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.

Device Description

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).

AI/ML Overview

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.

Summary

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February 17, 2022

Intuitive Surgical, Inc. Connor McCarty Sr. Regulatory Engineer 1266 Kifer Road Sunnyvale, California 94086

Re: K213710

Trade/Device Name: da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: NAY, GCJ, IZI Dated: November 22, 2021 Received: November 24, 2021

Dear Connor Mccarty:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mark Trumbore Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213710

Device Name

da Vinci® Fluorescence Imaging Vision System and da Vinci® Firefly Imaging System

Indications for Use (Describe)

da Vinci Fluorescence Imaging Vision System

da Vinci Firefly Imaging System

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary (21 CFR § 807.92(c))

I: SUBMITTER INFORMATION
Submitter:	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Contact:	Connor McCartySenior Regulatory EngineerConnor.McCarty@intusurg.com805.798.4205
Date Summary Prepared:	January 27, 2022
II: SUBJECT DEVICE INFORMATION
Device Trade Name:	da Vinci® Fluorescence Imaging Vision System andda Vinci® Firefly Imaging System
Common Name:	System, Surgical, Computer Controlled Instrument
Classification Name:	Endoscope and Accessories (21 CFR §876.1500)
Regulatory Class:	II
Product Code:	GCJ, NAY, IZI
Submission Type:	Traditional 510(k)
III: PREDICATE DEVICE INFORMATION
Predicate Devices:	Pinpoint Endoscopic Fluorescence Imaging System (K182606);da Vinci® Fluorescence Imaging Vision System andda Vinci® Firefly Imaging System (K210918, cleared on April 26, 2021)

IV: DEVICE DESCRIPTION

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V: INDICATIONS FOR USE

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

Upon interstitial administration and use of an ICG drug product consistent with its approved label, the dd 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 dd 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 do Vinci Firefly Imaging 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.

VI: COMPARISON OF SUBJECT AND PREDICATE DEVICES

No modifications are being made to the technological characteristics of the subject devices. This 510(k) is being submitted for a labeling change to add the following to the cleared indications for use statement: "Upon interstitial administration and use of an ICG drug product consistent with its approved label, the da Vinci Fluorescence Imaging Vision System and 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." A comparison of the indications for use and key technological characteristics between the subject and predicate devices is provided in Tables 1A/1B.

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TABLE 1A: Comparison of Subject and Predicate Devices – Indications for Use F T 1 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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Attribute	SUBJECT DEVICES:da Vinci® FluorescenceImaging Vision Systemand da Vinci® FireflyImaging System	PREDICATE DEVICE:(K182606)Pinpoint EndoscopicFluorescence ImagingSystem	PREDICATE DEVICES:(K210918)da Vinci® FluorescenceImaging Vision Systemand da Vinci® FireflyImaging System
Excitation Wavelength	802 – 805nm	805nm	Identical to subjectdevices
Excitation Power Density	Compliance with IEC60825 3R	Compliance with IEC60825 3R	Identical to subjectdevices
Scope Diameter	8.5mm, 12mm	5.5mm, 10mm	Identical to subjectdevices
Scope Length	296.85 - 543.6mm	320 – 423mm	Identical to subjectdevices
Working Distance	20 - 140mm	7 - 70mm	Identical to subjectdevices
Field of View	60° - 80°	70° - 75°	Identical to subjectdevices
Scope Viewing Angle	0°, 30°	0°, 30°, 45°	Identical to subjectdevices
Sensor Type	3 chip RGB CCD;Front and back sideilluminated CMOS HDsensor assembly	CMOS HD sensor assembly	Identical to subjectdevices
Sensor Resolution	1280 x 1024; 1920 x 1080output image	1920 x 1080output image	Identical to subjectdevices

TABLE 1B: Comparison of Subject and Predicate Devices – Key Technological Characteristics

VII: CONCLUSION

The labeling modification has no impact on the safety or effectiveness of the da Vinci Fluorescence Imaging Vision System and the da Vinci Firefly Imaging System. As such, the subject devices are substantially equivalent to the predicate devices.

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.