The Fuse 1C System is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The system is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult patients.

Device Description

The Fuse™ IC Colonoscopy System is a GI platform for diagnostic visualization and therapeutic intervention of the lower digestive tract. The system enables physicians to view high resolution wide field of view of up to 300°. The Fuse 1C is a modification of the legally marketed (K130718) PeerScope system Model H (the predicate device). The device has been modified to include a water bottle, cap, and tubing that are specified for use only with the Fuse1C.

The Fuse IC Colonoscopy System consists of the following components:

The Fuse 1C colonoscope is a flexible, adult size video colonoscope labeled for . repeatable clinical usage within health care facilities. The colonoscope design and materials have not been modified, aside from a change in market name.
The main control unit (FuseBox™) performs image processing and relays video . signals from the video colonoscope to external display monitors. The FuseBox also offers pneumatic controls and interfaces with various external accessories.
Ancillary components and accessories for use in reprocessing and irrigation. A . change in water bottle/cap/tubing is the difference between the predicate device and · the Fuse 1C device submitted herein for review.

AI/ML Overview

The provided text describes the 510(k) summary for the Fuse 1C Colonoscopy System. However, it does not contain information about the acceptance criteria or a study proving the device meets specific performance metrics. The document focuses on demonstrating substantial equivalence to a predicate device based on design, intended use, materials, labeling, and non-clinical testing of an accessory.

Therefore, I cannot populate the requested table or answer most of the questions about a specific performance study.

Here's a breakdown of what can be extracted and why other parts cannot:

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

Acceptance Criteria	Reported Device Performance
Not specified in the document.	The document states "All test results passed, demonstrating that the device is safe and effective in comparison with the predicate device." However, specific numerical performance criteria or results are not provided.

Reasoning: The document states that "Non-clinical testing has been performed on the device," including benchtop functional performance testing, laboratory validation of cleaning, high-level disinfection, and sterilization instructions, and biocompatibility testing. It concludes that "All test results passed, demonstrating that the device is safe and effective in comparison with the predicate device." However, it does not specify what the acceptance criteria were for each test, nor does it provide the quantitative results that "passed." This is typical for a 510(k) summary focused on substantial equivalence rather than original clinical efficacy trials.

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

Sample size: Not specified.
Data provenance: Not specified.

Reasoning: The document refers to "non-clinical testing" and "benchtop functional performance testing." These are laboratory-based tests, not human studies, so concepts like "sample size for the test set" and "data provenance" (in the context of patient data) do not directly apply in the way they would for a clinical trial.

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)

Number of experts: Not applicable/specified.
Qualifications of experts: Not applicable/specified.

Reasoning: Since the testing described is non-clinical (benchtop and laboratory validation), there would not be "experts" establishing ground truth in the sense of clinical diagnoses or interpretations. The "ground truth" would be established by the testing protocols and objective measurements in the laboratory.

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

Adjudication method: Not applicable.

Reasoning: As above, this applies to clinical studies involving human interpretation, not to non-clinical bench or lab tests.

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

MRMC study: No, an MRMC comparative effectiveness study was not done or reported in this document.
Effect size: Not applicable.

Reasoning: This document is for a colonoscopy system, not an AI-assisted diagnostic tool. The focus is on the device's technical specifications and safety/effectiveness for visualization and intervention, not on comparing reader performance with or without AI assistance.

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

Standalone performance: Not applicable.

Reasoning: This is a colonoscopy system, which is inherently a human-in-the-loop device. There is no "algorithm only" performance to evaluate in this context.

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

Type of ground truth: For the non-clinical tests, the "ground truth" would be defined by established engineering specifications, safety standards (e.g., ISO 10993-1 for biocompatibility), and validated laboratory assay results for cleaning, disinfection, and sterilization.

Reasoning: The ground truth for benchtop and laboratory validation is based on objective, measurable criteria defined by regulatory standards and engineering specifications rather than human expert consensus on clinical findings.

8. The sample size for the training set

Sample size for training set: Not applicable.

Reasoning: This document does not describe the development of an algorithm or AI model that would require a "training set."

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

Ground truth for training set: Not applicable.

Reasoning: As above, this document does not describe an AI model or algorithm development.

Summary of the document's content:

The document is a 510(k) summary for the Fuse 1C Colonoscopy System, which is a modification of a previously cleared device (Predicate Device: PeerScope System Model H, K130718). The primary modification is a change in the specified accessory: the water bottle, cap, and tubing set.

The manufacturer, EndoChoice, Inc., claims substantial equivalence to the predicate device due to identical intended use, design, materials (for the core colonoscope), and labeling (with updated instructions for the new accessory).

Non-clinical testing performed on the accessory water bottle, cap, and tubing included:

Benchtop functional performance testing
Laboratory validation testing of cleaning instructions
Laboratory validation testing of high-level disinfection instructions
Laboratory validation testing of sterilization instructions
Biocompatibility testing in conformance with ISO 10993-1

All these tests "passed," indicating that the accessory, and thus the modified system, is considered safe and effective in comparison with the predicate device. The document does not provide specific performance metrics or acceptance criteria beyond this general statement of passing tests.

Summary

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EndoChoice, Inc.

FEB - 6 2014

510(k) Summary Fuse 1C Colonoscopy System

1. Company Identification

Manufacturer:

EndoChoice Innovation Center, Ltd. (Formerly PeerMedical, Ltd.) 2 Hatochen St. Business Industrial Park North Caesarea, ISRAEL 38900 Establishment Registration: Active Status, awaiting establishment registration number

Owner/Operator:

EndoChoice, Inc. 11810 Wills Road Suite 100 Alpharetta, GA 30009 Owner/Operator Number: 10028290 Establishment Registration: 300759133

2. Contact Person

Daniel Hoefer Regulatory Affairs Manager EndoChoice, Inc.

3. Device Name

Trade name:	Fuse IC Colonoscopy System
Common/Usual Name:	Colonoscope, Video
Classification name:	Endoscope and Accessories

4. Device Classification

Common Name:	Colonoscope and accessories, flexible / rigid
Classification:	Colonoscope and accessories, 21CFR 876.1500
Product Code:	FDF
Committee:	Gastroenterology/Urology

5. Intended Use

The Fuse IC System consists of camera heads, endoscopes, video system, light source and other ancillary equipment

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K132839 Page 2 of 3

6. Device Description

The Fuse IC Colonoscopy System consists of the following components:

The Fuse 1C colonoscope is a flexible, adult size video colonoscope labeled for . repeatable clinical usage within health care facilities. The colonoscope design and materials have not been modified, aside from a change in market name.
The main control unit (FuseBox™) performs image processing and relays video . signals from the video colonoscope to external display monitors. The FuseBox also offers pneumatic controls and interfaces with various external accessories.
Ancillary components and accessories for use in reprocessing and irrigation. A . change in water bottle/cap/tubing is the difference between the predicate device and · the Fuse 1C device submitted herein for review.

7. Substantial Equivalence

7.1. Predicate devices

The Fuse IC System is a modification of, and is substantially equivalent to, the PeerScope System Model H (K 130718). The intended use, design, materials and labeling are all substantially equivalent.

7.2. Intended Use

The Fuse IC System is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The system is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult patients.

The Fuse IC System consists of camera heads, endoscopes, video system, light source and other ancillary equipment

The intended use is identical to the predicate device PeerScope System Model H.

7.3. Technical Characteristics

The Fuse IC system is technically identical to the predicate PeerScope System Model H, with the exception of a change in specified accessory.

This is not a change in technology. The change does not impact indications for use. Validation of the modification did not raise new questions of safety and effectiveness.

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EndoChoice, Inc.

7.4. Performance Characteristics

The system is now specified for use with the SCT-468 Reusable Water Bottle, Cap, and Tubing Set and SCT-469 Reusable Water Bottle, Cap, and Tubing with CO2 Set. These accessorial sub-components are included with the Fuse 1C system.

Summary of Differences
Category	Predicate Device(PeerScope system ModelB K130718)	Subject Device(Fuse 1C Colonoscope)
Colonoscope Model	PeerScope CS	Fuse 1C (trade namechange)
Water-feed system	Specified third party waterbottle, cap, and tubingpressurized by pump	EndoChoice re-usablewater bottle and waterbottle cap pressurized bypump. Accessory isspecified for use with Fuseendoscope system only.

The steps for operator use of each of the devices are identical, except that a specified accessory water bottle, cap and tubing set are now identified in instructions. Instructions for use of the accessory are now also included in a separate insert.

8. Non-clinical testing

Non-clinical testing has been performed on the device. Specifically, the following has been completed on the accessory water bottle, cap, and tubing:

Benchtop functional performance testing ●
Laboratory validation testing of the cleaning instructions .
Laboratory validation testing of the high-level disinfection instructions ●
Laboratory validation testing of sterilization instructions .
Biocompatibility testing in conformance with ISO 10993-1. .

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

9. Conclusion

The modification of the Fuse 1C is substantially equivalent to the predicate device PeerScope System Model H listed above. It is the same or equivalent in terms of design, intended use, materials, and labeling.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing its wings or body.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

February 6, 2014

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

K132839 Re:

Trade/Device Name: Fuse 1C Colonoscopy System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF Dated: December 31, 2013 Received: January 3, 2014

Dear Daniel 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.

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Page 2 - Daniel Hoefer

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,

Image /page/4/Picture/6 description: The image shows the name "Benjamin Fisher-S" in a simple, sans-serif font. The text is horizontally oriented and appears to be a logo or heading. The letters are black against a white background, providing a clear contrast.

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K132839

Device Name

Fuse 1C Colonoscopy System

Indications for Use (Describe)

The Fuse 1C Colonoscopy System is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The Fuse 1C Colonoscopy System is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult patients.

The Fuse 1 C Colonoscopy System consists of camera heads, endoscopes, light source and other ancillary equipment.

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

X] 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)

Image /page/5/Picture/14 description: The image shows the text "Benjamin R. Fisher" on the first line. The second line shows the date and time as "2014.02.06 11:13:40 05:00". The text appears to be a timestamp or record of some kind, possibly related to the name mentioned on the first line.

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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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.