(188 days)
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.
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.
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.
§ 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.