(42 days)
The VSn system is intended for viewing internal surgical sites during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures.
Visionsense Stereoscopic Vision System (VSu) consists of a proprietary CCD camera, embedded in the distal end of a rigid metal endoscope. An array of miniature lenses - the Lenticular Array (LA) - built onto the CCD surface during the wafer fabrication process, captures the image from slightly different angles, thus mimicking the natural human 'Stereo vision' obtained when the cycs simultaneously pick up two different images of the same object (right and left). The captured image is subsequently transmitted to a PC workstation, processed and presented on a stereoscopic display panel. Images are recorded and may be later downloaded for further analysis.
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) summary for the VISIONSENSE Stereoscopic Vision System (VSII), primarily focusing on demonstrating substantial equivalence to a predicate device for an expanded indication (neurosurgical procedures).
The key information available covers:
- Device Information: Trade name, common name, classification, review panel, product code, device class.
- Predicate Devices: K073279 (VSII General Surgery) and K964281 (Aesculap Angled Neuroendoscopes).
- Intended Use/Indications for Use: Viewing internal surgical sites during general surgical procedures and visualization of ventricles and structures within the brain during neurological surgical procedures.
- Technological Characteristics/Principles of Operation: Proprietary CCD camera, Lenticular Array for stereoscopic vision, PC workstation processing, stereoscopic display.
- Substantial Equivalence: Claimed based on technological similarity to the previously cleared general surgery VSII and to other neurosurgical endoscopic devices (Aesculap).
The document explicitly states: "No performance standards or special controls have been developed under Section 514 of the Federal Food, Drug, and Cosmetic Act ("FDC Act") for endoscopes. However, the VSII system and its components comply with international standards for electrical safety, electromagnetic compatibility, and biocompatibility."
This indicates that specific performance acceptance criteria for the expanded neurosurgical indication were not established or assessed in the traditional sense of a clinical performance study with predefined metrics. The submission relies on substantial equivalence to existing devices and compliance with general safety and electromagnetic standards rather than a study demonstrating meeting specific clinical performance acceptance criteria.
Therefore, I cannot populate the table or provide information for points 2 through 9 as requested, as these details are not present in the provided text.
§ 882.1480 Neurological endoscope.
(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).