(233 days)
The nView s1 is intended as an imaging system to provide both 2D and 3D imaging of adult and pediations over 6 years of age. The device is intended to provide fluoroscopic and tomographic imaging of patients during orthopedic surgical procedures where the clinician benefits from 3D visualization of complex anatomical structures, such as high contrast objects, bones, joints, cervical, thoracic, and lumbar regions of the spine, and joint fractures of the upper and lower extremities.
The nView s1 is indicated to image human anatomy up to 30 cm thickness. The nView s1 is not indicated for mammographic or lung nodule applications.
The nView s1 with navigation option is intended as a navigation system to localize anatomical structures in spine fusion procedures for tasks such as identifying vertebrae, and identifying entry points in the thoracic and lumbar spine regions; and for the task of pilot hole verification for pedicle screw placement of 4.5 mm screws in the thoracic and lumbar spine regions. The navigation option is indicated for posterior approach open spinal procedures in pediations over 6 years of age in which the use of stereotactic surgery may be appropriate, and where reference to a rigid spinous process can be identified relative to nView s1 images of the anatomy.
The nView s1 with nav option mobile fluoroscopic system is a cone beam computed fluoroscopic and tomographic X-ray system consisting of two mobile C-arm and a monitor cart. The mobile C-arm is comprised of a fixed anode X-ray tube with a high voltage generator, X-ray controls, markers for image registration during navigation, and a mechanical "C" shaped structure which supports the X-ray chain, the image receptor flat panel detector, and navigation tracking camera is rigidly attached to the operating table and connects to the C-arm via a cable.
The monitor cart is a mobile platform containing a flat panel display and a GPU computer that connects to the mobile C-arm by ethernet cable.
Navigation instrumentation consists of a navigated surgical probe and a patient reference.
The device contains software. The nav option tracks single-use sterile navigation instrumentation. It does not contain biologics, drugs, coatings, or additives.
The nView s1 with nav option employs X-rays as its imaging technology for visualizing human anatomy in both 2D and 3D. The X-ray tube powered by a generator produces X-rays, which image the patient under control of the user, at the direction of a physician. The images from the system assist the physicians in visualizing the patient's anatomy during surgical procedures. The device poth real-time image capture and post capture visualization suitable for use immediately before, during, or after surgery. The optional navigation feature uses optical camera technology to display a surgeon's probe on the image in real time during the surgery.
The device performs both 2D and 3D medical imaging generated by means of an iterative algorithm. The system uses of a scan captured with relation to a predefined scan reference frame to compute the three-dimensional representation of the imaged object. The images are displayed on the screen of the monitor cart. It is possible to display projection views as well as tomographic views. The navigation option utilizes optical camera technology to track the C-arm, the instruments, and the patient.
The provided text describes the nView s1 with nav option, a mobile fluoroscopic C-Arm imaging system with navigation capabilities. The 510(k) summary focuses on demonstrating substantial equivalence to a previously cleared predicate device (nView s1 with nav option, K211064) and a reference device (Medtronic Navigation Inc - StealthStation™ S8 system, K162309).
Here's an analysis of the acceptance criteria and the study proving the device meets them, based solely on the provided text:
1. A table of acceptance criteria and the reported device performance
The document primarily focuses on demonstrating equivalence rather than explicitly listing acceptance criteria with detailed success/failure values for all performance characteristics. However, it does state specific performance criteria for Registration Accuracy and Clinical Accuracy.
| Acceptance Criteria (Stated Performance Goals) | Reported Device Performance (Subject Device) |
|---|---|
| Registration Accuracy | • 3D positional accuracy: |
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.