The Arthrex SynergyID Endoscopic Imaging System is intended to be used as an endoscopic video camera in a variety of endoscopic surgical procedures, including but not limited to: orthopedic, laparoscopic, urologic, sinuscopic, and plastic surgical procedures. The device is also intended to be used as an accessory for microscopic surgery.

The Arthrex SynergyID Endoscopic Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. Upon intravenous administration and use of ICG consistent with its approved label, the system enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visualization of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the Arthrex SynergyID Endoscopic Imaging System is intended for use with standard of care white light, and when indicated. intraoperative cholangiography. The device is not intended for standalone use for billary duct visualization.

Device Description

The Arthrex SynergyID Endoscopic Imaging System comprises a non-sterile camera control unit (CCU) console, camera head, and light engine source. The system integrates ultra-high-definition camera technology, LED lighting, and an image management system into a single console with a tablet interface in an identical manner as the Arthrex UHD4 System cleared under K153218.

The Arthrex SynergyID Endoscopic Imaging System camera control unit interacts with the near-infrared light source to be able to provide near-infrared (NIR) imaging to visualize the presence of Indocyanine Green (ICG).The ICG fluoresces when illuminated through the laparoscope with NIR excitation light from the external laser engine and the fluorescence response is then imaged with the camera, processed and displayed on an Arthrex UHD4 System monitor.

AI/ML Overview

This document is a 510(k) summary for the Arthrex SynergyID Endoscopic Imaging System, which primarily focuses on establishing substantial equivalence to predicate devices rather than providing a detailed study proving performance against acceptance criteria. Therefore, much of the requested information regarding specific acceptance criteria, study methodologies, and performance metrics is not present in the provided text.

Based on the available information, here is a breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria or a "reported device performance" table as would be found in a clinical study report. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on design features, materials, intended use, principle of operation, and technical characteristics.

The "Performance Testing" section (not explicitly numbered as a table in the text, but a logical grouping of related information implicitly demonstrating performance through testing) outlines the types of tests conducted:

Test Category	Description / Purpose	Outcome
Biocompatibility	Performed in accordance with ISO 10993-1, related to patient contact.	Meets requirements.
Electrical Safety	Performed in accordance with IEC 60601-1.	Meets requirements.
Electromagnetic Compatibility (EMC)	Performed in accordance with IEC 60601-1-2.	Meets requirements.
Software Verification and Validation	Performed in accordance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.	Meets requirements.
System Performance (Non-Clinical)	Specific tests conducted on the Arthrex SynergyID system and its components (camera head, CCU, light engine) to ensure that the system performs as intended for NIR fluorescence imaging, and white light imaging. Includes evaluation of image quality, illumination, and functionality. Results are reportedly equivalent to the predicate.	Meets performance requirements and is equivalent to the predicate devices for both white light and NIR fluorescence imaging. Includes proper visualization of ICG.

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

The document describes non-clinical testing. Therefore, there is no patient test set or human subject data provenance (country of origin, retrospective/prospective) mentioned. The tests were performed on the device and its components in a laboratory or simulated environment to verify its technical performance, safety, and functionality.

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

Given that the testing described is non-clinical, there is no concept of "ground truth" established by medical experts in the context of diagnostic accuracy or clinical decision-making. The "ground truth" for the engineering and performance tests would be defined by engineering specifications, international standards (e.g., ISO, IEC), and the expected performance of a functioning device. These are typically verified by qualified engineers and technicians. The document does not specify the number or qualifications of engineers/technicians involved in test verification.

4. Adjudication Method for the Test Set:

Not applicable, as this was non-clinical testing. Adjudication methods like 2+1 or 3+1 are used for clinical trials involving human interpretation of data, which is not the case here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done as described in this document. The submission focuses on substantial equivalence based on technical specifications and non-clinical performance, not on direct comparison of human reader performance with and without AI assistance to quantifiably measure an effect size.

6. Standalone (Algorithm Only) Performance:

The device described is an "Endoscopic Imaging System" that provides real-time visible and near-infrared fluorescence imaging. It's a hardware and software system that enables visualization for human surgeons. The fluorescence imaging functions are integral to the system. While the "processing" of the fluorescence response is mentioned, it's not discussed as a standalone algorithm being evaluated for diagnostic performance independent of the human operator. Therefore, there is no standalone algorithm-only performance study described in this submission. The device is explicitly stated as "not intended for standalone use for biliary duct visualization" (implying human interpretation is always required).

7. Type of Ground Truth Used:

For the non-clinical performance testing, the "ground truth" is based on:

Engineering specifications and design requirements: Whether the system produces images of required resolution, brightness, and color accuracy under white light.
Physical principles of fluorescence: Whether the system correctly excites and detects fluorescence of Indocyanine Green (ICG) at appropriate wavelengths.
Comparison to predicate device performance: The system's performance is deemed equivalent to the predicate devices, implying those predicates set the de facto performance standard.
Compliance with international standards: Biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1), and EMC (IEC 60601-1-2) standards serve as the "ground truth" for these aspects.

8. Sample Size for the Training Set:

This document describes a regulatory submission for a medical device that includes imaging capabilities. It does not describe the development of a machine learning or AI model in the sense of needing a "training set." Therefore, a sample size for a training set is not applicable and not mentioned.

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

As there is no mention of an AI/ML training set, this question is not applicable based on the provided text.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left is the Department of Health & Human Services logo, and on the right is the FDA logo. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

Arthrex Inc. Troy Brooks Principal Regulatory Affairs Specialist 1 Arthrex Way Naples, Florida 34108

July 22, 2021

Re: K202582

Trade/Device Name: Arthrex SynergyID Endoscopic Imaging System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ, IZI Dated: June 17, 2021 Received: June 21, 2021

Dear Troy Brooks:

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 Aments, 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Neil R.P. Ogden Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202582

Device Name

Arthrex SynergyID Endoscopic Imaging System

Indications for Use (Describe)

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

Date Prepared	July 22, 2021
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	Troy Brooks, RACPrincipal Regulatory Affairs Specialist1-972-369-2712Troy.Brooks@Arthrex.com
Name of Device	Arthrex SynergyID Endoscopic Imaging System
Common Name	Endoscopic Video Camera System
Product Code	GCJ, IZI
Classification Name	21 CFR 876.1500: Endoscope and accessories21 CFR 892.1600: Angiographic x-ray systems
Regulatory Class	II
Predicate Device	K150956 – Pinpoint Endoscopic Fluorescence Imaging System (Primary Predicate)K153218 – Arthrex UHD4 System
Purpose of Submission	This 510(k) premarket notification is submitted to add near-infrared fluorescenceimaging, visualization of blood vessels, blood flow, related tissue perfusion and atleast one major of the major extra hepatic bile duct indications for use. This 510(k) isalso submitted to incorporate an external laser engine light source to provide the NIRexcitation light for fluorescence visibility.
Device Description	The Arthrex SynergyID Endoscopic Imaging System comprises a non-sterile cameracontrol unit (CCU) console, camera head, and light engine source. The systemintegrates ultra-high-definition camera technology, LED lighting, and an imagemanagement system into a single console with a tablet interface in an identicalmanner as the Arthrex UHD4 System cleared under K153218.The Arthrex SynergyID Endoscopic Imaging System camera control unit interacts withthe near-infrared light source to be able to provide near-infrared (NIR) imaging tovisualize the presence of Indocyanine Green (ICG).The ICG fluoresces whenilluminated through the laparoscope with NIR excitation light from the external laserengine and the fluorescence response is then imaged with the camera, processed anddisplayed on an Arthrex UHD4 System monitor.
Indications for Use	The Arthrex SynergyID Endoscopic Imaging System is intended to be used as anendoscopic video camera in a variety of endoscopic surgical procedures, including butnot limited to: orthopedic, laparoscopic, urologic, sinuscopic, and plastic surgicalprocedures. The device is also intended to be used as an accessory for microscopicsurgery.The Arthrex SynergyID Endoscopic Imaging System is indicated for use to provide realtime endoscopic visible and near-infrared fluorescence imaging. Upon intravenousadministration and use of ICG consistent with its approved label, the system enablessurgeons to perform minimally invasive surgery using standard endoscope visiblelight as well as visualization of vessels, blood flow and related tissue perfusion, and atleast one of the major extra-hepatic bile ducts (cystic duct, common bile duct orcommon hepatic duct), using near-infrared imaging. Fluorescence imaging of biliaryducts with the Arthrex SynergyID Endoscopic Imaging System is intended for use withstandard of care white light, and when indicated, intraoperative cholangiography. Thedevice is not intended for standalone use for biliary duct visualization.
SubstantialEquivalence Summary	The SynergyID System shares the same design features, materials, and intended useas the predicate, The Arthrex Synergy UHD4 System, cleared under K153218.Similarly, to the Arthrex Synergy UHD4, The SynergyID Endoscopic Imaging Systemintegrates ultra-high-definition camera technology, LED lighting, and an imagemanagement system into a single console with a tablet interface. The SynergyIDEndoscopic imaging system also interacts with an optimized camera head,endoscopes, and a flexible 0°- and 90°-degree light guide cable to support near-infrared illumination and imagining. The SynergyID Endoscopic Imaging System-camera control unit (CCU) interacts with the laser light source to provide near-infrared (NIR) imaging. The principle of operation the SynergyID recognizes the near-infrared illumination and imaging is equivalent to predicate, Pinpoint FluorescenceEndoscopic System cleared under K150956.
	Accordingly, Arthrex believes that the Arthrex SynergyID Endoscopic Imaging Systemis substantially equivalent to the original clearance Arthrex Synergy UHD4 clearedunder K153218 clearance and to the Pinpoint Endoscopic Fluorescence systemcleared under K150956.
Conclusion	The proposed Arthrex SynergyID Endoscopic Imaging System is substantiallyequivalent to the predicate device in which the basic design feature, intended use,principle of operation, major technical characteristics, product performance andfunctionality are the same as the Arthrex UHD4 System cleared under K153218 andthe Pinpoint Endoscopic Fluorescence System cleared under K150956.
	The Arthrex SynergyID principle of operation for visualization under white visiblelight, image management and accessory interaction remains identical as it wasoriginally cleared under K153218. The Arthrex SynergyID incorporates an externalengine light source which provides the NIR (near infrared) excitation light to causethe fluorescence illumination. The principle of operation of this external light sourceis identical to Pinpoint endoscopic fluorescence system video processor illuminator(VIP) cleared under K150956.
	The differences between the proposed Arthrex SynergyID Endoscopic Imaging Systemand the predicate devices listed above are primarily technological features that donot affect the performance, principle of operation or impede the system fromexecuting its intended use.
	Based on the indications for use, technological characteristics, and the summary ofdata submitted, Arthrex Inc. has determined that the proposed device is substantiallyequivalent to the currently marketed predicate device.

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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.