(28 days)
Da Vinci Fluorescence Imaging Vision System:
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 ducts (cystic duct, common hepatic duct), using near infrared imaging.
Fluorescence imaging of billary 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 billiary duct visualization.
Da Vinci Firefly Imaging System:
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 duct, (cystic duct, common bile duct or common hepatic duct), using near infrared imaging.
Fluorescence imaging of biliary ducts with the da Vinci Firended 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.
Two subject devices, the da Vinci Fluorescence Imaging Vision System and the da Vinci Firefly Imaging System, are bundled in this submission.
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 lmaging of enhanced, existing components of the da Vinci Si Surgical System: 8.5 mm or 12 mm endoscopes (0 degree) optimized for NIR fluorescence imaging, the 3D High-Definition (HD) stereoscopic camera head, the fluorescence-capable illuminator for use processor unit (light source), and supporting software functions. There are no changes being made to the described components from the previously-cleared version of the device (K124031).
The da Vinci Firefly Imaging System is a fully-integrated, adjunct endoscopic imaging system for the da Vinci X Surgical Systems. The da Vinci Firefly Imaging System consists of enhanced, existing components of the da Vinci X Surgical Systems: an 8 mm endoscope (0 degree) optimized for NIR fluorescence imaging, the fluorescence-capable Endoscope Controller, and supporting software functions. There are no changes being made to the described components from the previouslycleared version of the device (K141077).
There are two changes being made between the subject devices. The two changes are equivalent for both the da Vinci Fluorescence Imaging Vision System and the da Vinci First change is that a Fluorescence Imaging Kit will no longer be included with the subject devices, this Fluorescence lmaging Kit includes cross-labeled indocyanine green (ICG) fluorescence imaging agent, and syringe trays. Historically, the ICG labeling by itself has not included indications for use with an imaging medical device. Therefore, as a part of the previous 510(k) clearances for the da Vinci Fluorescence Imaging Vision System (K124031) and the da Vinci Firefly Imaging System (K141077), ICG was cross-labeled by Intuitive to include indications for use with the predicate devices. The labeling of the imaging agent ICG (trade name SP) AGENT GREEN), as published on the FDALabel Database, now includes indications for use with a fluorescence imaging device.
The second change is that the user manuals for both devices have been revised. The fluorescence imaging-related content in the subject devices user manuals has been updated to remove references to the Fluorescence lmaging Kit, for consistency with the expanded ICG imaging agent indications for use.
The provided text is a 510(k) summary for the da Vinci Fluorescence Imaging Vision System and the da Vinci Firefly Imaging System. It describes the device, its intended use, and the changes made in this particular submission.
However, the summary explicitly states:
"Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b) The information required by this section is not applicable. The changes in this 510(k) are limited to the removal of the Fluorescence Imaging Kit and revised labeling. Based on the risk management assessment of these changes, no design verification or validation testing is required to ensure safe and effective performance of the subject devices."
This means that this specific 510(k) submission does not contain new studies or data to prove the device meets acceptance criteria. The submission is focused on minor administrative changes (removal of a kit and label revisions) to previously cleared devices. Therefore, I cannot provide the detailed information requested regarding acceptance criteria and a study proving the device meets them from this document.
To answer your request, I would need access to the original 510(k) submissions (K124031 for the da Vinci Fluorescence Imaging Vision System and/or K141077 for the da Vinci Firefly Imaging System) where the initial performance data and acceptance criteria would have been established.
Based on the provided text, I can only state that no new studies were conducted or reported for this particular 510(k) submission (K210918).
§ 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.