(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.
§ 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.