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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.

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Da Vinci Fluorescence Imaging Vision System:

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 ducts (cystic duct, common hepatic duct), using near infrared imaging.

Fluorescence imaging of billary 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 billiary duct visualization.

Da Vinci Firefly Imaging System:

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 duct, (cystic duct, common bile duct or common hepatic duct), using near infrared imaging.

Fluorescence imaging of biliary ducts with the da Vinci Firended 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.

Two subject devices, the da Vinci Fluorescence Imaging Vision System and the da Vinci Firefly Imaging System, are bundled in this submission.

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 lmaging of enhanced, existing components of the da Vinci Si Surgical System: 8.5 mm or 12 mm endoscopes (0 degree) optimized for NIR fluorescence imaging, the 3D High-Definition (HD) stereoscopic camera head, the fluorescence-capable illuminator for use processor unit (light source), and supporting software functions. There are no changes being made to the described components from the previously-cleared version of the device (K124031).

The da Vinci Firefly Imaging System is a fully-integrated, adjunct endoscopic imaging system for the da Vinci X Surgical Systems. The da Vinci Firefly Imaging System consists of enhanced, existing components of the da Vinci X Surgical Systems: an 8 mm endoscope (0 degree) optimized for NIR fluorescence imaging, the fluorescence-capable Endoscope Controller, and supporting software functions. There are no changes being made to the described components from the previouslycleared version of the device (K141077).

There are two changes being made between the subject devices. The two changes are equivalent for both the da Vinci Fluorescence Imaging Vision System and the da Vinci First change is that a Fluorescence Imaging Kit will no longer be included with the subject devices, this Fluorescence lmaging Kit includes cross-labeled indocyanine green (ICG) fluorescence imaging agent, and syringe trays. Historically, the ICG labeling by itself has not included indications for use with an imaging medical device. Therefore, as a part of the previous 510(k) clearances for the da Vinci Fluorescence Imaging Vision System (K124031) and the da Vinci Firefly Imaging System (K141077), ICG was cross-labeled by Intuitive to include indications for use with the predicate devices. The labeling of the imaging agent ICG (trade name SP) AGENT GREEN), as published on the FDALabel Database, now includes indications for use with a fluorescence imaging device.

The second change is that the user manuals for both devices have been revised. The fluorescence imaging-related content in the subject devices user manuals has been updated to remove references to the Fluorescence lmaging Kit, for consistency with the expanded ICG imaging agent indications for use.

The provided text is a 510(k) summary for the da Vinci Fluorescence Imaging Vision System and the da Vinci Firefly Imaging System. It describes the device, its intended use, and the changes made in this particular submission.

However, the summary explicitly states:
"Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b) The information required by this section is not applicable. The changes in this 510(k) are limited to the removal of the Fluorescence Imaging Kit and revised labeling. Based on the risk management assessment of these changes, no design verification or validation testing is required to ensure safe and effective performance of the subject devices."

This means that this specific 510(k) submission does not contain new studies or data to prove the device meets acceptance criteria. The submission is focused on minor administrative changes (removal of a kit and label revisions) to previously cleared devices. Therefore, I cannot provide the detailed information requested regarding acceptance criteria and a study proving the device meets them from this document.

To answer your request, I would need access to the original 510(k) submissions (K124031 for the da Vinci Fluorescence Imaging Vision System and/or K141077 for the da Vinci Firefly Imaging System) where the initial performance data and acceptance criteria would have been established.

Based on the provided text, I can only state that no new studies were conducted or reported for this particular 510(k) submission (K210918).

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