(205 days)
Upon intravenous administration and use of an ICG consistent with its approved label, the 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 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.
The proposed system, Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF) is comprised of a 4K video processor (DPM-ENDOCAM-03P-MF), a 4K camera head (DPM-ENDOCAM-03P-CAM), Endoscope (DPM-ENDOSCOPE-0130/DPM-ENDOSCOPE-0100), a cold light source (DPM-LIGHT-03) and a light guide cable (DPM-FB-01).
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.
The provided text does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/human reader performance evaluation.
The document is a 510(k) Premarket Notification from the FDA regarding an Endoscopic Fluorescence Camera System. It details the device's technical specifications, intended use, and comparison to a predicate device. It also lists non-clinical tests performed to ensure compliance with medical device standards (e.g., electrical safety, electromagnetic compatibility, optical resolution).
Specifically, the document states:
- "No clinical tests were performed." This explicitly indicates that no studies involving human subjects or human-in-the-loop performance were conducted or are reported in this summary for the purpose of demonstrating substantial equivalence.
- The performance testing mentioned is focused on "imaging performance and light source performance" to support marketing claims and confirm safety and effectiveness, including an "in vivo fluorescence imaging study on animal model" to simulate clinical use and verify imaging effect, safety, and effectiveness. This is not equivalent to a clinical study involving human readers or AI performance on a clinical test set.
Therefore, I cannot provide the requested information regarding acceptance criteria, human reader performance, AI-specific study details (sample size for test/training set, ground truth establishment, expert adjudication), or MRMC studies, as these types of studies were not discussed or presented in the provided text.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 26, 2024
Zhuhai Dipu Medical Technology Co., Ltd. % Jovce Yang Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square Nanshan District Shenzhen, 518000 China
Re: K233840
Trade/Device Name: Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ, IZI Dated: [NOTE: Use date of most recent supplement] Received: May 29, 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/ofdocs/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.
{1}------------------------------------------------
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" (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 (OS) 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 QS 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 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).
{2}------------------------------------------------
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-devices/deviceadvice-comprehensive-regulatory-assistance/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.
Digitally signed by TANISHA TANISHA L. HITHE S L. HITHE -S Date: 2024.06.26 18:41:34 -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
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K233840
Device Name
Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF)
Indications for Use (Describe)
Upon intravenous administration and use of an ICG consistent with its approved label, the 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.
Upon intravenous administration and use of an ICG consistent with its approved label, the 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.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
510(k) Summary K233840
Date of Summary prepare: June 25, 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 TimesSquare, Nanshan District, Shenzhen518000 |
| Contact person: | Joyce Yang |
| Phone: | +86-755-86069197 |
| Email: | joyce@cefda.com |
3. Device Identification
| Trade Name: | Endoscopic Fluorescence Camera System |
|---|---|
| Common or Usual Name: | Endoscopic Imaging System |
| Model: | DPM-ENDOCAM-03PF |
| Classification name: | Endoscope and accessories |
| Review Panel: | Gastroenterology/Urology |
| Product Code: | GCJ, IZI |
| Device Class: | Class II |
| Regulation Number: | 21 CFR § 876.1500 |
Legally Marketed Predicate Device 4.
| Trade Name | PINPOINT Endoscopic Fluorescence ImagingSystem |
|---|---|
| Regulation number | 21 CFR § 876.1500 |
| Regulation class | Class II |
| Regulation name | Endoscope and accessories |
| 510(k) Number | K182606 |
| Product Code | GCJ; IZI |
| Manufacturer | Novadaq Technologies ULC. |
{5}------------------------------------------------
Device Description 5.
The proposed system, Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF) is comprised of a 4K video processor (DPM-ENDOCAM-03P-MF), a 4K camera head (DPM-ENDOCAM-03P-CAM), Endoscope (DPM-ENDOSCOPE-0130/DPM-ENDOSCOPE-0100), a cold light source (DPM-LIGHT-03) and a light guide cable (DPM-FB-01).
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.
6. Intended Use/ Indications for Use
Upon intravenous administration and use of an ICG consistent with its approved label, the 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 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.
7. Technological characteristics comparison
{6}------------------------------------------------
| Comparisonitem | Subject Device | Predicate Device(K182606) | Comments |
|---|---|---|---|
| ProductName | Endoscopic Fluorescence CameraSystem | PINPOINT EndoscopicFluorescence Imaging System | / |
| ProductCode | GCJ, IZI | GCJ, 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 EndoscopicFluorescence Camera Systemis intended to provide real-timeendoscopic visible and near-infrared fluorescencevisualization. The Systemenables surgeons to performminimally invasive surgeryusing standard endoscopevisible light as well as visualassessment of vessels, bloodflow and related tissueperfusion, and at least one ofthe major extra-hepatic bileducts, using near-infraredimaging.Upon intravenousadministration and use of anICG consistent with itsapproved label, the EndoscopicFluorescence Camera Systemis intended to be used toperform intraoperativefluorescence imaging andvisualization of the lymphaticsystem, including lymphaticvessels and lymph nodes. | Upon intravenous administration ofTRADENAME (ICG drug product),the PINPOINT EndoscopicFluorescenceImaging System is used withTRADENAME 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 andnear-infrared fluorescence imaging.The PINPOINT System enablessurgeons to perform minimallyinvasive surgeryusing standard endoscope visiblelight as well as visual assessment ofvessels, blood flow and relatedtissue perfusion, andat least one of the major extra-hepatic bile ducts (cystic duct,common bile duct or commonhepatic duct), using nearinfraredimaging.Fluorescence imaging of biliaryducts with the PINPOINT System isintended for use with standard ofcare white light,and when indicated, intraoperative | Same |
| Comparisonitem | Subject Device | Predicate Device(K182606) | Comments |
| cholangiography. The device is notintended for standalone use forbiliary ductvisualization.Upon interstitial administration ofTRADENAME (ICG drug product),the PINPOINT System is used toperformintraoperative fluorescence imagingand visualization of the lymphaticsystem, including lymphatic vesselsand lymphnodes. | |||
| Applicableuser | Physicians | Physicians | Same |
| Environmentof use | Healthcare facility/hospital | Healthcare facility /hospital | Same |
| Single use /Reusable | Reusable | Reusable | Same |
| Sterile /non-sterile | Marketed as non-sterile | Marketed as non-sterile | Same |
| DeviceSystemcomponents | - Video Processor- Camera Head- Endoscope- Light Source- Light Guide Cable | - Endoscopic video processor /illuminator (VPI)- Laparoscope- Camera head- Light guide cable | Same |
| Video outputsignals | DVI, HDMI, SDI | HD-SDI, DVI | Similar |
| Video outputresolution | 4096×2160p;3840×2160p;1920×1080p | 1920×1080 | Similar |
| Voltage | 100-230V~ | 100-240V~ | Similar |
| Frequency | 50/60 Hz | 50/60 Hz | Same |
| Powerconsumption | Video Processor: 350VALight Source: 200VA | 300VA | Similar |
| Comparisonitem | Subject Device | Predicate Device(K182606) | Comments |
| Imagesensors | 4K CMOS sensor assembly | CMOS HD sensor assembly | Similar |
| Aspect ratio | 16:9 | 16:9 | Same |
| Lightsources | - Visible (VIS): Light-emitting diodearray- Near infrared (NIR): NIR laser diode | - Visible (VIS): Light-emitting diodearray- Near infrared (NIR): NIR laserdiode | Same |
| Lightguidecable | Transmission spectrum: Visible + NIR | Transmission spectrum: Visible+NIR | Same |
| Sterilization: Autoclave | Sterilization: Autoclave | Same | |
| Imagingagent | SPY AGENT GREEN | SPY AGENT GREEN | Same |
| 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
{7}------------------------------------------------
{8}------------------------------------------------
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
{9}------------------------------------------------
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.
- equipment- Part 1-2: IEC 60601-1-2:2014 Medical electrical 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 . 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 testing was conducted on imaging performance and light source performance to support the marketing claims and to confirm that safety and effectiveness of the Endoscopic Fluorescence Camera System is at least equivalent to the predicate device. The in vivo fluorescence imaging study on animal model was performed to examine/detect corresponding reqions in order to simulate the clinical use, study the imaging effect, and verify the safety and effectiveness.
Brief discussion of clinical tests 9.
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 Endoscopic Fluorescence Camera 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.