Pentax Medical Video Duodenoscope ED32-i10

K202365 · Pentax of America, Inc. · FDT · Apr 1, 2021 · Gastroenterology, Urology

Device Facts

• Record ID: K202365
• Device Name: Pentax Medical Video Duodenoscope ED32-i10
• Applicant: Pentax of America, Inc.
• Product Code: FDT · Gastroenterology, Urology
• Decision Date: Apr 1, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The PENTAX Medical Video Duodenoscope ED32-i10 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.

Device Story

Video duodenoscope for visualization and therapeutic access to biliary tract via upper GI tract; used with video processor, monitor, and ancillary endoscopic devices. Input: optical image data from body cavity via distal CCD sensor. Operation: physician inserts scope via mouth; controls angulation, suction, and air/water feeding via control body; manipulates cannula/forceps via elevator mechanism at distal end. Output: real-time video feed on monitor for clinical guidance during procedures. Benefits: enables minimally invasive diagnostic and therapeutic interventions in biliary/GI anatomy; smaller 32 French insertion width improves access for patients with narrowed lumens and pediatric populations. Single-use, sterile distal end cap with elevator (OE-A65) facilitates cleaning and reduces cross-contamination risk.

Clinical Evidence

Bench testing only. No clinical data. Performance validated via simulated use testing, cleaning/disinfection validation (AAMI TIR 30:2011), optical performance (MTF, LSR, signal-to-noise), EMC/electrical safety (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18), and human factors leveraging predicate data.

Technological Characteristics

Video duodenoscope with 32 French insertion width. Features CCD imaging, LED/light guide illumination, and mechanical angulation/elevator control. Compatible with EPK-i5010/EPK-i7010 processors. Biocompatible patient-contacting materials. Reprocessable, except for single-use sterile distal end cap (OE-A65). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, AAMI TIR 30:2011.

Indications for Use

Indicated for optical visualization and therapeutic access to the biliary tract via the upper gastrointestinal tract (esophagus, stomach, duodenum, common bile, hepatic, and cystic ducts) in adult and pediatric patients.

Regulatory Classification

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.

Special Controls

*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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• PENTAX Medical Video Duodenoscope ED34-i10T2 (K192245)

Reference Devices

• PENTAX Video Processor EPK-i5010 (K122470)
• PENTAX Video Processor EPK-i7010 (K150618)

Submission Summary (Full Text)

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April 1, 2021

Pentax of America, Inc. William Goeller Vice President Ouality Assurance and Regulatory Affairs 3 Paragon Drive Montvale, NJ 07645-1782

Re: K202365

Trade/Device Name: Pentax Medical Video Duodenoscope ED32-i10 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FDT Dated: August 14, 2020 Received: August 19, 2020

# 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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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) K202365

Device Name

PENTAX Medical Video Duodenoscope ED32-i10

Indications for Use (Describe)

The PENTAX Medical Video Duodenoscope ED32-i10 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.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-family: Arial, sans-serif;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# K202365

### PENTAX Medical Video Duodenoscope ED32-i10 510(k) Summary

Image /page/3/Picture/2 description: The image shows the logo for Pentax Medical. The word "PENTAX" is written in large, red, bold letters. Below that, there is a gray line, and below that, the word "MEDICAL" is written in gray, bold letters.

This summary of 510(k) safety and effectiveness information is being submitted in acc with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 221 CFR 807.92. data included in this document is accurate and complete to the best of PENTAX Medical's knowledge.

#### SUBMITTER l.

- Applicant: PENTAX Medical HOYA Corporation PENTAX Division 3 Paragon Drive Montvale, New Jersey 07645-1782
Contact: William Goeller Vice President, Quality and Regulatory Affairs PENTAX Medical 3 Paragon Drive Montvale, New Jersey 07645-1782 Telephone: [phone] ext. 2318 FAX: [phone] Email: [e-mail]

# Date Prepared: 8/14/2020

#### DEVICE II.

The regulatory classification of PENTAX Medical Video Duodenoscope ED32-i10 is identified in Table 5.1.

| Name of the System | PENTAX Medical Video Duodenoscope ED32-i10 |
|----------------------|--------------------------------------------|
| Common Name | Video Duodenoscope |
| Regulation Number | 876.1500 |
| Regulation Names | Endoscope and accessories |
| Regulatory Class | Class II |
| Product Code | FDT |
| Classification Panel | Gastroenterology/ Urology |

Table 5.1. Regulatory Classification of PENTAX Medical Video Duodenoscope ED32-i10

### III. PREDICATE DEVICE

The predicate device for this submission, PENTAX Medical Video Duodenoscope ED34-i10T2 (K192245) is materially, structurally and mechanically identical to the subject device and has an identical optical design except the direction of view. The two endoscopes models differ mainly in their insertion portion dimensions.

Predicate Device: PENTAX Medical Video Duodenoscope ED34-i10T2 (K192245)

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PENTAX Medical is seeking clearance of a new product of Video Duodenoscope ED32-1 the compatible PENTAX Video Processors EPK-i5010 (K122470) and EPK-i7010 with GI Far (K150618). This 510(k) also captures some minor design changes that have occurred during the evolution of the product line. Although the changes are believed to be minor, the 510(k) is being submitted to account for technological advances in associated compatible devices and to ensure that FDA has the most current information concerning the PENTAX Medical Video Duodenoscope ED32-i10.

The subject devices have virtually the same indications for use, viewing directions, and image size as the predicates. The subject device uses the same processors and peripherals as the predicate device.

# The main differences between the subject devices and predicate devices are as follows:

- Introduction of a new line of Video Duodenoscope ED32-i10 as compatible Video Duodenoscope ED34-i10T2.
- The single use, sterile Distal End Cap with Elevator OE-A65 for the ED32-i10 has same mechanical constructions as another distal end cap OE-A63 for the ED34-i102, with the smaller width due to narrower insertion portion width.

# IV. DEVICE DESCRIPTION

The PENTAX Medical Video Duodenoscope ED32-i10 is intended to be used with a PENTAX Video Processor, documentation equipment, video monitor, endoscopic device and other 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 PENTAX Medical Video Duodenoscope ED32-i10 has a smaller insertion portion width (32 French size) compared to the predicate device, ED34-i10T2, (34 French size) and is expected to provide better access to patients for whom that the ED34-i10T2 may have had difficulties accessing, for example in patients with narrowed lumens and in pediatric patients.

The ED32-i10 is composed of the following main parts: an insertion portion, control body and PVE connector. The insertion 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. The angulation lock knob/lever is used to adjust the rotation torque of the

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angulation control knob. The cannula/forceps elevator mechanism is used to control t 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-A65). 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-A65) is provided as a sterile product. OE-A65 is attached to the elevator link of the distal end of ED32-i10. 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 guides the light from light 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 ED32-i10.

The PENTAX Medical ED32-i10 Video Imaging System is provided with the following accessories:

- 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 water feeding.
- Distal End Cap with Elevator - intended to guide the endoscopic device.

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.

#### V. INDICATIONS FOR USE

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The PENTAX Medical Video Duodenoscope ED32-i10 is intended to be used with endos 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.

# VI. COMPATIBLE VIDEO PROCESSORS

The PENTAX Medical Video Duodenoscope ED32-i10 is compatible with PENTAX Medical video processors EPK-i5010 and EPK-i7010, previously cleared with other PENTAX Medical Gl scopes K122470 and K150618, respectively.

# VII. COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE

The PENTAX Medical Video Duodenoscope ED32-i10 is functionally equivalent to the predicate devices, the PENTAX Medical Video Duodenoscope ED34-i10T2 (K192245). The only difference between the two devices are minor technological changes.

The changes in the subject device has been evaluated through performance testing and raise no issue of safety and effectiveness of the device as these differences have no effect on the performance, function or general intended use of the device.

The components of the PENTAX Medical Video Duodenoscope ED32-i10 has the same fundamental technology and operating principles as the predicate device, as well as the same intended use. Both the PENTAX Medical Video Duodenoscope ED32-i10 and the predicate device are intended for illuminating and viewing the inside of the human body. The components of the PENTAX Medical Video Duodenoscope ED32-i10 consist of the same components as the predicate device, including:

- . A video processor
- Video Duodenoscope to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract.
- Accessories, including but not limited to a keyboard, foot switch, White Balance Adjuster, and Condenser Earth Cable

The subject and predicate devices are identical with regard to

- Scope working length
- . Scope field of view
- Scope depth of field
- Scope tip angulation
- . Software requirements

The patient contacting materials of both the subject and predicate devices are identical and biocompatible. Both subject and the predicate scopes are reprocessed by the user except the Distal End Cap with Elevator (OE-A65) of ED32-i10 which is provided as a single-use, sterile product. The removal of the single use, sterile Distal End Cap with Elevator (OE-A65) of ED32-i10 allows the user to access all surfaces of the distal end area where patient fluid may be accumulated.

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#### VIII. NON-CLINICAL PERFORMANCE DATA

The PENTAX Medical Video Duodenoscope ED32-i10 has been successfully tested for their functions, performance and safety as per FDA recognized consensus standards. The following performance data are provided in support of the substantial equivalence determination.

Operational and Reprocessing Instructions for Use are provided for the scope.

- a. Reprocessing Validation
As result of the assessment, simulated use testing, cleaning, high level disinfecting and rinsing (after cleaning and after HLD) validation studies were conducted at the distal end, instrument/suction channel, and air/water channel of the ED32-i10 Video Duodenoscope ,and confirmed the effectiveness of reprocessing procedures in accordance 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.

All acceptance criteria were satisfied.

- b. 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 ED32-i10. The device is not provided sterile, therefore, shelf-life is not applicable.

The Distal End Cap with Elevator (OE-A65) is provided as a single-use, sterile product. Electron beam sterilization was conducted and a shelf-life of 2 years after sterilization was verified.

### c. O-ring Sealing Performance

The O-ring located on the elevator link has the same dimensions and sealing performance as the predicate device.

- d. Software
The subject device utilizes the same software as the predicate device.

### e. EMC and Electrical Safety

The acceptable level of electromagnetic compatibility (EMC) and electrical safety (ES) for the PENTAX Medical Video Duodenoscope ED32-i10 were confirmed by the following standards:

IEC 60601-1-2:2014; IEC 60601-1:2005+CORR 1:2006+CORR 2:2007+A1:2012; and IEC 60601-2-18:2009.

### f. System Performance

The system performance of the subject device demonstrated the equivalence to the predicate device. Test results also demonstrated six years of the service life for the ED32i10.

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# g. Optical Performance

As a part of Design Verification and Validation, optical properties including signal to noise, color, limiting spatial resolution (LSR), modulation transfer function (MTF), distortion, image intensity uniformity (IIU) and photobiological safety were measured for the ED32-i10 in conjunction with the EPK-i7010 and EPK-i5010 Video Processors. All results show that the optical characteristics of the subject device is equivalent to those of the predicate device.

# h. Distal End Cap with Elevator, OE-A65 Performance Testing

Verification studies including attachment performance tests were conducted on the Distal End Cap with Elevator, OE-A65, all test items satisfied the acceptance criteria and were determined to be acceptable.

# i. Human Factors Testing

The proposed manual reprocessing procedures of subject device ED32-i10 are identical with those of predicate device ED34-i10T2 (K192245), except the nomenclature of the distal end cap with elevator. Also, all critical tasks of ED32-i10 are identical to the critical tasks of ED34i10T2, and the user-interface is the same between ED32-i10 and ED34-i10T2. Therefore, Human Factors validation testing from the ED34-i10T2 was leveraged for the ED32-i10.

# 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 PENTAX Medical Video Duodenoscope ED32-i10 is as safe and effective as the predicate device. There are no differences in indications for use and intended use between the subject and predicate device and are therefore, substantially equivalent. The technological differences in terms of design features, performance characteristics and constituent materials are not substantive.

### IX. CONCLUSION

Accordingly, PENTAX Medical believes the PENTAX Medical Video Duodenoscope ED32-i10 is substantially equivalent to the identified predicate, the PENTAX Medical Video Duodenoscope ED34-i10T2, cleared by FDA in 2019 (K192245).