(138 days)
Upon intravenous administration and use of an ICG consistent with its approved label, the Iridium Module of the VS3-IR System is used to perform intraoperative fluorescence angiography.
Upon interstitial administration and use of ICG consistent with its approved label, the Endoscope configuration of the VS3-IR System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Clearance was originally given for the Visionsense Stereoscopic Vision System (VSII) in K073279, K081102, K082667, and K082355. Clearance was given for a 3D High Definition version of the VSII System called the VS3 Stereoscopic High Definition Vision System (VS3) in K123467, K131434, K141002. Clearance included the HD3D Camera, Laser Light Source (LLS), VS3 3D Endoscope, Camera Control Unit (CCU), Display Monitor, Xenon Light Source, and Endoscopic Light Cable.
Clearance was given for an iridium version of the VS3 system called the "VS3-IR System" in K150018 and K152204. This system introduced an iridium miniature microscope in K150018 and an iridium endoscope in K152204. The cleared system added a Light Integrator and an ICG Kit. The VS3-IR utilizes the VS3 system with a special Miniature Microscope (MMS) that is positioned 20cm to 45cm above the patient during the surgical procedure. The VS3-IR can also be used with an Iridium Endoscope to perform minimally invasive procedures. The VS3-IR is designed to work with Indocyanine Green (ICG) which is an IR fluorescence imaging agent and is supplied in the "VS3-IR Fluorescence ICG Kit". Each cleared "VS3-IR Fluorescence ICG Kit" contains six 25mg vials of sterile ICG imaging agent and six 10ml vials of sterile Water for Injection. ICG is a sterile, water soluble, tricarbocyanine dye with a peak spectral absorption at 785nm or 805nm in blood plasma or blood. ICG contains not more than 5.0% sodium iodide. ICG is to be administered intravenously. The sterile Water for Injection provided with the ICG, pH of 5.0 to 7.0, is used to dissolve the ICG. Before injection of ICG for each patient's imaging procedure, the ICG must be reconstituted using the sterile Water for Injection. ICG in blood has excitation at 785nm or 805nm. The VS3-IR system provides excitation light to the surgical field to excite the dye molecules, captures emission from the dye using an IR camera and measures the fluorescence signal intensity. The system enables high definition imaging for both fluorescence and visible light imaging, with real-time overlay of fluorescence and visible light images for display on the monitor. The system permits recording surgical procedures, storing them on removable storage devices, and playing the procedures back.
Clearance was given for adding three working channels to the VS3 in K153548 and the accessory "Trans-Anal Introducer" was cleared in K171208.
The VS3-IR system (805nm) was cleared for adding the excitation wavelength of 785nm in K183453.
The provided text describes a 510(k) premarket notification for the Medtronic VS3-IR device, seeking clearance to expand its indications for use. It details the device, its predicate, and performance data from various tests, but it does not contain a study explicitly proving the device meets specific acceptance criteria related to its clinical performance (e.g., sensitivity, specificity, accuracy) for fluorescence imaging and visualization of the lymphatic system.
The "Performance Data" section primarily focuses on:
- Biocompatibility: Confirmation that patient-contacting materials are the same as previously cleared devices and are biocompatible.
- Electrical Safety and EMC: Compliance with relevant IEC standards.
- Software Verification and Validation: Adherence to FDA guidance for "minor" level of concern software.
- Cybersecurity: Description of security features for a locked-down, stand-alone device.
The document discusses expanding the indications for use based on its substantial equivalence to a predicate device (PINPOINT Endoscopic Fluorescence Imaging System, K182606), particularly for visualizing the lymphatic system with interstitial administration of ICG. The substantial equivalence argument relies on technological characteristics being similar or having appropriate mitigations, rather than a direct clinical performance study with acceptance criteria for this expanded indication.
Therefore, I cannot fulfill all parts of your request because the provided document does not describe a study with clinical performance acceptance criteria, sample sizes for test sets, expert ground truth, adjudication methods, or MRMC studies for the expanded indication.
However, I can extract information related to the device's technical characteristics and the types of performance data that were submitted.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
As noted, the document does not present acceptance criteria for clinical performance (e.g., sensitivity, specificity, or accuracy for visualizing the lymphatic system) for the VS3-IR for its expanded indication, nor does it present device performance against such criteria. The reported "performance data" are related to safety, engineering, and software aspects.
| Performance Aspect | Acceptance Criteria (Not explicitly stated in clinical terms for the expanded indication) | Reported Device Performance |
|---|---|---|
| Expanded Indication Performance | N/A (No specific clinical performance acceptance criteria or results for lymphatic system visualization are provided in this document.) | Based on substantial equivalence to predicate device (PINPOINT) for interstitial administration of ICG for intraoperative fluorescence imaging and visualization of the lymphatic system. |
| Biocompatibility | Conformance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1. | Patient-contacting components (3D camera, 3D endoscopes, VS3-IR-Endoscopes) are constructed of Stainless Steel, Aluminum, and Glass, same as previously cleared devices. Materials are processed and manufactured in the same manner. Device is surface-contacting, limited exposure (up to 24 hours). |
| Electrical Safety & EMC | IEC 60601-1, IEC 60601-2-18, IEC 60601-1-6, IEC 60825-1 (Safety); IEC 60601-1-2 (EMC) | The system complies with specified IEC standards. |
| Software Verification & Validation | FDA's Guidance for Industry and FDA Staff for "minor" level of concern software. | V&V testing conducted; documentation provided as recommended by FDA guidance. Software considered "minor" level of concern. |
| Cybersecurity | (Implicit: Secure operation as a standalone device.) | Locked-down stand-alone device, not connected to a network, only accessible via user interface. OS fully locked down, user access to OS disabled. USB ports only for exporting videos and reading configuration data; cannot boot from USB; spurious/malicious software cannot run from USB; direct access to USB file system prevented by OS lock-down. |
2. Sample Size Used for the Test Set and Data Provenance:
No information is provided in this document regarding a test set sample size or clinical data provenance (e.g., country of origin, retrospective/prospective) for the expanded indication of lymphatic system visualization. The "Performance Data" section describes engineering and software tests, not clinical performance studies for this specific intended use.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable, as no clinical performance study with expert ground truth establishment for a test set is described in the provided text.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical performance study with adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study is mentioned or its results (effect size of human reader improvement with AI vs. without AI assistance) reported in the document.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
The document describes the VS3-IR system as an imaging device. While it performs "intraoperative fluorescence imaging and visualization," it is a tool for a surgeon, not an AI algorithm performing a diagnostic task autonomously. Therefore, a standalone algorithm performance study, in the typical sense of AI, is not applicable or described.
7. Type of Ground Truth Used:
For the expanded indication, the document relies on substantial equivalence to the predicate device (PINPOINT) which also has an indication for "intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes" using interstitial ICG. The basis for the predicate's clearance for this indication would have involved demonstrating its performance, but that information is not detailed here. No independent clinical ground truth (e.g., pathology, outcomes data, or expert consensus) is discussed for the VS3-IR in this document for this expanded indication.
8. Sample Size for the Training Set:
Not applicable. The document does not describe the development of an AI algorithm with a training set. The device is a fluorescence imaging system.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no AI algorithm with a training set is described.
Summary of what the document does convey for the expanded indication:
The clearance for the expanded indication ("Upon interstitial administration and use of ICG consistent with its approved label, the Endoscope configuration of the VS3-IR System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes") is based on demonstrating substantial equivalence to a predicate device (PINPOINT Endoscopic Fluorescence Imaging System, K182606) which has a similar indication. This substantial equivalence is primarily supported by the similarity in intended use, technological characteristics (e.g., imaging agent, imaging head, light source type, spectral bandwidth, imaging distance ranges for endoscope configuration, scope dimensions, emission band, emission capture, and visible/IR image display), and comprehensive non-clinical performance data (biocompatibility, electrical safety, EMC, software, cybersecurity) proving the device itself is safe and effective for its stated functions. The document does not present a de novo clinical study with specific acceptance criteria for the VS3-IR's performance in visualizing the lymphatic system.
§ 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.