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.

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.

AI/ML Overview

The provided document describes the FUJIFILM Processor VP-7000 and Light Source BL-7000 and its substantial equivalence to predicate devices, particularly focusing on the performance data for its new imaging features (BLI and BLI-bright).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with quantitative metrics for the clinical performance of the device's enhanced imaging modes (BLI, BLI-bright). Instead, it states that "All testing criteria were met" for non-clinical functional tests and for clinical evaluation, "The clinical study established that BLI and BLI-bright demonstrated substantial equivalence of diagnostic visualization (e.g. image quality) to the predicate FICE."

The primary goal of the clinical study was to demonstrate substantial equivalence of diagnostic visualization (image quality) compared to the FICE predicate. While a specific numerical acceptance criterion isn't given, the statement implies that the image quality was not worse than FICE, which was already a cleared device.

Acceptance Criteria (Implied)	Reported Device Performance
Non-clinical:
Software validation (IEC 62304)	All testing criteria were met.
Electrical safety (IEC 60601)	All testing criteria were met.
Functional testing of FICE, BLI-bright, LCI image processing features (Contrast Enhancement, Resolving Power, Noise, Artifact Creation, Color Reproduction)	All testing criteria were met, and in all instances the device functioned as intended.
Clinical:
Substantial equivalence of diagnostic visualization/image quality to predicate FICE (for BLI and BLI-bright)	BLI and BLI-bright demonstrated substantial equivalence of diagnostic visualization (e.g. image quality) to the predicate FICE.

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

Sample Size: The document does not specify the exact number of subjects (patients) or images in the clinical study's test set. It mentions each subject underwent an endoscopic examination using the VP-7000, BL-7000, and FUJIFILM's video endoscopes.
Data Provenance: The study was a "prospective clinical trial." The country of origin for the data is not explicitly stated, but given the FDA filing, it is likely that parts, if not all, of the data were collected in the United States or under similar clinical standards.

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

Number of Experts: The clinical study involved "multiple blinded investigators." The exact number is not specified.
Qualifications of Experts: The qualifications of these "investigators" are not detailed in the provided text. It can be inferred they are medical professionals qualified to interpret endoscopic images, but specific credentials (e.g., gastroenterologists, radiologists) or years of experience are not mentioned.

4. Adjudication Method for the Test Set

The study design was a "reader concurrence study." Images were "analyzed independently by multiple blinded investigators." It is not explicitly stated how discrepancies among readers were resolved or if a formal adjudication process (e.g., 2+1, 3+1) was used to establish a final ground truth for each image, beyond simply analyzing reader agreement (concurrence).

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

An MRMC-like study was performed in the sense that multiple readers evaluated multiple cases. However, this study was not a comparative effectiveness study designed to assess how much human readers improve with AI vs. without AI assistance.
The BLI, LCI, and FICE features are described as "adjunctive tools for gastrointestinal endoscopic examination which can be used to supplement Fujifilm white light endoscopy." They are image processing features, not necessarily "AI" in the modern sense (e.g., providing diagnostic suggestions).
The study's goal was to establish "substantial equivalence of diagnostic visualization (e.g. image quality) to the predicate FICE," not an improvement in human reader performance or diagnostic accuracy per se. Therefore, no effect size for human reader improvement with AI assistance is reported.

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

No standalone performance was reported in this document. The BLI, LCI, and FICE features are image processing enhancements intended to be used by a "licensed medical practitioner (user)" as "adjunctive tools" to "supplement" white light endoscopy. They are not presenting a standalone diagnostic output that would require a separate "algorithm only" performance evaluation.

7. The Type of Ground Truth Used

The document states that the clinical study evaluated "overall image quality" and "diagnostic visualization."
The images were analyzed independently by multiple blinded investigators using a "4-point Likert scale." This suggests that the ground truth for image quality/diagnostic visualization was established through expert consensus/opinion based on their scoring.
The document explicitly states: "BLI, LCI and FICE are not intended to replace histopathological sampling as a means of diagnosis." This indicates that histopathology was not the ground truth against which the image enhancements were directly evaluated for diagnostic accuracy outcomes.

8. The Sample Size for the Training Set

The document does not specify a separate training set. The BLI, LCI, and FICE enhancements are described as "achieved through proprietary software" and based on "signal processing" and manipulation of LED light intensity ratios. This suggests these are pre-defined image processing algorithms rather than machine learning models that require a distinct training set in the typical sense of AI development.

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

As no explicit training set for a machine learning model is mentioned, the concept of "ground truth for the training set" does not directly apply in the context of the information provided for these specific image processing features. The development of these enhancements would likely have involved engineering and optical principles to achieve desired visual effects, rather than a data-driven training process with established clinical ground truth labels.

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.

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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.

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.

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 BandSpectrum	21 CFR 876.1500	NWB
Endoscope, Accessories, Image Post-ProcessingFor 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

The VP-7000 Video Processor:

The BL-7000 Light Source:

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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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

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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	PrimaryPredicate:Fujifilm EPX-4440HD DigitalVideo Processorwith FICE andLight Source	Secondary Predicate:OLYMPUS CV-170VIDEO CENTER	Subject Device:FUJIFILM processorVP-7000 and Lightsource BL-7000
510(k) number		K140149	K122831	K163675
Indications for Use		The VP-4440 HDunit is used forendoscopicobservation,diagnosis,treatment, andimage recording. Itis intended toprocess electronicsignals transmittedfrom a videoendoscope (avideo camera in anendoscope). Thisproduct may beused on all patientsrequiringendoscopicexamination andwhen using aFujinon/Fujifilmmedical	This video system centeris intended to be usedwith OLYMPUS videoconverter, camera heads,endoscopes, monitors,EndoTherapyaccessories, and otherancillary equipment forendoscopic diagnosis,treatment, and videoobservation.	Processor VP-7000The VP-7000 unit isused for endoscopicobservation, diagnosis,treatment, and imagerecording.It is intended to processelectronic signalstransmitted from a videoendoscope (a videocamera in anendoscope).This product may beused on all patientsrequiring endoscopicexamination and whenusing aFujinon/FUJIFILM
Device	Parameters	PrimaryPredicate:Fujifilm EPX-4440HD DigitalVideo Processorwith FICE andLight Source	Secondary Predicate:OLYMPUS CV-170VIDEO CENTER	Subject Device:FUJIFILM processorVP-7000 and Lightsource BL-7000
		endoscope, lightsource, monitor,recorder andvarious peripheraldevices. FICE is anadjunctive toolwhich can be usedto supplementFUJIFILM whitelight endoscopy.FICE is notintended to replacehistopathologicalsampling as ameans ofdiagnosis.		medical endoscope andlight source togetherwith monitor, recorderand various peripheraldevices.BLI (Blue LightImaging), LCI (LinkedColor Imaging) andFICE (Flexible spectral-Imaging ColorEnhancement) areadjunctive tools forgastrointestinalendoscopic examinationwhich can be used tosupplement Fujifilmwhite light endoscopy.BLI, LCI and FICE arenot intended to replacehistopathologicalsampling as a means ofdiagnosis.Light Source BL-7000The BL-7000 LightSource is used forendoscopic observation,diagnosis, treatment,and image recording. Itis intended to provideillumination to anendoscope.The light source alsofunctions as a pump tosupply air through theendoscope while insidethe body to assist inobtaining clearvisualization to facilitatediagnostic examination.This product may be
Device	Parameters	PrimaryPredicate:Fujifilm EPX-4440HD DigitalVideo Processorwith FICE andLight Source	Secondary Predicate:OLYMPUS CV-170VIDEO CENTER	Subject Device:FUJIFILM processorVP-7000 and Lightsource BL-7000
				used on all patientsrequiring endoscopicexamination and whenusing aFujinon/FUJIFILMmedical endoscope andvideo processortogether with monitor,recorder and variousperipheral devices.
Processor		VP-4440HD	CV-170	VP-7000
	Power Rating	120V AC60Hz0.8A	100-240V AC50/60Hz200VA	100-240V AC50/60Hz0.8-0.5A
	CompatibleEndoscope	400 System Scope500 System Scope600 System Scope	100/130/140/150/160/180Series and GI/BF/VISERA Series scope	500 System Scope600 System Scope700* System Scope (notavailable in USA)
	Keyboard	DK-4440E	MAJ-1981	DK-7000E
	Bi-Directioncommunication	Available	Unknown	Available
	Peripheral	Printer	Printer	Printer
	Digital Output	HD-SDI:HDTV1080iDVI(Digital VisualInterface)Ethernet	HD-SDISD-SDIDVI(Digital VisualInterface)	HD-SDI:HDTV 1080iDVI(Digital VisualInterface)Ethernet
	Analog Output	RGB, Y/C,Composite	RGB, Y/C, Composite,Y/PbPr, VBS	RGB, Y/C, Composite
	Analog Input	Not available	Not available	Composite
	ColorAdjustment	Black, Red, Green,Blue, R-Hue,Chroma; 9steps	Red, Blue, Chroma;±8steps	Black, Red, Green,Blue, R-Hue, Chroma;9steps
	Enhancement	Hyper-Sharpness(Structureenhance)Color Enhance		Hyper-Sharpness(Structure enhance)Color Enhance
	FICE	Available	Not available	Available
	BLI	Not available	Not available	Available with E-600HL,EC-600LS, EG-600WR
Device	Parameters	PrimaryPredicate:Fujifilm EPX-4440HD DigitalVideo Processorwith FICE andLight Source	Secondary Predicate:OLYMPUS CV-170VIDEO CENTER	Subject Device:FUJIFILM processorVP-7000 and Lightsource BL-7000
	BLI-bright	Not available	Not available	Available with E-600HL,EC-600LS, EG-600WRv2, and EC-600WL v2and 700* seriesendoscopes
	LCI	Not available	Not available	Available with E-600HL,EC-600LS, EG-600WRv2, and EC-600WL v2and 700* seriesendoscopes
	Iris	Average/Peak/Auto	Average/Peak/Auto	Average/Peak/Auto
	PeakDetection level	Available	Unknown	Available
	Shutter Speed	1/800 Max	Unknown	1/800 Max
	Shutter SpeedPriority Mode	Available	Unknown	Available
	Default PumpLevelSelection	Off/L/M/H	High, Low, Off	Off/L/M/H
	Mask Type	Type1/Type2	Unknown	Type1/Type2
	Image Storage	External Deviceand CF Card(Max16GB)	MAJ-1925 Olympus 2GBUSB Portable Memory	External USB Memory(Max 2GB) and InternalStorage Memory
	DimensionsWxHxD mm	390x105x460 mm	295x145x425 mm	390x110x485 mm
	Weight	9.5kg	11kg	9kg
LightSource		XL-4450	CV-170	BL-7000
	Power Rating	120V AC	100-240V AC	100-240V AC
		60Hz	50/60Hz	50/60Hz
		3.3A	200VA	1.2-0.7A
	Lamp (powerconsumption)	Main Lamp: Xenonlamp (300W)	LED lamp	Main Lamp: 4 LEDLamps (79.2W)
		Emergency lamp:Halogen lamp(75W)		Emergency lamp: whenany LED lampmalfunctions (53.3W)
	Light Control	Peak/Average/Auto	Peak/Average/Auto	Peak/Average/Auto
	Air supply	Normal, Mid, Low	High, Low, Off	Normal, Mid, Low, Off
Device	Parameters	PrimaryPredicate:Fujifilm EPX-4440HD DigitalVideo Processorwith FICE andLight Source	Secondary Predicate:OLYMPUS CV-170VIDEO CENTER	Subject Device:FUJIFILM processorVP-7000 and Lightsource BL-7000
	pump	Off
	DimensionsWxHxD mm	390x155x450 mm	295x145x425 mm	390x155x485 mm
	Weight	15kg	11kg	12kg
Keyboard		DK-4440E	MAJ-1981	DK-7000E
		Basic US101KeyboardPrint for severalkeys are changedfor the operation ofVP-4440HD withFICE	Olympus Keyboard	Basic US101 KeyboardPrint for several keysare changed for theoperation of VP-7000

Comparison between the Subject Device and Predicate Devices

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*Not Available In USA

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.