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 Fujinon medical Endoscope, light source, monitor, recorder and various peripheral devices.

The XL-4450 light source is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to provide illumination to an endoscope. The light source also functions as a pump to supply air through the endoscope while inside the body to assist in obtaining clear visualization to facilitate diagnostic examination. This product may be used on all patients requiring endoscopic examination and when using Fujinon medical Endoscope, video processor, monitor, recorder and various peripheral devices.

Device Description

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

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

The VP-440HD 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 also incorporates internal or external digital storage capacity. The Processor also controls the light projected to the body cavity. The Processor also 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/60MzJO.8A. The Processor is housed in a steel-polycarbonate case measuring 390X105X460mm.

The XL-4450 Light Source: The Fujinon 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 Processor is housed in a steel-polycarbonate case measuring 390X155X485mm.

The DK-440E 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Fujinon EPX-4440HD Digital Video Processor:

NOTE: The provided 510(k) summary focuses primarily on the safety and performance aspects of a modified device compared to a predicate device, rather than defining and proving specific acceptance criteria in the way one might for a novel AI/software-as-a-medical-device (SaMD) product. The "acceptance criteria" discussed are more about meeting established regulatory and engineering standards, and the "study" is functional testing with physician evaluators for general performance and safety.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance (as per document)
Software Validation	All testing criteria were met.
Electrical Safety	All testing criteria were met (in accordance with IEC 60601 requirements).
Performance Testing (Functional)	"Functional testing consisting of visual comparison tests were conducted using physician evaluators. In all cases they passed the required testing regimens."
Predicate Equivalence	The sponsor believes the modified device maintains the same safety and performance levels as the previous generation processor.

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

Sample Size for Test Set: Not explicitly stated. The document mentions "physician evaluators" without specifying how many cases, images, or evaluation instances were part of their assessment.
Data Provenance: Not explicitly stated. The context suggests general functional testing, likely performed in a controlled environment by the manufacturer. It does not mention country of origin or whether clinical patient data was used. It's likely simulated or controlled test conditions given the nature of the evaluation.
Retrospective/Prospective: Not explicitly stated, but given it's functional testing for a device modification, it would typically be a prospective evaluation of the new device's capabilities in a controlled setting.

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

Number of Experts: Not explicitly stated. The document refers to "physician evaluators" (plural), but the exact number is not provided.
Qualifications of Experts: Not explicitly stated beyond "physician evaluators." No specialty (e.g., gastroenterologist who performs endoscopy) or years of experience are listed.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly stated. The statement "In all cases they passed the required testing regimens" suggests a unanimous agreement or a pass/fail criterion that was met by all evaluators, rather than a formal adjudication process between conflicting interpretations.

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

Was an MRMC study done? No, a traditional MRMC comparative effectiveness study as typically understood for AI algorithms (i.e., comparing human readers with and without AI assistance on diagnostic accuracy) was not performed. The study mentioned was a functional performance test for a hardware/software update, not an AI-assisted diagnostic tool.
Effect size of human readers with vs. without AI assistance: Not applicable, as no such study was conducted.

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

Was a standalone study done? Yes, in a sense. The "software validation" and "electrical safety" testing would represent a standalone evaluation of the device's technical functionality. The "performance testing using physician evaluators" also tested the device itself, although with human interaction. However, this is not an AI algorithm performing a diagnostic task. The spectral and structural enhancements are "achieved through proprietary software," implying an algorithm, but its performance was evaluated by physicians using the system, not as a standalone diagnosis.

7. Type of Ground Truth Used

Type of Ground Truth: For the "visual comparison tests conducted using physician evaluators," the ground truth was essentially the expert opinion/consensus of the physician evaluators regarding the successful functionality and acceptable image quality produced by the system. This is not pathology, outcomes data, or a pre-established clinical diagnosis.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is a video processor and light source, not a machine learning model that requires a "training set" in the conventional AI sense. While there is proprietary software for "spectral and structural enhancements," the document does not describe the development of this software in terms of machine learning training, but rather as a feature set of the device.

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

How Ground Truth for Training Set Was Established: Not applicable, as there is no mention of a training set for a machine learning model. If the "proprietary software" involved some form of learned enhancement, the document does not provide details on how such a model would have been trained or its ground truth established.

Summary

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510(k) Summary -

Fuiinon EPX-4440 HD Digital Video Processor

MAY 25 2011

Date Prepared: May 25, 2011

Sponsor:

Fujinon, Inc. 10 High Point Drive Wavne, NJ 07474

Contact:

Gina Walljasper Director, Quality and Regulatory Compliance Tel: (973) 633-5600 Fax: (973) 633-8818 E-mail: gina walljasper@fujinon.com

Trade name: Fujinon EPX-4440HD Video Processor and Light Source

Common name: Endoscopic Video Processor and Light Source

Classification name:

Endoscopic Video Imaging System/Component, Gastroenterology-Urology (Product Code FET) and Light Source, Endoscope, Xenon Arc (Product Code GCT)
Both product codes are covered under 21 CFR 876.1500
Predicate device(s): Fujinon 400 Series (K944620)

Device description:

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

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

The VP-440HD 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

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preference. The Processor also incorporates internal or external digital storage capacity. The Processor also controls the light projected to the body cavity. The Processor also 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/60MzJO.8A. The Processor is housed in a steel-polycarbonate case measuring 390X105X460mm.

Intended Use(s):

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 Fujinon medical Endoscope. light source, monitor, recorder and various peripherals.

The XL-4450 light source is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to provide illumination to an endoscope. The light source also functions as a pump to supply air through the endoscope while inside the body to assist in obtaining clear visualization to facilitate diagnostic examination. This product may be used on all patients requiring endoscopic examination and when using Fujinon medical Endoscope, digital video processor, monitor, recorder and various peripherals.

Technological characteristics: The subject device is a modification of the current Fujinon Video Processor. Basic technological characteristics have not changed. The Video Processor, Light Source and Keyboard remain essentially unchanged from the predicate device with the exception of additional cabling connections. The processor has been updated to allow for both digital and analog outputs. Previously these outputs were analog only with no digital storage capacity. Digital storage capability can be achieved by on-site storage (internal or CF card) or off-site (Ethernet).

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The Processor now incorporates a new connector for the 500 series of Fujinon endoscopes as well as the original series 400 scopes. The above changes were made for the purposes of user preference and general technological advancement: they were not the result of product recalls or · adverse events.

Non-clinical testing:

The EPX-4440HD Digital Video Processor is non-sterile and has no potential for patient contact. Testing of the VP-4440HD consisted of software validation electrical safety in accordance with IEC 60601 requirements and performance testing using physician evaluators. All testing criteria were met.

Non-clinical testing of the subject device consisted of electrical testing in accordance with IEC 60601 requirements, software validation in accordance with IEC 62304 requirements and physician evaluation of the spectral enhancement capability. Functional testing consisting of visual comparison tests were conducted using physician evaluators. In all cases they passed the required testing regimens. The sponsor believes that the testing regimen demonstrates the continued safety of the subject device.

Clinical testing:

NA

Conclusions:

Modifications to the predicate device consisted of:

Software additions: Allowing for either digital or analog outputs Addition of optional digital memory storage Adding an additional port for acceptance of newer generation endoscopes

Changes to the endoscopes were made for purposes of ergonomics and user, preferences. The changes were not made for reasons of product safety or adverse events.

Testing was performed to demonstrate the continued electrical safety of the device and the reliability of the software. The sponsor believes that the modified device maintains the same safety and performance levels as the previous generation processor while adding additional features for user convenience.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

Fujinon, Inc. c/o Robert Schiff, Ph.D., RAC, CQA, FRAPS Regulatory Affairs Consultant Schiff & Company, Inc. 1129 Bloomfield Avenue WEST CALDWELL NJ 07006

MAY 25 2011

Re: K102466

Trade/Device Name: Fujinon EPX-4440HD Digital Processor and Light Source Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FET and GCT Dated: May 19, 2011 Received: May 20, 2011

Dear Dr. Schiff:

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. 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

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Page 2

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,

Michael Lemon MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications For Use Statement

510(k) Number (If known): K102466

EPX-4440HD Digital Video Processor and Light Source Device Name:

Indications for Use (VP-4440HD):

Indications for Use (XL-4450):

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off)

Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K102466

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.