(188 days)
Not Found
No
The summary describes a camera system for fluorescence imaging and visualization, focusing on hardware components and imaging modalities. There is no mention of AI, ML, or any related concepts like algorithms for image analysis beyond basic processing for display.
No
The device is an imaging system used for visualization during surgery, not for treatment or therapy. It displays real-time images to assist surgeons.
No
The device is an imaging system designed for real-time visualization during surgery, not for diagnosing medical conditions. It provides visual assessment of tissue and structures using fluorescence imaging rather than diagnostic interpretation.
No
The device description explicitly lists multiple hardware components: a 3D 4K video processor, a 3D 4K camera head, an Endoscope, a cold light source, and a light guide cable. While it performs image processing, it is not solely software.
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 3D Endoscopic Fluorescence Camera System is an imaging system used during surgery to visualize internal structures in real-time. It uses light and fluorescence from an injected agent (ICG) to enhance visualization.
- Intended Use: The intended use clearly describes its application in providing real-time endoscopic visualization during surgical procedures to assess vessels, blood flow, tissue perfusion, bile ducts, and the lymphatic system. This is an in vivo (within the living body) application, not an in vitro (in glass/outside the body) test.
- Device Description: The components listed (video processor, camera head, endoscope, light source, light guide cable) are all typical components of a surgical imaging system, not an IVD.
- Performance Studies: The performance studies mentioned involve imaging performance testing and an in vivo animal model study, which are relevant to surgical imaging systems, not IVDs.
In summary, the 3D Endoscopic Fluorescence Camera System is a surgical imaging device used for visualization during procedures, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ, NAY, IZI
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.
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, extra-hepatic bile ducts, lymphatic system, lymphatic vessels and lymph nodes.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians in a 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 on imaging performance testing and light source performance was conducted to support the marketing claims and to confirm that the safety and effectiveness of the 3D 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 regions 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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"
1
(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
2
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.
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.
| 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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3
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 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: | 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. |
4
5. 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.
6. Intended Use/ Indications for Use
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.
7. Technological characteristics comparison
5
| Comparison
| item | Subject Device(K233892) | Predicate Device(K213710) | Comments |
|---|---|---|---|
| Product | |||
| Name | 3D Endoscopic Fluorescence | ||
| Camera System | da Vinci® Fluorescence / | ||
| Imaging Vision System and da | |||
| Vinci® Firefly Imaging System | |||
| Product | |||
| Code | GCJ, NAY, IZI | GCJ, NAY, IZI | Same |
| Regulation | |||
| Number | 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 | |||
| & Indications | |||
| for Use | 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. | da Vinci Fluorescence Imaging Vision | ||
| System | |||
| Upon intravenous administration and | |||
| use of an ICG drug product | |||
| consistent with its approved label, the | |||
| da Vinci Fluorescence Imaging Vision | |||
| System is intended to provide real- | |||
| time endoscopic visible and near- | |||
| infrared fluorescence imaging. The | |||
| da Vinci Fluorescence Imaging Vision | |||
| 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 extrahepatic bile ducts (cystic | |||
| duct, common bile duct or common | |||
| hepatic duct), using near infrared | |||
| imaging. | |||
| Fluorescence imaging of biliary ducts | |||
| with the da Vinci fluorescence | |||
| Imaging Vision System is intended | |||
| for use with standard of care white | |||
| light and, when indicated, | |||
| intraoperative cholangiography. The | |||
| device is not intended for standalone | |||
| use for biliary duct visualization. | |||
| Upon intravenous administration and | |||
| use of an ICG drug product | Same | ||
| Comparison | |||
| item | Subject Device(K233892) | Predicate Device(K213710) | Comme |
| nts | |||
| consistent with its approved label, the | |||
| da Vinci Fluorescence Imaging Vision | |||
| System is used to perform | |||
| intraoperative fluorescence imaging | |||
| and visualization of the lymphatic | |||
| system, including lymphatic vessels | |||
| and lymph nodes. | |||
| da Vinci Firefly Imaging System | |||
| Upon intravenous administration and | |||
| use of an ICG drug product | |||
| consistent with its approved label, the | |||
| da Vinci Firefly Imaging System is | |||
| intended to provide real-time | |||
| endoscopic visible and near-infrared | |||
| fluorescence imaging. The da Vinci | |||
| Firefly 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 extrahepatic | |||
| bile ducts (cystic duct, common bile | |||
| duct or common hepatic duct), using | |||
| near infrared imaging. | |||
| Fluorescence imaging of biliary ducts | |||
| with the da Vinci Firefly Imaging | |||
| System is intended for use with | |||
| standard of care white light and, | |||
| when indicated, intraoperative | |||
| cholangiography. The device is not | |||
| intended for standalone use for biliary | |||
| duct visualization. | |||
| Upon intravenous administration and | |||
| use of an ICG drug product | |||
| consistent with its approved label, the | |||
| da Vinci Firefly Imaging 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 | Same |
| Comparison | |||
| item | Subject Device(K233892) | Predicate Device(K213710) | Comme |
| nts | |||
| Reusable | |||
| Sterile /non- | |||
| sterile | Marketed as non-sterile | Marketed as non-sterile | Same |
| Device | |||
| System | |||
| components | - 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 output
signals | DVI, HDMI, SDI | HD-SDI, DVI | Similar |
| Video output
resolution | 4096×2160p;
3840×2160p;
1920×1080p | 1280×1024;
1920×1080 | Similar |
| Excitation
Wavelength | 785 nm ± 5 nm | 802-805 nm | Same |
| Endoscope
Diameter | 10.1 mm | 8.5 mm, 12 mm | Similar |
| Endoscope
length | 328 mm, 330 mm | 296.85 - 543.6 mm | Similar |
| Image
sensors | 4K CMOS sensor assembly | 3 chip RGB CCD;
Front and back side illuminated
CMOS HD sensor assembly | Similar |
| 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 |
| Imaging
agent | SPY AGENT GREEN | SPY AGENT GREEN | Same |
| Comparison
item | Subject Device(K233892) | Predicate Device(K213710) | Comments |
| 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
6
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
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 .
9
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.