(336 days)
No
The description focuses on the electromechanical aspects of the robotic arm, computer control for positioning, tremor filtering, and motion scaling. There is no mention of AI or ML algorithms being used for tasks like image analysis, decision support, or autonomous control beyond the surgeon's direct input. The pre-operative planning is based on existing navigation systems and fiducial markers, not AI/ML-driven analysis.
No
Explanation: This device is intended to assist the neurosurgeon in the spatial positioning and orientation of a biopsy instrument guide, rather than providing direct therapy. It is a surgical assistance system for diagnostic procedures.
No
Explanation: The device is described as a surgical system used for the spatial positioning and orientation of a biopsy instrument guide, which is a tool for performing a biopsy, not for diagnosing a condition. It assists in the guidance of a needle based biopsy rather than interpreting or analyzing medical data to diagnose a disease.
No
The device description explicitly details multiple hardware components including a computer-controlled electromechanical arm (Manipulator), Surgical Cart, Surgeon Console, Robot Control Cabinet (RCC), and Vision System, in addition to the system software.
Based on the provided information, the SYMBIS Surgical System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is performed outside of the living body (in vitro).
- SYMBIS Function: The SYMBIS Surgical System is a robotic arm intended for the spatial positioning and orientation of a biopsy instrument guide during a surgical procedure. It assists the surgeon in guiding a needle into the patient's body for a biopsy.
- Lack of Specimen Analysis: The SYMBIS system itself does not perform any analysis or testing of a biological specimen. Its role is purely in the physical guidance of an instrument during a surgical procedure.
The device is a surgical robotic system used for navigation and guidance during a biopsy procedure, which is an in vivo (within the living body) procedure.
N/A
Intended Use / Indications for Use
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.
Product codes
HAW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT and MRI modalities used for pre-operative planning and navigation
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physicians, neurosurgeons, Hospital, operating room
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Bench Testing:
- Design verification testing of the Surgeon Console, Surgical Cart, and Manipulator.
- Software verification for Manipulator control software, Surgical Cart software and Robot Control software.
- Testing was carried out to assure compliance with recognized electrical safety standards IEC 60601-1 and EMC/EMI standard IEC 60601-1-2 by an independent National Recognized Test Laboratory (NRTL).
- The biocompatibility of the Biopsy Instrument Guide manufactured by IMRIS has been verified by an independent lab. Successful completion of this test demonstrates that the Biopsy Instrument Guide meets biocompatibility requirements as per ISO 10993 series standards.
- The sterilization of the SYMBIS Biopsy Instrument Guide has been validated using AAMI/ISO11137-1:2006 and AAMI/ISO11137-2:2012 standards.
- Software testing was carried out to assure compliance with recognized standards IEC 60601-1-6 and IEC 62304:2006 standard.
- Human Factors Evaluation: A summative validation study was conducted with fifteen neurosurgeons. This study was conducted in a simulated surgical procedure that involved safety critical tasks. Training materials and user manuals were developed in concert with the product hardware and were assessed in the validation study. The goals of human factors validation testing were to validate risk mitigations to ensure use-safety and effectiveness of the system, identify and assess any hazards resulting from implemented mitigations and evaluate ease of use.
Clinical Validation: No clinical testing was provided with this submission using the SYMBIS Surgical System.
Key results: Performance test data demonstrates that the SYMBIS Surgical System is comparable to the predicate device and that the design output meets the design input requirements. The testing included dimensional measurements, mechanical and functional verification, electrical safety, software verification validation, human factor study and system level validation.
Key Metrics
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 30, 2015
IMRIS Inc. Mr. Sanjay Shah Manager, Regulatory Affairs 5101 Shady Oak Road Minnetonka, Minnesota 55343
Re: K143420
Trade/Device Name: SYMBIS Surgical System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: October 15, 2015 Received: October 26, 2015
Dear Mr. Sanjay Shah:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K143420
Device Name SYMBIS Surgical System
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Research and/or Educational Use Only | ☐ Commercial Use |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part §807.92.
I. SUBMITTER:
II.
| Submitter | IMRIS |
|---|---|
| 5101 Shady Oak Rd | |
| Minnetonka, MN 55343 | |
| USA | |
| Establishment Registration Number: 3010326005 | |
| Contact Person: | Sanjay Shah, P.Eng. |
| Senior Manager, Regulatory Affairs, QA | |
| Telephone: | 763.203.6380 |
| Fax: | 1 866 992 3224 |
| Email: | sshah@imris.com |
| Alternate Contact | |
| Person: | Daniel Biank, JD, MEng, PE, RAC |
| Sr. Vice President, CS, QA, RA and IT | |
| Telephone: | 763.203.6310 |
| Fax: | 1 866 992 3224 |
| Email: | dbiank@imris.com |
| Date Prepared: | October 29, 2015 |
| DEVICE | |
| Name of the Device: | SYMBIS Surgical System |
| Common Name: | Neurological Stereotaxic Instrument |
| Classification Name: | Stereotaxic Instrument (21 CFR 882.4560) |
| Regulatory Class: | II |
| Product Code: | HAW |
4
III. PREDICATE DEVICE:
| 510(k) | Decision Date | Device Name | Manufacturer |
|---|---|---|---|
| K101791 | Sep 23, 2010 | ROSA Surgical device | MEDTECH SAS |
| 1006 Rue De La Croix Verte | |||
| Parc Euromedecine (Bat8) | |||
| Montpellier, FR 34090. |
IV. DEVICE DESCRIPTION:
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.
5
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.
V. INDICATIONS FOR USE:
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 operating room for 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.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:
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. It is intended for use by trained physicians for needle based biopsy.
The SYMBIS Surgical System uses the Medtronic StealthStation® System, cleared under 510(k) K133444, as the third-party navigation system and the Medtronic Biopsy instrument Kit cleared under K971247 as the third-party instrument. IMRIS is not making any changes to the Medtronic StealthStation® System or the Medtronic Biopsy instrument Kit. The Medtronic Stealth Station (K133444) and Medtronic Biopsy Needle Kit (K971247) are not marketed with the subject device.
The StealthStation® System includes hardware and software that enables real-time surgical navigation using radiological patient images. The navigation system creates a translation map between points of patient anatomy and the corresponding points on radiologic images of the patient. Once this map is established through a process called registration, the software can display the relative position of a tracked instrument to a representation of the patient's anatomy. In this way the images can help guide the surgeon's planning and approach. Prior to operating, the surgeon may create, store, and simulate progression along one or more surgical trajectories. As an aid to visualization, the surgeon may also create and manipulate one or more 2D or 3D models of the anatomy. During surgery, the system tracks the position of specialized surgical instruments in or on the patient anatomy and continuously updates the instrument position on images either by optical tracking or electromagnetic tracking.
The IMRIS SYMBIS Surgical System is comparable to the ROSA Surgical device manufactured by Medtech SAS and cleared under K101791.
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| 510(k) | Decision
Date | Device Name | Manufacturer |
|---------|------------------|----------------------|--------------|
| K101791 | Sep 23, 2010 | ROSA Surgical Device | MEDTECH SAS |
Summary of the technological characteristics of the device compared to the predicate device:
| System
Characteristic | MEDTECH
ROSA Surgical Device
(K101791) | IMRIS
SYMBIS Surgical System
(submission subject) | Comparison | | | |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------|-----------|
| Indications for
Use | ROSA Surgical Device is a
computer-controlled
electromechanical arm. It is
intended to be used in the
operating room for the
spatial positioning and
orientation of an tool guide.
Guidance is based on a pre-
operative plan developed
with three-dimensional
imaging software, and uses
fiducial markers or optical
registration. The system is
intended for use by
neurosurgeons to guide
standard neurosurgical
instruments.
It is indicated for any
neurosurgical condition in
which the use of stereotactic
surgery may be appropriate. | The SYMBIS Surgical System is a
computer-controlled
electromechanical arm. The
manipulation of the arm is
performed by the
neurosurgeon. It is intended to
be used in the operating room
for 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. | Identical meaning
(Different Trade
name/component name,
we would like to have more
focus on training so we
have added word for use by
trained physicians) | | | |
| Where Used | Hospital | Hospital | Identical | | | |
| Users | Surgeon | Surgeon | Identical | | | |
| General
Device | Computer controlled
electromechanical multi-
jointed arm indicated for | Computer controlled
electromechanical multi-jointed
arm indicated for use as a | Identical | | | |
| System
Characteristic | MEDTECH
ROSA Surgical Device
(K101791) | IMRIS
SYMBIS Surgical System
(submission subject) | Comparison | | | |
| Description | use as a stereotactic
instrument | stereotactic instrument | | | | |
| Localization
means | Robot arm absolute
encoders | Robot arm absolute encoders | Identical | | | |
| Path Planning
and control
Software | ROSANNA from Medtech | Path planning using the
StealthStation®
from Medtronic, and control
using the SYMBIS control
software | Different
Justification
ROSA uses the path
planning capabilities
offered by the ROSANNA
navigation system.
SYMBIS uses the path
planning capabilities
offered by the Medtronic
StealthStation (K133444)
navigation system.
The control software for
the ROSA robot and for the
SYMBIS robot are similar in
that both respond to
movement commands, and
map the movement
commands to the
corresponding movement
of the joints of the arm. | | | |
| 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 | | | |
| Instrumentati
on | Navigation probe, Tool
holder Laser Pointer | Navigation probe, Tool holder | Different
Justification: | | | |
| System
Characteristic | MEDTECH
ROSA Surgical Device
(K101791) | IMRIS
SYMBIS Surgical System
(submission subject) | Comparison | | | |
| | | | SYMBIS uses the
registration method
provided by the Medtronic
StealthStation (K133444),
which does not require a
laser pointer. | | | |
| | | | Instrument
fixation | Instruments are mounted
onto robot arm's end
effector | Instruments are mounted onto
robot arm's end effector | Identical |
| | | | Instrument
calibration
method | Calibrated at the factory | Calibrated at the factory | Identical |
| | System
immobilization between
the patient
and the device | Coupled to patient HFD via
rigid, adjustable linkage | Coupled to patient HFD via
rigid, adjustable linkage | Identical | | |
| | Patient
Immobilization (head
holder) | HFD Employed for Head
Fixation | HFD Employed for Head
Fixation | Identical | | |
| | CT & MRI
modalities | CT and MRI modalities used
for pre-operative planning
and navigation through the
path planning software | CT and MRI modalities used for
pre-operative planning and
navigation through the path
planning software | 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 | |
7
8
9
| System | MEDTECH | IMRIS | Comparison |
|---|---|---|---|
| Characteristic | ROSA Surgical Device | ||
| (K101791) | SYMBIS Surgical System | ||
| (submission subject) | |||
| 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 | ||
| Optical | |||
| registration | |||
| with | |||
| laser | |||
| telemeter | Optical registration via laser | ||
| telemeter supported on | |||
| ROSA system | Not Supported | Different | |
| Justification: | |||
| SYMBIS uses the | |||
| registration method | |||
| provided by the Medtronic | |||
| StealthStation (K133444), | |||
| which does not require a | |||
| laser pointer. | |||
| 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 | ||
| Cooperative | |||
| movement | Cooperative movement | ||
| supported by manually | |||
| guiding the instrument to | |||
| the entry point | Cooperative movement | ||
| supported through | |||
| teleoperation at the surgeon | |||
| console. Surgeon uses the hand | |||
| controller to manually guide the | |||
| instrument to the entry point | Different | ||
| Justification: | |||
| In both cases the user | |||
| manually guides the | |||
| position of the instrument. | |||
| 3D | |||
| Stereoscopic | |||
| Camera for | |||
| Situational | |||
| Awareness | Not Supported | 3D Stereoscopic camera for | |
| situational awareness | |||
| supported by SYMBIS | Different | ||
| Justification: | |||
| A 3D Camera is used to | |||
| visualize the Manipulator | |||
| and patient surgical site, to | |||
| aid the surgeon in | |||
| positioning instruments | |||
| near the patient head | |||
| Support for | |||
| drilling | |||
| through robot- | Drilling through the robot- | ||
| held instrument guide is | |||
| supported with the ROSA | Not supported | Different | |
| Justification: |
10
| System | MEDTECH | IMRIS | Comparison |
|---|---|---|---|
| Characteristic | ROSA Surgical Device | ||
| (K101791) | SYMBIS Surgical System | ||
| (submission subject) | |||
| held | |||
| instrument | |||
| guide | system | The SYMBIS system is used | |
| after the burr hole is | |||
| created. Therefore support | |||
| of drilling through a robot- | |||
| held instrument guide is | |||
| not required. | |||
| 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 |