Upon intravenous administration and use of an ICG consistent with its approved label, the 3D Endoscopic Fluorescence Camera System is intended to provide real-time endoscopic visible and near-infrared fluorescence visualization. The System enables surgeons to perform minimally invasive surgery using standard endoscope 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 intravenous administration and use of an ICG consistent with its approved label, the 3D Endoscopic Fluorescence Camera System is intended to be used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Device Description

The proposed system, 3D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF) is comprised of a 3D 4K video processor (DPM-ENDOCAM-06P-MF), a 3D 4K camera head (DPM-ENDOCAM- 06P-CAM), Endoscope (DPM-ENDOSCOPE-3D01/DPM-ENDOSCOPE- 3D02), a cold light source (DPM-LIGHT-03) and a light guide cable (DPM-FB-01).

3D Endoscopic Fluorescence Camera System is capable of providing real-time endoscopic visible and near-infrared fluorescence imaging.

During surgical procedures, the system 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, the system 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.

AI/ML Overview

The provided document is a 510(k) summary for the Zhuhai Dipu Medical Technology Co., Ltd. 3D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF). However, it does not contain any information about acceptance criteria or a study proving the device meets specific acceptance criteria related to its performance metrics for diagnostic or visualization accuracy.

The summary focuses on demonstrating substantial equivalence to a predicate device (da Vinci® Fluorescence Imaging Vision System and da Vinci® Firefly Imaging System) based on similar intended use and technological characteristics, as well as compliance with various non-clinical safety and performance standards.

Here's a breakdown of why the requested information cannot be fully provided from this document:

A table of acceptance criteria and the reported device performance: This information is not present. The document lists "Performance conducted on imaging performance testing" but does not detail acceptance criteria or specific numerical performance results from these tests.
Sample sized used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method for the test set: Not mentioned.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is an imaging system, not an AI-assisted diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned in this document.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This device is an imaging system, not an algorithm. Standalone algorithm performance is not applicable and not mentioned.
The type of ground truth used: Not mentioned for any specific performance metrics.
The sample size for the training set: Not applicable as this is not an AI/ML device with a training set.
How the ground truth for the training set was established: Not applicable.

The closest information provided related to performance is:

Non-clinical testing: "Performance conducted on imaging performance testing was and light source performance to support the marketing claims and to confirm that safetv and effectiveness of the 3D Endoscopic Fluorescence Camera System is at least equivalent to the predicate device."
In-vivo study on animal model: "The in vivo fluorescence imaging study on animal model was performed to examine/detect corresponding regions in order to simulate the clinical use, study the imaging effect, and verify the safety and effectiveness."

However, neither of these statements provides the specific acceptance criteria or quantitative performance results requested. The document explicitly states: "No clinical tests were performed." This reinforces that there would be no human reader studies, AI performance metrics, or ground truth established via clinical data in this submission.

In summary, based solely on the provided text, the detailed information about acceptance criteria and specific performance study results is not available.

Summary

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Zhuhai Dipu Medical Technology Co., Ltd. % Joyce Yang Consultant Shenzhen Joyantech Consulting Co., Ltd 1713A, 17th Floor, Block A. Zhongguan Times Square Nanshan District Shenzhen, Guangdong 518000 China

Re: K233892

Trade/Device Name: 3D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ, NAY, IZI Dated: May 13, 2024 Received: May 13, 2024

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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-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 (1-800-638-2041 or 301-796-7100).

Sincerely.

for Yan Fu -

Digitally signed by Yan Fu -S
Date: 2024.06.13 20:45:36 -04'00'

Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical & 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) K233892

Device Name

3D Endoscopic Fluorescence Camera System

Indications for Use (Describe)

Upon intravenous administration and use of an ICG consistent with its approved label, the 3D Endoscopic Fluorescence Camera System is intended to provide real-time endoscopic visible and near-infrared fluorescence visualization. The System enables surgeons to perform minimally invasve surgery using standard endoscope 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.

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 K233892

Date of Summary prepare: June 12, 2024

1. Submission Sponsor

Applicant Name:	Zhuhai Dipu Medical Technology Co., Ltd.
Address:	1F, Building 13, GMP Production Workshop,Zhuhai International Health Harbor, No. 628 AirportWest Road, Sanzao Town, Jinwan District, Zhuhai,China
Contact person:	WANG HUAN
Phone:	+8613521289729
Email:	huan.wang@digipmc.com

2. Submission correspondent

Name:	Shenzhen Joyantech Consulting Co., Ltd
Address:	1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District, Shenzhen 518000
Contact person:	Joyce Yang
Phone:	+86-755-86069197
Email:	joyce@cefda.com

3. Device Identification

Trade Name:	3D Endoscopic Fluorescence Camera System
Common or Usual Name:	Endoscopic Imaging System
Model:	DPM-ENDOCAM-06PF
Classification name:	Endoscope and accessories
Review Panel:	Gastroenterology/Urology
Product Code:	GCJ, NAY, IZI
Device Class:	Class II
Regulation Number:	21 CFR § 876.1500

Legally Marketed Predicate Device 4.

Trade Name	da Vinci® Fluorescence Imaging Vision System and da Vinci® Firefly Imaging System
Regulation number	21 CFR § 876.1500
Regulation class	Class II
Regulation name	Endoscope and accessories
510(k) Number	K213710
Product Code	NAY, GCJ, IZI
Manufacturer	Intuitive Surgical, Inc.

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5. Device Description

3D Endoscopic Fluorescence Camera System is capable of providing real-time endoscopic visible and near-infrared fluorescence imaging.

6. Intended Use/ Indications for Use

7. Technological characteristics comparison

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Comparisonitem	Subject Device(K233892)	Predicate Device(K213710)	Comments
ProductName	3D Endoscopic FluorescenceCamera System	da Vinci® Fluorescence /Imaging Vision System and daVinci® Firefly Imaging System
ProductCode	GCJ, NAY, IZI	GCJ, NAY, IZI	Same
RegulationNumber	21 CFR § 876.1500	21 CFR § 876.1500	Same
Classification	Class II	Class II	Same
Type of use	Prescription Use	Prescription Use	Same
Intended use& Indicationsfor Use	Upon intravenousadministration and use of anICG consistent with itsapproved label, the 3DEndoscopic FluorescenceCamera System is intended toprovide real-time endoscopicvisible and near-infraredfluorescence visualization. TheSystem enables surgeons toperform minimally invasivesurgery using standardendoscope visible light as wellas visual assessment ofvessels, blood flow and relatedtissue perfusion, and at leastone of the major extra-hepaticbile ducts, using near-infraredimaging.Upon intravenousadministration and use of anICG consistent with itsapproved label, the 3DEndoscopic FluorescenceCamera System is intended tobe used to performintraoperative fluorescenceimaging and visualization of thelymphatic system, includinglymphatic vessels and lymphnodes.	da Vinci Fluorescence Imaging VisionSystemUpon intravenous administration anduse of an ICG drug productconsistent with its approved label, theda Vinci Fluorescence Imaging VisionSystem is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. Theda Vinci Fluorescence Imaging VisionSystem enables surgeons to performminimally invasive surgery usingstandard endoscopic visible light aswell as visual assessment of vessels,blood flow and related tissueperfusion, and at least one of themajor extrahepatic bile ducts (cysticduct, common bile duct or commonhepatic duct), using near infraredimaging.Fluorescence imaging of biliary ductswith the da Vinci fluorescenceImaging Vision System is intendedfor use with standard of care whitelight and, when indicated,intraoperative cholangiography. Thedevice is not intended for standaloneuse for biliary duct visualization.Upon intravenous administration anduse of an ICG drug product	Same
Comparisonitem	Subject Device(K233892)	Predicate Device(K213710)	Comments
		consistent with its approved label, theda Vinci Fluorescence Imaging VisionSystem is used to performintraoperative fluorescence imagingand visualization of the lymphaticsystem, including lymphatic vesselsand lymph nodes.
		da Vinci Firefly Imaging System
		Upon intravenous administration anduse of an ICG drug productconsistent with its approved label, theda Vinci Firefly Imaging System isintended to provide real-timeendoscopic visible and near-infraredfluorescence imaging. The da VinciFirefly Imaging System enablessurgeons to perform minimallyinvasive surgery using standardendoscopic visible light as well asvisual assessment of vessels, bloodflow and related tissue perfusion, andat least one of the major extrahepaticbile ducts (cystic duct, common bileduct or common hepatic duct), usingnear infrared imaging.
		Fluorescence imaging of biliary ductswith the da Vinci Firefly ImagingSystem is intended for use withstandard of care white light and,when indicated, intraoperativecholangiography. The device is notintended for standalone use for biliaryduct visualization.
		Upon intravenous administration anduse of an ICG drug productconsistent with its approved label, theda Vinci Firefly Imaging System is used toperform intraoperative fluorescenceimaging and visualization of thelymphatic system, including lymphaticvessels and lymph nodes.
Applicableuser	Physicians	Physicians	Same
Environmentof use	Healthcare facility/hospital	Healthcare facility/hospital	Same
Single use /	Reusable	Reusable	Same
Comparisonitem	Subject Device(K233892)	Predicate Device(K213710)	Comments
Reusable
Sterile /non-sterile	Marketed as non-sterile	Marketed as non-sterile	Same
DeviceSystemcomponents	- 3D 4K Video Processor- 3D 4K Camera Head- Endoscope (0 degree and 30 degree)- Light Source- Light Guide Cable	- Video Processor- Endoscope (0 degree and 30 degree)- 3D HD Camera head- Light Source- Light guide cable	Same
Video outputsignals	DVI, HDMI, SDI	HD-SDI, DVI	Similar
Video outputresolution	4096×2160p;3840×2160p;1920×1080p	1280×1024;1920×1080	Similar
ExcitationWavelength	785 nm ± 5 nm	802-805 nm	Same
EndoscopeDiameter	10.1 mm	8.5 mm, 12 mm	Similar
Endoscopelength	328 mm, 330 mm	296.85 - 543.6 mm	Similar
Imagesensors	4K CMOS sensor assembly	3 chip RGB CCD;Front and back side illuminatedCMOS HD sensor assembly	Similar
Lightsources	- Visible (VIS): Light-emitting diodearray- Near infrared (NIR): NIR laserdiode	- Visible (VIS): Light-emitting diodearray- Near infrared (NIR): NIR laser diode	Same
Lightguidecable	Transmission spectrum: Visible+NIR	Transmission spectrum: Visible + NIR	Same
Imagingagent	SPY AGENT GREEN	SPY AGENT GREEN	Same
Comparisonitem	Subject Device(K233892)	Predicate Device(K213710)	Comments
Type ofprotectionagainstelectricshock(as per IEC60601-1)	Class I	Class I	Same
Degree ofprotectionagainstelectricshocks(as per IEC60601-1)	CF-type	CF-type	Same
Laserclassification(as per IEC60825-1)	Class 3R	Class 3R	Same
Radiofrequencyemissions(as perCISPR 11)	Group 1, Class A	Group 1, Class A	Same

Table 1 Technological characteristics comparison

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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.

8. 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 IEC equipment-Part 1-2: General . 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 .
ISO 8600-1:2015 Endoscopes Medical endoscopes and endotherapy devices --. Part 1: General requirements
ISO 8600-3:2019 Endoscopes Medical endoscopes and endotherapy devices .

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Part 3: Determination of field of view and direction of view of endoscopes with optics

ISO 8600-4:2014 Endoscopes Medical endoscopes and certain accessories -. Part 4: Determination of maximum width of insertion portion
ISO 8600-5:2020 Optics and photonics Medical endoscopes and endotherapy . devices - Part 5 Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics: Determination of optical resolution of rigid endoscopes with optics

Performance conducted on imaging performance testing was and light source performance to support the marketing claims and to confirm that effectiveness of the 3D Endoscopic Fluorescence Camera safetv and System is at least equivalent to the predicate device. The in vivo fluorescence imaging study on animal model was performed to examine/detect corresponding regions in order to simulate the clinical use, study the imaging effect, and verify the safety and effectiveness.

9. Brief discussion of clinical tests

No clinical tests were performed.

10. 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 3D Endoscopic Fluorescence Camera System performs according to specifications and functions as intended. Therefore, the proposed system is substantially equivalent to its predicate device.

Regulation Number and Section

§ 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.