Arthrex SynergyID Endoscopic Imaging System

K202582 · Arthrex, Inc. · GCJ · Jul 22, 2021 · Gastroenterology, Urology

Device Facts

• Record ID: K202582
• Device Name: Arthrex SynergyID Endoscopic Imaging System
• Applicant: Arthrex, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jul 22, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

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 Story

System comprises camera control unit (CCU), camera head, and external laser light engine; integrates ultra-high-definition camera, LED lighting, and image management. Used in OR by surgeons for minimally invasive procedures. Inputs: visible light and NIR excitation light; ICG-enhanced tissue fluorescence. CCU processes fluorescence response from ICG-perfused tissue; displays real-time overlay on UHD4 monitor. Assists surgeons in identifying blood flow, tissue perfusion, and biliary anatomy during surgery. Benefits: improved intraoperative visualization of critical structures; supports standard white light and NIR imaging modes.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

System includes CCU, camera head, and external laser light engine. Features UHD camera technology, LED lighting, and tablet interface. Supports NIR excitation for ICG fluorescence. Connectivity includes flexible 0- and 90-degree light guide cables. Software-based image management system.

Indications for Use

Indicated for patients undergoing endoscopic surgical procedures (orthopedic, laparoscopic, urologic, sinuscopic, plastic, microscopic) requiring real-time visible and near-infrared (NIR) fluorescence imaging. Enables visualization of vessels, blood flow, tissue perfusion, and extra-hepatic bile ducts using intravenous Indocyanine Green (ICG). 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

• Pinpoint Endoscopic Fluorescence Imaging System (K150956)
• Arthrex UHD4 System (K153218)

Submission Summary (Full Text)

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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 [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><span style="font-size:16px;"> <div> <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </div></span></div> | <div style="display:flex; align-items:center;"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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# 510(k) Summary

| Date Prepared | July 22, 2021 |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Arthrex Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 |
| Contact Person | Troy Brooks, RAC<br>Principal Regulatory Affairs Specialist<br>1-972-369-2712<br>[e-mail] |
| 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 accessories<br>21 CFR 892.1600: Angiographic x-ray systems |
| Regulatory Class | II |
| Predicate Device | K150956 – Pinpoint Endoscopic Fluorescence Imaging System (Primary Predicate)<br>K153218 – Arthrex UHD4 System |
| Purpose of Submission | This 510(k) premarket notification is submitted to add near-infrared fluorescence<br>imaging, visualization of blood vessels, blood flow, related tissue perfusion and at<br>least one major of the major extra hepatic bile duct indications for use. This 510(k) is<br>also submitted to incorporate an external laser engine light source to provide the NIR<br>excitation light for fluorescence visibility. |
| Device Description | The Arthrex SynergyID Endoscopic Imaging System comprises a non-sterile camera<br>control unit (CCU) console, camera head, and light engine source. The system<br>integrates ultra-high-definition camera technology, LED lighting, and an image<br>management system into a single console with a tablet interface in an identical<br>manner as the Arthrex UHD4 System cleared under K153218.<br><br>The Arthrex SynergyID Endoscopic Imaging System camera control unit interacts with<br>the near-infrared light source to be able to provide near-infrared (NIR) imaging to<br>visualize the presence of Indocyanine Green (ICG).The ICG fluoresces when<br>illuminated through the laparoscope with NIR excitation light from the external laser<br>engine and the fluorescence response is then imaged with the camera, processed and<br>displayed on an Arthrex UHD4 System monitor. |
| Indications for Use | The Arthrex SynergyID Endoscopic Imaging System is intended to be used as an<br>endoscopic video camera in a variety of endoscopic surgical procedures, including but<br>not limited to: orthopedic, laparoscopic, urologic, sinuscopic, and plastic surgical<br>procedures. The device is also intended to be used as an accessory for microscopic<br>surgery.<br><br>The Arthrex SynergyID Endoscopic Imaging System is indicated for use to provide real<br>time endoscopic visible and near-infrared fluorescence imaging. Upon intravenous<br>administration and use of ICG consistent with its approved label, the system enables<br>surgeons to perform minimally invasive surgery using standard endoscope visible<br>light as well as visualization of vessels, blood flow and related tissue perfusion, and at<br>least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or<br>common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary<br>ducts with the Arthrex SynergyID Endoscopic Imaging System is intended for use with<br>standard of care white light, and when indicated, intraoperative cholangiography. The<br>device is not intended for standalone use for biliary duct visualization. |
| Substantial<br>Equivalence Summary | The SynergyID System shares the same design features, materials, and intended use<br>as the predicate, The Arthrex Synergy UHD4 System, cleared under K153218.<br>Similarly, to the Arthrex Synergy UHD4, The SynergyID Endoscopic Imaging System<br>integrates ultra-high-definition camera technology, LED lighting, and an image<br>management system into a single console with a tablet interface. The SynergyID<br>Endoscopic imaging system also interacts with an optimized camera head,<br>endoscopes, and a flexible 0°- and 90°-degree light guide cable to support near-<br>infrared illumination and imagining. The SynergyID Endoscopic Imaging System-<br>camera control unit (CCU) interacts with the laser light source to provide near-<br>infrared (NIR) imaging. The principle of operation the SynergyID recognizes the near-<br>infrared illumination and imaging is equivalent to predicate, Pinpoint Fluorescence<br>Endoscopic System cleared under K150956. |
| | Accordingly, Arthrex believes that the Arthrex SynergyID Endoscopic Imaging System<br>is substantially equivalent to the original clearance Arthrex Synergy UHD4 cleared<br>under K153218 clearance and to the Pinpoint Endoscopic Fluorescence system<br>cleared under K150956. |
| Conclusion | The proposed Arthrex SynergyID Endoscopic Imaging System is substantially<br>equivalent to the predicate device in which the basic design feature, intended use,<br>principle of operation, major technical characteristics, product performance and<br>functionality are the same as the Arthrex UHD4 System cleared under K153218 and<br>the Pinpoint Endoscopic Fluorescence System cleared under K150956. |
| | The Arthrex SynergyID principle of operation for visualization under white visible<br>light, image management and accessory interaction remains identical as it was<br>originally cleared under K153218. The Arthrex SynergyID incorporates an external<br>engine light source which provides the NIR (near infrared) excitation light to cause<br>the fluorescence illumination. The principle of operation of this external light source<br>is identical to Pinpoint endoscopic fluorescence system video processor illuminator<br>(VIP) cleared under K150956. |
| | The differences between the proposed Arthrex SynergyID Endoscopic Imaging System<br>and the predicate devices listed above are primarily technological features that do<br>not affect the performance, principle of operation or impede the system from<br>executing its intended use. |
| | Based on the indications for use, technological characteristics, and the summary of<br>data submitted, Arthrex Inc. has determined that the proposed device is substantially<br>equivalent to the currently marketed predicate device. |

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