(42 days)
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.
The NvisionVLE® Imaging System is intended to provide an image of tissue microstructure. The safety and effectiveness of this device for diagnostic analysis (i.e. differentiating normal versus specific abnormalities) in any tissue microstructure or specific disease has not been evaluated.
The NinePoint Medical NvisionVLE® Imaging System is a high-resolution volumetric imaging system based on optical coherence tomography (OCT). In an analogous fashion to ultrasound imagery, OCT images are formed from the time delay and magnitude of the signal reflected from the tissue of interest. The NvisionVLE Imaging System employs an advanced form of OCT known as sweptsource OCT (SS-OCT), or Optical Frequency Domain Imaging (OFDI), in combination with a scanning optical probe to acquire high-resolution, cross-sectional, real-time imagery of tissue called Volumetric Laser Endomicroscopy (VLE).
In addition to the imaging capability, the device provides a means of marking areas of tissue with an additionally integrated 1470nm laser. The ability to create temporary laser marks directly on tissue enables a clinician to place visual reference marks on tissue regions of clinical interest immediately following their identification via VLE. The device consists of the following five main components and accessories: (i) a mobile NvisionVLE Console with an integrated computer and two touch-screen interfaces; (ii) proprietary NvisionVLE Software used to acquire, process, and visualize VLE images; (iii) a single-use, sterile NvisionVLE Marking Probe that is inserted through the working channel of an endoscope; (iv) a single-use, sterile NvisionVLE Inflation System that is used to inflate the Marking Probe's balloon to facilitate placement; and (v) a Probe Lock Accessory to prevent longitudinal motion of the Marking Probe within the endoscope.
The purpose of this 510(k) submission is to add an artificial intelligence software tool referred to as Image and Visualization Enhancements (IVE) to the previously cleared, predicate NvisionVLE Imaging System (K153479). The IVE software module allows enhanced visualization (segmentation and colorized display) of the following commonly observed image features (also referred to as IVE features): (1) hyper-reflective surface, (2) layering and (3) hypo-reflective structures. The segmentation algorithm was developed using an artificial intelligence machine learning technique known as deep learning. Here, an artificial neural network was trained with manually labelled examples of each feature and then locked for realtime inference on new image data acquired by the device. Display of each feature can be toggled via the user interface, where a respective color overlay is presented. The default display of the IVE features is disabled and the standard VLE image data displayed per the cleared NvisionVLE Imaging System. Segmentation of these structures are based on existing image features, and IVE simply increases the conspicuity via the color overlays, thus aiding image review. It is a convenience tool and a resource for the clinician and as such, it does not alter the standard of care or the role of the physician in reviewing and assessing images generated by the system.
The provided text describes the acceptance criteria and a study proving the device meets those criteria. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that "The target true positive and true negative detection fractions were prospectively set." However, the specific target values for these fractions are not explicitly listed in numerical form in the provided text. Instead, it states that the observed results *exceeded their target value with a significance level a
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.