Arthrex SynergyID Endoscopic Imaging System

K223759 · Arthex, Inc. · GCJ · Feb 24, 2023 · Gastroenterology, Urology

Device Facts

• Record ID: K223759
• Device Name: Arthrex SynergyID Endoscopic Imaging System
• Applicant: Arthex, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Feb 24, 2023
• 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 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 within the thoracic cavity. 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. Upon interstitial administration and use of ICG consistent with its approved label, the Arthrex SynergyID Endoscopic Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Device Story

Endoscopic video imaging system; includes camera control unit (CCU), camera heads, laser light source, and laparoscopes. Inputs: visible light and NIR fluorescence signals from surgical site following ICG administration. Operation: NIR laser excites ICG; fluorescence response captured by CMOS sensor; processed by CCU; displayed on monitor. Used in OR by surgeons for minimally invasive procedures. Output: real-time visible and NIR fluorescence video. Benefits: intraoperative visualization of perfusion, biliary anatomy, and lymphatic structures to guide surgical decision-making.

Clinical Evidence

Bench testing only. Verification activities included engineering evaluation, functional analysis, and software validation/verification (moderate level of concern). Biocompatibility testing per ISO 10993-5 and 10993-10. Electrical safety and EMC testing per AAMI/ANSI ES60601-1 and IEC 60601-1-2.

Technological Characteristics

System includes CCU, camera heads, laser light source, and laparoscopes. CMOS image sensor; 3840 x 2160 resolution; 60 FPS. NIR excitation at 785nm; detection bandwidth 810-940nm. Connectivity via integrated console with tablet interface. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 60825-1.

Indications for Use

Indicated for patients undergoing endoscopic diagnostic and surgical procedures (orthopedic, spine, laparoscopic, urologic, sinuscopic, plastic, thoracic) requiring visible light or near-infrared fluorescence imaging. Enables visualization of vessels, blood flow, tissue perfusion, biliary ducts, and lymphatic system (vessels/nodes) using ICG contrast agent. 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 Synergy® Endoscopic Imaging System (K202582)
• PINPOINT Endoscopic Fluorescence Imaging System (K182606)
• TIPCAM1 Rubina Video Endoscope System (K201526)
• Arthrex NanoScope System (K201134)

Submission Summary (Full Text)

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February 24, 2023

Arthex Inc. Troy Brooks Regulatory Affairs Team Lead 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K223759

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: February 16, 2023 Received: February 17, 2023

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 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. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 medical devices and radiation-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,

# Colin K. Chen -S

Colin Kejing Chen Acting 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) K223759

#### 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 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 within the thoracic cavity. 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 nearinfrared 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.

Upon interstitial administration and use of ICG consistent with its approved label, the Arthrex SynergyID 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)

| <span style="font-family: sans-serif;"> <svg height="15" width="15"> <rect fill="none" height="15" stroke="black" width="15" x="0" y="0"></rect> <line stroke="black" x1="2" x2="13" y1="2" y2="13"></line> <line stroke="black" x1="13" x2="2" y1="2" y2="13"></line> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: sans-serif;"> <svg height="15" width="15"> <rect fill="none" height="15" stroke="black" width="15" x="0" y="0"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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| Date Prepared | January 27, 2023 |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Arthrex Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 |
| Contact Person | Troy Brooks, RAC<br>Regulatory Affairs Team Lead<br>1-239-643-5553<br>[e-mail] |
| Name of Device | Arthrex Synergy® Endoscopic Imaging System |
| Common Name | Endoscopic Video Imaging 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 |
| Primary Predicate<br>Device | K202582 - Arthrex Synergy® Endoscopic Imaging System, Arthrex Inc. |
| Additional Predicate<br>Devices | K182606 - PINPOINT Endoscopic Fluorescence Imaging System, Novadaq Technologies<br>K201526 - TIPCAM1 Rubina Video Endoscope System, Karl Storz Endoscopy America<br>K201134 - Arthrex NanoScope System, Arthrex Inc. |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance for<br>expanded indications for use for the existing Arthrex Synergy® Endoscopic Imaging<br>System cleared under K202582. |
| Device Description | The Arthrex Synergy® Endoscopic Imaging System includes a non-sterile camera<br>control unit (CCU) console, camera heads, a laser light source, and laparoscopes.<br>The system integrates ultra-high-definition camera technology, LED lighting, and<br>an image management system into a single console with a tablet interface. The<br>system provides real-time visible and near-infrared light illumination and imaging. |
| | The Arthrex Synergy® Endoscopic Imaging System CCU interacts with the laser light<br>source to be able to provide near-infrared (NIR) imaging to visualize the presence of<br>Indocyanine Green (ICG). The ICG fluoresces when illuminated through a laparoscope<br>with NIR excitation light from the laser light source and the fluorescence response is<br>then imaged with the camera, processed and displayed on a monitor. |
| Indications for Use | The Arthrex Synergy® Endoscopic Imaging System is intended to be used as an<br>endoscopic video camera to provide visible light imaging in a variety of endoscopic<br>diagnostic and surgical procedures, including but not limited to: orthopedic, spine,<br>laparoscopic, urologic, sinuscopic, plastic surgical procedures, and procedures within<br>the thoracic cavity. The device is also intended to be used as an accessory for<br>microscopic surgery. |
| | The Arthrex Synergy® 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<br>at 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 Synergy® Endoscopic Imaging System is intended for use with<br>standard of care white light, and when indicated, intraoperative cholangiography.<br>The device is not intended for standalone use for biliary duct visualization. |
| | Upon interstitial administration and use of ICG consistent with its approved label,<br>the Arthrex Synergy® Endoscopic Imaging System is used to perform intraoperative<br>fluorescence imaging and visualization of the lymphatic system, including lymphatic<br>vessels and lymph nodes. |

## 510(k) Summary

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### Technological Comparison

| | Arthrex<br>SynergyID<br>Endoscopic<br>Imaging System | Arthrex<br>SynergyID<br>Endoscopic<br>Imaging System | Novadaq<br>PINPOINT<br>Endoscopic<br>Fluorescence<br>Imaging System | Karl Storz<br>TIPCAM1 Rubina<br>Video Endoscope<br>System | Arthrex<br>NanoScope<br>System | Comparison |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | Subject Device | | K182606<br>Additional<br>Predicate | K201526<br>Additional<br>Predicate | K201134<br>Additional<br>Predicate | |
| Classification | Class II | Class II | Class II | Class II | Class II | Equivalent |
| Product Code | GCJ, IZI | GCJ, IZI | GCJ, IZI | GCJ, FGB, HET | GCJ, HRX | Equivalent |
| 21 CFR | 876.1500<br>Endoscope and<br>Accessories | 876.1500<br>Endoscope and<br>Accessories | 876.1500<br>Endoscope and<br>Accessories | 876.1500<br>Endoscope and<br>Accessories | 876.1500<br>Endoscope and<br>Accessories | Equivalent |
| Combination<br>Product | No | No | No | No | No | Equivalent |
| Indications<br>For Use | The Arthrex<br>SynergyID<br>Endoscopic<br>Imaging System<br>is intended to<br>be used as an<br>endoscopic video<br>camera to<br>provide visual<br>imaging in a<br>variety of<br>endoscopic<br>diagnostic and<br>surgical<br>procedures,<br>including but<br>not limited to:<br>orthopedic,<br>spine,<br>laparoscopic,<br>urologic,<br>sinuscopic,<br>plastic surgical<br>procedures,<br>and procedures<br>within the<br>thoracic cavity.<br>The device is also<br>intended to be<br>used as an<br>accessory for<br>microscopic<br>surgery.<br><br>The Arthrex<br>SynergyID<br>Endoscopic<br>Imaging System<br>is indicated for<br>use to provide<br>real time<br>endoscopic<br>visible and<br>near-infrared<br>fluorescence<br>imaging. Upon<br>intravenous<br>administration<br>and use of ICG<br>consistent with<br>its approved | The Arthrex<br>SynergyID<br>Endoscopic<br>Imaging System<br>is intended to<br>be used as an<br>endoscopic video<br>camera in a<br>variety of<br>endoscopic<br>surgical<br>procedures,<br>including but<br>not limited to:<br>orthopedic,<br>laparoscopic,<br>urologic,<br>sinuscopic, and<br>plastic surgical<br>procedures. The<br>device is also<br>intended to be<br>used as an<br>accessory for<br>microscopic<br>surgery.<br><br>The Arthrex<br>SynergyID<br>Endoscopic<br>Imaging System<br>is indicated for<br>use to provide<br>real time<br>endoscopic<br>visible and<br>near-infrared<br>fluorescence<br>imaging. Upon<br>intravenous<br>administration<br>and use of ICG<br>consistent with<br>its approved<br>label, the system<br>enables surgeons<br>to perform<br>minimally<br>invasive surgery<br>using standard<br>endoscope | Upon<br>intravenous<br>administration<br>of TRADENAME<br>(ICG drug<br>product), the<br>PINPOINT<br>Endoscopic<br>Fluorescence<br>Imaging System<br>is used with<br>TRADENAME to<br>perform<br>intraoperative<br>fluorescence<br>angiography,<br>and it is also<br>indicated for use<br>in fluorescence<br>imaging of biliary<br>ducts, and when<br>indicated, during<br>intraoperative<br>cholangiography.<br><br>The PINPOINT<br>Endoscopic<br>Fluorescence<br>Imaging System<br>is indicated for<br>use to provide<br>real time<br>endoscopic<br>visible and near-<br>infrared<br>fluorescence<br>imaging. The<br>PINPOINT<br>System enables<br>surgeons to<br>perform<br>minimally<br>invasive surgery<br>using standard<br>endoscope<br>visible light as<br>well as visual<br>assessment of<br>vessels, blood<br>flow and related<br>tissue perfusion, | The TIPCAM1<br>Rubina Video<br>Endoscope<br>System is<br>intended to be<br>used together<br>with the camera<br>control unit<br>during diagnostic<br>and/or surgical<br>procedures<br>when endoscopic<br>video assistance<br>is required. For<br>use in all<br>endoscopy and<br>endoscopic<br>surgery within<br>the peritoneal<br>and thoracic<br>cavity, including<br>gynecological<br>and urological<br>anatomy. | The Arthrex<br>NanoScope<br>System is<br>intended to be<br>used as an<br>endoscopic video<br>camera in a<br>variety of<br>endoscopic<br>diagnostic and<br>surgical<br>procedures,<br>including but<br>not limited to:<br>orthopedic,<br>spine,<br>laparoscopic,<br>urologic,<br>sinuscopic, and<br>plastic surgical<br>procedures. The<br>device is also<br>intended to be<br>used as an<br>accessory for<br>microscopic<br>surgery. | The subject<br>device includes<br>the following<br>additional<br>indications<br>for use:<br>- fluorescence<br>imaging and<br>visualization<br>of the<br>lymphatic<br>system,<br>including<br>lymphatic<br>vessels and<br>lymph nodes<br>- use as an<br>endoscopic<br>video camera<br>(i.e. visual<br>imaging) in<br>diagnostic<br>and surgical<br>procedures<br>for spine and<br>within the<br>thoracic cavity |
| | to perform<br>minimally<br>invasive surgery<br>using standard<br>endoscope<br>visible light as<br>well as<br>visualization of<br>vessels, blood<br>flow and related<br>tissue perfusion,<br>and at least one<br>of the major<br>extra-hepatic<br>bile ducts (cystic<br>duct, common<br>bile duct or<br>common hepatic<br>duct), using<br>near-infrared<br>imaging.<br>Fluorescence<br>imaging of biliary<br>ducts with the<br>Arthrex Synergy®<br>Endoscopic<br>Imaging System<br>is intended for<br>use with<br>standard of care<br>white light, and<br>when indicated,<br>intraoperative<br>cholangiography.<br>The device is not<br>intended for<br>standalone use<br>for biliary duct<br>visualization.<br>Upon interstitial<br>administration<br>and use of ICG<br>consistent with<br>its approved<br>label, the Arthrex<br>SynergyD<br>Endoscopic<br>Imaging System<br>is used to<br>perform<br>intraoperative<br>fluorescence<br>imaging and<br>visualization of<br>the lymphatic<br>system, including<br>lymphatic vessels<br>and lymph<br>nodes. | visualization of<br>vessels, blood<br>flow and related<br>tissue perfusion,<br>and at least one<br>of the major<br>extra-hepatic<br>bile ducts (cystic<br>duct, common<br>bile duct or<br>common hepatic<br>duct), using<br>near-infrared<br>imaging.<br>Fluorescence<br>imaging of biliary<br>ducts with the<br>Arthrex Synergy®<br>Endoscopic<br>Imaging System<br>is intended for<br>use with<br>standard of care<br>white light, and<br>when indicated,<br>intraoperative<br>cholangiography.<br>The device is not<br>intended for<br>standalone use<br>for biliary duct<br>visualization. | extra-hepatic<br>bile ducts (cystic<br>duct, common<br>bile duct or<br>common hepatic<br>duct), using<br>near-infrared<br>imaging.<br>Fluorescence<br>imaging of biliary<br>ducts with the<br>PINPOINT<br>System is<br>intended for use<br>with standard of<br>care white light,<br>and when<br>indicated,<br>intraoperative<br>cholangiography.<br>The device is not<br>intended for<br>standalone use<br>for biliary duct<br>visualization.<br>Upon interstitial<br>administration<br>of TRADENAME<br>(ICG drug<br>product), the<br>PINPOINT<br>System is used<br>to perform<br>intraoperative<br>fluorescence<br>imaging and<br>visualization of<br>the lymphatic<br>system, including<br>lymphatic vessels<br>and lymph<br>nodes. | | | |
| System<br>Components | Camera Control<br>Unit<br>Light Source<br>Camera Heads<br>Scopes | Camera Control<br>Unit<br>Light Source<br>Camera Heads<br>Scopes | Video Processor<br>Illuminator (VPI)<br>Camera Head<br>Scopes | Camera Control<br>Unit<br>Camera/Scope<br>(integrated) | Console<br>Camera/Scope<br>(integrated) | Equivalent to<br>the primary<br>predicate<br>K202582.<br>Similar to<br>predicates<br>K182606<br>and K201526. |
| Imaging<br>Modes | White Light<br>NIR Fluorescence | White Light<br>NIR Fluorescence | White Light<br>NIR Fluorescence | White Light | White Light | Equivalent<br>per white light<br>indications and<br>NIR fluorescence<br>indications. |
| Safety<br>Standards | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-18<br>IEC 60825-1 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-18<br>IEC 60825-1 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-18<br>IEC 60825-1 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-18 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-18 | Equivalent |
| Light<br>Source | Integrated<br>(Visible)<br>External (NIR) | Integrated<br>(Visible)<br>External (NIR) | Integrated | Integrated | Integrated | Equivalent<br>to primary<br>predicate<br>K202582. |
| Image Sensor | CMOS | CMOS | CMOS | CMOS | CMOS | Equivalent |
| Image<br>Resolution | 3840 x 2160…