The Fuse® Colonoscopy System is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. 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 Fuse® Colonoscopy System consists of EndoChoice camera heads, endoscopes, video system, light source and other ancillary equipment.

Device Description

The Fuse Colonoscopy System is a GI platform indicated for diagnostic visualization and therapeutic intervention of the lower digestive tract in adult patients. The purpose of this submission is to expand the product sizes available for the legally marketed unmodified version Fuse 1C System (K132839) by adding two additional lengths: 133cm and 150cm to the current 168cm Fuse 1C colonoscope.

This 510(k) submission also presents several design changes to the system. The indications for use, fundamental technology and operation principals of the legally marketed device were not changed. The system labeled for healthcare facilities/hospitals enables physicians to view a high- resolution wide field of view of up to 330°

AI/ML Overview

The provided text is a 510(k) summary for the "Fuse® Colonoscopy System," which is a medical device, not an AI algorithm. Therefore, the questions related to AI algorithm performance (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set) are not applicable.

The document describes modifications to an existing device (Fuse™ 1C System, K132839) and aims to prove substantial equivalence to the predicate device, not to prove the device meets acceptance criteria for an AI algorithm.

However, I can extract and present the information available regarding the device's performance testing and acceptance, which focuses on safety and effectiveness in comparison to its predicate.

Here's a breakdown of the relevant information from the document:

1. Table of Acceptance Criteria and Reported Device Performance (as pertains to device modification):

The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds for an AI's performance metrics (e.g., AUC > 0.9). Instead, it focuses on demonstrating that the modified device's design outputs meet its design input requirements and that it performs "as well as the predicate" in terms of safety and effectiveness.

Category	Acceptance Criteria (Implicit for safety/effectiveness vs. Predicate)	Reported Device Performance
Colonoscope Working Length	Industry-accepted standard for working lengths. Safety and effectiveness maintained despite adding shorter lengths (133cm, 150cm).	Both designs (original and modified with additional lengths) utilize industry-accepted standard for working lengths.
Angulation Knob Brake	Industry-accepted standard for handle brake. Safety and effectiveness maintained despite adding R/L angulation.	Both designs utilize industry-accepted standard for handle brake.
Umbilical Cord Plug / Socket	Industry-accepted standard for usability. Safety and effectiveness maintained with integrated design.	Both designs utilize industry-accepted standard for usability.
Post-procedure Reprocessing Method	Industry-accepted standard for reprocessing compliance. Safety and effectiveness maintained with automated reprocessing option.	Both designs utilize industry-accepted standard for reprocessing compliance.
Insertion Tube Coating	Similar properties to predicate device's coating (TPU). Biocompatibility and performance maintained.	Both materials are TPU, having similar properties.
Adhesives	Similar properties to predicate device's adhesives (Epoxy resin). Biocompatibility and performance maintained.	Both materials are epoxy resins, having similar properties.
Software	Enhanced features do not negatively impact safety or effectiveness, and may improve performance.	Version 1.1.7 (modified) provides enhanced features over Version 1.0 (predicate). Specific performance metrics are not detailed but passed testing.
General Performance (Safety & Effectiveness)	The modified device must be as safe and effective as the predicate device for its intended use. Design outputs must meet design inputs.	"All test results passed, demonstrating that the device is safe and effective in comparison with the predicate device."

2. Sample size used for the test set and the data provenance:

Not applicable for an AI algorithm.
For the device, the performance testing involved "benchtop functional, performance, and software testing," "Laboratory Safety / EMC compatibility re-testing," "Laboratory AER validation," and "Laboratory Biocompatibility testing." The sample sizes for these engineering and lab tests are not specified in this summary, but would typically involve a defined number of units or samples as per particular test standards.
Data Provenance: Testing was performed "within EndoChoice's laboratory and by accredited third parties." The origin of input "data" in the sense of patient data is not relevant here as it's a hardware/software device validation, not an AI model trained on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This relates to AI algorithm validation where expert consensus establishes ground truth for classification tasks. The Fuse® Colonoscopy System is a visualization and intervention tool, not an AI diagnostic system.

4. Adjudication method for the test set:

Not applicable. This relates to AI algorithm validation using expert review.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. This type of study is typically done for diagnostic tools (human readers interpreting images) where AI assistance is being evaluated. The Fuse® Colonoscopy System is an imaging system itself, not an AI assistant to image interpretation.

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

Not applicable. This refers to AI algorithm performance. The device itself is "standalone" in the sense that its performance characteristics (e.g., optical quality, mechanical function, electrical safety) are evaluated intrinsically, but it requires a human user (physician) for its clinical application.

7. The type of ground truth used:

For the engineering and laboratory tests performed, "ground truth" implies meeting the specified engineering requirements and international standards. For example, for biocompatibility, the ground truth is adherence to ISO 10993; for electrical safety, it's adherence to IEC 60601-1.
It's not "expert consensus, pathology, or outcomes data" in the context of validating an AI diagnostic algorithm.

8. The sample size for the training set:

Not applicable. This refers to AI algorithms. The device does contain software (Version 1.1.7), but this appears to be for system control and image processing, not a machine learning model that requires a "training set" in the AI sense.

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

Not applicable. This refers to AI algorithms.

In summary, the provided document focuses on demonstrating substantial equivalence of a modified medical device to a legally marketed predicate device, rather than the validation of an AI algorithm against specific performance criteria. The evaluation is centered on engineering bench tests, laboratory validations, and compliance with recognized standards, ensuring the modifications do not negatively impact the device's safety and effectiveness.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized representation of three human profiles facing to the right, symbolizing the department's focus on people and health.

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

September 30, 2014

EndoChoice, Inc. Tamar Fuerst RA Manager 11810 Wills Road Alpharetta, GA 30009

Re: K141598

Trade/Device Name: Fuse® Colonoscopy System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF Dated: September 3, 2014 Received: September 5, 2014

Dear Tamar Fuerst.

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. Iisting 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Herbert P. Lerner -S

for

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

Enclosure

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Indications for Use

510(k) Number (if known) K141598

Device Name Fuse® Colonoscopy System

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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

FOR FDA USE ONLY

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

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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 design on the left, followed by the word "ENDOChoice" in blue and green text. The first part of the word, "ENDO", is in blue, while the second part, "Choice", is in green.

This special 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

Applicant information:

EndoChoice Inc.

11810 Wills Road Alpharetta, GA 30009 Establishment Registration: 300759133

Contact Person:	Tamar Fuerst, EndoChoice Innovation Center Ltd.
Phone:	(+972) 4-626-7321
Fax:	(+972) 4-626-0205
E-mail:	tamar.fuerst@endochoice.com
Date Prepared:	June 2nd, 2014
Device information:
Trade Name:	Fuse® Colonoscopy System
Common Name:	Colonoscope and accessories, flexible/rigid
Classification Name:	Endoscope and accessories
Classification:	Class II per 21 CFR 876.1500
Product Code:	FDF
Predicate Device:	Fuse™ 1C System (K132839)
Reason for Submission:	Modification of an existing device.

Intended use and indications for use:

The Fuse® Colonoscopy system is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. 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 Fuse® Colonoscopy system consists of EndoChoice camera heads, endoscopes, video system, light source and other ancillary equipment.

Device Description:

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Characteristics Comparison:

The modified version of the Fuse 1C System incorporates the following additional features compared to the unmodified version of the Fuse 1C System (K132839) which is the predicate:

Category	FuseTM 1C System(K132839)unmodified version	Fuse® 1C System modifiedversion	Impact ofmodification/change ondevice performance
Colonoscopeworking length	Standard (168 cm)	Standard (168cm)andShortened (133cm, 150cm)	Both designs utilizeindustry-acceptedstandard for workinglengths
AngulationKnob Brake	U/D	U/DR/L	Both designs utilizeindustry-acceptedstandard for handle brake.
Umbilical cordplugUmbilical cordsocket	Discrete	Integrated	Both designs utilizeindustry-acceptedstandard for usability.
Post procedurereprocessingmethod	Manual	ManualandAutomated	Both designs utilizeIndustry-acceptedstandard for reprocessingcompliance.
Insertion tubecoating	TPU	TPU	Both materials are a TPU,having similar properties.
Adhesives	Epoxy resin	Epoxy resin	Both materials are epoxyresins, having similarproperties.
Software	Version 1.0	Version 1.1.7	Enhanced features.

Table 5.1

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 and by accredited third parties.

In house Benchtop functional, performance, and software testing
Laboratory Safety / EMC compatibility re-testing. ●
. Laboratory AER validation
Laboratory Biocompatibility testing

All test results passed, demonstrating that the device is safe and effective in comparison with the predicate device.

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The following standards were used / relied upon for testing:

AAMI / ANSI ES 60601-1:2005/(R) 2012 and C1:2009/(R) 2012 AAMI / ANSI ES60601-1:2005/A1:2012 IEC 60601-1-2:2007 IEC 60601-2-18 Edition 3.0 2009-08 IEC 62304:2006 ISO 10993:2009 Part #1 ISO 10993:2009 Part #5 ISO 10993:2010 Part #10 ISO 10993:2012 Part #12 ISO 8600-1 third edition 2013 ISO 8600-3 First edition 1997-07-01 ISO 8600-4 First edition 1997-07-01 ISO 8600-6 First edition 2005-03-15 ASTM E 1837- 96 (reapproved 2007)

Substantial Equivalence:

The data presented above demonstrate that:

The modified version of the Fuse 1C System and the unmodified version Fuse 1C a. System (K132839), the legally marketed predicate, have the same intended use and indications for use in the lower digestive tract.
b. The modified version of the Fuse 1C System uses the same technological characteristics as the predicate. It includes additional colonoscope insertion tube sizes.
The modified version contains similar materials, and similar reprocessing techniques. C.

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 the predicate in all testing performed. It is the opinion of EndoChoice Inc., that the modified version of the Fuse 1C System is substantially equivalent to the predicate device 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.