The PENTAX Medical VIDEO PROCESSOR EPK-3000 is intended to be used with the PENTAX VNL8-J10, VNL11-J10, and VNL15-J10 endoscopes, light sources (including strobe), video monitors and other ancillary equipment for ENT endoscopic observation and nasopharyngo-laryngoscopic (ENT) diagnosis, treatment and video observation.

The PENTAX Medical VIDEO PROCESSOR EPK-3000 includes PENTAX i-Scan™, a digital, post-processing imaging enhancement technology, i-Scan is intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling.

PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series

The PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series (VNL8-J10, VNL11-J10, and VNL15-J10) are intended to be used with a PENTAX EPK-3000 Video Processor (including Light source), documentation equipment, video monitor, endoscopic device and other ancillary equipment for optical visualization (via a video monitor) of, and, for VNL15-J10 only, therapeutic access to, nasal, pharyngeal and the upper airway anatomy.

Device Description

PENTAX Medical EPK-3000 Video Imaging System is used for ENT endoscopic observation and nasopharyngo-laryngoscopic (ENT) diagnosis, treatment, and video observation.

The System functions by receiving image signals from the image sensor in an endoscope, which are processed within a processor and then output to a monitor. Brightness, color balance, and other properties of the displayed images can be adjusted using the buttons on the system's control panel. The light from a xenon lamp at the distal end of the endoscope illuminates the body cavities of the patient through the endoscope connected to the video processor.

The primary components of the system include the following:

PENTAX Medical Video Processor EPK-3000
PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series (VNL-J10 Series)

The PENTAX Medical EPK-3000 Video Imaging System is provided with the following accessories:

. Keyboard - input device for the video processor.
Foot Switch - used to remotely control processor functions.
White Balance Adjuster - used as the object of 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 the reprocessing, it seals the instrument Channel Inlet in order to full 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.

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

The PENTAX Medical Video Processor EPK-3000 is intended to be used with the PENTAX compatible endoscopes, light sources (including strobe), vide monitors and other ancillary equipment for ENT endoscopic observation and nasopharyngo-laryngoscopic (ENT) diagnosis, treatment, and video observation.

PENTAX Medical Video Processor EPK-3000 functions with the PENTAX i-Scan technology, a digital filter-based image enhancement technique with three modes, i-Scan 1, 2, and 3. PENTAX i-Scan™ is intended to give the user an enhanced view of the texture of the mucosal surface and blood vessels.

White light is captured from a 150-Watt xenon lamp housed in the EPK-3000 Video Processor. All visualization is done with the white light mode first. White light illuminates the tissue and transfers the captured light through the video scope or a charged coupled device (CCD). Note that the white light visualization mode is always used first by the physician. The modification of the combination of red, green, blue (RGB) components for each pixel occurs when the i-Scan function is turned on in the EPK-3000 Video Processor. The resulting i- Scan image is then displayed on the observation monitor.

The PENTAX Medical Video Processor EPK-3000 is compatible with PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series. The PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series are intended to be used with a PENTAX Video Processor (including Light source), documentation equipment, video monitor, endoscopic device and other ancillary equipment for optical visualization (via a video monitor) of, and/or therapeutic access to, nasal, pharyngeal, laryngeal and the upper airway anatomy. Three scopes are included in the VNL-J10 Series of scopes that is the subject of this submission: VNL8-J10, VNL11-J10, and VNL15-J10.

The VNL-J10 Series endoscopes are inserted transorally or transnasally to visualize subjects under illumination transmitted from a video processor with a solid-state image sensor located at the distal end of the endoscope, and provide images of the target anatomy on the video monitor. The endoscopes are flexible which allows the insertion portion to shape according to the body cavity. They are also composed of an Insertion Portion, Control Body, PVE Connector, and Light Guide Plug.

The VNL15-J10 can be used with endoscopic devices, each of which is introduced from the instrument channel inlet of the control body. Additionally, suctioning from the instrument channel at the distal end of the endoscope by pressing the suction control valve is available with this model. The VNL8-110 and the VNL11-J10 do not have an instrument channel.

AI/ML Overview

The provided text describes the PENTAX Medical EPK-3000 Video Imaging System, a medical device for ENT endoscopic observation. The document is a 510(k) summary, which aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness on its own. Therefore, much of the information requested, particularly regarding acceptance criteria and detailed study results that prove the device meets specific performance criteria for new features, is not explicitly present in the provided text in the way one might expect for a de novo submission.

However, I can extract information related to the device's technical specifications and the comparison with a predicate device, which forms the basis for its clearance. The "acceptance criteria" here are largely implied by the successful comparison to the predicate device and compliance with various recognized standards.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) summary focused on substantial equivalence to a predicate device (PENTAX Medical ENT Video Imaging System (K162151)), the "acceptance criteria" are implicitly met by demonstrating that the new device is either identical or equivalent in performance to the predicate and complies with relevant standards. Specific quantitative acceptance criteria for novel image enhancement features like i-Scan are not detailed with numerical thresholds but are instead assessed against the predicate's overall visualization capabilities.

Acceptance Criteria (Implied by Substantial Equivalence & Standards Compliance)	Reported Device Performance (PENTAX Medical EPK-3000 Video Imaging System)
I. Functional Equivalence to Predicate
- Intended Use	Same as predicate.
- Fundamental Technology and Operating Principles	Same as predicate.
- Visualization of Vascular Structure & Mucosal Surfaces (White Light)	Equivalent to predicate (evaluated by experienced ENT physicians).
- Visualization of Vascular Structure & Mucosal Surfaces (i-Scan)	Equivalent to predicate (evaluated by experienced ENT physicians).
- Scope Working Length	Identical or equivalent.
- Scope Field of View/Depth of Field	Identical or equivalent.
- Scope Tip Angulation	Identical or equivalent.
- Illumination	Identical or equivalent.
- Noise Reduction	Identical or equivalent.
- Surface, Contrast, and Tone Enhancement	Identical or equivalent.
- Software Requirements	Identical or equivalent.
- Power Requirements	Identical or equivalent.
II. Reprocessing Validation
- Simulated Use Testing	All acceptance criteria satisfied.
- Soil Accumulation	All acceptance criteria satisfied.
- Cleaning Efficacy	All acceptance criteria satisfied.
- High Level Disinfection (HLD) Efficacy	All acceptance criteria satisfied.
- Rinsing Validation	All acceptance criteria satisfied.
- STERRAD® NX® Efficacy Study after Cleaning and HLD	All acceptance criteria satisfied.
- STERRAD® 100NX® Efficacy Study after Cleaning	All acceptance criteria satisfied.
III. Biocompatibility (Patient-Contacting Materials)
- Cytotoxicity Test	Passing results.
- Sensitization Test	Passing results.
- Intracutaneous Reactivity Test	Passing results.
IV. Electrical Safety & EMC
- IEC 60601-1, IEC 60601-2-18 (Medical Electrical Equipment)	Complies with standards.
- IEC 61000-3-2, IEC 61000-3-3, IEC 61000-4-2, IEC 61000-4-6, IEC 61000-4-8, IEC 61000-4-11 (EMC)	Complies with standards.
- IEC 62304:2006 (Medical Device Software Lifecycle Processes)	Complies with standards.
- CISPR 11:2009 (Industrial, scientific and medical (ISM) radio-frequency equipment)	Complies with standards.
V. Software Verification and Validation
- Software V&V Testing (Moderate level of concern)	Conducted and documentation provided as recommended by FDA guidance.
VI. Optical Bench Performance
- Signal to Noise, Color (IEE), Resolution, Modulation Transfer Function, Distortion, Light Distribution, Spectral Distribution, Total Luminous Flux, Photobiological Safety	Performance of subject and predicate devices concluded to be equivalent.
VII. Endoscope Operability, Image Quality, Endotherapy Device Insertability, Single-Use Suction Valve Testing	Verification and validation testing conducted.

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

Test Set Sample Size: Not explicitly stated. The text mentions "A library of images was captured" for the clinical usability test and "side-by-side bench and clinical usability tests." The number of images or cases in the "library" is not quantified.
Data Provenance: The clinical usability study was performed by PENTAX Medical, implying the data was generated specifically for this submission. The country of origin is not specified, but the submission is to the U.S. FDA by PENTAX of America, Inc. It was a "non-significant risk clinical study with IRB approval," which indicates it was a prospective study.

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

Number of Experts: Not explicitly stated, but referred to as "experienced ENT physicians."
Qualifications of Experts: "Experienced ENT physicians." Specific details like years of experience or board certification are not provided in this summary.

4. Adjudication Method for the Test Set:

Adjudication Method: Not specified. The text merely states that "These images were evaluated by experienced ENT physicians." It doesn't describe how consensus or a definitive ground truth was reached from multiple readers' evaluations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

MRMC Comparative Effectiveness Study: A clinical usability test was performed which compares the subject device's performance to a predicate device, and physicians evaluated images from both. This technically involves multiple readers (experienced ENT physicians) evaluating multiple cases (images from the subject and predicate devices). However, it's not described as a formal "MRMC comparative effectiveness study" in the sense of a rigorous statistical design to quantify human reader improvement with AI vs. without AI assistance.
Effect Size: No specific effect size is reported for how much human readers improve with AI (i-Scan) vs. without AI assistance (white light). The study concluded that the subject device's ability to visualize vascular structure and/or mucosal surface (both with white light and i-Scan) was equivalent to the predicate device. The i-Scan feature itself is positioned as an "optional adjunct" for enhanced viewing, not as a tool to improve human diagnosis over white light in quantified terms within this submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The i-Scan technology is a "digital, post-processing imaging enhancement technology." While it operates as an algorithm, its performance is described in the context of human evaluation of the resulting images ("i-Scan is intended to give the user an enhanced view..."). The clinical usability study involved human readers evaluating the images enhanced by i-Scan, demonstrating its utility as an adjunct. There is no mention of a standalone diagnostic accuracy study of the i-Scan algorithm without a human reader interpreting the enhanced image against a diagnostic ground truth.

7. The Type of Ground Truth Used:

For the clinical usability test, there isn't an explicit "ground truth" (e.g., pathology report) against which the device's diagnostic accuracy is measured. Instead, the "ground truth" for the comparison was the expert evaluation/consensus of "experienced ENT physicians" who assessed the ability to visualize vascular structure and/or mucosal surface in images from both the subject and predicate devices. The study aimed to show equivalence in visualization capabilities, not diagnostic accuracy against a definitive disease state.

8. The Sample Size for the Training Set:

Training Set Sample Size: The document does not mention a training set for the i-Scan algorithm or any other machine learning component in the traditional sense, as it focuses on demonstrating substantial equivalence of a video imaging system. The i-Scan is described as a "digital filter-based image enhancement technique," implying it might use pre-defined filters and algorithms rather than requiring ongoing machine learning with a specific training set.

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

As no training set is mentioned for an AI/ML algorithm requiring ground truth, this information is not applicable and therefore not provided in the document.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 5, 2018

Pentax Medical James W. Monroe Director, Regulatory Affairs 3 Paragon Drive Montvale, NJ 07645

Re: K172156

Trade/Device Name: PENTAX Medical EPK-3000 Video Imaging System Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible or Rigid) And Accessories Regulatory Class: Class II Product Code: EOB. PEA Dated: March 2, 2018 Received: March 5, 2018

Dear James W. Monroe:

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.

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely yours,

Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172156

Device Name

PENTAX Medical EPK-3000 Video Imaging System

Indications for Use (Describe) PENTAX Medical EPK-3000 Video Imaging System consists of PENTAX Medical VIDEO PROCESSOR EPK-3000, PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series, and other ancillary equipment.

PENTAX Medical VIDEO PROCESSOR EPK-3000

PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series

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

I. SUBMITTER

PENTAX of America, Inc., HOYA Corporation PENTAX Division 3 Paragon Drive Montvale, New Jersey 07645-1782 Phone: 201-571-2129 Ext 2129 Fax: 201-571-2340

Contact: James W. Monroe Date Prepared: July 14, 2017 Date Revised: March 02, 2018

II. DEVICE

The PENTAX Medical EPK-3000 Video Imaging System is composed of two parts: (1) the PENTAX Medical Video Processor EPK-3000, and (2) the PENTAX Medical Video Naso-Pharyngo- Laryngoscope VNL-J10 Series.

Device Name	PENTAX Medical EPK-3000 Video Imaging System
	PENTAX Medical VideoProcessor EPK-3000	PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10Series
Common Name	Endoscope, Accessories, Image Post-Processing For Color Enhancement	Naso-Pharyngo-Laryngoscope
ClassificationName	Endoscope and accessories	Nasopharyngoscope (flexible orrigid) and accessories
Regulation No.	876.1500	874.4760
Device Class	2	2
Product Code	PEA	EOB

III. PREDICATE DEVICES

A previously cleared PENTAX Medical ENT Imaging System has been chosen as a predicate device:

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Subject Device	Predicate Device
PENTAX Medical EPK-3000 Video ImagingSystem - PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL8-J10, VNL11-J10, and VNL15-J10 and PENTAX MedicalVideo Processor, EPK-3000	PENTAX Medical ENT Video ImagingSystem (K162151) - PENTAX MedicalVideo-Naso-Pharyngo-Laryngoscope VNL-1570STK and PENTAX Medical VideoProcessor, EPK-i5010

IV. DEVICE DESCRIPTION

PENTAX Medical EPK-3000 Video Imaging System is used for ENT endoscopic observation and nasopharyngo-laryngoscopic (ENT) diagnosis, treatment, and video observation.

The primary components of the system include the following:

PENTAX Medical Video Processor EPK-3000
PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series (VNL-J10 Series) ●

The PENTAX Medical EPK-3000 Video Imaging System is provided with the following accessories:

. Keyboard - input device for the video processor.
Foot Switch - used to remotely control processor functions.
White Balance Adjuster - used as the object of 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 the reprocessing, it seals the instrument Channel Inlet in order to full 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.

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V. INDICATIONS FOR USE

PENTAX Medical EPK-3000 Video Imaging System consists of PENTAX Medical Video Processor EPK-3000, PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series, and other ancillary equipment.

PENTAX Medical Video Processor EPK-3000

The PENTAX Medical Video Processor EPK-3000 is intended to be used with the PENTAX VNL8-J10, VNL11-J10, and VNL15-J10 endoscopes, light sources (including strobe), video monitors and other ancillary equipment for ENT endoscopic observation and nasopharyngo-laryngoscopic (ENT) diagnosis, treatment and video observation.

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The PENTAX Medical Video Processor EPK-3000 includes PENTAX i-Scan™, a digital, postprocessing imaging enhancement technology. i-Scan is intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling.

PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series

VI. COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE

The components of the PENTAX Medical EPK-3000 Video Imaging System have the same fundamental technology and operating principles as the predicate devices, as well as the same intended use. Both the PENTAX Medical EPK-3000 Video Imaging System and the predicate device are intended for illuminating and viewing the inside of the human body.

The components of the PENTAX Medical EPK-3000 Video Imaging System consist of the same components as the predicate devices, including:

. A video processor, including integrated light source
Naso-Pharyngo-Laryngoscopes to observe the nasal, pharyngeal and the upper airway ● anatomy
. Accessories, including by not limited to a keyboard, foot switch, White Balance Adjuster, and Condenser Earth Cable

The subject and predicate devices are identical or equivalent with regard to

. Scope working length
. Scope field of view depth of field
Scope tip angulation
Software requirements
Power requirements ●
Illumination
. Noise reduction
Surface, contrast, and tone enhancement ●

The patient contacting components of both the subject and predicate devices are biocompatible. Both subject and the predicate scopes are reprocessed by the user. Side-by-side bench and clinical usability tests were conducted that have also shown the EPK-3000 Video Imaging System to be substantially equivalent to the predicate device.

The technological differences between the subject and predicate devices include

Minor differences in specifications between subject and predicate device components .
The minor differences between the subject and predicate devices do not impact the intended use and do not raise different questions of safety and effectiveness. Performance data, specifically optical bench

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and animal testing, is provided to support substantial equivalence of the subject and predicate devices.

VII. PERFORMANCE DATA

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

a. Reprocessing Validation

The following testing has been performed for the VNL-J10 Series scopes:

Simulated Use Testing ●
Soil Accumulation
. Cleaning Efficacy
High Level Disinfection (HLD) Efficacy
Rinsing Validation
STERRAD® NX® Efficacy Study after Cleaning and HLD
STERRAD® 100NX® Efficacy Study after Cleaning ●

All acceptance criteria were satisfied.

b. Biocompatibility

The biocompatibility evaluation of the patient contacting materials of the PENTAX Medical EPK-3000 Video Imaging System was conducted in accordance with the "FDA Blue Book Memorandum #G95-1: Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing (May 1, 1995)", and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The system is considered a surface device with mucosal contact of limited duration (<24 hours).

The following tests were conducted with passing results:

. Cytotoxicity Test
Sensitization Test
Intracutaneous Reactivity Test ●

Electrical Safety and Electromagnetic Compatibility (EMC) C.

The PENTAX Medical Video Processor EPK-3000 and PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series were tested and comply with the following standards for electrical safety and EMC.

IEC 60601-1, IEC 60601-2-18 ●
IEC 61000-3-2 and IEC 61000-3-3, IEC 61000-4-2 IEC 61000-4-6, IEC 61000-4-8, IEC ● 61000-4-11
IEC 62304:2006 ●
CISPR 11:2009 ●

d. Software Verification and Validation

Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket

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Submissions for Software Contained in Medical Devices." The software for this device is considered a "moderate" level of concern based on the FDA guidance.

Performance Testing e.

Bench Testing

Optical testing was performed to compare the PENTAX Medical EPK-3000 Video Imaging System with the PENTAX Medical model, VNL-1570STK (K162151). Testing consisted of Signal to Noise, Color (IEE), Resolution, Modulation Transfer Function, Distortion, Light Distribution, Spectral Distribution, Total Luminous Flux, and Photobiological Safety testing. It was concluded that the performance of the subject and predicate devices are equivalent.

Verification and validation testing was also conducted, including endoscope operability, image quality, endotherapy device insertability, and single-use suction valve testing.

Clinical Usability Testing

PENTAX Medical performed a non-significant risk clinical study with IRB approval to show comparative data with the subject device. PENTAX Medical Video Processor EPK-3000 used in conjunction with PENTAX VNL8-J10, VNL11-J10, and VNL15-J10 Naso-pharyngo-laryngoscopes (subject) in comparison to the PENTAX Medical PENTAX model, VNL-1570STK and EPK-i5010 (K162151), predicate device. A library of images was captured to display vascular structure and/or mucosal surfaces from subject device and predicate device for both white light images (WLE) and i-Scan images. These images were evaluated by experienced ENT physicians and subject devices were evaluated as having equivalent ability to visualize vascular structure and/or mucosal surface to for both white light images (WLE) and i-Scan images, as compared to the predicate device.

VIII. CONCLUSION

The data submitted support the safety of the device and software and software verification and validation demonstrate that the PENTAX Medical EPK-3000 Video Imaging System performs as intended in the specified use conditions. The optical data analysis demonstrates the substantial equivalence of the PENTAX Medical EPK-3000 Video Imaging System to the predicate device. Furthermore, a non-significant risk clinical study with IRB approval shows subject device has equivalent ability to visualize vascular structure and/or mucosal surface to for both white light images (WLE) and i-Scan images, as compared to the predicate device.

The subject and predicate devices have the same intended use and there are no significant differences in technical characteristics that raise different questions of safety and effectiveness. The data provided in this 510(k) Premarket Notification support the equivalence of the subject and predicate devices.

Regulation Number and Section

§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.

(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.