The PENTAX Medical EPK-i5010 Video Processor is intended to be used with the PENTAX camera heads, endoscopes, light sources, monitors and other ancillary equipments for bronchoscopic diagnosis, treatment and video observation.
The PENTAX Medical EPK-i5010 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. i-Scan is compatible with PENTAX k-series and i-series video bronchoscopes.

Device Description

The PENTAX EPK-i5010 video processor consists of a video system, integrated light source, monitor, and ancillary equipment. This processor when connected to a compatible EB family bronchoscope is intended for endoscopic diagnostic, treatment and video observation.
The PENTAX i-Scan technology is a digital filter-based image enhancement technique with three modes, i-Scan 1, 2 and 3. i-Scan 1 enhances image topography and edges and i-Scan 2 and 3 enhances the color tone of the image by dissecting and recombining the individual red, green and blue (RGB) components of a white light image.
PENTAX i-Scan™ modes 1, 2, and 3, are intended to give the user an enhanced view of the texture of the mucosal surface and blood vessels. i-Scan 1 provides the user with a view that sharpens surface vessels and enhances surface texture of the mucosa. i-Scan 2 provides the user with increased visibility of blood vessels while also providing the same enhancements to the mucosa achieved in i-Scan 3 provides the user with increased visibility of blood vessels including dimly illuminated far-field regions while also providing the same enhancement to the mucosa achieved in i-Scan 1. The user can select either white light image or i-Scan modes by pressing a pre-programmed button on the scope, by using a pre-programmed foot pedal or by pressing a keyboard button. i-Scan is intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling.
White light is captured from a 300 Watt xenon lamp housed in the EPK-i5010 video processor. All visualization is done with the white light mode first. White light (BGR) 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 RGB components for each pixel occurs when the i-Scan function is turned on in the EPK-i5010 video processor. The resulting i-Scan image is then displayed on the observation monitor.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details based on the provided document. It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical trial for a novel AI device. Therefore, some information typically found for AI device studies (like a deep dive into AI model training, specific performance metrics for disease detection, or expert consensus on ground truth for a diagnostic task) is not explicitly detailed.

The device in question is the PENTAX Medical EPK-i5010 Video Processor with EB Family, which includes PENTAX i-Scan™, a digital, post-processing imaging enhancement technology. The primary function described is image enhancement for bronchoscopic diagnosis, treatment, and video observation, as an "optional adjunct following traditional white light endoscopy" and "not intended to replace histopathological sampling."

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of explicit acceptance criteria with numerical targets for clinical performance (e.g., sensitivity, specificity for a diagnostic task). Instead, the studies aim to demonstrate safety, effectiveness, and substantial equivalence to a predicate device. The performance is assessed through various engineering and non-clinical tests.

Acceptance Criteria Category	Specific Criteria (Implicitly Met)	Reported Device Performance (Summary)
Electrical Safety	Compliance with IEC 60601-1:2005+A1:2012, IEC 60601-1-2:2007, IEC 60601-1-6:2010, IEC 60601-2-18:2009	Confirmed by testing in accordance with mentioned standards.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2:2007	Confirmed by testing in accordance with mentioned standards.
Software Verification & Validation	Compliance with FDA Guidance for "Content of Premarket Submissions for Software Contained in Medical Devices," IEC 62304:2006 (Class B, Moderate Concern), ISO 14971:2007, IEC 62471:2006	All testing conducted in compliance with listed standards; V&V demonstrate device performs as intended.
Optical Performance (Image Quality)	Demonstrate equivalence of distortion, resolution, and color performance compared to predicate. Demonstrate enhanced view of mucosal surface and blood vessels with i-Scan.	Optical bench testing and animal study images confirmed comparable performance to predicate and demonstrated i-Scan enhancements.
Safety and Effectiveness	Device is safe and performs as intended in specified use conditions.	Supported by hardware and software verification, validation, and optical data analysis.
Substantial Equivalence	Same intended use, indications for use, fundamental operating principle, and scientific technology as predicate/reference devices.	Established through comparison of technological characteristics and performance data.

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

Test Set Description: The "test set" primarily comprises images obtained during a non-clinical animal study and optical bench testing. It's not a clinical diagnostic test set for evaluating specific disease detection performance.
Sample Size:
- Animal Study: A "library of images" was obtained. The exact number of individual images or animal subjects is not specified.
- Bench Testing: Images were generated from the porcine pulmonary location using two PENTAX bronchoscopes (one HD, one standard def) and one Olympus bronchoscope. The number of images is not specified.
Data Provenance:
- Country of Origin: Not specified, but given Pentax's global presence, it could be from various locations.
- Retrospective/Prospective: The animal study and bench testing were likely prospectively generated for the purpose of this submission. The historical data for the reference predicate (PENTAX EPK-i5010 Video Processor K122470) would be retrospective for comparison, but the new data generated for the current submission is prospective.

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

Number of Experts: The document does not specify the number of human experts used for formal "ground truth" establishment in the context of disease diagnosis.
Qualifications of Experts: Not specified. Given the nature of an image enhancement device, the evaluation of image quality (e.g., "enhanced view of the texture of the mucosal surface and blood vessels") would likely involve experienced endoscopists, but their roles and specific qualifications are not detailed. The primary goal was to show technical performance and equivalence, not a direct clinical diagnostic improvement verified by experts.

4. Adjudication Method for the Test Set

The document does not describe any formal adjudication method (e.g., 2+1, 3+1 consensus) for establishing ground truth or evaluating the test set images. The evaluation appears to be technical in nature (e.g., optical performance metrics) and qualitative assessment of image enhancement.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Data for an MRMC comparative effectiveness study, which would quantify how much human readers improve with AI vs. without AI assistance, is not provided or mentioned. The i-Scan technology is a "digital, post-processing imaging enhancement technology," which means it's an imaging aid. The study presented here focuses on technical performance and equivalence, not on a direct comparison of diagnostic accuracy with and without the i-Scan function by multiple human readers across many cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The device is an "imaging enhancement technology" intended to be an "optional adjunct following traditional white light endoscopy" and specifically "not intended to replace histopathological sampling." Therefore, a "standalone" performance evaluation in the context of diagnostic accuracy was not conducted nor would it be appropriate since the device is designed as a human-in-the-loop aid, not a standalone diagnostic algorithm. The reported optical performance and image enhancement capabilities are effectively the "standalone" performance of the image processing aspect.

7. The Type of Ground Truth Used

Given that the device is an image enhancement tool and not a diagnostic AI that provides a specific disease classification, the "ground truth" in this context refers more to:

Reference Optical Measurements: For bench testing, established physical and optical performance parameters (distortion, resolution, color accuracy) serve as ground truth for technical equivalence.
Real-world Image Characteristics: The animal study images provide a real-world, yet controlled, "ground truth" for evaluating how the i-Scan technology enhances relevant anatomical features (mucosal surface, blood vessels) compared to white light and other technologies (Olympus NBI). This is a qualitative assessment of the image output itself.
Compliance with Standards: For electrical, EMC, and software, the ground truth is adherence to the specified international standards.

There is no mention of pathology confirmation or outcomes data being used as ground truth for evaluating the diagnostic performance of the i-Scan feature for specific lesions or conditions.

8. The Sample Size for the Training Set

The document does not specify a training set size. The i-Scan technology is described as a "digital, post-processing imaging enhancement technology" with "three modes, i-Scan 1, 2, and 3." This description suggests it might be based on fixed digital filters or algorithms rather than a machine learning model that requires a "training set" in the conventional sense (i.e., for learning from data to make predictions). If any machine learning elements are present, they are not detailed as such, and no training data is specified.

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

As no "training set" (in the machine learning sense) is specified, there is no information on how ground truth for a training set was established. The i-Scan modes are described as enhancing "image topography and edges" and "color tone" by dissecting and recombining RGB components, implying a rule-based or filter-based approach rather than a data-trained predictive model.

Summary

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

October 29, 2015

Pentax of America, Inc. Mr. Krishna Govindarajan Senior Manager, Regulatory Affairs 3 Paragon Drive Montvale, NJ 07645

Re: K143727

Trade/Device Name: Pentax Medical EKP-i5010 Video Processor With EB Family Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ, PEA Dated: September 28, 2015 Received: September 29, 2015

Dear Mr. Govindarajan,

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"

(21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely 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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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
510(k) Number (if known)	K143727
Device Name	PENTAX Medical EPK-i5010 Video Processor with EB Family
Indications for Use (Describe)	The PENTAX Medical EPK-i5010 Video Processor is intended to be used with the PENTAX camera heads, endoscopes,light sources, monitors and other ancillary equipments for bronchoscopic diagnosis, treatment and video observation.The PENTAX Medical EPK-i5010 includes PENTAX i-Scan™, a digital, post-processing imaging enhancementtechnology. i-Scan is intended to be used as an optional adjunct following traditional white light endoscopy and is notintended to replace histopathological sampling. i-Scan is compatible with PENTAX k-series and i-series videobronchoscopes.
Type of Use (Select one or both, as applicable)
	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)	Page 1 of 1
	PSC Publishing Services (301) 443-6740 EF

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510(k) Summary

The following summary is provided in accordance with 21 CFR 807.92:

I. SUBMITTER

PENTAX of America, Inc., HOYA Corporation PENTAX Division 3 Paragon Drive Montvale, New Jersey 07645-1782

Phone: 201-251-2300 x 2125 201-799-4117 Fax:

Contact Person: Krishna Govindarajan Date Prepared: October 28, 2015

II. DEVICE

Name of Device:	PENTAX Medical EPK-i5010 Video Processor with EB Family
Common or Usual Name:	Endoscopic Video Processor and Light Source
Classification Name:	Endoscopic video imaging system/component,
Classification Name:	Bronchoscopes (Flexible or rigid) and accessories (21 CFRPart 874.4680)
Regulatory Class:	Class II
Product Code:	EOQ and PEA

III. PREDICATE DEVICE

The OLYMPUS EVIS EXERA III Video System CV - 190 Video System Center and CLV -190, Xenon Light Source (K121959) is the primary predicate for this submission.

The PENTAX EPK-i5010 Video Processor (K122470; dated April 22, 2013) is the reference device for this submission.

This reference device has not been subject to a design-related recall.

IV. DEVICE DESCRIPTION

The PENTAX i-Scan technology is a digital filter-based image enhancement technique with three modes, i-Scan 1, 2 and 3. i-Scan 1 enhances image topography and edges and i-Scan 2 and 3 enhances the color tone of the image by dissecting and recombining the individual red, green and blue (RGB) components of a white light image.

PENTAX Medical EPK-i5010 Video Processor with EB Family 510(k) Summary

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PENTAX i-Scan™ modes 1, 2, and 3, are intended to give the user an enhanced view of the texture of the mucosal surface and blood vessels. i-Scan 1 provides the user with a view that sharpens surface vessels and enhances surface texture of the mucosa. i-Scan 2 provides the user with increased visibility of blood vessels while also providing the same enhancements to the mucosa achieved in i-Scan 3 provides the user with increased visibility of blood vessels including dimly illuminated far-field regions while also providing the same enhancement to the mucosa achieved in i-Scan 1. The user can select either white light image or i-Scan modes by pressing a pre-programmed button on the scope, by using a pre-programmed foot pedal or by pressing a keyboard button. i-Scan is intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling.

White light is captured from a 300 Watt xenon lamp housed in the EPK-i5010 video processor. All visualization is done with the white light mode first. White light (BGR) 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 RGB components for each pixel occurs when the i-Scan function is turned on in the EPK-i5010 video processor. The resulting i-Scan image is then displayed on the observation monitor.

The table below are the list of accessories and compatible devices that are used with the EPK-i5010 Video Processor.

Accessories Name	Intended Use	Model Number
PENTAX Condenser EarthCable	Condenser earth cable OL-Z4 is intended to reduce high- frequency noise which is generated during high- frequency electro cautery device use together with Pentax endoscopes.	OL-Z4
PENTAX Foot Switch	Foot Switch OS-A61 is used to remotely control processor functions.	OS-A61
PENTAX Keyboard	Keyboard OS-A79 is used as an input device for the video processor.	OS-A79
PENTAX White BalanceAdjuster	White Balance Adjuster OS- A43H is a white tube used as the object of white balance feature.	OS-A43H

Table 1: List of Accessories

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Compatible Devices	Manufacturer	Model Name
Printer	Sony Corporation	UP-55MD
	Sony Corporation	UP-21MD
	Sony Corporation	UP-D23MD
	Sony Corporation	UP-D23MDA
USB Flash Memory	SanDisk	SDCZ6-1024-A10
LCD Monitor	NDS Surgical Imaging	Radiance 19

Table 2: List of Compatible Devices

The EPKi-5010 is compatible with PENTAX k-series video bronchoscopes.

V. INDICATIONS FOR USE

The PENTAX Medical EPK-i5010 Video Processor is intended to be used with the PENTAX camera heads, endoscopes, light sources, monitors and other ancillary equipment for bronchoscopic diagnosis, treatment and video observation.

The PENTAX Medical EPK-i5010 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. i-Scan is compatible with PENTAX k-series video bronchoscopes.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The PENTAX Medical EPK-i5010 Video Processor with EB Family (subject device) has the same intended use and fundamental operating principle as the OLYMPUS EVIS EXERA III Video System CV - 190 Video System Center and CLV - 190, Xenon Light Source (K121959) (primary predicate device). Both devices also have the same indications for use; namely, for use in bronchoscopic diagnosis, treatment and video observation in the pulmonary anatomy. The devices differ slightly with regard to design and technological characteristics. Performance data, specifically optical bench and animal testing, is provided to support substantial equivalence of the devices.

The PENTAX Medical EPK-i5010 Video Processor with EB Family (subject device) has the same intended use, design, fundamental operating principle, and scientific technology, including the PENTAX i-Scan image enhancement technology, compared to the commercially available PENTAX EPK-i5010 Video Processor (reference device). There were minor changes made to the EPK-i5010 Video Processor with EB Family to address the requirements of the 3rd edition of IEC 60601. However, these changes did not affect the

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final product specification and did not raise any questions of safety or effectiveness. The only substantive difference between the subject and primary predicate device is in use of the device in different anatomical locations. The subject device is used for bronchoscopic diagnosis, treatment and video observation in the pulmonary anatomy and the predicate device is used for gastrointestinal endoscopic diagnosis, treatment and video observation in the upper and lower gastrointestinal anatomical location.

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Electrical Safety and electromagnetic compatibility (EMC)

The acceptable level of Electromagnetic Compatibility (EMC) and Electrical Safety (ES) for the PENTAX Medical EPK-i5010 Video Processor with EB Family was confirmed by testing in accordance with the following standards:

1. IEC 60601-1:2005+A1:2012. Medical electrical equipment Part 1: General requirements for basic safety and essential performance
1. IEC 60601-1-2:Edition 3:2007, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
1. IEC 60601-1-6 Edition 3.0:2010. Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
1. IEC 60601-2-18 Edition 3.0:2009: , Medical electrical equipment- Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment

Software Verification and Validation Testing

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

All testing of the software was conducted in compliance with the following standards:

1. ISO 14971 Second Edition:2007, Medical devices -Application of risk management to medical devices
1. IEC 62304 First Edition:2006, Medical device software- Software life cycle processes
1. IEC 62471 First Edition:2006, Photobiological safety of lamps and lamp systems

PENTAX Medical EPK-i5010 Video Processor with EB Family 510(k) Summary

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Optical Performance Testing (Bench and Animal non-clinical testing)

Animal Study

A library of images [white light endoscopic (WLE), PENTAX i-Scan™, and Olympus Narrow Band Imaging (NBI)] were obtained from the porcine pulmonary mucosa. The images were used for image evaluation and quantitative data analysis.

Bench Testing

i-Scan and Artifact Analysis were performed with the images from the porcine pulmonary location that were gathered using two PENTAX bronchoscopes, one high definition and one standard definition, along with an Olympus bronchoscope. In addition, PENTAX and Olympus bronchoscopes were compared and optical bench testing was conducted to evaluate the effects of processing features and demonstrate the equivalence of the distortion, resolution and color performance of the subject compared to the predicate.

The animal and optical bench test image data gathered with bronchoscopes establish the equivalence of the subject and predicate device.

VIII. CONCLUSIONS

The data submitted support the safety of the device and the hardware and software verification and validation demonstrate that the PENTAX Medical EPK-5010 Video Processor performs as intended in the specified use conditions. The optical data analysis demonstrate that the PENTAX Medical EPK-i5010 Video Processor performs comparably to the predicate device that is currently marketed for the same indication for use.

Regulation Number and Section

§ 874.4680 Bronchoscope (flexible or rigid) and accessories.

(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.