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Upon intravenous administration and use of an ICG consistent with its approved label, the FloNavi Endoscopic Fluorescence Imaging System is intended to provide real time endoscopic visible and near-infrared fluorescence imaging. During minimally invasive surgery, the FloNavi Endoscopic Fluorescence 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 extra-hepatic bile ducts, using near-infrared imaging.

Upon interstitial administration and use of an ICG consistent with its approved label, the FloNavi Endoscopic Fluorescence Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

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This document is an FDA 510(k) clearance letter for the FloNavi Endoscopic Fluorescence Imaging System. It does not contain information about the acceptance criteria, device performance, study design, or validation results. Therefore, I cannot provide the requested information based on the provided text.

The letter primarily covers:

• The FDA's determination of substantial equivalence.
• Regulatory classifications and product codes.
• Applicable regulations for the device.
• Guidance on when a new 510(k) might be required for changes.
• General controls and other requirements such as the Quality System (QS) regulation and Unique Device Identification (UDI) Rule.
• Contact information for the FDA.
• Indications for Use for the device.

To answer your questions, I would need a different document, such as a summary of safety and effectiveness, or the 510(k) submission itself, which would detail the performance testing and validation efforts.

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Upon intravenous administration and use of an ICG consistent with its approved label, the FloNavi Endoscopic Fluorescence Imaging System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. During minimally invasive surgery, the FloNavi Endoscopic Fluorescence 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 extra-hepatic bile ducts, using near-infrared imaging.

Upon interstitial administration and use of an ICG consistent with its approved label, the FloNavi Endoscopic Fluorescence Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

The proposed system, FloNavi Endoscopic Fluorescence Imaging System (FloNavi System) is comprised of an image processing unit, a camera head, and a light source (including a flexible light guide cable).

There are two models of the proposed system. The primary components of each model are provided in Table 1.

Model 1: Image Processing Unit: OPTO-CAM214K, Camera Head: OPTO-CHD214KE/OPTO-CHD214KH, Light Source: OPTO-LED214K
Model 2: Image Processing Unit: OPTO-CAM2100, Camera Head: OPTO-CHD2100, Light Source: OPTO-LED2100

FloNavi Endoscopic Fluorescence Imaging System is capable of providing real-time endoscopic visible and near-infrared fluorescence imaging.

During surgical procedures, FloNavi 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, FloNavi 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 proposed system is designed to be used with rigid endoscopes, monitors and other ancillary equipment.

The requested information about the acceptance criteria and study proving device performance is not available in the provided text. The document is an FDA 510(k) clearance letter and summary, which confirms substantial equivalence to a predicate device based on non-clinical testing, but does not detail acceptance criteria or specific performance study results of the type requested.

The document explicitly states:
"No clinical tests were performed." and "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 FloNavi Endoscopic Fluorescence Imaging System is at least equivalent to the predicate device."

Therefore, I cannot provide:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. Effect size of human readers with vs. without AI assistance (as no clinical AI assistance study is mentioned).
6. Standalone performance (algorithm only) was done. (While non-clinical performance was done, it's not described in terms of specific standalone algorithm performance, but rather overall system performance.)
7. Type of ground truth used.
8. Sample size for the training set.
9. How the ground truth for the training set was established.

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