DA VINCI FLUORESCENCE IMAGING VISION SYSTEM

K124031 · Intuitive Surgical, Inc. · OWN · Sep 13, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K124031
• Device Name: DA VINCI FLUORESCENCE IMAGING VISION SYSTEM
• Applicant: Intuitive Surgical, Inc.
• Product Code: OWN · Gastroenterology, Urology
• Decision Date: Sep 13, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

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 bile duct and 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.

Device Story

Endoscopic imaging system; provides HD visible light and near-infrared (NIR) fluorescence imaging during minimally invasive surgery. Components: 12mm/8.5mm endoscopes, 3D HD stereoscopic camera head, illuminator, and Fluorescence Imaging Kit (IndoCyanine Green (ICG) agent). Surgeon operates system to visualize vessels, blood flow, tissue perfusion, and extrahepatic biliary ducts. ICG injected intravenously; hepatic cells uptake and secrete ICG into biliary ducts; NIR imaging detects fluorescence. Surgeon views output on display; assists in intraoperative identification of biliary anatomy. Adjunctive to standard white light and intraoperative cholangiography. Benefits: improved visualization of biliary structures during robotic cholecystectomy.

Clinical Evidence

Prospective study (N=72) of robotic cholecystectomy; 100% of surgeons identified at least one biliary duct. Independent assessment (N=55) showed 98.2% identification rate for at least one extrahepatic duct. Fluorescence imaging showed significantly higher visualization of all three ducts compared to white light. Additional literature (N=96) and single-center study (N=154) support consistent visualization and comparable safety profile to white light.

Technological Characteristics

Endoscopic imaging system; 3D HD stereoscopic camera; NIR fluorescence imaging; ICG-based contrast agent. No changes in materials or design from predicate. Standalone/integrated with IS3000 da Vinci SI Surgical System. Software-based image processing for visible and NIR overlay.

Indications for Use

Indicated for patients undergoing minimally invasive surgery requiring real-time endoscopic visible and near-infrared fluorescence imaging for visual assessment of vessels, blood flow, tissue perfusion, and extrahepatic bile ducts (cystic, common bile, and common hepatic). Intended for adjunctive use with white light and intraoperative cholangiography; not for standalone biliary visualization.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Intuitive Surgical da Vinci Fluorescence Imaging Vision Systems (K101077)

Submission Summary (Full Text)

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# 510(k) Summary (21 CFR § 807.92(c))

| Submitter: | Intuitive Surgical, Inc.<br>1266 Kifer Road<br>Sunnyvale, CA 94086 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Cindy Domecus, R.A.C. (US & EU)<br>Principal, Domecus Consulting Services LLC<br>Regulatory Consultant to Intuitive Surgical<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| 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<br>(Clearance Date: 04 February 11) |

#### Device Description:

i

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:

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,

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.

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.

#### 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 [phone] or [phone] 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:

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.

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 ________________________________________________________________________________________________________________________________________________________________