(294 days)
The VS3 Iridium System is intended for viewing anatomical structures during invasive surgery and for viewing fluorescent images for the visual assessment of blood flow and lymphatic flow. The unit is indicated for viewing internal surgical sites during general surgical procedures. It provides an adjunctive method for the evaluation of tissue perfusion and related tissue transfer circulation in tissue and free flaps used in general, plastic, micro-and reconstructive surgical procedures. It also enables the identification of functional lymphatic vessel, and/or lymph nodes. The VS3 Iridium System is also intended to visualize tissues that have taken up the pafolacianine during procedures that are consistent with the approved labeling of that dye.
Upon intravenous administration and use of an ICG consistent with its approved labeling, 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 labeling, 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.
Upon administration and use of pafolacianine in accordance with its approved labeling, the VS3-IR 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 Traditional 510(k) premarket notification is to expand the indication for use statement to include the additional cleared infrared dye, pafolacianine sodium injection, for use with infrared imaging.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The provided text focuses on expanding the indications for use of the VS3 Iridium System to include pafolacianine. The acceptance criteria are implicitly tied to demonstrating the safety and efficacy of the device when used with this new fluorescent dye, specifically its ability to detect target lesions.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Ability to detect target lesions (FR+ ovarian cancer) when used with pafolacianine | 33% (95% CI [0.243, 0.427]) of patients had at least one confirmed FR+ ovarian cancer evaluable lesion detected by the combination of OTL38 (pafolacianine) and Near Infrared (NIR) fluorescent light, but not under normal light or palpation. |
| Safety of the VS3 Iridium System (imaging subgroup) when used with OTL38 (pafolacianine) | 0 (zero) treatment-emergent adverse device effects (TEAE) reported in the imaging subgroup (n=127). |
The study aimed to demonstrate the benefit of using the VS3 Iridium System with pafolacianine (OTL38) for detecting folate receptor positive (FR+) ovarian cancer that would otherwise be missed.
Study Details:
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Sample size used for the test set and the data provenance:
- Sample Size: The imaging subgroup (those using the VS3 Iridium System) had a sample size of n=127.
- Data Provenance: The study was a "phase 3, randomized, single dose, open-label study." While the specific country of origin is not explicitly stated for the data, the clinicaltrials.gov identifier (NCT03180307) indicates it was a registered clinical trial, which typically involves prospective data collection.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the text. The text mentions "confirmed FR+ ovarian cancer evaluable lesion," but it doesn't detail how this confirmation (ground truth) was established or who established it.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the text.
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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:
- This was not a MRMC comparative effectiveness study in the typical sense of evaluating human readers with and without AI assistance for interpretation.
- It was a study evaluating a device (VS3 Iridium System) used with a fluorescent dye (pafolacianine) to detect lesions not visible with normal light or palpation. The "effect size" is the proportion of patients where these additional lesions were found (33%).
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this was not a standalone (algorithm only) study. The device is a "visualization system" used by surgeons/clinicians for intraoperative imaging. The detection of lesions relies on the combination of the OTL38 (pafolacianine) and NIR fluorescent light observed by humans.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The text frequently mentions "confirmed FR+ ovarian cancer evaluable lesion." This strongly implies that the ground truth for the presence of these lesions was based on pathology or other definitive clinical confirmation methods (e.g., biopsy). However, the exact method and who confirmed it are not detailed.
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The sample size for the training set:
- The provided text describes a Phase 3 clinical study designed to test the performance of the device, not to train it. The VS3 Iridium System is primarily an imaging and visualization system, not an AI-driven diagnostic algorithm that would typically require a separate "training set" in the context of machine learning. Therefore, information about a training set is not applicable/provided for this type of device and study.
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How the ground truth for the training set was established:
- As mentioned above, information about a training set is not applicable/provided for this device and study.
§ 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.