FloNavi Endoscopic Fluorescence Imaging System

K221861 · Guangdong Optomedic Technologies, Inc. · GCJ · Feb 18, 2023 · Gastroenterology, Urology

Device Facts

• Record ID: K221861
• Device Name: FloNavi Endoscopic Fluorescence Imaging System
• Applicant: Guangdong Optomedic Technologies, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Feb 18, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

Upon intravenous administration and use of an ICG consistent with its approved label, the FloNavi Endoscopic Fluorescence Imaging System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. During minimally invasive surgery, the FloNavi Endoscopic Fluorescence Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts, using near-infrared imaging. Upon interstitial administration and use of an ICG consistent with its approved label, the FloNavi Endoscopic Fluorescence Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Device Story

FloNavi Endoscopic Fluorescence Imaging System provides real-time visible and near-infrared (NIR) fluorescence imaging during minimally invasive surgery. System components include an image processing unit, camera head, and light source. Input consists of visible light illumination and NIR excitation light; the system captures reflected visible light and ICG-induced fluorescence. The device processes these signals to display real-time video on a monitor. Operated by physicians in hospital settings, the system assists surgeons in visualizing blood flow, tissue perfusion, bile ducts, and lymphatic structures. Output enables intraoperative visual assessment, aiding surgical decision-making and potentially improving patient outcomes by identifying critical anatomical structures and perfusion status. The system is used with ICG imaging agents.

Clinical Evidence

No clinical data. Bench testing only. Performance testing included imaging and light source verification, and compliance with electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), endoscopic equipment safety (IEC 60601-2-18), laser safety (IEC 60825-1), and photobiological safety (IEC 62471).

Technological Characteristics

System includes image processing unit, camera head (4K or HD CMOS), and LED light source with NIR laser diode. Connectivity via DVI, HDMI, SDI. Reusable, non-sterile. Laser Class 3R. Complies with IEC 60601-1, 60601-1-2, 60601-2-18, 60825-1, and 62471.

Indications for Use

Indicated for use in patients undergoing minimally invasive surgery requiring real-time endoscopic visible and near-infrared fluorescence imaging for assessment of vessels, blood flow, tissue perfusion, and major extra-hepatic bile ducts, or visualization of the lymphatic system (vessels and nodes) following ICG administration.

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 (K182606)

Reference Devices

• Image 1 SPIES System (K160044)
• Power LED 175 (K123956)
• O-Mec laparoscopes 690 Series (K201151)

Submission Summary (Full Text)

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February 18, 2023

Guangdong OptoMedic Technologies, Inc. % Joyce Yang Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square Nanshan District Shenzhen, Guangdong 518100 China

Re: K221861

Trade/Device Name: FloNavi Endoscopic Fluorescence Imaging System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ, IZI Dated: January 13, 2023 Received: January 17, 2023

Dear Joyce Yang:

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.

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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 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.

# Jianting Wang -S

Jianting Wang 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) K221861

### Device Name

FloNavi Endoscopic Fluorescence Imaging System

## Indications for Use (Describe)

Upon intravenous administration and use of an ICG consistent with its approved label, the FloNavi Endoscopic Fluorescence Imaging System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. During minimally invasive surgery, the FloNavi Endoscopic Fluorescence Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts, using near-infrared imaging.

Upon interstitial administration and use of an ICG consistent with its approved label, the FloNavi Endoscopic Fluorescence 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)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary - K221861

Date of Summary prepare: February 7, 2023

# 1. Submission Sponsor

| Applicant Name: | Guangdong OptoMedic Technologies, Inc. |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Suite 503, Building A, Golden Valley Intellicreation<br>Community, No.2 Yonganbei Street, Daxu,<br>Guicheng, Nanhai, 528200, Foshan, Guangdong,<br>P.R.China |
| Contact person: | Jane Guo |
| Phone: | [phone] |
| Email: | [e-mail] |

#### 2. Submission correspondent

| Name: | Shenzhen Joyantech Consulting Co., Ltd |
|-----------------|---------------------------------------------------------------------------------------------|
| Address: | 1713A, 17th Floor, Block A, Zhongguan Times<br>Square, Nanshan District, Shenzhen<br>518000 |
| Contact person: | Joyce Yang |
| Phone: | [phone] |
| Email: | [e-mail] |

#### 3. Device Identification

| Trade Name: | FloNavi Endoscopic Fluorescence Imaging System |
|-----------------------|--------------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Endoscopic Imaging System |
| Model: | OPTO-CAM214K, OPTO-CHD214KE, OPTO-CHD214KH, OPTO-LED214K;<br>OPTO-CAM2100, OPTO-CHD2100, OPTO-LED2100; |
| Classification name: | Endoscope and accessories |
| Review Panel: | Gastroenterology/Urology |
| Product Code: | GCJ |
| Device Class: | Class II |
| Regulation Number: | 21 CFR § 876.1500 |

#### Legally Marketed Predicate Device 4.

| Predicate Device: | |
|--------------------|----------------------------------------------------|
| Trade Name: | PINPOINT Endoscopic Fluorescence Imaging<br>System |
| Regulation number: | 21 CFR § 876.1500 |
| Regulation class: | Class II |

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| Regulation name: | Endoscope and accessories |
|--------------------|------------------------------------|
| 510(k) Number: | K182606 |
| Product Code: | GCJ; IZI |
| Manufacturer: | Novadaq Technologies ULC. |
| | |
| Reference Device: | |
| Trade Name: | Image 1 SPIES System |
| Regulation number: | 21 CFR § 876.1500 |
| Regulation class: | Class II |
| Regulation name: | Endoscope and accessories |
| 510(k) Number: | K160044 |
| Product Code: | FET |
| Manufacturer: | Karl Storz Endoscopy America, Inc. |
| | |
| Trade Name: | Power LED 175 |
| Regulation number: | 21 CFR § 876.1500 |
| Regulation class: | Class II |
| Regulation name: | Endoscope and accessories |
| 510(k) Number: | K123956 |
| Product Code: | FCW, NTN |
| Manufacturer: | Karl Storz Endoscopy America, Inc. |

#### Device Description 5.

The proposed system, FloNavi Endoscopic Fluorescence Imaging System (FloNavi System) is comprised of an image processing unit, a camera head, and a light source (including a flexible light guide cable).

There are two models of the proposed system. The primary components of each model are provided in Table 1.

| FloNavi Endoscopic<br>Fluorescence<br>Imaging System | Primary component |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Model 1 | Image Processing Unit: OPTO-CAM214K<br>Camera Head: OPTO-CHD214KE/OPTO-CHD214KH<br>Light Source: OPTO-LED214K |
| Model 2 | Image Processing Unit: OPTO-CAM2100<br>Camera Head: OPTO-CHD2100<br>Light Source: OPTO-LED2100 |

| Table 1 System Model and primary component | | | | | |
|--------------------------------------------|--|--|--|--|--|
|--------------------------------------------|--|--|--|--|--|

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Except slight differences in appearance, other differences between components of either model are shown in Table 2.

| Image Processing Unit | | | |
|-------------------------|--------------------------------------------------------------------|-----------------------------------------------|-------------------------|
| Item | OPTO-CAM214K | OPTO-CAM2100 | |
| Video outputs | DVI, HDMI, 4×3G-SDI, 12G-SDI | SDI, DVI, CVBS, S-VIDEO | |
| Video output resolution | $4096 \times 2160p, 3840 \times 2160p, 1920 \times 1080p, 50/60Hz$ | $1920 \times 1080p, 720 \times 576i, 50/60Hz$ | |
| Size (mm) | 403*370*150 | 403*370*150 | |
| Weight (kg) | 9±15% | 9±15% | |
| Camera Head | | | |
| Item | OPTO-CHD214KH | OPTO-CHD214KE | OPTO-CAM2100 |
| Image sensor | 4K CMOS sensor assembly | 4K CMOS sensor assembly | HD CMOS sensor assembly |
| Focusing mechanism | Manual | Motor-driven | Manual |
| Weight (kg) | | 0.6±15% | 0.5±15% |
| Light Source | | | |
| Item | OPTO-LED214K | OPTO-LED2100 | |
| Size (mm) | 403*370*150 | 403*370*150 | |
| Weight (kg) | 11±15% | 11±15% | |
| Light guide cable | Diameter: 4.5mm | Diameter: 4.8 mm | |

FloNavi Endoscopic Fluorescence Imaging System is capable of providing real-time endoscopic visible and near-infrared fluorescence imaging.

During surgical procedures, FloNavi may be operated to provide visualization similar to that provided by conventional imaging systems used in surgical endoscopy. The area of interest is illuminated with visible light from the light source and the resulting reflecting light is imaged by the camera and displayed on the video monitor. When used with the VIS-only laparoscopes, the System is only capable of the conventional mode of visualization described herein.

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To provide NIR fluorescence imaging, FloNavi is used with the imaging agent, indocyanine green (ICG). The patient is injected with ICG imaging agent. The ICG fluoresces when illuminated through the laparoscope with NIR excitation light from the light source, and the fluorescence response is then imaged with the camera, processed and displayed on a video monitor.

The proposed system is designed to be used with rigid endoscopes, monitors and other ancillary equipment. The compatible rigid endoscope is O-Mec laparoscopes 690 Series (Model: 690-331030H), which was cleared under K201151.

## Intended Use/ Indications for Use

Upon intravenous administration and use of an ICG consistent with its approved label, the FloNavi Endoscopic Fluorescence Imaging System is intended to provide realtime endoscopic visible and near-infrared fluorescence imaging. During minimally invasive surgery, the FloNavi Endoscopic Fluorescence Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts, using near-infrared imaging.

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

| Comparison item | Subject Device (K221861) | Predicate Device(K182606) | |
|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Product Name | FloNavi<br>Fluorescence<br>Imaging System | PINPOINT<br>Fluorescence Imaging System | |
| Product Code | GCJ | GCJ, IZI | |
| Regulation Number | 21 CFR § 876.1500 | 21 CFR § 876.1500 | |
| Classification | Class II | Class II | |
| Type of use | Prescription Use | Prescription Use | |
| Comparison item | Subject Device (K221861) | Predicate Device(K182606) | |
| Intended use &<br>Indication s for Use | Upon intravenous<br>administration and use of<br>an ICG consistent with its<br>approved label, the FloNavi<br>Endoscopic Fluorescence<br>Imaging System is intended<br>to provide real-time<br>endoscopic visible and<br>near-infrared fluorescence<br>imaging. During minimally<br>invasive surgery, the<br>FloNavi Endoscopic<br>Fluorescence Imaging<br>System enables surgeons<br>to perform minimally<br>invasive surgery using<br>standard endoscopic visible<br>light as well as visual<br>assessment of vessels,<br>blood flow and related<br>tissue perfusion, and at<br>least one of the major extra-<br>hepatic bile ducts, using<br>near-infrared imaging.<br>Upon interstitial<br>administration and use of<br>an ICG consistent with its<br>approved label, the FloNavi<br>Endoscopic Fluorescence<br>Imaging System is used to<br>perform intraoperative<br>fluorescence imaging and<br>visualization of the<br>lymphatic system, including<br>lymphatic vessels and<br>lymph nodes. | Upon intravenous administration of<br>TRADENAME (ICG drug product),<br>the PINPOINT Endoscopic<br>Fluorescence Imaging System is<br>used with TRADENAME to perform<br>intraoperative fluorescence<br>angiography, and it is also indicated<br>for use in fluorescence imaging of<br>biliary ducts, and when indicated,<br>during intraoperative<br>cholangiography.<br>The PINPOINT Endoscopic<br>Fluorescence Imaging System is<br>indicated for use to provide real time<br>endoscopic visible and near-infrared<br>fluorescence imaging. The<br>PINPOINT System enables<br>surgeons to perform minimally<br>invasive surgery using standard<br>endoscope visible light as well as<br>visual assessment of vessels, blood<br>flow and related tissue perfusion,<br>and at least one of the major extra-<br>hepatic bile ducts (cystic duct,<br>common bile duct or common<br>hepatic duct), using near infrared<br>imaging.<br>Fluorescence imaging of biliary<br>ducts with the PINPOINT System is<br>intended for use with standard<br>of care white light, and when<br>indicated, intraoperative<br>cholangiography. The device is not<br>intended for standalone use for<br>biliary duct visualization.<br>Upon interstitial administration of<br>TRADENAME (ICG drug product),<br>the PINPOINT System is<br>used to perform intraoperative<br>fluorescence imaging and<br>visualization of the lymphatic<br>system,<br>including lymphatic vessels and<br>lymph nodes. | |
| Applicable user | Physicians | Physicians | |
| Environment of use | Healthcare facility/hospital | Healthcare facility /hospital | |
| Single use / Reusable | Reusable | Reusable | |
| Sterile /non-sterile | Marketed as non-sterile | Marketed as non-sterile | |
| Device System<br>components | - Image Processing Unit<br>- Camera Head<br>- Light Source | - Endoscopic video processor /<br>illuminator (VPI)<br>- Laparoscope | |
| Comparison item | Subject Device (K221861) | Predicate Device(K182606) | |
| | - Light Guide Cable | - Camera head | |
| | | - Light guide cable | |
| Video output signals | OPTO-CAM214K:<br>DVI, HDMI, 4×3G-SDI,<br>12G-SDI | HD-SDI, DVI | |
| Video output signals | OPTO-CAM2100:<br>SDI, DVI, CVBS, S-VIDEO | | |
| Video output resolution | OPTO-CAM214K:<br>4096×2160p; 3840×2160p;<br>1920×1080p | 1920×1080 | |
| Video output resolution | OPTO-CAM2100:<br>1920×1080p; 720×576i | | |
| Voltage | 110-240V~ | 100-240V~ | |
| Frequency | 50/60 Hz | 50/60 Hz | |
| Power consumption | Image Processing Unit:<br>150VA<br>Light Source: 200VA | 300VA | |
| Image sensors | OPTO-CHD214KE/OPTO-<br>CHD214KH :<br>4K CMOS sensor assembly | CMOS HD sensor assembly…