Arthrex Synergy Vision Endoscopic Imaging System

K233451 · Arthrex, Inc. · GCJ · Jan 18, 2024 · Gastroenterology, Urology

Device Facts

• Record ID: K233451
• Device Name: Arthrex Synergy Vision Endoscopic Imaging System
• Applicant: Arthrex, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jan 18, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

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 Story

System includes non-sterile camera control unit (CCU), camera heads, laser light source, and endoscope. Integrates ultra-high-definition camera, LED lighting, and image management into a single console with tablet interface. Used in OR/clinic by surgeons for minimally invasive procedures. Inputs: visible light and NIR fluorescence signals from ICG-enhanced tissue. Operation: laser light source provides NIR excitation; ICG fluoresces; camera captures response; system processes and displays image on monitor. Output: real-time visible and NIR fluorescence video. Assists surgeons in visualizing anatomy, blood flow, and lymphatic structures during surgery; enhances surgical precision and decision-making.

Clinical Evidence

No clinical data. Bench testing only, including design verification, software testing, biocompatibility (ISO 10993 series), electrical safety (IEC 60601-1), and EMC (IEC 60601-1-2).

Technological Characteristics

System includes CCU, camera heads, laser light source, and endoscope. Features LED lighting, ultra-high-definition imaging, and tablet interface. Connectivity: wireless technology. Biocompatibility per ISO 10993-1, -5, -12, -17, -18. Electrical safety per IEC 60601-1 (Ed 3.2), IEC 60601-2-18. EMC per IEC 60601-1-2 (Ed 4.1). Software testing per FDA 2023 guidance.

Indications for Use

Indicated for patients undergoing endoscopic diagnostic and surgical procedures (orthopedic, spine, laparoscopic, urologic, sinuscopic, plastic, thoracic, microscopic). Enables real-time visible and near-infrared (NIR) fluorescence imaging using ICG for visualization of vessels, blood flow, tissue perfusion, biliary ducts, and lymphatic system (vessels/nodes). Not for standalone biliary duct visualization.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Arthrex SynergyID Endoscopic Imaging System (K223759)

Submission Summary (Full Text)

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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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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 ([e-mail]) or phone [phone] 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)

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.

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.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 |
| Contact Person | Name: Lai Saeteurn<br>Title: Regulatory Affairs Specialist II<br>Phone: [phone]<br>Email: [e-mail] |
| Trade Name | Arthrex Synergy Vision Endoscopic Imaging System |
| Common Name | 21 CFR 876.1500: Endoscope and accessories<br>21 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 is<br>submitted to obtain clearance for the Arthrex Synergy<br>Vision Endoscopic Imaging System. |
| Device Description | The Arthrex Synergy Vision Endoscopic Imaging System<br>includes a non-sterile camera control unit (CCU)<br>console, camera heads, a laser light source, and<br>endoscope. The system integrates ultra-high-definition<br>camera technology, light emitting diode (LED) lighting,<br>and an image management system into a single console<br>with a tablet interface. The system provides real-time<br>visible and near-infrared light illumination and imaging.<br><br>The Arthrex Synergy Vision Endoscopic Imaging System<br>interacts with the laser light source to be able to<br>provide near-infrared (NIR) imaging to visualize the<br>presence of Indocyanine Green (ICG). The ICG<br>fluoresces when illuminated through a laparoscope with<br>NIR excitation light from the laser light source and the<br>fluorescence response is then imaged with the camera,<br>processed, and displayed on a monitor. |
| Indications for Use | The Arthrex Synergy Vision Endoscopic Imaging System<br>is intended to be used as an endoscopic video camera<br>to provide visible light imaging in a variety of<br>endoscopic diagnostic and surgical procedures,<br>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 assessments<br>were conducted and test results confirm the subject<br>device is biocompatible for its intended use. |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Electrical safety and EMC testing was conducted on the<br>subject device. The test results confirm the subject<br>device conforms with electrical safety and EMC<br>standards. |
| | Software testing was conducted and documentation<br>was provided in this submission. The test results<br>confirm the Arthrex software functions met product<br>requirements and design specifications for the device |
| Technological Comparison | The Arthrex Synergy Vision Endoscopic Imaging System<br>has the same intended use and indications for use as<br>the predicate device. |
| | The subject device and predicate device have the same<br>technological characteristics (i.e., principle of operation,<br>accessories/components, user interface, basic software<br>design, cleaning/reprocessing requirements, wireless<br>technology, electrical safety, and EMC) with differences<br>in user interface workflow/layout, internal hardware<br>components, and additional device accessories. |
| Conclusion | All verification activities were successfully completed to<br>confirm the subject device meets product requirements<br>and design specifications established for the device,<br>including compliance with FDA-recognized standards for<br>electrical safety, electromagnetic compatibility,<br>biological safety, and recommendations per FDA<br>guidance document for software testing. |
| | The Arthrex Synergy Endoscopic Imaging System did not<br>require animal testing or human clinical studies to<br>support the determination of substantial equivalence. |
| | Based on the same intended use/indications for use,<br>similar technological characteristics, and successful<br>completion of non-clinical testing, the Arthrex Synergy<br>Vision Endoscopic Imaging System is as safe and<br>effective as the legally marketed predicate device. Any<br>differences between the subject device and predicate<br>device are considered minor and do not raise different<br>questions concerning safety and effectiveness. |