The PENTAX Medical Video Processor EPK-i8020c is intended to be used with the PENTAX Medical camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal endoscopic diagnosis, treatment and video observation.

The PENTAX Medical EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX i-ScanTM), and optical imaging enhancement technology (OE). These imaging enhancement technologies are intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan and OE are compatible with PENTAX Medical video gastrointestinal endoscopes.

The PENTAX Medical Video Upper Gl Scope EG29-i20c is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the upper gastrointestinal tract. This anatomy includes the organs; tissues; and subsystems: esophagus, stomach, and duodenum.

This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in patient populations with greater than 20 kg of body weight.

The PENTAX Medical Video Colonoscope EC38-120cL is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the lower gastrointestinal tract. This anatomy includes the organs, tissues, and subsystems: Large Bowel to the cecum, terminal ileum of the small bowel.

This endoscope is introduced via the rectum, as decided by the physician, when indications consistent with the need for the procedure are observed in patient populations with greater than 20 kg of body weight.

Device Description

The PENTAX Medical Video Processor EPK-i8020c is intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. The video processor consists of a video system, integrated light source, monitor, and ancillary equipment.

The EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX Medical i-scan™) and an optical imaging enhancement technology (OE). These post-imaging functions are not intended to replace histopathological sampling.

The brand name "INSPIRA™" is provided for the EPK-i8020c video processor and the name is supposed to be found in the instructions for use (IFU) and/or in the commercial materials such as brochures.

The PENTAX Medical Video Upper GI Scope EG29-i20c is designed to be used with a PENTAX Medical Video Processor, video monitor, endoscopic devices such as biopsy forceps and other ancillary equipment for optical visualization (via a video monitor) of, and/or therapeutic access to the upper gastrointestinal tract.

The PENTAX Medical Video Colonoscope EC38-i20cL is designed to be used with a PENTAX Medical Video Processor, video monitor, endoscopic devices such as biopsy forceps and other ancillary equipment for optical visualization (via a video monitor) of, and/or therapeutic access to the lower digestive tract. The device is equipped with stiffness setting mechanism for the insertion tube. This feature enables the physician to choose the stiffness of the insertion tube, depending on the preferred level.

AI/ML Overview

The document provides information on the PENTAX Medical EPK-i8020c Video Imaging System, including its components (Video Processor EPK-i8020c, Video Upper GI Scope EG29-i20c, and Video Colonoscope EC38-i20cL) and their intended uses. It also details the non-clinical performance data used to support the substantial equivalence determination to predicate devices.

However, the document does not contain the specific details required to answer all parts of your request, particularly regarding detailed acceptance criteria, reported device performance metrics in a table, an AI component, and the specifics of a study proving the device meets acceptance criteria in the way you've outlined.

The document primarily focuses on demonstrating substantial equivalence to existing predicate devices through various technical and performance tests, rather than setting and meeting a specific set of quantitative acceptance criteria for a new clinical performance claim or an AI algorithm.

Here's what can be extracted and what is missing:

Acceptance Criteria and Device Performance Study (Based on provided document)

The document describes various non-clinical performance tests to demonstrate substantial equivalence, rather than a single study with specific acceptance criteria for a novel AI feature. The "acceptance criteria" here are generally compliance with recognized standards or demonstration of equivalence to predicate devices.

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

Acceptance Criteria Category	Description / Standard / Equivalence	Reported Device Performance
Reprocessing Validation	Effectiveness of reprocessing per FDA's 2015 Guidance; AAMI TIR 30:2011 for residual soil/extraction efficiency.	All acceptance criteria were satisfied for EG29-i20c and EC38-i20cL.
Sterilization and Shelf Life	Validation of System 1E liquid chemical sterilization.	Validated for EG29-i20c and EC38-i20cL. Device not provided sterile, shelf-life not applicable.
Biocompatibility	ISO 10993-1:2018 (cytotoxicity, sensitization, intracutaneous reactivity).	Risk levels of local toxicity determined as "Acceptable" by applying risk evaluation criteria.
Software and Cybersecurity	IEC 62304:2006 + A1:2015; FDA Guidances for Software/Cybersecurity.	Software verification & validation, including cybersecurity assessments, were conducted. (Implied compliance).
Electrical Safety and EMC	IEC 60601-1-2:2014; IEC 60601-1:2005+A1:2012; IEC 60601-2-18:2009.	Acceptable level of electrical safety (ES) and electromagnetic compatibility (EMC) confirmed.
System Performance	Equivalence to predicate device.	Demonstrated equivalence to the predicate device.
Mechanical Performance	Comparison of stiffness setting mechanism (EC38-i20cL) to OLYMPUS EVIS EXERA III Colonovideoscope CF-HQ190.	Verified by comparing to the reference device.
Optical Performance	Measurement of optical properties of imaging and illumination.	All results show optical characteristics are equivalent to predicate and reference devices.
Animal Image Capture Study	Ability to visualize vascularity and mucosal surface for each anatomical area, compared to predicate/reference.	Subject device can visualize vascularity and mucosal surface for each anatomical area as well as the predicate device and the reference device.

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

The document does not specify a "test set" in the context of clinical images or patient data for an algorithm. The non-clinical tests mentioned rely on physical devices, simulated use, and animal models.

For Reprocessing Validation: Simulated use testing. Sample size not specified.
For Biocompatibility: Materials assessed in accordance with ISO standards. Sample size not specified.
For Animal Image Capture Study: Animal model used. Sample size not specified.

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

Not applicable as there is no mention of a human-expert-annotated "test set" for an AI algorithm or clinical performance study. The ground truth for the non-clinical tests is based on objective measurements, standards, or comparison to established predicate devices/methods.

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

Not applicable.

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 MRMC study or AI assistance claim is described in the provided document. The device includes "digital post-processing imaging enhancement technology (PENTAX i-Scan™)" and "optical imaging enhancement technology (OE)", but this is described as an "optional adjunct following traditional white light endoscopy" and "not intended to replace histopathological sampling." It is not presented as an AI-assisted diagnostic tool that would typically undergo an MRMC study to compare human performance with and without AI.

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

This document does not describe the performance of a standalone algorithm for diagnostic purposes. The imaging enhancements (i-Scan, OE) are adjuncts for visual inspection by a clinician.

7. The type of ground truth used

For the non-clinical performance tests:

Reprocessing Validation: AAMI TIR 30:2011 for residual soil accumulation and extraction efficiency.
Biocompatibility: ISO 10993-1:2018 (toxicity, sensitization, intracutaneous reactivity).
Electrical Safety and EMC: IEC and ISO standards.
Optical Performance/Animal Image Capture Study: Comparison against predicate and reference devices' images and visualization capabilities.

No histological pathology or specific clinical outcomes data are mentioned as ground truth for a diagnostic performance study.

8. The sample size for the training set

Not applicable. There is no mention of an AI algorithm requiring a training set in this submission. The imaging enhancement technologies are likely rule-based image processing or optical filtering techniques rather than deep learning AI.

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

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

July 28, 2023

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

K231249 Re:

Trade/Device Name: PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: PEA, FDS, FDF Dated: April 28, 2023 Received: May 1, 2023

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.

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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 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-devices/medical-device-safety/medicaldevice-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-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-devices/device-advicecomprehensive-regulatory-assistance/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) K231249

Device Name

PENTAX Medical EPK-i8020c Video Imaging System

Indications for Use (Describe)

This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in patient populations with greater than 20 kg of body weight.

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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510(k) SUMMARY

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

1. SUBMITTER

Applicant: PENTAX Medical HOYA Corporation PENTAX Division 3 Paragon Drive Montvale. New Jersey 07645-1782

William Goeller Contact: Vice President, Quality and Regulatory Affairs PENTAX Medical 3 Paragon Drive Montvale, New Jersey 07645-1782 Telephone: (201)571-2300 ext. 2318 FAX: (201)391-4189 Email: william.goeller@pentaxmedical.com

Date Prepared: 7/7/2023

2. SUBJECT DEVICE

The PENTAX Medical EPK-i8020c Video Imaging System comprises of three devices: (1) the PENTAX Medical Video Processor EPK-i8020c, (2) the PENTAX Medical Video Upper GI Scope EG29-i20c, and (3) the PENTAX Medical Video Colonoscope EC38i20cL.

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	PENTAX Medical EPK-i8020c Video Imaging System
DeviceName	PENTAX MedicalVideo ProcessorEPK-i8020c	PENTAX MedicalVideo Upper GI ScopeEG29-i20c	PENTAX MedicalVideo ColonoscopeEC38-i20cL
CommonName	Gastroscope and Accessories, Flexible/Rigid
ClassificationName	Endoscope and accessories
Regulation No.	876.1500
Device Class	II
Product Code	PEA	FDS	FDF
ClassificationPanel	Gastroenterology / Urology

The PENTAX Medical Video Processor EPK-i8020c is compatible also with the following endoscopes that have been cleared in the past Premarket Notifications:

Device Name	Model name
PENTAX / PENTAX MedicalVideo Upper GI Scope	EG34-i10, EG29-i10, EG27-i10,EG17-J10, EG-3890TK, EG-2490K,EG29-i10c
PENTAX / PENTAX MedicalVideo Colonoscope	EC38-i10L, EC34-i10L, EC34-i10TL,EC-2990Li, EC-3890TLK,EC38-i10cL, EC34-i10cL
PENTAX MedicalVideo Duodenoscope	ED34-i10T2, ED32-i10
PENTAX MedicalUltrasound Upper GI Video Scope	EG38-J10UT, EG36-J10UR, EG34-J10U

3. PREDICATE DEVICE

A previously cleared PENTAX Medical Video Processor and Video Scopes have been chosen as a predicate device:

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Subject Device	Predicate Device
PENTAX Medical Video ProcessorEPK-i8020c	PENTAX Medical Video ProcessorEPK-i7010 (K150618)
PENTAX Medical Video Upper GI ScopeEG29-i20c	PENTAX Video Upper G.I. ScopeEG29-i10 (K131902)
PENTAX Medical Video ColonoscopeEC38-i20cL	PENTAX Video ColonoscopeEC38-i10L (K131855)

4. REFERENCE DEVICE

A previously cleared PENTAX Medical Video Scopes have been chosen as a reference device:

Model Name	Model Number	CompatibleVideo processor	510(k) ClearanceNumber
PENTAX MedicalVideo Processor	EPK-i7010(With water bottle assembly)		K191282
	EG-3890TK
PENTAXVideo Upper G.I. Scope	EG27-i10EG-2490K		K131902
PENTAX MedicalVideo Upper GI Scope	EG34-i10EG17-J10		K180292 K210177
PENTAXVideo Colonoscope	EC-3890TLKEC34-i10LEC-2990Li	EPK-i7010	K131855
PENTAX MedicalVideo Colonoscope	EC34-i10TL		K180285
PENTAX MedicalVideo Duodenoscope	ED34-i10T2ED32-i10		K192245 K202365
PENTAX MedicalVideo Upper GI Scope	EG29-i10c	EPK-i5500c	K190805
PENTAX MedicalVideo Colonoscope	EC38-i10cLEC34-i10cL

Reference device for video scopes

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Model Name	ModelNumber	CompatibleVideoprocessor	UltrasoundScanner	510(k)ClearanceNumber
PENTAX MedicalUltrasound Upper GIVideo Scopes	EG38-J10UT	EPK-i7010	ARIETTA 70	K200090
	EG36-J10UR
	EG34-J10U		ARIETTA 850	K203166

Reference device for ultrasound video scopes

Reference device for stiffness setting mechanism (EC38-i20cL)

Model Name	Manufacturer	510(k) Clearance Number
EVIS EXERA IIICOLONOVIDEOSCOPECF-HQ190L	OLYMPUS MEDICALSYSTEMS CORP.	K131780

5. DEVICE DESCRIPTION

PENTAX Medical Video Processor EPK-i8020c

The brand name "INSPIRA™" is provided for the EPK-i8020c video processor and the name is supposed to be found in the instructions for use (IFU) and/or in the commercial materials such as brochures.

PETNAX Medical Video Upper GI Scope EG29-i20c

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PENTAX Medical Video Colonoscope EC38-i20cL

6. INTENDED USE AND INDICATIONS FOR USE

Intended use and Indications for use for PENTAX Medical Video Processor EPKi8020c

The PENTAX Medical EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX i-Scan [14), and optical imaging enhancement technology (OE). These imaging enhancement technologies are intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan and OE are compatible with PENTAX Medical video gastrointestinal endoscopes.

Intended use and Indications for use for PENTAX Medical Video Upper GI Scope EG29-i20c

The PENTAX Medical Video Upper GI Scope EG29-i20c is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the upper gastrointestinal tract. This anatomy includes the organs; tissues; and subsystems: esophagus, stomach, and duodenum.

This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in patient populations with greater than 20 kg of body weight.

Intended use and Indications for use for PENTAX Medical Video Colonoscope EC38-i20cL

The PENTAX Medical Video Colonoscope EC38-i20cL is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the lower gastrointestinal tract. This anatomy includes the organs, tissues, and subsystems: Large Bowel to the cecum, terminal ileum of the small bowel.

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7. COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE

The subject device is functionally equivalent to the predicate device, and the difference between the two devices are minor technological changes such as the application of CMOS image sensor for the new endoscopes and of LED light source for the new video processor.

The changes in the subject device have been evaluated through performance testing including image quality animal study and raised 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 subject device have the same fundamental technology and principle of operation as the predicate device. Both the subject device and the predicate device are intended for illuminating and viewing the inside of the human body. The components of the subject device consist of the same components as the predicate device, including:

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

The subject device is identical or enhanced to the predicate device with regards to;

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

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8. NON-CLINICAL PERFORMANCE DATA

The PENTAX Medical EPK-i8020c Video Imaging System 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.

i. Reprocessing Validation
As result of the assessment, simulated use testing, cleaning, high level disinfecting and rinsing (after cleaning and after HLD) validation studies of the EG29-i20c and EC38-i20cL were conducted 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." 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.
ii. 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 EG29-i20c and EC38-i20cL. The device is not provided sterile; therefore, shelf-life is not applicable.
iii. Biocompatibility
Biocompatibility of the EG29-i20c and EC38-i20cL scopes on the direct and indirect contact materials was confirmed by assessing the cytotoxicity, sensitization, and intracutaneous reactivity in accordance with ISO 10993-1: 2018 "Biological evaluation of medical devices". The risk levels of local toxicity were determined as "Acceptable" as a result of applying the risk level of local toxicity to the risk evaluation criteria.
iv. Software and Cybersecurity
Software verification and validation including cybersecurity assessments were conducted according to IEC 62304: 2006 + A1: 2015 and FDA Guidance for Industry and Staff "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", and "Postmarket Management of Cybersecurity in Medical Devices".

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Electrical Safety and EMC v.
The acceptable level of electrical safety (ES) and electromagnetic compatibility (EMC) 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.

vi. System Performance
The system performance of the subject device demonstrated the equivalence to the predicate device.
vii. Mechanical Performance
The performance of stiffness setting mechanism for the PENTAX Medical Video Colonoscope EC38-i20cL was verified by comparing to the OLYMPUS EVIS EXERA III Colonovideoscope CF-HO190 (K131780) that is equipped with the variable stiffness feature.
viii. Optical Performance
As a part of Design Verification and Validation, optical properties of imaging and illumination performances were measured for the PENTAX Medical EPK-i8020c Video Imaging System. All results show that the optical characteristics of the subject device are equivalent to those of the predicate device and the reference device.
ix. Animal Image Capture Study
An animal image capture study was performed as a part of optical and color performance testing. The results indicate that the subject device can visualize vascularity and mucosal surface for each anatomical area as well as the predicate device and the reference device.

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, PENTAX Medical concludes that the subject device 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.

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9. CONCLUSION

Accordingly, PENTAX Medical believes the PENTAX Medical EPK-i8020c Video Imaging System does not raise any different questions of safety and effectiveness, and that the subject device of the PENTAX Medical Video Processor EPK-i8020c, the PENTAX Medical Video Upper GI Scope EG29-i20c, and the PENTAX Medical Video Colonoscope EC38-i20cL is substantially equivalent to the identified predicate, the PENTAX Medical Video Processor EPK-i7010, cleared by FDA in K150618, the PENTAX Video Upper G.I. Scope EG29-i10 (K131902), and the PENTAX Video Colonoscope EC38-i10L (K131855), respectively.

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.