(336 days)
The SYMBIS Surgical System is a computer-controlled electromechanical arm. The arm is performed by the neurosurgeon. It is intended to be used in the spatial positioning and orientation of a biopsy instrument guide.
Guidance is based on a pre-operative plan developed using the Medtronic StealthStation® along with fiducial marker or optical registration. The system is intended for use by neurosurgeons to guide a biopsy needle.
It is intended for use by trained physicians for needle based biopsy.
The SYMBIS Surgical System is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument guide. The system is intended for use by trained physicians for needle based biopsy.
The SYMBIS Surgical System consists of the a Surgeon Console, Surgical Cart, Manipulator, Robot Control Cabinet (RCC), Vision System, Platform Room Integration Kit and System Software.
The Manipulator is a master/slave robot configured with either a left arm or a right arm is mounted to the Surgical Cart. The Surgical Cart is used to transport the Manipulator to and from the operating room, as well as serve as a stationary platform for robotic surgery. The Surgical Cart has an onboard immobilization system to prevent horizontal movement when positioned for surgery. The Instrument Guide is attached to the draped Manipulator and is used by the surgeon to guide the trajectory of a stereotactic instrument (e.g. Biopsy Needle). The Manipulator has six (6) degrees of freedom (DOF). The SYMBIS System provides tremor filtering and motion scaling while the surgeon positions the Manipulator and Instrument Guide to the target position. A Vision System mounted to the Surgical Cart provides the surgeon with a high definition, three-dimensional view of the patient, surgical site, and Manipulator.
The Surgeon Console provides the surgeon with workstation console from which the surgeon controls the Manipulator. The Surgeon Console is located in the operating room. The surgeon, seated at the Surgeon Console, controls all movements of the Manipulator with a hand controller and foot pedal. The upper and middle displays on the Surgeon Console are medical grade, high definition monitors, and the middle monitor is capable of displaying 3 dimensional (3D) images The upper display provides the video output from a third-party navigation system (i.e. Medtronic Stealth station s7/i7). The middle display provides the 3D video output from the field camera, to provide situational awareness to the surgeon when moving the robot near the patient, surgical site, and OR staff. The video from the Vision System, along with the video from the third-party navigation system, is used by the surgeon to manipulate the Instrument Guide to the entry position.
The Robot Control Cabinet (RCC) is an electronics rack and contains to operate the Surgical Cart, Manipulator and Surgeon Console. It is situated in the hospital's equipment room, adjacent to the surgical suite. The RCC includes the supporting electronic, power supply, and computers for the system.
The platform room integration kit includes motor drivers to run the Manipulator, an OR Pendant with an E-Stop, cable interface mounting plates and system integration cables.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance for SYMBIS Surgical System
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion/Characteristic | Acceptance Criteria (Predicate Device K101791) | Reported Device Performance (SYMBIS Surgical System) | Comparison / Notes |
|---|---|---|---|
| Indications for Use | For spatial positioning and orientation of a tool guide in neurosurgery. Applicable to any neurosurgical condition in which stereotactic surgery is appropriate. | For spatial positioning and orientation of a biopsy instrument guide in neurosurgery. Intended for use by trained physicians for needle-based biopsy. | Identical meaning (with added emphasis on "trained physicians" and specific to "biopsy needle"). |
| Where Used | Hospital | Hospital | Identical |
| Users | Surgeon | Surgeon | Identical |
| General Device | Computer controlled electromechanical multi-jointed arm. | Computer controlled electromechanical multi-jointed arm. | Identical |
| Localization means | Robot arm absolute encoders | Robot arm absolute encoders | Identical |
| Image-guided | Surgeon positions ROSA to desired biopsy trajectory using path planning software. | Surgeon positions SYMBIS to desired biopsy trajectory using path planning software. | Identical |
| Registration Method | Fiducial Markers, Optical Registration device | Fiducial Markers, Optical Registration device | Identical |
| Instrument Fixation | Instruments are mounted onto robot arm's end effector. | Instruments are mounted onto robot arm's end effector. | Identical |
| Instrument Calibration | Calibrated at the factory | Calibrated at the factory | Identical |
| System Immobilization | Coupled to patient HFD via rigid, adjustable linkage. | Coupled to patient HFD via rigid, adjustable linkage. | Identical |
| Patient Immobilization | HFD Employed for Head Fixation | HFD Employed for Head Fixation | Identical |
| Modalities | CT & MRI modalities | CT and MRI modalities used for pre-operative planning and navigation. | Identical |
| Merge images | No support for Biopsy procedures for merging of multi-modal images in the path planning software. | No support for Biopsy procedures for merging of multi-modal images in the path planning software. | Identical |
| Save/load path planning | Path planning can be saved and loaded using the path planning software. | Path planning can be saved and loaded using the path planning software. | Identical |
| Fiducial markers registration and pointer probe | Optical registration accomplished with fiducial markers and registration probe using the path planning software. | Optical registration accomplished with fiducial markers and registration probe using the path planning software. | Identical |
| Registration based on ultrasound measures | Ultrasound based registration with patient is not supported with the path planning software. | Ultrasound based registration with patient is not supported with the path planning software. | Identical |
| Deadman switch for cooperative movement | Deadman switch employed for robotic arm movement. | Deadman switch employed for robotic arm movement. | Identical |
| Accuracy verification on anatomical landmarks | Accuracy verification performed on anatomical landmarks via a navigation probe. | Accuracy verification performed on anatomical landmarks via a navigation probe. | Identical |
| Application Accuracy | ** |
§ 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).