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 nearinfrared 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 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.

Device Description

The da Vinci Firefly Imaging System provides visualization in two modes: standard, visible-light imaging mode and a near-infrared fluorescence imaging mode, consisting of either a black-and-white surgical image or completely black background with the nearinfrared fluorescence depicted in a color overlay. For near-infrared fluorescence imaging, indocyanine green (ICG) fluorescence imaging agent is required.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
785nm Fluorescence System Performance	Met the acceptance criteria for all design requirements and specifications, specifically for Firefly Clinical Applications test cases.
Safety and Effectiveness (Change Impact)	No issues of safety or effectiveness and no new risks were identified with the change to the 785nm Fluorescence System.
Illumination Requirements (Firefly Mode)	Verification testing (limited to illumination requirements in Firefly Mode) demonstrated compliance.
Compatibility with Endoscopes	The 785nm Fluorescence Vision System and applicable endoscopes met compatibility acceptance criteria. No issues of safety or effectiveness and no new risks were identified regarding compatibility.
White Light Performance	Not applicable; white light LED and components are unchanged from the previously cleared 805nm system, so no new testing was required or reported for white light performance in this particular submission.
Substantial Equivalence (Near-Infrared)	The modified device, using an excitation wavelength of 785 nm, maintains substantially equivalent near-infrared imaging compared to the predicate device (805nm laser).
Substantial Equivalence (Imaging Modes/Energy)	In terms of imaging modes and energy used and/or delivered, the subject device is substantially equivalent to the predicate devices.
Labeling	Labeling was updated to reflect the 785nm laser change and is substantially equivalent to the predicate device's labeling.

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

The provided text does not explicitly state the sample size for the test set used in the "Delta validation testing" or "Delta design verification testing."

The data provenance is also not explicitly detailed. It can be inferred that the testing was conducted internally by Intuitive Surgical, Inc. as part of their design verification and validation processes. There is no mention of country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

The provided text does not provide information regarding the number of experts used or their specific qualifications for establishing ground truth within these tests. The tests are described as "validation testing" and "design verification testing" against "design requirements and specifications" and "clinical applications test cases," suggesting an internal product-centric validation rather than a clinical ground truth established by external experts in an MRMC study.

4. Adjudication Method for the Test Set

The provided text does not mention any adjudication method like 2+1 or 3+1. The description of testing ("met the acceptance criteria for all of the design requirements and specifications") implies a direct assessment against predefined engineering or performance metrics rather than a consensus-based review of clinical cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this document. The device is an imaging system (da Vinci Firefly Imaging System), not an AI-assisted diagnostic tool that directly aids human readers in interpretation. The filing describes a modification to an existing imaging system (change in excitation wavelength from 805nm to 785nm), and the testing focused on verifying the performance of this modified system against its design specifications and maintaining substantial equivalence. Therefore, there is no discussion of human reader improvement with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is an imaging system used during surgery, and its functionality involves providing real-time visible and near-infrared fluorescence imaging to surgeons. It is inherently a human-in-the-loop device as it provides visual information for a surgeon to interpret and act upon. The text does not describe any standalone algorithmic performance without human interpretation.

7. The Type of Ground Truth Used

The "ground truth" for the testing described appears to be based on engineering design requirements and specifications for the imaging system's performance, particularly related to the 785nm fluorescence system, illumination, and compatibility. It also references "Firefly Clinical Applications test cases," which suggests scenarios designed to evaluate the system's performance in clinical contexts, likely validated against anticipated imaging results or known technical benchmarks. It does not mention expert consensus, pathology, or outcomes data as the primary ground truth for this particular submission.

8. The Sample Size for the Training Set

The provided text does not mention a training set because this submission describes a modification to a medical device (an imaging system, specifically a change in laser wavelength) and not an AI/ML algorithm that would typically require a training set. The testing performed was for verification and validation of the hardware change.

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

Since there is no mention of a training set, the method for establishing its ground truth is not applicable to this document.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 20, 2022

Intuitive Surgical Inc. Melissa Gonzalez Regulatory Project Manager 1266 Kifer Road Sunnyvale, California 94086

Re: K222827

Trade/Device Name: da Vinci Firefly Imaging System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: NAY Dated: September 14, 2022 Received: September 19, 2022

Dear Melissa Gonzalez:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part

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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 (QS) 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

Device Name

da Vinci Firefly Imaging System

Indications for Use (Describe)

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)

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510(k) Summary

Prepared on: 2022-09-16

Contact Details

21 CFR 807.92(a)(1)

Applicant Name	Intuitive Surgical, Inc.
Applicant Address	1266 Kifer Road Sunnyvale CA 94086 United States
Applicant Contact Telephone	408-523-8684
Applicant Contact	Mrs. Melissa Gonzalez
Applicant Contact Email	melissa.gonzalez@intusurg.com

Device Name 21 CFR 807.92(a)(2)

Device Trade Name	da Vinci Firefly Imaging System
Common Name	Endoscope and accessories
Classification Name	System, Surgical, Computer Controlled Instrument
Regulation Number	876.1500
Product Code	NAY

Legally Marketed Predicate Devices 21 CFR 807.92(a)(3)

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K213710	da Vinci Firefly Imaging System	NAY

Device Description Summary 21 CFR 807.92(a)(4)## evice Description Summary

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

Upon intravenous administration and use of an ICG druq product consistent with its approved label, the da Vinci Firefly lmaging System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci Firefly maging 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 biliary ducts with the da Vinci Firenced 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.

Indications for Use Comparison

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The indications for use are unchanged from the previously-cleared versions of the devices.

Technological Comparison

21 CFR 807.92(a)(6)

lmaging Mode and Energy used and/or delivered (Near-Infrared): The subject device has been modified to use an excitation wavelength (785 nm) that targets the center of the allowable absorption while maintaining substantially equivalent near-infrared imaging. In terms of imaging modes and energy used and/or delices are substantially equivalent to the predicate devices.

Labeling: The content in the subject device user manual has been updated to reflect the change from an 805nm laser (predicate) to a 785nm (subject) laser in Table B.1 Warning Label (page 40). There are no other changes to the user manual. The labeling is substantially equivalent to the predicate device.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

To confirm that the change to the subject device does not raise new or different questions of device safety or effectiveness, the following testing activities were required to verify and validate the 785nm Fluorescence System.

Delta validation testing for the 785nm Fluorescence System with the 8mm Endoscope Plus was limited to the Firefly Clinical Applications test cases. The 785nm Fluorescence Vision System met the acceptance criteria for all of the design requirements and specifications. No issues of safety or effectiveness and no new risks were identified.
Delta design verfication testing was performed with the 785mm Fluorescence System. Verfication testing was limited to illumination requirements in Firefly Mode. Additional testing, including white light testing was not required as the white light LED and other components are unchanged compared to the 805nm Fluorescence System most recently cleared under K213710.
In conjunction with the Design Validation, compatibility testing of the 785nm with the applicable Endoscopes was tested. The 785nm Fuorescence Vision System and compatibility acceptance criteria. No issues of safety or effectiveness and no new risks were identified.

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.