTAX Medical Video Duodenoscope ED34-i10T2 is intended to be used with a PENTAX Video Processor, documentation equipment, video monitor, endoscopic device ancillary equipment for optical visualization (via a video monitor) of, and/or 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.

The ED34-i10T2 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 portion includes the distal end and bending section. The objective lens, light guide, instrument channel, elevator link, 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 connector is connected to the video processor via electrical contacts.

The bending section is bent by the angulation control knob to operate the endoscope 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 the position of the cannula which is inserted through the Instrument Channel.

The cannula/forceps elevator control lever is used to operate the cannula/forceps elevator of the Distal End Cap with Elevator (OE-A63). 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 functions of the video processor and any external device from the control body, as necessary.

The single use, Distal End Cap with elevator (OE-A63) is provided as a sterile product. OE-A63 is attached to the elevator link of the distal end of ED34-i10T2. 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 image inside the body cavity is displayed on the monitor.

The PENTAX Medical Video Processors EPK-i5010 and EPK-i7010 are compatible with PENTAX Medical Video Duodenoscope ED34-i10T2.

The primary components of the system include the following:

The PENTAX Medical ED34-i10T2 Video Imaging System is provided with the following accessories:

Keyboard input device for the video processor.
White Balance Adjuster – controls the white balance feature.
Condenser Earth Cable - used to reduce high-frequency noise generated during high-frequency electro cautery device use with Pentax endoscopes.
Inlet Seal - prevents suctioned fluid from coming out of the instrument Channel Inlet during the use of suction function. During reprocessing, it seals the instrument Channel Inlet in order to fill the chemical solution inside the channel.
Bite Block - prevents patients from biting the endoscope insertion tube during an endoscopic examination.
Suction Control Valve - intended to control suction.
Air/Water Valve - intended to control air and waterfeeding.
Distal End Cap with Elevator intended to guide the endoscopicdevice.

Additional accessories for reprocessing are provided with the device. These include a Cleaning Adapter, Soaking Cap, Ventilation Cap, Endoscope Cleaning Brush Kits, and replacement O- Rings.

AI/ML Overview

The provided FDA 510(k) summary for the PENTAX Medical Video Duodenoscope ED34-i10T2 does not include information about acceptance criteria or a study proving the device meets those criteria in the context of clinical performance or diagnostic accuracy.

The submission is a Special 510(k), which typically addresses minor modifications to an already cleared device. In this specific case, the primary purpose of the submission is to obtain clearance for "updated instructions that enhance awareness of Distal End Cap attachment process" and a minor software change due to component obsolescence.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth, and expert involvement for clinical performance evaluation are not present in this document, as they would have been assessed during the original clearance of the predicate device (K192245).

Here's a breakdown of what can be extracted from the document regarding "performance data," which in this context refers to engineering and software validation rather than clinical efficacy:

Acceptance Criteria and Study for PENTAX Medical Video Duodenoscope ED34-i10T2 (Special 510(k) Submission K210710)

1. Table of Acceptance Criteria and Reported Device Performance

As this is a Special 510(k) for minor changes (updated instructions and software component change), the "acceptance criteria" and "reported device performance" referenced relate to software and cybersecurity testing, rather than clinical performance metrics like sensitivity, specificity, or reader agreement. The document explicitly states: "Functions realized by these two software are identical, and the difference of the software versions does not affect safety or effectiveness for the device, or any hardware performance such as CPU processing speed."

Acceptance Criteria Category	Specific Criteria (Implicit for Special 510(k))	Reported Device Performance (Summary)
Software Functional Equivalence	Software update does not alter device functions.	Functions of two software versions are identical.
Software Safety & Effectiveness	Software update does not affect device safety or effectiveness.	No effect on safety or effectiveness.
Software Hardware Performance	Software update does not affect hardware performance.	No effect on hardware performance (e.g., CPU processing speed).
Software Verification & Validation	Compliance with relevant standards and guidances.	Conducted according to IEC 62304: 2006 + A1: 2015.
Cybersecurity Assessments	Compliance with relevant FDA cybersecruity guidances.	Conducted according to FDA guidances for cybersecurity management.

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

Test set for software changes: Not explicitly stated as a number of cases or patients. The "test set" would refer to the software verification and validation protocols and test cases derived from software requirements. These are internal engineering tests, not a clinical study.
Data provenance: Not applicable in the context of clinical study data for this submission. The software changes are internal to the device and its manufacturing process.

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

Not applicable as this is a software/engineering verification and validation, not a clinical study requiring expert diagnosis for ground truth. Software testing typically involves software engineers and quality assurance personnel.

4. Adjudication Method for the Test Set

Not applicable for this type of software verification and validation described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a MRMC comparative effectiveness study was not done as part of this Special 510(k) submission. This type of study would evaluate human reader performance with and without AI assistance, which is not relevant to the minor software and instruction changes addressed here.

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

No, a standalone performance study in the context of clinical diagnostic accuracy or image analysis was not done for this submission. The "algorithm" here refers to the device's operational software, not an AI for interpretation. Software verification and validation address the algorithm's functional correctness.

7. The Type of Ground Truth Used

For the software verification and validation mentioned, the "ground truth" would be the expected behavior or specified requirements of the software and hardware, as defined by engineering specifications and design documents. It is not clinical ground truth (e.g., pathology, expert consensus).

8. The Sample Size for the Training Set

Not applicable. This device does not involve a machine learning algorithm that requires a "training set" in the typical sense for clinical applications. The software changes are due to component obsolescence, not model retraining.

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

Not applicable, as there is no "training set" for a clinical algorithm in this submission.

Summary of the K210710 Submission:

This 510(k) is a Special 510(k) for the PENTAX Medical Video Duodenoscope ED34-i10T2. It concerns two minor modifications:

Updated Instructions: Enhancing awareness of the Distal End Cap attachment process.
Minor Software Change: Due to obsolescence of electronic components. The submission asserts that the new software versions are functionally identical to the previous one and do not affect the device's safety, effectiveness, or hardware performance.

The "performance data" provided relates specifically to the software and cybersecurity aspects of these minor changes. The submission confirms that software verification and validation, including cybersecurity assessments, were conducted according to relevant standards (IEC 62304) and FDA guidances. The conclusion is that the updated device remains substantially equivalent to its predicate.

Summary

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April 9, 2021

PENTAX of America, Inc. William Goeller VP Quality Assurance and Regulatory Affairs 3 Paragon Drive Montvale, NJ 07645-1782

Re: K210710

Trade/Device Name: PENTAX Medical Video Duodenoscope ED34-i10T2 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FDT Dated: March 7, 2021 Received: March 10, 2021

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);

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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-safetyreporting-combination-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 -S

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) K210710

Device Name

PENTAX Medical Video Duodenoscope ED34-i10T2

Indications for Use (Describe)

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

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)

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PENTAX Medical Video Duodenoscope ED34-i10T2 Special 510(k) Submission

510(k) Summary

1. Submitter:

PENTAX of America, Inc., HOYA Corporation PENTAX Division 3 Paragon Drive Montvale, New Jersey 07645-1782 Phone: 201-571-2318 Ext 2318 Fax: 201-571-2340 Contact: William Goeller Date Prepared: March 31, 2021

II. DEVICE

The purpose of this special 510(k) is to get clearance to the updated instructions that enhance awareness of Distal End Cap attachment process.

Table 5.1: Regulatory Classification of PENTAX Medical Video Duodenoscope ED34-i10T2
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Device Name	PENTAX Medical Video Duodenoscope ED34-i10T2
Common Name	Video Duodenoscope
Classification Name	Endoscope and accessories
Regulation No.	876.1500
Device Class	2
Product Code	FDT
Classification Panel	Gastroenterology/ Urology

III. PREDICATE DEVICES

The predicate device for this submission, PENTAX Medical ED34-i10T2 Video Duodenoscope (K192245), is materially, optically, structurally, mechanically identical to the subject device.

Device Description:

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

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PENTAX Medical Video Duodenoscope ED34-i10T2 Special 510(k) Submission

seal is attached to the instrument channel inlet. The PVE connector is connected to the video processor via electrical contacts.

The remote button is used to operate the functions of the video processor and any external device from the control body, as necessary.

The single use, Distal End Cap with elevator (OE-A63) is provided as a sterile product. OE-A63 is attached to the elevator link of the distal end of ED34-i10T2. 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 PENTAX Medical Video Processors EPK-i5010 and EPK-i7010 are compatible with PENTAX Medical Video Duodenoscope ED34-i10T2.

The primary components of the system include the following:

The PENTAX Medical ED34-i10T2 Video Imaging System is provided with the following accessories:

Keyboard input device for the video processor. .
. White Balance Adjuster – controls the white balance feature.
. Condenser Earth Cable - used to reduce high-frequency noise generated during high-frequency electro cautery device use with Pentax endoscopes.
. Inlet Seal - prevents suctioned fluid from coming out of the instrument Channel Inlet during the use of suction function. During reprocessing, it seals the instrument Channel Inlet in order to fill the chemical solution inside the channel.
Bite Block - prevents patients from biting the endoscope insertion tube during an endoscopic examination.
Suction Control Valve - intended to control suction.
. Air/Water Valve - intended to control air and waterfeeding.
Distal End Cap with Elevator intended to guide the endoscopicdevice. ●

Additional accessories for reprocessing are provided with the device. These include a Cleaning Adapter, Soaking

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PENTAX Medical Video Duodenoscope ED34-i10T2 Special 510(k) Submission

Cap, Ventilation Cap, Endoscope Cleaning Brush Kits, and replacement O- Rings.

IV. INDICATIONS FOR USE

The PENTAX Medical Video Duodenoscope ED34-i10T2 is intended to be used with endoscopic devices and other ancillary equipment 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.

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

V. COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE

PENTAX Medical ED34-i10T2 Video Duodenoscope has the same Intended use, fundamental technology, operating principles, components and materials as the predicate device.

The only differences between the subject and predicate devices include:

The updated instructions that enhance awareness of Distal End Cap attachment process.
. The following minor change has been applied to the subject software: Two different software versions are installed in PENTAX Medical Video Duodenoscope ED34-i10T2, dependent on the manufacturing timing. These two software versions are released due to the obsolescence of electronic components used for the endoscope. Functions realized by these two software are identical, and the difference of the software versions does not affect safety or effectiveness for the device, or any hardware performance such as CPU processing speed.

VI. PERFORMANCE DATA

The following performance data are provided to support the subject and predicate devices.

a. Software and Cybersecurity

A minor change was applied to ED34-i10T2 software. Two different software versions are installed in PENTAX Medical Video Duodenoscope ED34-i10T2, dependent on the manufacturing timing. Functions realized by these two software are identical, and the difference of the software versions does not affect safety or effectiveness for the device, or any hardware performance such as CPU processing speed.

Software verification and validation including cybersecurity assessments were conducted according to IEC 62304: 2006 + A1: 2015 and FDA Guidances for Industry and Staff "Guidance for the Content of Premarket Submissions forSoftware Contained in Medical Devices.", "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" and "Postmarket Management of Cybersecurity in Medical Devices."

VII. CONCLUSION

PENTAX Medical concluded that the PENTAX Medical ED34-i10T2 is substantially equivalent to the predicate device ED34-i10T2 cleared in K192245.

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.