(236 days)
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.
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.
Model 1: Image Processing Unit: OPTO-CAM214K, Camera Head: OPTO-CHD214KE/OPTO-CHD214KH, Light Source: OPTO-LED214K
Model 2: Image Processing Unit: OPTO-CAM2100, Camera Head: OPTO-CHD2100, Light Source: OPTO-LED2100
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.
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 requested information about the acceptance criteria and study proving device performance is not available in the provided text. The document is an FDA 510(k) clearance letter and summary, which confirms substantial equivalence to a predicate device based on non-clinical testing, but does not detail acceptance criteria or specific performance study results of the type requested.
The document explicitly states:
"No clinical tests were performed." and "Performance testing was conducted on imaging performance and light source performance to support the marketing claims and to confirm that safety and effectiveness of the FloNavi Endoscopic Fluorescence Imaging System is at least equivalent to the predicate device."
Therefore, I cannot provide:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Effect size of human readers with vs. without AI assistance (as no clinical AI assistance study is mentioned).
- Standalone performance (algorithm only) was done. (While non-clinical performance was done, it's not described in terms of specific standalone algorithm performance, but rather overall system performance.)
- Type of ground truth used.
- Sample size for the training set.
- How the ground truth for the training set was established.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 IntellicreationCommunity, No.2 Yonganbei Street, Daxu,Guicheng, Nanhai, 528200, Foshan, Guangdong,P.R.China |
| Contact person: | Jane Guo |
| Phone: | +86 (757) 8670 2920 |
| Email: | guoweijuan@optomedic.com |
2. Submission correspondent
| Name: | Shenzhen Joyantech Consulting Co., Ltd |
|---|---|
| Address: | 1713A, 17th Floor, Block A, Zhongguan TimesSquare, Nanshan District, Shenzhen518000 |
| Contact person: | Joyce Yang |
| Phone: | +86-755-86069197 |
| Email: | joyce@cefda.com |
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;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 ImagingSystem |
| 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 EndoscopicFluorescenceImaging System | Primary component |
|---|---|
| Model 1 | Image Processing Unit: OPTO-CAM214KCamera Head: OPTO-CHD214KE/OPTO-CHD214KHLight Source: OPTO-LED214K |
| Model 2 | Image Processing Unit: OPTO-CAM2100Camera Head: OPTO-CHD2100Light 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) | 403370150 | 403370150 | |
| 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) | 403370150 | 403370150 | |
| 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 | FloNaviFluorescenceImaging System | PINPOINTFluorescence 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 &Indication s for Use | Upon intravenousadministration and use ofan ICG consistent with itsapproved label, the FloNaviEndoscopic FluorescenceImaging System is intendedto provide real-timeendoscopic visible andnear-infrared fluorescenceimaging. During minimallyinvasive surgery, theFloNavi EndoscopicFluorescence ImagingSystem enables surgeonsto perform minimallyinvasive surgery usingstandard endoscopic visiblelight as well as visualassessment of vessels,blood flow and relatedtissue perfusion, and atleast one of the major extra-hepatic bile ducts, usingnear-infrared imaging.Upon interstitialadministration and use ofan ICG consistent with itsapproved label, the FloNaviEndoscopic FluorescenceImaging System is used toperform intraoperativefluorescence imaging andvisualization of thelymphatic system, includinglymphatic vessels andlymph nodes. | Upon intravenous administration ofTRADENAME (ICG drug product),the PINPOINT EndoscopicFluorescence Imaging System isused with TRADENAME to performintraoperative fluorescenceangiography, and it is also indicatedfor use in fluorescence imaging ofbiliary ducts, and when indicated,during intraoperativecholangiography.The PINPOINT EndoscopicFluorescence Imaging System isindicated for use to provide real timeendoscopic visible and near-infraredfluorescence imaging. ThePINPOINT System enablessurgeons to perform minimallyinvasive surgery using standardendoscope visible light as well asvisual assessment of vessels, bloodflow and related tissue perfusion,and at least one of the major extra-hepatic bile ducts (cystic duct,common bile duct or commonhepatic duct), using near infraredimaging.Fluorescence imaging of biliaryducts with the PINPOINT System isintended for use with standardof care white light, and whenindicated, intraoperativecholangiography. The device is notintended for standalone use forbiliary duct visualization.Upon interstitial administration ofTRADENAME (ICG drug product),the PINPOINT System isused to perform intraoperativefluorescence imaging andvisualization of the lymphaticsystem,including lymphatic vessels andlymph 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 Systemcomponents | - Image Processing Unit- Camera Head- Light Source | - Endoscopic video processor /illuminator (VPI)- Laparoscope | |
| Comparison item | Subject Device (K221861) | Predicate Device(K182606) | |
| - Light Guide Cable | - Camera head | ||
| - Light guide cable | |||
| Video output signals | OPTO-CAM214K:DVI, HDMI, 4×3G-SDI,12G-SDI | HD-SDI, DVI | |
| Video output signals | OPTO-CAM2100:SDI, DVI, CVBS, S-VIDEO | ||
| Video output resolution | OPTO-CAM214K:4096×2160p; 3840×2160p;1920×1080p | 1920×1080 | |
| Video output resolution | OPTO-CAM2100:1920×1080p; 720×576i | ||
| Voltage | 110-240V~ | 100-240V~ | |
| Frequency | 50/60 Hz | 50/60 Hz | |
| Power consumption | Image Processing Unit:150VALight Source: 200VA | 300VA | |
| Image sensors | OPTO-CHD214KE/OPTO-CHD214KH :4K CMOS sensor assembly | CMOS HD sensor assembly | |
| Image sensors | OPTO-CHD2100:HD CMOS sensor assembly | ||
| Aspect ratio | 16:9 | 16:9 | |
| Light sources | - Visible (VIS): Light-emitting diode array- Near infrared (NIR): NIRlaser diode | - Visible (VIS): Light-emitting diodearray- Near infrared (NIR): NIR laserdiode | |
| Light guidecable | Transmissionspectrum | Visible + NIR | Visible + NIR |
| Fiberdiameter | OPTO-LED214K: 4.5mm;OPTO-LED2100: 4.8 mm | 4.9 mm | |
| Length | 3 m/3.5m | 3 m | |
| Sterilization | Autoclave | Autoclave | |
| Type ofprotectionagainst electric shock(as per IEC 60601-1) | Class I | Class I | |
| Comparison item | Subject Device (K221861) | Predicate Device(K182606) | |
| Degree of protectionagainst electric shocks(as per IEC 60601-1) | CF-type | CF-type | |
| Laser classification(as per IEC 60825-1) | Class 3R | Class 3R | |
| Radiofrequencyemissions(as per CISPR 11) | Group 1, Class A | Group 1, Class A |
Table 3 Technological characteristics comparison
6. Technological characteristics comparison
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Summary of Technological Characteristics:
As shown in the comparison table, the proposed system and its predicate has the same intended use and indications for use and similar technological characteristics.
7. Summary of non-clinical testing
The non-clinical test results demonstrated that the proposed device complies with the following standards:
- AAMI/ANSI ES 60601-1:2005/(R)2012 Medical Electrical Equipment- Part 1: . General requirements for basic safety and essential performance.
- 60601-1-2:2014 Medical electrical equipment- Part 1-2: General IEC . requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests.
- IEC 60601-2-18:2009 Medical electrical equipment Part 2-18: Particular . requirements for the basic safety and essential performance of endoscopic equipment
- IEC 60825:2014 Safety of laser products Part 1: Equipment classification and . requirements was assessed and showed that subject device is a Class 3R laser device.
- IEC 62471:2006 Photobiological safety of lamps and lamp systems .
Performance testing was conducted on imaging performance and light source performance to support the marketing claims and to confirm that safety and effectiveness of the FloNavi Endoscopic Fluorescence Imaging System is at least equivalent to the predicate device.
8. Brief discussion of clinical tests
No clinical tests were performed.
9. Conclusions
The subject device and the predicate device have the same intended use, similar technological characteristics. The technological differences will not cause safety and effectiveness problems for the subject device as compared to its predicate device. Performance tests demonstrate that the FloNavi Endoscopic Fluorescence Imaging
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System performs according to specifications and functions as intended. Therefore,
the proposed system is substantially equivalent to its predicate device.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.