The do Vinci Fluorescence Imaging Vision System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The do Vinc® 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 extrahepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near infrared imaging.

Fluorescence imaging of biliary ducts with the do 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.

Device Description

The Intuitive Surgical da Vinci Fluorescence Imaging Vision System is an endoscopic imaging system for high definition (HD) visible light and near-infrared fluorescence imaging during minimally invasive surgery. The Intuitive Surgical do Vinci Fluorescence Imaging Vision System consists of the following elements in addition to the standard components of the IS3000 da Vinci SI Surgical System:

. 12mm and 8.5 mm endoscopes (0 degree) optimized for NIR fluorescence imaging in addition to VIS imaging,
. A 3D High Definition stereoscopic camera head optimized for NIR fluorescence imaging in addition to VIS imaging,
. An illuminator for use with the video processor unit, and
. A Fluorescence Imaging Kit [IndoCyanine Green (ICG) fluorescence imaging agent, aqueous solvent, and syringe trays]

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Intuitive Surgical® da Vinci® Fluorescence Imaging Vision System, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The provided document focuses on supporting an expanded indication for use—specifically, the visualization of extrahepatic biliary ducts. Therefore, the acceptance criteria are implicitly tied to the ability to visualize these ducts effectively and safely.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance (Proxies)
Visualize at least one extrahepatic biliary duct.	At least one (1) biliary duct identified with fluorescence imaging in 100% (72/72) of subjects in the prospective study.
Acceptable identification rate by an independent reviewer.	At least one extrahepatic biliary duct identified in 98.2% (54/55) of subjects by an independent reviewer in a subset of the prospective study cases.
Superiority/Consistency over White Light for Bile Duct Viz.	Fluorescence imaging enabled visualization of all three (3) ducts in a significantly higher percentage of cases compared to standard white light visualization.
Comparable Safety Profile.	Comparable safety profile for extrahepatic biliary duct visualization compared to white light visualization.
Substantial Equivalence to General Vessel Visualization.	Data supports substantial equivalence of "extrahepatic biliary duct visualization" to the cleared general indications for "visual assessment of vessels."

Study Details

2. Sample Size Used for the Test Set and Data Provenance

Prospective Study: 72 subjects undergoing robotic cholecystectomy procedures. A subset of 55 cases from this study was assessed by an independent reviewer. The country of origin is not explicitly stated. Given the submitter's location (Sunnyvale, CA) and the mention of a "single center US study," it's highly probable that the prospective study and its subset are U.S.-based. This was a prospective study.
Published Literature: 96 subjects from three (3) different centers. The country of origin is not specified but could be international given "different centers." This would likely be a retrospective analysis of published data.
Single Center US Study: 154 consecutive robotic-assisted cholecystectomy cases. This was a retrospective study from the U.S.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Prospective Study: The operating surgeons identified the biliary ducts in the 72 subjects. For a subset of 55 cases, an "independent reviewer" performed an assessment. The exact number of operating surgeons or the independent reviewer's qualifications are not specified beyond "independent reviewer."
Published Literature/Single Center US Study: The method of ground truth establishment and expert involvement for these datasets is not detailed in the summary, other than "demonstrated consistent visualization."

4. Adjudication Method

For the prospective study, the primary assessment was by the operating surgeons. For a subset, an "independent reviewer assessment" was performed. It's unclear if there was a formal adjudication process (e.g., 2+1, 3+1 consensus) between these assessments or if the independent reviewer's assessment was a separate, singular evaluation. No explicit adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The summary does compare the device's performance to standard white light visualization, stating: "Fluorescence imaging enabled visualization of all three (3) ducts in a significantly higher percentage of cases as compared to standard white light visualization."
However, it does not explicitly describe a formal MRMC study comparing human readers with AI assistance versus without AI assistance. The comparison is between two imaging modalities (fluorescence vs. white light), both interpreted by human surgeons.
Therefore, an "effect size of how much human readers improve with AI vs without AI assistance" cannot be determined from this text, as the device is an imaging system, not an AI for image interpretation. The device provides information to human readers.

6. Standalone (Algorithm Only) Performance

No, a standalone (algorithm only) performance study was not done.
The device is an imaging system intended for use by surgeons for real-time visualization. The summary explicitly states: "The device is not intended for standalone use for biliary duct visualization." and "The da Vinci Fluorescence Imaging Vision System is intended for adjunctive use only in conjunction with standard white light and, when indicated, intraoperative cholangiography (IOC) for extrahepatic biliary duct visualization."

7. Type of Ground Truth Used

The ground truth for the test sets (prospective study, published literature, single-center study) was primarily based on expert visual identification of biliary ducts during surgery (by operating surgeons or independent reviewers), likely correlated with surgical findings and potentially intraoperative cholangiography (IOC) mentioned as a standard of care. There is no explicit mention of pathology or long-term outcomes data being used as ground truth for detection in this context.

8. Sample Size for the Training Set

The summary does not mention a training set in the context of a machine learning algorithm. This device is an imaging system, not an AI-driven diagnostic or interpretative algorithm that typically requires a training set. The data presented are for evaluating the performance of the imaging system itself in visualizing structures in a clinical setting.

9. How the Ground Truth for the Training Set Was Established

As no training set is discussed or implied for an AI algorithm, this question is not applicable based on the provided text.

Summary

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510(k) Summary (21 CFR § 807.92(c))

Submitter:	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Contact:	Cindy Domecus, R.A.C. (US & EU)Principal, Domecus Consulting Services LLCRegulatory Consultant to Intuitive SurgicalTelephone: 650.343.4813Fax: 650.343.7822Email: domecusconsulting@comcast.net
Date Summary Prepared:	11 September 2013
Device Trade Name:	Intuitive Surgical® da Vinci® Fluorescence Imaging Vision System
Common Name:	Endoscopic Instrument Control System
Classification Name:	System, Surgical, Computer Controlled Instrument (21 CFR §876.1500)
Product Code:	GCJ, NAY, IZI
Equivalent Devices:	Intuitive Surgical da Vinci Fluorescence Imaging Vision Systems K101077(Clearance Date: 04 February 11)

Device Description:

This 510(k) is being submitted for a revision to the indications for use to include visualization of extrahepatic biliary ducts with the do Vinci Fluorescence Imaging Vision System. There are no changes in the design, technology, materials, manufacturing, performance, specifications or method of use for the cleared da Vinci Fluorescence Imaging Vision System. A brief description of the device follows:

. 12mm and 8.5 mm endoscopes (0 degree) optimized for NIR fluorescence imaging in addition to VIS imaging,
. A 3D High Definition stereoscopic camera head optimized for NIR fluorescence imaging in addition to VIS imaging,

510(k) Summary

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. An illuminator for use with the video processor unit, and
. A Fluorescence Imaging Kit [IndoCyanine Green (ICG) fluorescence imaging agent, aqueous solvent, and syringe trays]

Intended Use:

The da Vinci Fluorescence Imaging Vision System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The do 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 extrahepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near infrared imaging.

Comparison to Predicate Device:

There are no changes in the design, technology, materials, manufacturing, performance, specifications or method of use related to the proposed revision to the indications for use. The labeling revision to include visualization of specific vessels, namely, "extrahepatic biliary ducts," is equivalent to the cleared general indications for use that allows for visualization of vessels.'

Technological Characteristics:

The technological characteristics of the subject device are identical to the predicate device that is already cleared for visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging. The route of administration, dosing and excretion of ICG is the same for the general and specific indications for use. Importantly, ICG is taken up almost exclusively by the hepatic parenchymal cells and is secreted entirely into the extrahepatic biliary ducts. As such, imaging of these specific vessels is simply a byproduct of standard ICG fluorescence imaging conducted under the currently cleared general indications for use. In other words, extrahepatic biliary duct visualization is possible after ICG injection for any usage.

Clinical Data:

This premarket notification includes the results from a prospective study on 72 subjects undergoing robotic cholecystectomy procedures. In all cases, the operating surgeons were able to identify at least one (1) biliary duct with fluorescence imaging. Based on an independent reviewer assessment of a subset of these cases (N=55), this study demonstrated that at least one extrahepatic biliary duct could be identified in 98.2% of the subjects with an acceptable safety profile. Fluorescence imaging enabled visualization of all three (3) ducts in a significantly higher percentage of cases as compared to standard white light visualization. Additionally, this premarket notification contains published literature on 96 subjects from three (3) different centers that demonstrated consistent visualization of extrahepatic biliary ducts under fluorescence imaging in robotic and non-robotic cholecystectomy surgeries. Data

510(k) Summary

PAGE 2

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from a single center US study reporting on 154 consecutive robotic-assisted cholecystectomy cases that utilized fluorescence imaging was also submitted. The data included herein shows a comparable safety and effectiveness profile of extrahepatic biliary duct visualization as compared to white light visualization. Lastly, this data supports substantial equivalence of the specific indications for use ("extrahepatic biliary duct visualization") as compared to the general indications for use that allows for visual assessment of vessels.

Summary:

Based on the information provided in this premarket notification, use of the Intuitive Surgical do Vinci Fluorescence Imaging Vision System to visualize extrahepatic biliary ducts is substantially equivalent to the device's general indications for use that allows for visual assessment of vessels during endoscopic surgeries. The do Vinci Fluorescence Imaging Vision System is intended for adjunctive use only in conjunction with standard white light and, when indicated, intraoperative cholangiography (IOC) for extrahepatic biliary duct visualization. The use of the do Vinci Fluorescence Imaging Vision System to visualize extrahepatic biliary ducts during endoscopic procedures does not raise different questions of safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

September 13, 2013

Intuitive Surgical, Inc. % Cindy Domecus Regulatory Consultant 1266 Kifer Road, Building 101 Sunnyvale, California 94086-5206

Re: K124031

Trade/Device Name: da Vinci® Fluorescence Imaging Vision System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OWN Dated: August 08, 2013 Received: August 09, 2013

Dear Ms. Domecus:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (2 l

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Page 2 - Ms. Cindy Domecus

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number if Known: K124031

Device Name: Intuitive Surgical® do Vinci® Fluorescence Imaging Vision System

Indications for Use:

Prescription Use 图 (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrent of CDRH, Office of Device Evaluation (ODE)

Neil R Ogden 2013.09.13 14:45:09 -04'00'

(Division Sign-Off) for MXM

Division of Surgical Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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.