The Arthrex Synergy Vision Endoscopic Imaging System is intended to be used as an endoscopic video camera to provide visible light imaging in a variety of endoscopic diagnostic and surgical procedures, including but not limited to: orthopedic, spine, laparoscopic, urologic, sinuscopic, plastic surgical procedures, and procedures within the thoracic cavity. The device is also intended to be used as an accessory for microscopic surgery.

The Arthrex Synergy Vision 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 Synergy Vision 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 biliary duct visualization.

Upon interstitial administration and use of ICG consistent with its approved label, the Arthrex Synergy Vision Endoscopic Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Device Description

The Arthrex Synergy Vision Endoscopic Imaging System includes a non-sterile camera control unit (CCU) console, camera heads, a laser light source, and endoscope. The system integrates ultra-high-definition camera technology, light emitting diode (LED) lighting, and an image management system into a single console with a tablet interface. The system provides real-time visible and near-infrared light illumination and imaging.

The Arthrex Synergy Vision Endoscopic Imaging System interacts with the laser 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 a laparoscope with NIR excitation light from the laser light source and the fluorescence response is then imaged with the camera, processed, and displayed on a monitor.

AI/ML Overview

The provided text describes the Arthrex Synergy Vision Endoscopic Imaging System. However, it does not contain specific acceptance criteria, performance metrics, or details of a study that would demonstrate the device meets such criteria in terms of clinical performance or diagnostic accuracy.

Instead, the document focuses on regulatory clearance for a medical device by demonstrating substantial equivalence to a predicate device. The "Performance Data" section details non-clinical testing related to safety and functionality, rather than clinical efficacy or accuracy.

Therefore, I cannot populate the requested table or answer most of the questions as the information is not present in the provided text.

Here's what can be extracted and what cannot:

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

Acceptance Criteria Category	Reported Device Performance (from non-clinical testing)
Biocompatibility	Device is biocompatible for its intended use (conforms to ISO 10993 standards)
Electrical Safety	Conforms with electrical safety standards (e.g., IEC 60601-1)
Electromagnetic Compatibility (EMC)	Conforms with EMC standards (e.g., IEC 60601-1-2)
Software Functionality	Arthrex software functions met product requirements and design specifications
Design Verification	Met Arthrex product requirements and design specifications for system and individual components (through inspection, engineering analysis, functional testing)
Clinical Performance/Accuracy	Not specified in the provided text.

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

Not applicable for clinical performance testing. The reported "testing" refers to non-clinical engineering and safety validations. No patient data or clinical test sets are mentioned.

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)

Not applicable. No expert review or ground truth establishment for clinical performance is mentioned.

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

Not applicable. No adjudication method for clinical performance is mentioned.

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

No such study was done. The document explicitly states: "The Arthrex Synergy Endoscopic Imaging System did not require animal testing or human clinical studies to support the determination of substantial equivalence."

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

Not applicable. The device is an imaging system providing visible and near-infrared fluorescence imaging, not an AI-driven diagnostic algorithm that would typically have standalone performance.

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

Not applicable for clinical performance. The "ground truth" for the non-clinical tests involved compliance with engineering standards and predefined design specifications.

8. The sample size for the training set

Not applicable. The non-clinical testing does not involve training data in the context of machine learning.

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

Not applicable.

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). On the left is the Department of Health & Human Services USA seal. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below it.

January 18, 2024

Arthrex, Inc. Lai Saeteurn Regulatory Affairs Specialist II 1370 Creekside Boulevard Naples, Florida 34108

Re: K233451

Trade/Device Name: Arthrex Synergy Vision Endoscopic Imaging System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ, IZI Dated: October 19, 2023 Received: October 20, 2023

Dear Lai Saeteurn:

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download)

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Page

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/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,

Jessica Carr -S

Jessica Carr, PhD 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

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Enclosure

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Indications for Use

Submission Number (if known)

K233451

Device Name

Arthrex Synergy Vision Endoscopic Imaging System

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image shows the logo for Arthrex. The logo consists of the word "Arthrex" in a bold, sans-serif font, followed by a stylized image of a surgical instrument. The instrument appears to be a type of clamp or forceps, with a handle and two curved blades. The logo is simple and professional, conveying a sense of precision and expertise.

K233451 510(k) Summary

Date Prepared	October 19, 2023
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	Name: Lai SaeteurnTitle: Regulatory Affairs Specialist IIPhone: 239-643-5553Email: Lai.Saeteurn@Arthrex.com
Trade Name	Arthrex Synergy Vision Endoscopic Imaging System
Common Name	21 CFR 876.1500: Endoscope and accessories21 CFR 892.1600: Angiographic x-ray systems
Product Code	GCJ, IZI
Classification Name	Laparoscope, General & Plastic Surgery
Regulatory Class	Class II
Primary Predicate Device	K223759 Arthrex SynergyID Endoscopic Imaging System
Purpose of Submission	This Traditional 510(k) premarket notification issubmitted to obtain clearance for the Arthrex SynergyVision Endoscopic Imaging System.
Device Description	The Arthrex Synergy Vision Endoscopic Imaging Systemincludes a non-sterile camera control unit (CCU)console, camera heads, a laser light source, andendoscope. The system integrates ultra-high-definitioncamera technology, light emitting diode (LED) lighting,and an image management system into a single consolewith a tablet interface. The system provides real-timevisible and near-infrared light illumination and imaging.The Arthrex Synergy Vision Endoscopic Imaging Systeminteracts with the laser light source to be able toprovide near-infrared (NIR) imaging to visualize thepresence of Indocyanine Green (ICG). The ICGfluoresces when illuminated through a laparoscope withNIR excitation light from the laser light source and thefluorescence response is then imaged with the camera,processed, and displayed on a monitor.
Indications for Use	The Arthrex Synergy Vision Endoscopic Imaging Systemis intended to be used as an endoscopic video camerato provide visible light imaging in a variety ofendoscopic diagnostic and surgical procedures,including but not limited to: orthopedic, spine

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laparoscopic, urologic, sinuscopic, plastic surgical procedures, and procedures within the thoracic cavity. The device is also intended to be used as an accessory for microscopic surgery. The Arthrex Synergy Vision 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 Synergy Vision 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 biliary duct visualization. Upon interstitial administration and use of ICG consistent with its approved label, the Arthrex Synergy Vision Endoscopic Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. Performance Data Non-clinical testing was developed and performed on the Arthrex Synergy Vision Endoscopic Imaging System to confirm the device meets product requirements and device specifications. These tests included design verification, software testing, biocompatibility testing, electrical safety, and electromagnetic compatibility (EMC) testing. The testing methods are the same between the subject device and predicate device. Biological testing and toxicological risks assessments were performed in accordance with ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (FDA Recognition Number: 2-258); ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (FDA Recognition Number: 2-245); ISO 10993-12:2021, Biological evaluation of

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medical devices - Part 12: Sample preparation and reference materials (FDA Recognition Number: 2-289); ISO 10993-17:2002, Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (FDA Recognition Number: 2-237); and ISO 10993-18:2020, Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (FDA Recognition Number: 2-298).

Electrical safety and EMC testing was performed in accordance with IEC 60601-1 Edition 3.2 2020-08, CONSOLIDATED VERSION Medical electrical equipment -Part 1: General requirements for basic safety and essential performance (FDA Recognized Number: 19-49); IEC 60601-1-2 Edition 4.1 2020-09, CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (FDA Recognized Number: 19-36); IEC 60601-1-6:2010, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (FDA Recognition Number: 5-89), IEC 60601-2-18:2009, Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment (FDA Recognition Number: 9-114); and IEC TR 60601-4-2:2016, Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems (FDA Recognition Number: 19-19).

Software testing was performed in accordance with recommendations in FDA guidance document "Content of Premarket Submissions for Device Software Functions" (issued June 2023).

Design verification testing included inspection, engineering analysis, and functional testing of the subject device, both as a system and as individual components. The test results confirm the subject device met Arthrex product requirements and design specifications for the device.

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Image /page/7/Picture/3 description: The image shows the Arthrex logo. The logo consists of the word "Arthrex" in a bold, sans-serif font, followed by a stylized image of a surgical instrument. The instrument appears to be a type of clamp or forceps, with a handle and a pair of jaws.

	Biological testing and toxicological risks assessmentswere conducted and test results confirm the subjectdevice is biocompatible for its intended use.
	Electrical safety and EMC testing was conducted on thesubject device. The test results confirm the subjectdevice conforms with electrical safety and EMCstandards.
	Software testing was conducted and documentationwas provided in this submission. The test resultsconfirm the Arthrex software functions met productrequirements and design specifications for the device
Technological Comparison	The Arthrex Synergy Vision Endoscopic Imaging Systemhas the same intended use and indications for use asthe predicate device.
	The subject device and predicate device have the sametechnological characteristics (i.e., principle of operation,accessories/components, user interface, basic softwaredesign, cleaning/reprocessing requirements, wirelesstechnology, electrical safety, and EMC) with differencesin user interface workflow/layout, internal hardwarecomponents, and additional device accessories.
Conclusion	All verification activities were successfully completed toconfirm the subject device meets product requirementsand design specifications established for the device,including compliance with FDA-recognized standards forelectrical safety, electromagnetic compatibility,biological safety, and recommendations per FDAguidance document for software testing.
	The Arthrex Synergy Endoscopic Imaging System did notrequire animal testing or human clinical studies tosupport the determination of substantial equivalence.
	Based on the same intended use/indications for use,similar technological characteristics, and successfulcompletion of non-clinical testing, the Arthrex SynergyVision Endoscopic Imaging System is as safe andeffective as the legally marketed predicate device. Anydifferences between the subject device and predicatedevice are considered minor and do not raise differentquestions concerning 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.