(205 days)
No
The summary describes a camera system for fluorescence imaging and mentions image processing, but there is no mention of AI, ML, or any related concepts like algorithms for analysis, detection, or interpretation of the images beyond basic processing for display.
No.
The device is an imaging system designed for visualization, not for providing therapeutic treatment.
Yes
Explanation: The device provides "real-time endoscopic visible and near-infrared fluorescence visualization" and enables "visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts." It also performs "intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes." This information is used for assessment and visualization, which are key aspects of diagnosis in a medical context.
No
The device description explicitly lists multiple hardware components: a 4K video processor, a 4K camera head, an Endoscope, a cold light source, and a light guide cable. This indicates it is a hardware-based system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Endoscopic Fluorescence Camera System is an imaging system used during surgical procedures to visualize internal structures in real-time using visible and near-infrared light. It works in conjunction with an intravenously administered imaging agent (ICG).
- No Sample Analysis: The device does not analyze samples taken from the body. It is used to visualize structures within the body.
The device is a surgical imaging system that utilizes an imaging agent administered in vivo (within the living organism) to enhance visualization during surgery. This is distinct from the in vitro (in glass/outside the living organism) nature of IVDs.
N/A
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 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.
Product codes
GCJ, IZI
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic visible light, Near-infrared imaging
Anatomical Site
vessels, blood flow and related tissue perfusion, major extra-hepatic bile ducts, lymphatic system (including lymphatic vessels and lymph nodes)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians / Healthcare facility/hospital
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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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)
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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 Airport | |
| West 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: | 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 Imaging
System |
|-------------------|----------------------------------------------------|
| 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
| Comparison
item | Subject Device | Predicate Device(K182606) | Comme
nts |
|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Product
Name | Endoscopic Fluorescence Camera
System | PINPOINT Endoscopic
Fluorescence Imaging System | / |
| Product
Code | GCJ, IZI | GCJ, IZI | Same |
| Regulation
Number | 21 CFR § 876.1500 | 21 CFR § 876.1500 | Same |
| Classificatio
n | Class II | Class II | Same |
| Type of use | Prescription Use | Prescription Use | Same |
| 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. | Upon intravenous administration of
TRADENAME (ICG drug product),
the PINPOINT Endoscopic
Fluorescence
Imaging System is used with
TRADENAME to perform
intraoperative fluorescence
angiography, and it is also indicated
for use in fluorescence imaging of
biliary ducts, and when indicated,
during intraoperative
cholangiography.
The PINPOINT Endoscopic
Fluorescence Imaging System is
indicated for use to provide real time
endoscopic visible and
near-infrared fluorescence imaging.
The PINPOINT 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 (cystic duct,
common bile duct or common
hepatic duct), using nearinfrared
imaging.
Fluorescence imaging of biliary
ducts with the PINPOINT System is
intended for use with standard of
care white light,
and when indicated, intraoperative | Same |
| Comparison
item | Subject Device | Predicate Device(K182606) | Comme
nts |
| | | cholangiography. The device is not
intended for standalone use for
biliary duct
visualization.
Upon interstitial administration of
TRADENAME (ICG drug product),
the PINPOINT System is used to
perform
intraoperative fluorescence imaging
and visualization of the lymphatic
system, including lymphatic vessels
and lymph
nodes. | |
| Applicable
user | Physicians | Physicians | Same |
| Environment
of 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 |
| Device
System
components | - Video Processor
- Camera Head
- Endoscope
- Light Source
- Light Guide Cable | - Endoscopic video processor /
illuminator (VPI) - Laparoscope
- Camera head
- Light guide cable | Same |
| Video output
signals | DVI, HDMI, SDI | HD-SDI, DVI | Similar |
| Video output
resolution | 4096×2160p;
3840×2160p;
1920×1080p | 1920×1080 | Similar |
| Voltage | 100-230V~ | 100-240V~ | Similar |
| Frequency | 50/60 Hz | 50/60 Hz | Same |
| Power
consumption | Video Processor: 350VA
Light Source: 200VA | 300VA | Similar |
| Comparison
item | Subject Device | Predicate Device(K182606) | Comme
nts |
| Image
sensors | 4K CMOS sensor assembly | CMOS HD sensor assembly | Similar |
| Aspect ratio | 16:9 | 16:9 | Same |
| Light
sources | - Visible (VIS): Light-emitting diode
array - Near infrared (NIR): NIR laser diode | - Visible (VIS): Light-emitting diode
array - Near infrared (NIR): NIR laser
diode | Same |
| Light
guide
cable | Transmission spectrum: Visible + NIR | Transmission spectrum: Visible
NIR | Same |
| | Sterilization: Autoclave | Sterilization: Autoclave | Same |
| Imaging
agent | SPY AGENT GREEN | SPY AGENT GREEN | Same |
| Type of
protection
against
electric
shock
(as per IEC
60601-1) | Class I | Class I | Same |
| Degree of
protection
against
electric
shocks
(as per IEC
60601-1) | CF-type | CF-type | Same |
| Laser
classification
(as per IEC
60825-1) | Class 3R | Class 3R | Same |
| Radio
frequency
emissions
(as per
CISPR 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.