Search Results

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 extra-hepatic bile 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 interstitial administration and use of an ICG drug product 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 extra-hepatic 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 of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.

Upon interstitial 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.

The da Vinci Fluorescence Imaging Vision System is a fully-integrated, adjunct endoscopic imaging system for the da Vinci Si Surgical System. The da Vinci Fluorescence Imaging Vision System consists of enhanced, existing components of the da Vinci Si Surgical System: 8.5 mm or 12 mm endoscopes (0 degree or 30 degree) optimized for NIR fluorescence imaging, the 3D High-Definition (HD) stereoscopic camera head, the fluorescence-capable illuminator for use with the existing video processor unit (light source), and supporting software functions. There are no changes to the device components from the previously cleared version of the device (K210918).

The da Vinci Firefly Imaging System is a fully-integrated, adjunct endoscopic imaging system for the da Vinci Xi and da Vinci X Surgical Systems. The da Vinci Firefly Imaging System consists of enhanced, existing components of the da Vinci Xi and da Vinci X Surgical Systems: an 8 mm endoscope (0 degree or 30 degree) optimized for NIR fluorescence imaging, the fluorescence-capable Endoscope Controller, and supporting software functions. There are no changes to the device components from the previously cleared version of the device (K210918).

The provided text is a 510(k) summary for the da Vinci® Fluorescence Imaging Vision System and da Vinci® Firefly Imaging System. It describes a labeling change to add interstitial administration of ICG for visualization of the lymphatic system.

Here's the information about acceptance criteria and studies as derived from the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics. Instead, it relies on demonstrating that the labeling modification (adding interstitial ICG administration for lymphatic visualization) has "no impact on the safety or effectiveness" of the device. The substantial equivalence argument is primarily based on the fact that no modifications are being made to the technological characteristics of the subject devices from a previously cleared version (K210918).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe a new clinical study with a specific test set. This 510(k) is for a labeling change, not a new device or significant modification requiring extensive re-testing. The previous clearance (K210918) would have involved relevant performance data, but details are not provided in this specific document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as a new test set and associated ground truth establishment were not part of this 510(k) submission for a labeling change.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as a new test set and adjudication for new performance claims were not part of this 510(k) submission.

5. 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

Not applicable. The described devices are imaging systems, not AI-powered diagnostic tools, and no MRMC study is mentioned in this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The devices are imaging systems with a human operator (surgeon) in the loop for visualization.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not explicitly stated in this document. Given that this is a labeling change based on an existing device, the "ground truth" for its original clearance (K210918) would likely have been established through a combination of clinical observation during surgical procedures using ICG, potentially corroborated by other intraoperative imaging methods or anatomical knowledge, to confirm accurate visualization of vessels, blood flow, and bile ducts. For the new indication (lymphatic system visualization), it relies on the known biological interaction of ICG with the lymphatic system when administered interstitially, and the device's ability to image this fluorescence.

8. The sample size for the training set

Not applicable. This submission relates to a labeling change for an already cleared device, not the development of a new algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable, as no new training set is described in this document.

Ask a specific question about this device