Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes image processing techniques (BLI, LCI, FICE) achieved through "proprietary software" and evaluated through a reader study comparing image quality to a predicate device. There is no mention of AI, ML, or related concepts like training/test sets for algorithmic learning.

Therapeutic

No

The device is intended for endoscopic observation, diagnosis, and image recording, and is explicitly stated as an "adjunctive tool for gastrointestinal endoscopic examination." It does not directly provide therapy or treatment.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that the VP-7000 unit is used for "endoscopic observation, diagnosis, treatment, and image recording." It also mentions features like BLI, LCI, and FICE as "adjunctive tools for gastrointestinal endoscopic examination," which are clearly aimed at aiding diagnosis, even if they don't replace histopathological sampling.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components: the VP-7000 Video Processor and the BL-7000 Light Source, both housed in physical cases with specific dimensions and power requirements. While the VP-7000 utilizes proprietary software for image enhancement, it is an integral part of a larger hardware system.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The VP-7000 and BL-7000 are used for endoscopic observation, diagnosis, treatment, and image recording. They process and illuminate images from inside the body using an endoscope. This is an in vivo (within the living body) procedure, not an in vitro (outside the living body) test.
Intended Use: The intended use clearly states it's for endoscopic examination and processing signals from a video endoscope.
Device Description: The description details how the device processes images from the endoscope and provides light for the procedure.
Performance Studies: The performance study described is a clinical trial evaluating image quality during endoscopic procedures, not a study on the performance of a diagnostic test on biological samples.

Therefore, the VP-7000 and BL-7000 system falls under the category of medical devices used for imaging and visualization within the body, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Processor VP-7000

The VP-7000 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 and light source together with monitor, recorder and various peripheral devices. BLI (Blue Light Imaging), LCI (Linked Color Imaging) and FICE (Flexible spectral-Imaging Color Enhancement) are adjunctive tools for gastrointestinal endoscopic examination which can be used to supplement Fujifilm white light endoscopy. BLI, LCI and FICE are not intended to replace histopathological sampling as a means of diagnosis.

Light Source BL-7000

The BL-7000 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 a Fujinon/FUJIFILM medical endoscope and video processor together with monitor, recorder and various peripheral devices.

Product codes (comma separated list FDA assigned to the subject device)

FET, NTN, NWB, PEA

Device Description

VP-7000 and BL-7000 are intended to be used in conjunction with Fujinon/FUJIFILM endoscopes for endoscopic observation, diagnosis, treatment, and image recording. The description for each of the components of the subject device is below:

The VP-7000 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 digital storage capacity. The Processor also controls the light projected to the body cavity. The Processor provides for optional structural enhancement through user modes FICE, BLI, BLI-bright and LCI. Spectral and structural enhancements are achieved through proprietary software. The device is AC operated at a power setting of 100-240V/50-60Hz/0.8-0.5A. The Processor is housed in a steel-polycarbonate case measuring 390x110x485mm.

The DK-7000E Keyboard is a standard accessory of VP-7000. It 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-7000 Processor. The Keyboard resembles a standard computer keyboard, and is provided with an instruction label attached to it.

The BL-7000 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 79.2W 4 LED lamps. Brightness control is performed by the user. The device is AC operated at a power setting of 100-240V/50-60Hz/1.2-0.7A. The Light Source is housed in a steel-polycarbonate case measuring 390x155x485mm.

Mentions image processing

Yes. "Spectral and structural enhancements are achieved through proprietary software." and "The VP-7000 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)." and "BLI (Blue Light Imaging), LCI (Linked Color Imaging) and FICE (Flexible spectral-Imaging Color Enhancement) are adjunctive tools for gastrointestinal endoscopic examination which can be used to supplement Fujifilm white light endoscopy." and "VP-7000 and BL-7000 are the same as the cleared EPX-4440HD Digital Video Processor with FICE and Light source (K140149) device, with the exception of additional image processing options termed as "BLI" (Blue Light Imaging) and LCI (Linked Color Imaging) for providing image enhanced endoscopy adjunct to white light imaging (WLI)." and "BLI and LCI are image processing features that a licensed medical practitioner (user) can utilize, as adjunctive tools, to supplement the white light endoscopic examination." and "Functional testing of the FICE, BLI-bright and LCI image processing features included Contrast Enhancement (or Color and Contrast Enhancement), Resolving Power, Noise, Artifact Creation, and Color Reproduction."

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Video endoscopy

Anatomical Site

Gastrointestinal tract (i.e., colon, duodenum, esophagus, or gastric region)

Indicated Patient Age Range

All patients

Intended User / Care Setting

Licensed medical practitioner, clinical setting.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

The BLI and BLI-bright features were evaluated in a prospective clinical trial to objectively assess the overall image quality of each of the BLI and BLI-bright presets in comparison to the FICE presets (K140149). 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 (patient) underwent an endoscopic examination using VP-7000 Video Processor. BL-7000 Light Source and FUJIFILM's video endoscopes during a single clinical procedure, first with white light imaging (WLI), followed by an examination with FICE, BLI and BLI-bright imaging. The 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.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical testing:
Testing of the VP-7000 consisted of software validation in accordance with IEC 62304 and electrical safety in accordance with IEC 60601 requirements. Functional testing of the FICE, BLI-bright and LCI image processing features included Contrast Enhancement (or Color and Contrast Enhancement), Resolving Power, Noise, Artifact Creation, and Color Reproduction. All testing criteria were met, and in all instances the device functioned as intended.

Clinical testing:
The BLI and BLI-bright features were evaluated in a prospective clinical trial to objectively assess the overall image quality of each of the BLI and BLI-bright presets in comparison to the FICE presets (K140149). 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 (patient) underwent an endoscopic examination using VP-7000 Video Processor. BL-7000 Light Source and FUJIFILM's video endoscopes during a single clinical procedure, first with white light imaging (WLI), followed by an examination with FICE, BLI and BLI-bright imaging. The 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 clinical study established that BLI and BLI-bright demonstrated substantial equivalence of diagnostic visualization (e.g. image quality) to the predicate FICE.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found. The clinical study established that BLI and BLI-bright demonstrated substantial equivalence of diagnostic visualization (e.g. image quality) to the predicate FICE.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K140149, K122831

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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

April, 25, 2017

FUJIFILM Medical System U.S.A., Inc. Shraddha S More Specialist. Regulatory Affairs and Quality Assurance 10 High Point Drive Wayne, NJ 07470

Re: K163675

Trade/Device Name: FUJIFILM Processor VP-7000 and Light source BL-7000 Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Codes: FET, NTN, NWB, PEA Dated: March 21, 2017 Received: March 21, 2017

Dear Shraddha S More:

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 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,

Benjamin R. Fisher -S

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

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Indications for Use

510(k) Number (if known) K163675

Device Name

FUJIFILM Processor VP-7000 and Light source BL-7000

Indications for Use (Describe)

Processor VP-7000

The VP-7000 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 and light source together with monitor, recorder and various peripheral devices.

BLI (Blue Light Imaging), LCI (Linked Color Imaging) and FICE (Flexible spectral-Imaging Color Enhancement) are adjunctive tools for gastrointestinal endoscopic examination which can be used to supplement Fujifilm white light endoscopy.

BLI, LCI and FICE are not intended to replace histopathological sampling as a means of diagnosis.

Light Source BL-7000

The BL-7000 Light Source is used for endoscopic observation, diagnosis, treatment, and image recording, If 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 obtaining clear visualization to facilitate diagnostic examination.

This product may be used on all patients requiring endoscopic examination and when using a Fujinon/FUJIFILM medical endoscope and video processor together with monitor, recorder and various peripheral devices.

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

FUJIFILM Processor VP-7000 and Light Source BL-7000

Date: March 21, 2017

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 Person:

Shraddha More Specialist, Regulatory Affairs and Quality Assurance Telephone: (973) 686-2627 Facsimile: (973) 633-8818 E-Mail: smore@fujifilm.com

Identification of the Proposed Device:

Proprietary/Trade Name: Common Name: Device Class: Review Panel:

FUJIFILM Processor VP-7000 and Light Source BL-7000 Endoscopic Video Imaging System/Component Class II Gastroenterology and Urology

Classification Information:

Classification Name	CFR Section	Product Codes
Endoscopic Video Imaging System/Component,
Gastroenterology- Urology	21 CFR 876.1500	FET
Led Light source, Endoscope and accessories	21 CFR 876.1500	NTN
Endoscope and accessories, Narrow Band
Spectrum	21 CFR 876.1500	NWB
Endoscope, Accessories, Image Post-Processing
For Color Enhancement	21 CFR 876.1500	PEA

Predicate Device

Primary: Fujifilm EPX-4440HD Digital Video Processor with FICE and Light Source ● (K140149)
Secondary: Olympus Video System Center CV-170 (K122831) ●

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Device Description

VP-7000 and BL-7000 are intended to be used in conjunction with Fujinon/FUJIFILM endoscopes for endoscopic observation, diagnosis, treatment, and image recording. The description for each of the components of the subject device is below:

The VP-7000 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 digital storage capacity. The Processor also controls the light projected to the body cavity. The Processor provides for optional structural enhancement through user modes FICE. BLI. BLI-bright and LCI. Spectral and structural enhancements are achieved through proprietary software. The device is AC operated at a power setting of 100-240V/50-60Hz/0.8-0.5A. The Processor is housed in a steelpolycarbonate case measuring 390x110x485mm.

The DK-7000E Keyboard is a standard accessory of VP-7000. It 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-7000 Processor. The Keyboard resembles a standard computer keyboard, and is provided with an instruction label attached to it.

The BL-7000 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 79.2W 4 LED lamps. Brightness control is performed by the user. The device is AC operated at a power setting of 100-240V/50-60Hz/1.2-0.7A. The Light Source is housed in a steel-polycarbonate case measuring 390x155x485mm.

Intended Use / Indications for Use

Processor VP-7000

The VP-7000 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 and light source together with monitor, recorder and various peripheral devices.

BLI (Blue Light Imaging), LCI (Linked Color Imaging) and FICE (Flexible spectral-Imaging Color Enhancement) are adjunctive tools for qastrointestinal endoscopic examination which can be used to supplement Fujifilm white light endoscopy.

BLI, LCI and FICE are not intended to replace histopathological sampling as a means of diagnosis.

Light Source BL-7000

The BL-7000 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.

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This product may be used on all patients requiring endoscopic examination and when using a Fujinon/FUJIFILM medical endoscope and video processor together with monitor, recorder and various peripheral devices.

Summary of Technological Characteristics

The differences between the technological characteristics of the subject device and predicate devices are provided in the table below.

VP-7000 and BL-7000 are the same as the cleared EPX-4440HD Digital Video Processor with FICE and Light source (K140149) device, with the exception of additional image processing options termed as "BLI" (Blue Light Imaging) and LCI (Linked Color Imaging) for providing image enhanced endoscopy adjunct to white light imaging (WLI). As with the EPX-440HD 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 of various patient and procedural data between EMR (Electronic Medical Record) systems.

BLI and LCI are image processing features that a licensed medical practitioner (user) can utilize, as adjunctive tools, to supplement the white light endoscopic examination. The BLI and LCI features of VP-7000 and BL-7000 use narrow band short wavelength LED lights for outputting the spectrum image. BLI mode produces higher-contrast images of micro vessels by increasing the intensity ratio of the Violet LED light relatively as compared with WLI mode. BLI-bright mode can create brighter images than BLI, by slightly decreasing the intensity ratio of the Violet LED light relatively as compared with WLI mode. LCI mode produces enhanced mucous color by signal processing and increases the ratio of the Violet LED light relatively as compared with WLI mode.

The technological characteristics of BL-7000 are substantially equivalent to the predicate EPX-4440HD light source, except that it uses LED lights (like the CV-170) rather than Xenon lights.

Performance Data

Non-clinical testing:

VP-7000 and BL-7000 have no potential for patient contact. Therefore, biocompatibility testing for the subject device is not applicable.

Testing of the VP-7000 consisted of software validation in accordance with IEC 62304 and electrical safety in accordance with IEC 60601 requirements. Functional testing of the FICE, BLI-bright and LCI image processing features included Contrast Enhancement (or Color and Contrast Enhancement), Resolving Power, Noise, Artifact Creation, and Color Reproduction. All testing criteria were met, and in all instances the device functioned as intended.

Clinical testing:

The BLI and BLI-bright features were evaluated in a prospective clinical trial to objectively assess the overall image quality of each of the BLI and BLI-bright presets in comparison to the FICE presets (K140149). 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 (patient) underwent an endoscopic examination using VP-7000 Video Processor. BL-7000 Light Source and FUJIFILM's video endoscopes during a single clinical procedure, first with white light imaging (WLI), followed by an

6

examination with FICE, BLI and BLI-bright imaging. The 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 clinical study established that BLI and BLI-bright demonstrated substantial equivalence of diagnostic visualization (e.g. image quality) to the predicate FICE.

Conclusions

FUJIFILM Processor VP-7000 and Light Source BL-7000 are substantially equivalent to their predicate devices, the EXP-4440HD Digital Video Processor with FICE and Light Source system (K140149) and the Olympus Video System Center CV-170 (K122831). VP-7000 and BL-7000 have the same intended use and similar indications, technological characteristics, and principles of operation as their predicate devices. The minor technological differences between VP-7000 and BL-7000 and their predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that Processor VP-7000 and Light Source BL-7000 are as safe and effective as the EXP-4440HD Digital Video Processor with FICE and Light source.

Thus, VP-7000 and BL-7000 are substantially equivalent to their predicate devices.

| Device | Parameters | Primary
Predicate:
Fujifilm EPX-
4440HD Digital
Video Processor
with FICE and
Light Source | Secondary Predicate:
OLYMPUS CV-170
VIDEO CENTER | Subject Device:
FUJIFILM processor
VP-7000 and Light
source BL-7000 |
|---------------------|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | | K140149 | K122831 | K163675 |
| Indications for Use | | The VP-4440 HD
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 | This video system center
is intended to be used
with OLYMPUS video
converter, camera heads,
endoscopes, monitors,
EndoTherapy
accessories, and other
ancillary equipment for
endoscopic diagnosis,
treatment, and video
observation. | Processor VP-7000
The VP-7000 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 |
| Device | Parameters | Primary
Predicate:
Fujifilm EPX-
4440HD Digital
Video Processor
with FICE and
Light Source | Secondary Predicate:
OLYMPUS CV-170
VIDEO CENTER | Subject Device:
FUJIFILM processor
VP-7000 and Light
source BL-7000 |
| | | endoscope, light
source, monitor,
recorder and
various peripheral
devices. FICE is an
adjunctive tool
which can be used
to supplement
FUJIFILM white
light endoscopy.
FICE is not
intended to replace
histopathological
sampling as a
means of
diagnosis. | | medical endoscope and
light source together
with monitor, recorder
and various peripheral
devices.

BLI (Blue Light
Imaging), LCI (Linked
Color Imaging) and
FICE (Flexible spectral-
Imaging Color
Enhancement) are
adjunctive tools for
gastrointestinal
endoscopic examination
which can be used to
supplement Fujifilm
white light endoscopy.

BLI, LCI and FICE are
not intended to replace
histopathological
sampling as a means of
diagnosis.

Light Source BL-7000
The BL-7000 Light
Source is used for
endoscopic observation,
diagnosis, treatment,
and image recording. It
is intended to provide
illumination to an
endoscope.

Comparison between the Subject Device and Predicate Devices

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*Not Available In USA