(111 days)
The 7D Surgical System is a stereotaxic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments used by surgeons. The system is also intended to be used as the primary surgical luminaire during image guided surgery. The device is indicated for cranial surgery where reference to a rigid anatomical structure can be identified.
The 7D Surgical System Cranial Application is intended for use as a stereotaxic image guided surgical navigation system during cranial surgical procedures. The Cranial Application software assists in guiding surgeons during cranial surgical procedures such as biopsies, tumor resections, and shunt and lead placements. The Cranial Application software works in conjunction with 7D Surgical Machine Vision Guidance System which consists of clinical software, optically tracked surgical Pointer, a reference frame instrument and platform/computer hardware which is substantially equivalent to K162375. Image guidance, or Machine Vision, tracks the position of instruments in relation to the surgical anatomy and identifies this position on DICOM scan images or intraoperative structured light images of the patient. The Cranial software functionality is described in terms of its feature sets which are categorized as imaging modalities, registration, planning, and views. Feature sets include functionality that contributes to clinical decision making and are necessary to achieve system performance.
The 7D Surgical System Cranial Application is comprised of 5 major components:
- Cart
- Arm
- Head
- Tracked surgical 7D Surgical System Cranial Instruments
- Software
The provided document, a 510(k) summary for the 7D Surgical System Cranial Application, outlines the device's acceptance criteria and the studies conducted to demonstrate its safety and effectiveness for FDA clearance.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally framed around demonstrating substantial equivalence to predicate devices and meeting established safety and performance standards for image-guided surgical systems. The document doesn't provide specific quantitative "acceptance criteria values" in the format of a typical performance table (e.g., "accuracy must be
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).