Fuse Colonoscopy System: The Fuse Colonoscope with FuseBox Processor is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The system consists of EndoChoice camera heads, endoscopes, video system, light source and other ancillary equipment. Fuse Colonoscopes, in conjunction with the FuseBox® processor, are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult patients. The system includes Lumos, a digital post processing inage enhancement technology. Lumos is intended to be used as an optional adjunct following white light endoscopy and is not intended to replace histopathological sampling as a means of diagnosis.

Fuse 1G Gastroscopy System: The Fuse 1G Gastroscope with FuseBox Processor is intended for diagnostic visualization of the digestive tract. The system also provides access for therventions using standard endoscopy tools. The system consists of EndoChoice camera heads, endoscopes, video system, light source and other ancillary equipment. The Fuse 1G Gastroscope, in conjunction with the FuseBox processor, is indicated for use within the upper digestive tract (including the esophagus, stomach and duodenum). The system includes Lumos, a digital post processing image enhancement technology. Lumos is intended to be used as an optional adjunct following white light endoscopy and is not intended to replace histopathological sampling as a means of diagnosis.

Device Description

The Fuse Endoscopy System is a GI platform indicated for diagnostic visualization and therapeutic intervention of the digestive tract. The system labeled for healthcare facilities/hospitals enables physicians to view a high-resolution wide field of view. The FuseBox is responsible for image processing, transferring video signals from the endoscope, pneumatic control, and outputting high definition (HD 1080p) video signal. The current FuseBox version, unlike the version used with the two predicate devices, includes image post processing algorithm as an adjunct tool to white light visualization.

The feature provides real-time enhancement and will be used as an adjunctive tool. to supplement the white light endoscopic examination. The new feature may enhance appearance of surface vessels, visualization of the mucosal surface texture and visibility of borders of areas of interest when present.

AI/ML Overview

The provided text describes the Fuse® Endoscopy System with FuseBox® Processor, which includes a digital post-processing image enhancement technology called Lumos. The information primarily focuses on establishing substantial equivalence to predicate devices for regulatory approval, rather than detailed acceptance criteria and a specific study proving it meets those criteria.

However, I can extract the available information and structure it as requested, making note of where specific details are not provided in the document.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria for the Lumos feature. Instead, it refers to overall device safety and effectiveness. The performance characteristics mentioned are comparisons to predicate devices for the white light aspects of the system. For Lumos, it states its function as an "enhancement feature."

Characteristic / Acceptance Criteria (Implied)	Reported Device Performance (Lumos Feature)
Intended Use	Same as predicates: Diagnostic visualization of the digestive tract and access for therapeutic interventions. Lumos is an adjunct to white light endoscopy and not intended to replace histopathological sampling for diagnosis.
Enhancement Mechanism	Image processing of local contrast enhancement of intensity and tone, resulting in modification of the combination of RGB components for each pixel. Allows retaining the neutral color of the tissue for human observers.
Number of Enhancement Levels	2 graduating enhancement modes for each intended use: Low gastro, high gastro; Low colono, high colono.
Safety and Effectiveness	All test results demonstrated that the device is safe and effective in comparison with the predicate device. The impact of the differences (Lumos) is insignificant in terms of device safety and effectiveness for the device's intended use.
Image Quality (General)	Image quality testing (spatial resolution, field of view, depth of field, uniformity, geometric distortion, noise properties and color performance) was performed. Results demonstrated the device is safe and effective.
Clinical Survey Impact	Clinical Survey on videos with Lumos compared to white light was performed, indicating satisfactory performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Clinical Survey on videos with the Lumos compared to white light" was performed. However, it does not provide any details regarding:

The sample size of videos or cases used in this clinical survey.
The provenance of the data (e.g., country of origin).
Whether the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not specify the number of experts or their qualifications used to establish ground truth for the "Clinical Survey on videos." It only states that a clinical survey was conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not provide any information about the adjudication method used for the "Clinical Survey on videos."

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

The document mentions a "Clinical Survey on videos with the Lumos compared to white light." While this implies a comparison, it does not explicitly state that it was a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Furthermore, it does not provide any effect size or quantitative measure of how much human readers improve with AI (Lumos) vs. without AI assistance. It only broadly states that the feature "may enhance appearance of surface vessels, visualization of the mucosal surface texture and visibility of borders of areas of interest."

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

The document describes Lumos as an "optional adjunct" and an "adjunctive tool to supplement the white light endoscopic examination." This strongly suggests that it is not intended for standalone performance but rather for human-in-the-loop use. No standalone algorithm performance study is described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the type of ground truth used for the "Clinical Survey on videos." Given the context of "diagnostic visualization" and "adjunct following white light endoscopy," it's plausible that expert interpretation/consensus of standard white light imagery or potentially pathological findings serve as an implicit ground truth, but this is not mentioned. It specifically states that Lumos "is not intended to replace histopathological sampling as a means of diagnosis."

8. The sample size for the training set

The document does not provide any information regarding the sample size for a training set. The descriptions focus on the device's function and comparison to predicate devices, not on the development or training of the Lumos algorithm.

9. How the ground truth for the training set was established

Since no training set details (including sample size) are provided, the document does not describe how ground truth for a training set was established.

Summary

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

August 1, 2016

EndoChoice, Inc. Daniel Hoefer Regulatory Affairs Manager 11810 Wills Road Alpharetta. GA 30009

Re: K160275

Trade/Device Name: Fuse® Endoscopy System with FuseBox® Processor Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Codes: PEA, FDF, FDS Dated: June 30, 2016 Received: July 1, 2016

Dear Mr. Hoefer:

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

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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/Resourcesfor You/Industry/default.htm. 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 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,

Joyce M. Whang -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

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Indications for Use

510(k) Number (if known) K160275

Device Name

Fuse® Endoscopy System with FuseBox® Processor

Indications for Use (Describe) Fuse Colonoscopy System

The Fuse Colonoscope with FuseBox Processor is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The system consists of EndoChoice camera heads, endoscopes, video system, light source and other ancillary equipment. Fuse Colonoscopes, in conjunction with the FuseBox® processor, are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult patients. The system includes Lumos, a digital post processing inage enhancement technology. Lumos is intended to be used as an optional adjunct following white light endoscopy and is not intended to replace histopathological sampling as a means of diagnosis.

Fuse 1G Gastroscopy System

The Fuse 1G Gastroscope with FuseBox Processor is intended for diagnostic visualization of the digestive tract. The system also provides access for therventions using standard endoscopy tools. The system consists of EndoChoice camera heads, endoscopes, video system, light source and other ancillary equipment. The Fuse 1G Gastroscope, in conjunction with the FuseBox processor, is indicated for use within the upper digestive tract (including the esophagus, stomach and duodenum). The system includes Lumos, a digital post processing image enhancement technology. Lumos is intended to be used as an optional adjunct following white light endoscopy and is not intended to replace histopathological sampling as a means of diagnosis.

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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Image /page/3/Picture/0 description: The image shows the logo for EndoChoice. The logo consists of a green and blue swirl on the left, followed by the word "ENDOChoice" in blue and green. The first four letters, "ENDO", are in blue, while the rest of the word, "Choice", is in green.

This traditional 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92

510K Summary - K160275

I. Applicant information:

EndoChoice Inc. 11810 Wills Road Alpharetta, GA 30009 Establishment Registration: 3007591333

Contact Person:	Daniel Hoefer, EndoChoice Inc. USA
Phone:	678-708-4743
Fax:	678-878-3373
E-mail:	daniel.hoefer@endochoice.com
Date Prepared:	July 29, 2016

II. Device information:

Trade Name:	Fuse® Endoscopy System with FuseBox® Processor
Common Name:	Endoscope and accessories, flexible/rigid
Classification:	Class II per 21 CFR 876.1500
Product Code:

Classification Name	CFRSection	ProductCodes
Endoscope, accessories, imagepost processing for colorenhancement	21 CFR876.1500	PEA
Colonoscope And Accessories,Flexible/Rigid		FDF
Gastroscope And Accessories,Flexible/Rigid		FDS

III. Predicate Device:

Fuse Gastroscopy System K152182 (EndoChoice Inc.) Fuse Colonoscopy System K141598 (EndoChoice Inc.)

No reference devices were used in this submission.

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IV. Device Description:

V. Indication for Use:

Fuse Colonoscopy System

The Fuse Colonoscope with FuseBox Processor is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The system consists of EndoChoice camera heads, endoscopes, video system, light source and other ancillary equipment. Fuse Colonoscopes, in conjunction with the FuseBox® processor, are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult patients. The system includes Lumos, a digital post processing image enhancement technology. Lumos is intended to be used as an optional adjunct following white light endoscopy and is not intended to replace histopathological sampling as a means of diagnosis.

Fuse 1G Gastroscopy System

The Fuse 1G Gastroscope with FuseBox Processor is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The system consists of EndoChoice camera heads, endoscopes, video system, light source and other ancillary equipment. The Fuse 1G Gastroscope, in conjunction with the FuseBox processor, is indicated for use within the upper digestive tract (including the esophagus, stomach and duodenum). The system includes Lumos, a digital post processing image enhancement technology. Lumos is intended to be used as an optional adjunct following white light endoscopy and is not intended to replace histopathological sampling as a means of diagnosis.

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Comparison of Characteristics and intended use VI.

Table	5	.1

Category	Predicate:Fuse Colonoscopy SystemK141598 (EndoChoice Inc.)	Predicate:Fuse Gastroscopy SystemK152182 (EndoChoice Inc.)	Proposed device:Fuse System withFuseBox Processor
Performance Characteristics
Intended use	Diagnostic visualization of thedigestive tract. The systemalso provides access fortherapeutic interventions usingstandard endoscopy tools. Thesystem consists of EndoChoicecamera heads, endoscopes,video system, light source andother ancillary equipment.	Diagnostic visualization of thedigestive tract. The systemalso provides access fortherapeutic interventions usingstandard endoscopy tools. Thesystem consists ofEndoChoice camera heads,endoscopes, video system,light source and otherancillary equipment.	Same as predicates
Mode of Operation	The Processor relays the imagefrom the endoscope to a videomonitor	The Processor relays theimage from the endoscope to avideo monitor	Same as predicates
User Interface	Manual and GUI	Manual and GUI	Same as predicates
Field of View	300° horizontal330° diagonal	210° horizontal245° diagonal	Same as predicates(combined)
Depth of Field [mm]	3-100	3-100	Same as predicates
FuseBox Characteristics
Digital Output (Display)	3 channels DVI	3 channels DVI	Same as predicates
Analog Video Output(Image ManagementSystem)	3 X S Video	3 X S Video	Same as predicates
Imaging algorithm forenhancement feature	None	None	*Lumos Adaptive MatrixImagingTM
Enhancement mechanism	None	None	Image processing of localcontrast enhancement ofintensity and toneresulting in modificationof the combination ofRGB components foreach pixel.Fuse system enhancementmechanism allowsretaining the neutral colorof the tissue for humanobserver.
Number of enhancement	None	None	2 graduating enhancement
Category	Predicate:Fuse Colonoscopy SystemK141598 (EndoChoice Inc.)	Predicate:Fuse Gastroscopy SystemK152182 (EndoChoice Inc.)	Proposed device:Fuse System withFuseBox Processor
levels			modes for each intendeduse:Low gastro, high gastroLow colono, high colono
Adjustable image settings(GUI)	Red, blue, Brightness	Red, blue, Brightness,Sharpness (default level only)	**Adjustable sharpnesslevels added
LED Intensity control	Yes	Yes	Same as predicates
Zoom	Yes	Yes	Same as predicates
Freeze/Release	Yes	Yes	Same as predicates
Flash Mode	Yes	Yes	Same as predicates
Control signals	White balanceA/W pump controlLED control	White balanceA/W pump controlLED control	Same as predicates
Illumination	Integral LED illumination	Integral LED illumination	Same as predicates
CCD type	Color	Color	Same as predicates
Electrical class	Class I , Type BF	Class I , Type BF	Same as predicates
Umbilical cord	90 degree orientation available	90 degree orientation available	Same as predicates
Locking lever	Yes	Yes	Same as predicates

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*The main difference is the addition of Lumos Adaptive Matrix Imaging) feature. The feature is used as an adjunct to the white light image for visualization of the digestive tract.

** Addition of manually adjustable sharpness levels in order to support user preference, the low level is similar to default sharpness level of predicate K152182

VII. Performance testing:

The following testing has been performed to demonstrate that the design outputs of the modified version meet the design input requirements. The tests were performed within EndoChoice's laboratory or by accredited third parties.

In house Bench tests functional/software testing:

. Image quality testing (spatial resolution, field of view, depth of field, uniformity, geometric distortion, noise properties and color performance)
Clinical Survey on videos with the Lumos compared to white light .

All test results demonstrated that the device is safe and effective in comparison with the predicate device.

Substantial Equivalence:

The data presented above demonstrate that:

The Fuse Endoscopy System with FuseBox Processor and the predicate devices, have a.

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the same intended use.

The Fuse Endoscopy System with FuseBox Processor and the predicate devices have b. similar indications, the Lumos Adaptive Matrix Imaging feature is an addition to the indication for use
Fuse Endoscopy System with FuseBox Processor and the predicate devices have C. similar technological characteristics
The Fuse Endoscopy System with FuseBox Processor and the predicate devices have d. same performance characteristics of white light. The Lumos Adaptive Matrix Imaging) provides an additional feature adjunct to white light endoscopy.

VIII. Conclusion:

Based on the results of verification, validation, and performance testing, the impact of the above differences is insignificant in terms of the device safety and effectiveness for the device's intended use. The modified device performs as well as intended in all testing performed. It is the opinion of EndoChoice Inc., that the modified version of the Fuse Endoscopy System is substantially equivalent to the predicate devices in terms of safety and effectiveness.

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.