What is the FDA product code for da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System?

NAY. It is classified under 21 CFR 876.1500 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System?

Pinpoint Endoscopic Fluorescence Imaging System (K182606); da Vinci Fluorescence Imaging Vision System and da Vinci Firefly Imaging System (K210918).

Who can help prepare an FDA 510(k) submission like da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System

Q: Who is the manufacturer of da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System?

Intuitive Surgical, Inc. filed the 510(k) submission for da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System (K213710).

K213710 · Intuitive Surgical, Inc. · NAY · Feb 17, 2022 · Gastroenterology, Urology

Device Facts

Record ID	K213710
Device Name	da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System
Applicant	Intuitive Surgical, Inc.
Product Code	NAY · Gastroenterology, Urology
Decision Date	Feb 17, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1500
Device Class	Class 2

Intended Use

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. 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 Story

Integrated endoscopic imaging system for da Vinci Si, Xi, and X surgical platforms; utilizes 8mm/8.5mm/12mm endoscopes optimized for near-infrared (NIR) fluorescence. Inputs: NIR light signals from ICG-enhanced tissue; outputs: real-time 3D HD stereoscopic video overlaying visible light and fluorescence. Operated by surgeons in OR during minimally invasive procedures. System processes optical signals to provide visual assessment of blood flow, tissue perfusion, biliary ducts, and lymphatic structures. Assists surgeons in intraoperative decision-making by highlighting anatomical structures and perfusion status; enhances surgical precision and patient outcomes by providing real-time visual feedback.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and labeling modifications.

Technological Characteristics

Integrated endoscopic system; 8.5mm/12mm/8mm endoscopes; 3-chip RGB CCD or CMOS HD sensors; excitation wavelength 802-805nm; complies with IEC 60825 3R for laser safety. Connectivity via da Vinci surgical system architecture. Software-based image processing for NIR fluorescence overlay.

Indications for Use

Indicated for patients undergoing minimally invasive surgery requiring real-time endoscopic visible and near-infrared fluorescence imaging. Used for visual assessment of vessels, blood flow, tissue perfusion, biliary ducts, and lymphatic system (vessels and nodes) following administration of ICG drug product. Not for standalone biliary duct 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

Pinpoint Endoscopic Fluorescence Imaging System (K182606)
da Vinci Fluorescence Imaging Vision System and da Vinci Firefly Imaging System (K210918)

Related Devices

K210918 — da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System · Intuitive Surgical, Inc. · Apr 26, 2021
K101077 — DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100 · Intuitive Surgical, Inc. · Feb 4, 2011
K180146 — KARL STORZ ICG Imaging System · Karl Storz Endoscopy America, Inc. · Apr 17, 2018
K141077 — DA VINCI FIREFLY IMAGING SYSTEM · Intuitive Surgical, Inc. · Aug 12, 2014
K212695 — KARL STORZ ICG Imaging System · Karl Storz Endoscopy America · Nov 15, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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 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. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------|--| | <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | | | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 510(k) Summary (21 CFR § 807.92(c)) | I: SUBMITTER INFORMATION | | |-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086 | | Contact: | Connor McCarty Senior Regulatory Engineer Connor.McCarty@intusurg.com 805.798.4205 | | Date Summary Prepared: | January 27, 2022 | | II: SUBJECT DEVICE INFORMATION | | | Device Trade Name: | da Vinci® Fluorescence Imaging Vision System and da 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 and da Vinci® Firefly Imaging System (K210918, cleared on April 26, 2021) | ### IV: 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). {5}------------------------------------------------ ### 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. 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 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. 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. # 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. {6}------------------------------------------------ #### TABLE 1A: Comparison of Subject and Predicate Devices – Indications for Use F T 1 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {7}------------------------------------------------ | Attribute | SUBJECT DEVICES: da Vinci® Fluorescence Imaging Vision System and da Vinci® Firefly Imaging System | PREDICATE DEVICE: (K182606) Pinpoint Endoscopic Fluorescence Imaging System | PREDICATE DEVICES: (K210918) da Vinci® Fluorescence Imaging Vision System and da Vinci® Firefly Imaging System | |--------------------------|----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------| | Excitation Wavelength | 802 – 805nm | 805nm | Identical to subject devices | | Excitation Power Density | Compliance with IEC 60825 3R | Compliance with IEC 60825 3R | Identical to subject devices | | Scope Diameter | 8.5mm, 12mm | 5.5mm, 10mm | Identical to subject devices | | Scope Length | 296.85 - 543.6mm | 320 – 423mm | Identical to subject devices | | Working Distance | 20 - 140mm | 7 - 70mm | Identical to subject devices | | Field of View | 60° - 80° | 70° - 75° | Identical to subject devices | | Scope Viewing Angle | 0°, 30° | 0°, 30°, 45° | Identical to subject devices | | Sensor Type | 3 chip RGB CCD; Front and back side illuminated CMOS HD sensor assembly | CMOS HD sensor assembly | Identical to subject devices | | Sensor Resolution | 1280 x 1024; 1920 x 1080 output image | 1920 x 1080 output image | Identical to subject devices | # 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.