NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System
NinePoint Medical, Inc.The NvisionVLE Imaging System by NinePoint Medical, Inc. is a high-resolution optical coherence tomography (OCT) imaging device designed to visualize tissue microstructures, especially in the esophagus. It uses a specialized probe and advanced imaging software to provide clinicians with real-time, cross-sectional images of tissue, enhanced by AI-based segmentation to color-highlight important features. This helps clinicians better review and mark areas of interest in the tissue during evaluation, aiding in diagnosis and treatment planning.
Intended Use
The NvisionVLE Imaging System is indicated for use as an imaging tool in the evaluation of human tissue microstructure, including esophageal tissue microstructure, by providing two-dimensional, cross-sectional, real-time depth visualization and may be used to mark areas of tissue. The software provides segmentation and display of common imaging features, including hyper-reflective surface, layering, and hypo-reflective structures.
Technology
The device consists of a mobile imaging console, proprietary software that uses a deep learning AI model for feature segmentation, single-use sterile optical probe and inflation system for balloon placement, and a probe lock accessory. It employs swept-source OCT (SS-OCT) to acquire high-resolution, real-time, volumetric cross-sectional images (Volumetric Laser Endomicroscopy). The AI software provides color overlays for specific image features to enhance visualization without altering the underlying image data.
Performance
Performance testing evaluated AI segmentation accuracy against human expert-labeled ground truth data, using data from about 40% of a 1000-patient clinical registry. True positive detection rates ranged from ~89.6% to 92.9% and true negative detection rates from ~92.9% to 97.8% for tissue surface, layering, and hypo-reflective structures, exceeding target performance criteria with statistical significance (p<0.05). Bench tests confirmed safety and performance, supporting substantial equivalence to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/21/2018
1 month - 2
FDA Approval
11/2/2018
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