The PENTAX Medical EPK-i7010 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 -7010 includes a digital post-processing imaging enhancement technology (PENTAX i-Scan™) and an 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 video bronchoscopes.

Device Description

The PENTAX Medical EPK-i7010 Video Processor contains PENTAX i-Scan and Optical Enhancement (OE) technologies.

The PENTAX i-Scan technology is 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.

In addition to i-Scan, OE is intended to provide alternative methods to improve blood vessel visibility by using band limited light illumination source. The OE technology emphasizes mucosal microvasculature and fine mucosal structures on the bronchial surface.

The following accessories are provided for use with the PENTAX Medical EPK-i7010 Video Processor and EB Family of Scopes:

. 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 highfrequency electro cautery device use with Pentax endoscopes.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes. However, it does not contain a table of acceptance criteria or a detailed study that proves the device meets specific performance acceptance criteria in terms of clinical efficacy or diagnostic accuracy.

The document focuses on demonstrating substantial equivalence to a predicate device (PENTAX Medical EPK-i5010 Video Processor with EB Family) and a reference device (PENTAX Medical EPK-i7010 Video Processor with GI Family), primarily through bench testing comparing optical parameters and a qualitative animal study to show similar visual experience.

Here's a breakdown of the requested information based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is NOT explicitly provided in a table format within the document. The document describes various tests performed but does not list specific numerical acceptance criteria for each test or a direct comparison demonstrating the device "meets" those criteria in a quantitative sense. Instead, it states that the performance of the subject and predicate devices are "equivalent" or show "similarity of visual experience."

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

Test Set Sample Size:
- Bench Testing (Optical): Not specified (e.g., number of scopes, measurements taken).
- Animal Testing: "A library of images was captured." The exact number of images or individual animal cases is not specified.
Data Provenance:
- Bench Testing: In-house testing, likely derived from laboratory measurements.
- Animal Testing: Porcine animal study (not human data). No specific country of origin is mentioned, but "PENTAX Medical performed a porcine animal study" implies it was conducted by the manufacturer or a contracted lab. The study type is prospective for the animal model.

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

This information is NOT provided. The studies described (bench testing and animal testing) do not mention the use of experts to establish a "ground truth" in a clinical diagnostic sense. The animal study focused on showing "similar visual experience" which would likely involve subjective assessment, but expert involvement and their qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is NOT provided. Given the nature of the tests described (bench and animal studies focusing on optical/visual similarity rather than diagnostic accuracy), a formal adjudication method like "2+1" or "3+1" for clinical ground truth establishment is not mentioned or applicable.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

No, an MRMC comparative effectiveness study was NOT done. This device is an endoscope video processor with image enhancement technologies (i-Scan and OE), not an AI-assisted diagnostic tool for which human reader improvement would typically be measured. The study focused on demonstrating optical equivalence and similar visual experience compared to a predicate device.

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

Not directly applicable in the typical sense of a diagnostic algorithm. The i-Scan and OE technologies are "imaging enhancement technologies" intended to be an "optional adjunct following traditional white light endoscopy." They are not standalone diagnostic algorithms that provide a diagnosis without human interpretation. The "performance testing" described (bench and animal) assesses the technical performance of the imaging system itself, not the diagnostic performance of the enhancement algorithms in a standalone mode.

7. The Type of Ground Truth Used

Bench Testing: Physical properties and measurements (e.g., signal-to-noise ratio, resolution, color accuracy, light distribution). The "ground truth" would be the standard physical measurements or specifications for these parameters.
Animal Testing: Visual observation of pig laryngeal anatomy. The "ground truth" here is the visual appearance of the anatomy as rendered by different processors, to assess "similarity of visual experience." It is not a pathological or outcomes-based ground truth for disease detection.

8. The Sample Size for the Training Set

This information is NOT provided and is not applicable. The document describes a video processor with image enhancement technologies, not a machine learning or AI-based system that would typically require a "training set" in the context of diagnostic algorithm development. The "software verification and validation" (IEC 62304:2006) refers to standard software engineering practices for medical devices, not machine learning model training.

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

This information is NOT provided and is not applicable. As noted above, this device does not appear to be an AI/ML system that requires a "training set" with established ground truth.

Summary

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July 3, 2018

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

Re: K173679

Trade/Device Name: PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) And Accessories Regulatory Class: Class II Product Code: EOO Dated: June 1. 2018 Received: June 4, 2018

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. 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 (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 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,

Michael J. Ryan -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) K173679

Device Name

PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes

Indications for Use (Describe)

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: 201-571-2318 Fax: 201-2340

Contact: William Goeller Date Prepared: November 8, 2017

II. DEVICE

Device Name	PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes
Common Name	Endoscopic Video Processor and Light Source
Classification Name	Endoscopic video imaging system/component
Regulation No.	21 CFR Part 874.4680
Regulation Name	Bronchoscopes (Flexible or Rigid) and accessories
Device Class	2

III. PREDICATE DEVICES

The PENTAX Medical EPK-i5010 Video Processor with EB Family (K143727) is the predicate device for this 510(k) Premarket Notification as the processors have the same intended use and the minor technology differences do not raise new issues of safety and effectiveness.

The PENTAX Medical EPK-i7010 Video Processor with GI Family (K150618) is utilized as a Reference Device for this 510(k) Premarket Notification as the processor is identical to the subject device.

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IV. DEVICE DESCRIPTION

The purpose of this 510(k) is to expand the indications for the PENTAX Medical EPK-i7010 Video Processor with GI Family (K150618) to include the PENTAX Video Bronchoscopes, EB Family (K131028): EB-1970TK, EB-1170K, EB-1570K, EB-1970K, EB-1575K, EB-1975K, EB -1990i).

The PENTAX Medical EPK-i7010 Video Processor contains PENTAX i-Scan and Optical Enhancement (OE) technologies.

The following accessories are provided for use with the PENTAX Medical EPK-i7010 Video Processor and EB Family of Scopes:

. 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 highfrequency electro cautery device use with Pentax endoscopes.

V. INDICATIONS FOR USE

The PENTAX Medical EPK-i7010 includes a digital post-processing imaging enhancement technology (PENTAX i-Scan™) and an 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 video bronchoscopes.

COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE

There are no differences between the subject and predicate devices with regard to intended use. Both subject and predicate devices are intended for illuminating the inside of the human body.

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The subject and predicate video processors have virtually identical indications for use and are substantially equivalent with regard to design, technological characteristics, energy used, performance, safety, and effectiveness.

The subject and reference processors are identical with regard to design, technological characteristics, energy used, performance, safety, and effectiveness. The sole difference is the addition of a bronchoscopic indication.

There are no significant differences in technical characteristics that raise new questions of safety and effectiveness. The data provided in this 510(k) Premarket Notification support the equivalence of the subject and predicate devices.

VI. PERFORMANCE DATA

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

a. Electrical Safety and Electromagnetic Compatibility (EMC)

The PENTAX Medical EPK-i7010 Video Processor and PENTAX Medical EB Family of Scopes were tested and comply with the following standards for electrical safety and EMC.

. CISPR 11:2009, A1:2010 Group 1 Class B
. IEC 61000-4-2:2008; IEC 61000-4-3:2006; A1:2007, A2:2010, IEC 61000-4-4:2012; IEC 61000-4-5:2005; IEC 61000-4-6:2013; IEC 61000-4-8:2009; IEC 61000-4-11:2004; IEC 61000-3-2:2014; IEC 61000-3-3:2013
IEC 60601-1-2:2007; IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012; IEC 60601-2-18:2009
ANSI/AAMI ES60601-1:2005 + A2:2010 + A1:2012 ●
IEC 62304:2006 ●
CAN/CSA-C22.2 NO. 60601-2-18:11

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

c. Performance Testing

Bench Testing

Optical testing was performed with the PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes, as well as PENTAX Medical EKP-i5010 with EB Family. 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.

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Animal Testing

PENTAX Medical performed a porcine animal study to show the similarity of visual experience of the PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes (subject) in comparison to PENTAX Medical EKP-i5010 Video Processor with EB Family (predicate).

A library of images was captured to show visual experience for both processors for white light images (WLE) and i-Scan images. Images of the pig larynx demonstrate similar visual experience between scopes.

VIII. CONCLUSION

The data submitted in support of the safety of the device and the hardware and software verification and validation demonstrate that the PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes performs as intended in the specified use conditions. The optical data analysis demonstrates the equivalence of the PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes to the predicate device. Furthermore, a porcine animal study shows the similarity of visual experience with PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes in comparison with 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

§ 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.