The VP-4440HD unit is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to process electronic signals transmitted from a video endoscope). This product may be used on all patients requiring endoscopic examination and when using a Fujinon/Fujifilm medical endoscope, light source, monitor, recorder and various peripheral devices. FICE is an adjunctive tool for gastromtestination which can be used to supplement FUJIFILM white light endoscopy. FICE is not intended to replace histopathological sampling as a means of diagnosis.

Device Description

This system is intended to be used in coniunction with Fuiifilm endoscopes to provide illumination, visual display and data storage during endoscopic procedures.

The EPX-4440HD Digital Video Processor with FICE and light source consists of three components used in conjunction with one another:

The VP-4440HD Video Processor: The Processor relays the image from the endoscope to a video monitor. Projection can be either analog or digital at the user's preference. The Processor incorporates internal or external digital storage capacity. The Processor also controls the light projected to the body cavity. The Processor provides for optional structural enhancement at the user's option. Spectral and structural enhancements are achieved through proprietary software. The device is AC operated at a power setting of 120V/60MzJ0.8A. The Processor is housed in a steel-polycarbonate case measuring 390x105x460mm.

The XL-4450 Light Source: The Fujinon/Fujifilm endoscope employs fiber bundles to transmit light from the light source and subsequently to the body cavity. The Light Source employs a 300W Xenon lamp with a 75W emergency back-up Halogen lamp. Brightness control is performed by the user. The device is AC operated at a power setting of 120V/60MzJ3.3A. The Light Source is housed in a steel-polycarbonate case measuring 390x155x450mm.

The DK-4440E Keyboard: The Keyboard is used to enter pertinent procedural information (patient, physician, date, etc.) for display on the video monitor and digital/analog storage systems. The Keyboard is also used to control operational features of the VP-4440HD Processor. The Keyboard resembles a standard computer keyboard in size and shape.

The VP-4440HD Digital Video Processor with FICE and light source is the same as the cleared EPX-4440HD Digital Video Processor and Light source (K102466) device, with the exception of the addition of the imaging algorithm termed "FICE" (Flexible spectral-Imaging Color Enhancement). As with the predicate device, the subject processor receives an image from the endoscope via a connector cable. The subject processor is capable of bi-directional communication that allows importation and exportation of various patient and procedural data between EMR (Electronic Medical Record) systems.

FICE is an image processing feature that a licensed medical practitioner (user) can utilize, as an adiunctive tool, to supplement the white light endoscopic examination. FICE extracts spectral images of specific wavelength components from the original full spectral (white light) image through an image processing algorithm that, assigns a spectral wavelength component in the Red (R), Green (G) and Blue (B) spectrum and displays the enhanced color image. FICE may enhance color contrast to improve visibility of the selected structures, borders of areas of interests.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance

Criterion	Acceptance Criteria (Implied)	Reported Device Performance
Non-clinical Performance
Software Validation	In accordance with IEC 62304	"All testing criteria were met, and in all instances the device functioned as intended."
Electrical Safety	In accordance with IEC 60601	"All testing criteria were met, and in all instances the device functioned as intended."
Functional Testing (FICE)	Contrast enhancement, dynamic range, resolution, noise, artifact creation, and color reproduction should meet specified levels/standards.	"All testing criteria were met, and in all instances the device functioned as intended."
Clinical Performance (Image Quality of FICE presets)	Image quality of each FICE preset should be at least comparable to optical filtering of the white light source (Olympus EVIS EXERA II 180 System's Narrow Band Imaging - NBI).	"Overall means between all readers demonstrated at least comparable image quality of each FICE setting in one or more locations within the gastrointestinal tract."

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

Test Set (Clinical Study): Each subject underwent two (2) gastrointestinal endoscopic examinations during a single clinical procedure. The document doesn't explicitly state the total number of subjects or individual images in the test set.
Data Provenance: Prospective clinical trial. The country of origin of the data is not specified.

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

Number of Experts: Multiple blinded investigators. The exact number is not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Images were analyzed independently by "multiple blinded investigators using a 4-point Likert scale." The document does not specify a formal adjudication method (e.g., 2+1, 3+1 consensus). It appears to rely on the "overall means between all readers."

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

MRMC Study: Yes, a reader concurrence study was performed, which is a type of MRMC study comparing FICE (an AI/image processing feature) to optical filtering (NBI).
Effect Size: The study aimed to establish "substantial equivalence of diagnostic visualization (e.g. image quality) to the predicate optical filtering method." The reported outcome is that "Overall means between all readers demonstrated at least comparable image quality of each FICE setting in one or more locations within the gastrointestinal tract." This indicates FICE performed similarly to or as well as NBI for image quality; a specific quantitative effect size of human reader improvement with AI assistance vs. without is not provided, as the study focused on comparability rather than improvement. The FICE feature itself is described as an "adjunctive tool," not necessarily a comprehensive AI diagnosis system.

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

Based on the provided text, the FICE feature is described as an "adjunctive tool for gastrointestinal endoscopic examination which can be used to supplement FUJIFILM white light endoscopy." The clinical study focused on readers evaluating image quality generated by FICE. There is no indication of a standalone performance study of the FICE algorithm without human interpretation.

7. The Type of Ground Truth Used

Type of Ground Truth: The clinical study compared the "overall image quality" observed by multiple blinded investigators using a Likert scale. This suggests a form of expert consensus/reader perception for image quality as the ground truth. It's important to note that the FICE feature is "not intended to replace histopathological sampling as a means of diagnosis," indicating that the "ground truth" for diagnosis in a clinical sense would still be pathology. However, for the purpose of this study measuring the effectiveness of the FICE image processing, reader evaluation of image quality served as the primary measure.

8. The Sample Size for the Training Set

The document describes performance testing for an image processing feature (FICE) which is integrated into a video processor. It does not explicitly mention a "training set" in the context of machine learning model development. This suggests the FICE algorithm might be based on pre-defined spectral filters or rule-based image processing rather than a deep learning model that requires a dedicated training set. If there was a training phase for the algorithm, its sample size is not disclosed.

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

As a dedicated "training set" is not mentioned and the FICE algorithm's nature isn't fully detailed as a deep learning model, the method for establishing ground truth for a training set is not applicable or not provided in this document.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.

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

August 22, 2014

FujiFilm Medical Systems U.S.A., Inc. Mary K. Moore Senior Director, Regulatory Affairs and Quality 10 High Point Drive Wayne, NJ 07470

Re: K140149

Trade/Device Name: EPX-4440HD Digital Video Processor with FICE and Light Source Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscopes and accessories Regulatory Class: II Product Code: PEA, FET, GCT Dated: July 18, 2014 Received: July 18, 2014

Dear Mary K. Moore,

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.

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.

{1}------------------------------------------------

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.

Herbert P. Lerner -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K140149

Device Name

EPX-4440HD Digital Video Processor with FICE and Light Source

Indications for Use (Describe)

Indications for Use (VP-4440HD with FICE):

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

ロ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

{3}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

K140149

510(k) SUMMARY

FUJIFILM Medical Systems U.S.A., Inc.'s EPX-4440HD Digital Video Processor with FICE and Light Source

Date: August 20, 2014

Submitter's Information:

FUJIFILM Medical Systems U.S.A., Inc., Endoscopy Division 10 High Point Drive Wayne, NJ 07470 USA FDA Establishment Registration Number: 2431293

Contact Persons:

Mary K. Moore Senior Director, Regulatory Affairs and Quality Assurance Telephone: (800) 385-4666 ext. 522498 Facsimile: (973) 686-2616 E-Mail: mkmoore@fujifilm.com

ldentification of the Proposed Device:

Proprietary/Trade Name: Fujifilm EPX-4440HD Video Processor with FICE and Light Source Common Name: Endoscopic Video Processor and Light Source Classification Information:

Classification Name	CFR Section	Product Codes
Endoscope, accessories, image post-processing for color enhancement	21 CFR 876.1500	PEA
Endoscopic Video ImagingSystem/Component, Gastroenterology-Urology.	21 CFR 876.1500	FET
Light source, Endoscope, Xenon Arc	21 CFR 876.1500	GCT

Predicate Devices:

Fujifilm Medical Systems U.S.A., Inc.'s EPX-4440HD Digital Video Processor and Light Source (K102466)
. Olympus Medical Systems Corp.'s EVIS EXERA II 180 System (K100584)

{5}------------------------------------------------

Indications for Use

Indications for Use (VP-4440HD with FICE):

The VP-4440HD unit is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to process electronic signals transmitted from a video endoscope (a video camera in an endoscope). This product may be used on all patients requiring endoscopic examination and when using a Fujinon/Fujifilm medical endoscope, light source, monitor, recorder and various peripheral devices. FICE is an adjunctive tool for gastrointestinal endoscopic examination which can be used to supplement FUJIFILM white light endoscopy. FICE is not intended to replace histopathological sampling as a means of diagnosis.

Device Description

This system is intended to be used in coniunction with Fuiifilm endoscopes to provide illumination, visual display and data storage during endoscopic procedures.

The EPX-4440HD Digital Video Processor with FICE and light source consists of three components used in conjunction with one another:

{6}------------------------------------------------

importation and exportation of various patient and procedural data between EMR (Electronic Medical Record) systems.

Performance Testing

Non-clinical testing:

The EPX-4440HD Digital Video Processor is non-sterile and has no potential for patient contact. Testing of the VP-4440HD with FICE consisted of software validation in accordance with IEC 62304 and electrical safety in accordance with IEC 60601 requirements. Functional testing of the FICE image processing feature included contrast enhancement, dynamic range, resolution, noise, artifact creation, and color reproduction. All testing criteria were met, and in all instances the device functioned as intended.

Clinical testing:

The FICE feature was evaluated in a prospective clinical trial to objectively assess the overall image quality of each of the FICE presets in comparison to optical filtering of the white light source. The study design was a reader concurrence study designed in accordance with the FDA document "Guidance on Solid State X-ray Imaging Devices, and consisted of two parts: (1) acquisition of images; and (2) reader study. Each subject underwent two (2) gastrointestinal endoscopic examinations during a single clinical procedure, one with the Olympus EVIS EXERA II 180 System (White Light Imaging (WLI) and Narrow Band Imaging (NBI)), and one with the subject Fuiifilm EPX-4440HD Digital Video Processor and compatible videoendoscope (WLI and all 10 FICE modes). Images were taken from different anatomic locations within the gastrointestinal tract (i.e., colon, duodenum, esophagus, or gastric region), and analyzed independently by multiple blinded investigators using a 4-point Likert scale. The goal of the clinical study was to establish that FICE demonstrated substantial equivalence of diagnostic visualization (e.g. image quality) to the predicate optical filtering method through a direct comparison between the two imaging modalities. Overall means between all readers demonstrated at least comparable image quality of each FICE setting in one or more locations within the gastrointestinal tract."

Substantial Equivalence

The EXP-4440HD Digital Video Processor with FICE and Light Source is substantially equivalent to the EXP-4440HD Digital Video Processor and Light Source and the Olympus EVIS EXERA II 180 System. The EXP-4440HD Digital Video Processor with FICE and Light Source has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the EXP-4440HD Digital Video Processor with FICE and Light Source and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the EXP-4440HD Digital Video Processor with FICE and Light Source is as safe and effective as the EXP-4440HD Digital Video Processor and

{7}------------------------------------------------

Light Source and the Olympus EVIS EXERA II 180 System. Thus, the EXP-4440HD Digital Video Processor with FICE and Light Source is substantially equivalent.

Conclusions:

The Fujifilm EPX-440HD Digital Video Processor with FICE and Light Source is substantially equivalent to similar legally marketed devices and conforms to applicable medical device safety and performance standards.

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.