(29 days)
The VS3-Iridium System is intended to provide real-time visible and near infrared fluorescence imaging in both open and minimally invasive procedures.
Upon intravenous administration and use of an ICG consistent with its approved labeling, the VS3-Iridium System is used to perform fluorescence imaging visualization of vessels, blood flow and tissue perfusion before during and after general minimally invasive surgical procedures and plastic, micro-, reconstructive surgeries.
Upon interstitial administration and use of ICG consistent with its approved labeling, the Endoscope configuration of the VS3-Iridium System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Upon administration and use of pafolacianine consistent with its approved labeling, the VS3-Iridium 785 nm System is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.
The VS3-Iridium System is an advanced stereoscopic visualization system made up of a combination of hardware and software to provide high definition visible and near infrared (IR) fluorescent imaging. The visualization system can incorporate an endoscope for minimally invasive surgical procedures and a microscope positioned above the patient during open surgical procedures.
The VS3-Iridium System including the endoscope and the microscope is designed to work with an approved infrared dye (Indocyanine green (ICG) or pafolacianine sodium injection or pafolacianine). ICG may be excited at excitation at either 785 or 805 nm, and pafolacianine is excited only by the 785 nm wavelength. The principle of operation is the same for both infrared dyes. That is, the VS3-Iridium System provides excitation light to the surgical field to excite the dye molecules and captures emission from the dye using an IR camera, enabling qualitative and quantitative measurement of the IR intensity. Near IR fluorescence imaging with ICG permits the system to visualize blood flow and related tissue circulation, of lymphatic flow.
The VS3-Iridium System allows the capture of normal (white) light image in parallel with the fluorescence IR image and displays both to the surgeon to provide a view of the anatomy. In addition, the VS3-Iridium System permits recording surgical procedures, storing them on removable storage devices, and replaying the procedures.
This document describes a 510(k) premarket notification for the VS3-Iridium System (VS3-IR), an advanced stereoscopic visualization system. The filing seeks to re-frame the indications for use statement to align with the specific indications of legally marketed Indocyanine green (ICG) products and pafolacianine, and to eliminate the need for the VS3-Iridium Fluorescence ICG Kit.
Here's an analysis of the provided information about acceptance criteria and supporting studies:
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Table of acceptance criteria and reported device performance:
The document explicitly states: "No performance data are needed to support the modified indications for use. As noted above, there are no technological changes associated with the proposed labeling changes. Additionally, no new surgical procedures or tissue types are being referenced in the modified indications for use."
Therefore, there is no table of acceptance criteria or reported device performance for this specific 510(k) submission, as the changes are purely administrative regarding the Indications for Use statement and the removal of an accessory, not a modification to the device's technological characteristics or its core performance. The FDA granted substantial equivalence based on the device being "the same or similar" to previously cleared versions.
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Sample size used for the test set and the data provenance: Not applicable. No new performance data was required for this 510(k) submission as there were no technological changes to the device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new performance data was required for this 510(k) submission.
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Adjudication method for the test set: Not applicable. No new performance data was required for this 510(k) submission.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The VS3-Iridium System is described as a visualization system for real-time visible and near infrared fluorescence imaging, not an AI-assisted diagnostic or interpretative tool that would involve human readers improving with AI assistance. This submission specifically deals with changes to the Indications for Use, not a new AI component or performance evaluation.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The VS3-Iridium System is a visualization system used by a surgeon, implying human-in-the-loop operation. This submission does not introduce or evaluate any new standalone algorithmic performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No new performance data was required for this 510(k) submission.
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The sample size for the training set: Not applicable. This submission concerns re-framing indications for use and removing an accessory, not a new algorithm development or training.
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How the ground truth for the training set was established: Not applicable. As above, this submission concerns re-framing indications for use and removing an accessory, not a new algorithm development or training.
Summary of the Study and Rationale for No New Performance Data:
The core of this 510(k) submission (K223020) is a "special 510(k) premarket notification to re-frame the indications for use statement to be consistent with specific indications of legally marketed ICG products, eliminating the need for the VS3-Iridium Fluorescence ICG Kit."
The manufacturer, Visionsense, Ltd., argues that:
- There are no changes in the technological characteristics of the visualization system hardware, software, or accessories.
- The only change in the system configuration is to obsolete the VS3-IR ICG Kit.
- The proposed changes in the indications for use statement are to reflect the previous discontinuation of a 3D module and associated endoscopes, streamline ICG-related indications, and reflect that these indications are derived from approved ICG drug labeling.
- These changes are considered a "simple statement of product functionality that has always been present and does not represent any new use for the system."
- There are "no questions related to safety or effectiveness of the device when used as labeled," and the change is "not considered a critical change to the intended therapeutic, diagnostic, prosthetic, or surgical use of the device."
Based on these justifications, the FDA determined that "No performance data are needed to support the modified indications for use." The device was deemed substantially equivalent to its own previously cleared versions (K150018, K152204, K183453, K191851, K210265) because the modifications were administrative and did not alter the technological characteristics or intended use in a way that would raise new questions of safety or effectiveness.
§ 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.