(31 days)
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.
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.
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.
§ 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.