(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 | <2 mm | <2 mm | Identical |
| Display real-time instrument position on preoperative images | Real-time instrument position displayed on pre-operative images in the path planning software. | Real-time instrument position displayed on pre-operative images in the path planning software. | Identical |
| Provide mechanical guidance for surgical instruments | Surgeon manually inserts the biopsy needle through the instrument guide. | Surgeon manually inserts the biopsy needle through the instrument guide. | Identical |
| Surgeon carries out final gesture through the instrument guide | Surgeon manually advances biopsy needle through instrument guide. | Surgeon manually advances biopsy needle through instrument guide. | Identical |
| Electrical, Mechanical, Thermal Safety | Industry recognized standards (IEC series). | Industry recognized standards (IEC series). | Identical |
| EMC/EMI compatibility | Industry recognized standards (IEC series). | Industry recognized standards (IEC series). | Identical |
| Biocompatibility | Industry recognized standards (IEC series). | Industry recognized standards (ISO series). | Identical (just different standard designation) |
| Human Factors | Unknown | Industry recognized standards (IEC 62366:2007) and human factors study. | Different (SYMBIS performed HF study concluding no significant risks). |
| Cleaning, Disinfection, and Sterilization applicability | Manipulator arm draped (sterile drape) and disposed. Biopsy instrument guide reprocessed (sterilized). | Manipulator arm draped (sterile drape) and disposed. Biopsy instrument guide sterile and disposed after use. | Different (SYMBIS uses single-use/disposable guide to reduce contamination/degradation). |
| Path Planning and Control Software | ROSANNA from Medtech | Medtronic StealthStation® (K133444) for path planning; SYMBIS control software for control. | Different (different third-party navigation systems, but similar control software functionality). |
| Instrumentation | Navigation probe, Tool holder, Laser Pointer | Navigation probe, Tool holder | Different (SYMBIS uses StealthStation's registration method which doesn't require a laser pointer). |
| Optical registration with laser telemeter | Supported on ROSA system | Not Supported | Different (SYMBIS uses StealthStation's registration method). |
| 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 hand controller to manually guide the instrument. | Different (ROSA implies direct manual guidance, SYMBIS specifies teleoperation via console/controller, but both involve user-guided manual positioning). |
| 3D Stereoscopic Camera for Situational Awareness | Not Supported | Supported by SYMBIS | Different (SYMBIS has this feature). |
| Support for drilling through robot-held instrument guide | Supported with ROSA system | Not supported | Different (SYMBIS used after burr hole is created, so not required). |
| Associated equipment | Sterile drapes, Fiducial markers, Neurosurgical head holder. | Sterile drapes, Fiducial markers, Neurosurgical head holder, Stealth Station. | Different (SYMBIS integrates with Medtronic StealthStation). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes bench testing for design verification and validation, as well as a summative human factors validation study.
- Design Verification and Validation (Bench Testing): No specific "test set" sample size in terms of patient data is mentioned for these tests. The testing focuses on compliance with standards (e.g., electrical safety, software, biocompatibility, sterilization) and functional performance of the device components. This is not patient data; it's device performance testing.
- Human Factors Evaluation: Fifteen neurosurgeons participated in this study.
- Data Provenance: The document does not specify the country of origin for any data beyond listing the submitter (IMRIS Inc.) as being from Minnetonka, MN, USA. There is no mention of retrospective or prospective data in the context of patient studies. The studies described are bench tests and a simulated human factors study, not clinical trials with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- For the Human Factors Evaluation, 15 neurosurgeons participated. Their qualifications are stated as "neurosurgeons," but no further details (e.g., years of experience) are provided. Their role was to participate in a simulated surgical procedure to assess use-safety, effectiveness, and ease of use, not to establish ground truth for a test set in the traditional sense of medical image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- No adjudication method is mentioned. The human factors study involved neurosurgeons operating the system, and their feedback/performance was assessed, not a consensus interpretation of medical data.
- For the bench testing, conformity to engineering specifications and standards served as the "ground truth," not expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC comparative effectiveness study was done or mentioned in the document. The device is a computer-controlled electromechanical arm for surgical guidance, not an AI-assisted diagnostic or interpretive tool that would involve "human readers" in the typical sense of MRMC studies. It's a robotic assistance system, not an AI interpretation system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This question is not directly applicable to the SYMBIS Surgical System as described. The system is explicitly designed for "human-in-the-loop" performance, where the "arm is performed by the neurosurgeon" and "the surgeon controls all movements of the Manipulator." There is no mention of a standalone algorithm-only mode or performance evaluation.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For design verification and validation, the ground truth was established by adherence to product specifications and recognized industry standards (e.g., IEC, ISO, AAMI). For example, a specified application accuracy of "<2 mm" is a measurable metric against which the device's performance is compared.
- For the human factors evaluation, the "ground truth" was the assessment of "use-safety and effectiveness of the system, identify and assess any hazards resulting from implemented mitigations and evaluate ease of use" by the participating neurosurgeons in a simulated environment. This is less about a single patient-specific ground truth (like a pathology report) and more about overall system usability and safety performance.
8. The sample size for the training set
- No training set is mentioned as this device is not a machine learning or AI-based diagnostic tool that typically requires a training set of data. It is a robotic surgical assistance device whose control software's "training" would be part of its engineering design and development, rather than data-driven machine learning.
9. How the ground truth for the training set was established
- Not applicable, as no training set (in the context of machine learning) is referenced for this device.
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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.
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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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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 ContactPerson: | 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 |
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III. PREDICATE DEVICE:
| 510(k) | Decision Date | Device Name | Manufacturer |
|---|---|---|---|
| K101791 | Sep 23, 2010 | ROSA Surgical device | MEDTECH SAS1006 Rue De La Croix VerteParc 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.
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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) | DecisionDate | 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:
| SystemCharacteristic | MEDTECHROSA Surgical Device(K101791) | IMRISSYMBIS Surgical System(submission subject) | Comparison | |||
|---|---|---|---|---|---|---|
| Indications forUse | ROSA Surgical Device is acomputer-controlledelectromechanical arm. It isintended to be used in theoperating room for thespatial positioning andorientation of an tool guide.Guidance is based on a pre-operative plan developedwith three-dimensionalimaging software, and usesfiducial markers or opticalregistration. The system isintended for use byneurosurgeons to guidestandard neurosurgicalinstruments.It is indicated for anyneurosurgical condition inwhich the use of stereotacticsurgery may be appropriate. | The SYMBIS Surgical System is acomputer-controlledelectromechanical arm. Themanipulation of the arm isperformed by theneurosurgeon. It is intended tobe used in the operating roomfor the spatial positioning andorientation of a biopsyinstrument guide.Guidance is based on a pre-operative plan developed usingthe Medtronic StealthStation®along with fiducial marker oroptical registration. The systemis intended for use byneurosurgeons to guide abiopsy needle.It is intended for use by trainedphysicians for needle basedbiopsy. | Identical meaning(Different Tradename/component name,we would like to have morefocus on training so wehave added word for use bytrained physicians) | |||
| Where Used | Hospital | Hospital | Identical | |||
| Users | Surgeon | Surgeon | Identical | |||
| GeneralDevice | Computer controlledelectromechanical multi-jointed arm indicated for | Computer controlledelectromechanical multi-jointedarm indicated for use as a | Identical | |||
| SystemCharacteristic | MEDTECHROSA Surgical Device(K101791) | IMRISSYMBIS Surgical System(submission subject) | Comparison | |||
| Description | use as a stereotacticinstrument | stereotactic instrument | ||||
| Localizationmeans | Robot arm absoluteencoders | Robot arm absolute encoders | Identical | |||
| Path Planningand controlSoftware | ROSANNA from Medtech | Path planning using theStealthStation®from Medtronic, and controlusing the SYMBIS controlsoftware | DifferentJustificationROSA uses the pathplanning capabilitiesoffered by the ROSANNAnavigation system.SYMBIS uses the pathplanning capabilitiesoffered by the MedtronicStealthStation (K133444)navigation system.The control software forthe ROSA robot and for theSYMBIS robot are similar inthat both respond tomovement commands, andmap the movementcommands to thecorresponding movementof the joints of the arm. | |||
| Image-guided | Surgeon positions ROSA todesired biopsy trajectoryusing path planningsoftware | Surgeon positions SYMBIS todesired biopsy trajectory usingpath planning software | Identical | |||
| RegistrationMethod | Fiducial MarkersOptical Registration device | Fiducial MarkersOptical Registration device | Identical | |||
| Instrumentation | Navigation probe, Toolholder Laser Pointer | Navigation probe, Tool holder | DifferentJustification: | |||
| SystemCharacteristic | MEDTECHROSA Surgical Device(K101791) | IMRISSYMBIS Surgical System(submission subject) | Comparison | |||
| SYMBIS uses theregistration methodprovided by the MedtronicStealthStation (K133444),which does not require alaser pointer. | ||||||
| Instrumentfixation | Instruments are mountedonto robot arm's endeffector | Instruments are mounted ontorobot arm's end effector | Identical | |||
| Instrumentcalibrationmethod | Calibrated at the factory | Calibrated at the factory | Identical | |||
| Systemimmobilization betweenthe patientand the device | Coupled to patient HFD viarigid, adjustable linkage | Coupled to patient HFD viarigid, adjustable linkage | Identical | |||
| PatientImmobilization (headholder) | HFD Employed for HeadFixation | HFD Employed for HeadFixation | Identical | |||
| CT & MRImodalities | CT and MRI modalities usedfor pre-operative planningand navigation through thepath planning software | CT and MRI modalities used forpre-operative planning andnavigation through the pathplanning software | Identical | |||
| Merge images | No support for Biopsyprocedures for merging ofmulti-modal images in thepath planning software | No support for Biopsyprocedures for merging ofmulti-modal images in the pathplanning software | Identical | |||
| Save/loadpath planning | Path planning can be savedand loaded using the pathplanning software | Path planning can be saved andloaded using the path planningsoftware | Identical |
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| System | MEDTECH | IMRIS | Comparison |
|---|---|---|---|
| Characteristic | ROSA Surgical Device(K101791) | SYMBIS Surgical System(submission subject) | |
| Fiducialmarkersregistrationand pointerprobe | Optical registrationaccomplished with fiducialmarkers and registrationprobe using the pathplanning software | Optical registrationaccomplished with fiducialmarkers and registration probeusing the path planningsoftware | Identical |
| Opticalregistrationwithlasertelemeter | Optical registration via lasertelemeter supported onROSA system | Not Supported | DifferentJustification:SYMBIS uses theregistration methodprovided by the MedtronicStealthStation (K133444),which does not require alaser pointer. |
| Registrationbasedon ultrasoundmeasures | Ultrasound basedregistration with patient isnot supported with the pathplanning software | Ultrasound based registrationwith patient is not supportedwith the path planning software | Identical |
| Cooperativemovement | Cooperative movementsupported by manuallyguiding the instrument tothe entry point | Cooperative movementsupported throughteleoperation at the surgeonconsole. Surgeon uses the handcontroller to manually guide theinstrument to the entry point | DifferentJustification:In both cases the usermanually guides theposition of the instrument. |
| 3DStereoscopicCamera forSituationalAwareness | Not Supported | 3D Stereoscopic camera forsituational awarenesssupported by SYMBIS | DifferentJustification:A 3D Camera is used tovisualize the Manipulatorand patient surgical site, toaid the surgeon inpositioning instrumentsnear the patient head |
| Support fordrillingthrough robot- | Drilling through the robot-held instrument guide issupported with the ROSA | Not supported | DifferentJustification: |
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| System | MEDTECH | IMRIS | Comparison |
|---|---|---|---|
| Characteristic | ROSA Surgical Device(K101791) | SYMBIS Surgical System(submission subject) | |
| heldinstrumentguide | system | The SYMBIS system is usedafter the burr hole iscreated. Therefore supportof drilling through a robot-held instrument guide isnot required. | |
| Deadmanswitch forcooperativemovement | Deadman switch employedfor robotic arm movement | Deadman switch employed forrobotic arm movement | Identical |
| Accuracyverification onanatomicallandmarks | Accuracy verificationperformed on anatomicallandmarks via a navigationprobe | Accuracy verification performedon anatomical landmarks via anavigation probe | Identical |
| ApplicationAccuracy | <2 mm | <2 mm | Identical |
| Display real-timeinstrumentposition onpreoperativeimages | Real-time instrumentposition displayed on pre-operative images in the pathplanning software | Real-time instrument positiondisplayed on pre-operativeimages in the path planningsoftware | Identical |
| Providemechanicalguidancefor surgicalinstruments | Surgeon manually insertsthe biopsy needle throughthe instrument guide | Surgeon manually inserts thebiopsy needle through theinstrument guide | Identical |
| Surgeoncarries outfinal gesturethrough theinstrumentguide | Surgeon manually advancesbiopsy needle throughinstrument guide | Surgeon manually advancesbiopsy needle throughinstrument guide | Identical |
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| SystemCharacteristic | MEDTECHROSA Surgical Device(K101791) | IMRISSYMBIS Surgical System(submission subject) | Comparison |
|---|---|---|---|
| Associatedequipment | Sterile drapes, Fiducialmarkersand Neurosurgical headholder. | Sterile drapes, Fiducial markersNeurosurgical head holder,Stealth Station | DifferentJustification for the StealthStation:SYMBIS uses the MedtronicStealthStation (K133444)for biopsy navigation. |
| Electrical,Mechanical,ThermalSafety | Industry recognizedstandards (IEC series of thestandards) | Industry recognized standards(IEC series of the standards) | Identical |
| EMC/EMIcompatibility | Industry recognizedstandards (IEC series of thestandards) | Industry recognized standards(IEC series of the standards) | Identical |
| HumanFactors | Unknown | Industry recognized standards(IEC 62366:2007) | DifferentJustification:The Human Factors studyconducted for the SYMBISrobot concluded that thereare no significant HumanFactors risks with the use ofthe SYMBIS robot. |
| Cleaning,Disinfection,andSterilizationapplicability | Manipulator arm drapedbefore use with steriledrape, which is disposedafter use.Biopsy instrument guide isreprocessed (sterilized)before use | Manipulator arm draped beforeuse with sterile drape, which isdisposed after use.Biopsy instrument guide issterile and disposed after use | DifferentJustification:The SYMBIS instrumentguide is single use(disposable) to reduce therisk on contaminationand/or functionaldegradation fromreprocessing. |
| Biocompatibility | Industry recognizedstandards (IEC series of thestandards) | Industry recognized standards(ISO series of the standards) | Identical |
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VII. PERFORMANCE DATA
Design Verification and Validation Test (Bench Testing)
The IMRIS Surgical System passed the following tests and meets product specifications. The main tests include
- 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.
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.
Clinical Validation:
No clinical testing was provided with this submission using the SYMBIS Surgical System.
| Recognition # | Identifier | Title |
|---|---|---|
| 5-77 | AAMI / ANSI ES60601-1:2005/C1:2009/A2:2010 | Medical electrical equipment – Part 1: General requirementsfor basic safety and essential performance (IEC 60601-1:2005, MOD). |
| 19-1 | IEC 60601-1-2:2007 | Medical Electrical Equipment – Part 1-2: GeneralRequirements for Basic Safety and Essential Performance –Collateral Standard: Electromagnetic compatibility – |
Standards:
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| Recognition # | Identifier | Title |
|---|---|---|
| Requirements and Tests (Edition 3) | ||
| 13-8 | IEC 62304:2006 | Medical device software – Software life cycle processes |
| N/A | IEC 62366:2007 | Medical devices -- Application of usability engineering to medical devices |
| 14-407 | ANSI/AAMI/ISO 11137-1:2006/(R)2010 | Sterilization of health care products—Radiation—Part 1:Requirements for development, validation, and routine control of a sterilization process for medical devices |
| 14-297 | ANSI/AAMI/ISO 11137-2:2012 | Sterilization of health care products -- Radiation -- Part 2:Establishing the sterilization dose |
| 14-355 | ISO 11607-1:2006 | Packaging for terminally sterilized medical devices – Part 1:Requirements for materials, sterile barrier systems, and packaging systems |
| 14-356 | ISO 11607-2:2006 | Packaging for terminally sterilized medical devices - Part 2:Validation requirements for forming, sealing, and assembly processes |
| 14-229 | ASTM F1980(R)2011 | Standard Guide For Accelerated Aging Of Sterile Barrier Systems For Medical Devices |
| 14-288 | ASTM F1886/F1886M-09 | Standard Test Method For Determining Integrity Of Seals For Flexible Packaging By Visual Inspection |
| 14-283 | ASTM F88/F88M-09 | Standard Test Method For Seal Strength Of Flexible Barrier Materials |
| 14-378 | ASTM F1929-98[2004] | Standard Test Method For Detecting Seal Leaks In Porous Medical Packaging By Dye Penetration |
CONCLUSIONS VIII.
The non-clinical data support the safety of the device and the hardware verification and validation demonstrate that the SYMBIS Surgical System should perform as intended in the specified use conditions.
The non-clinical data demonstrate that the SYMBIS Surgical System performs comparably to the predicate device that is currently marketed for the same intended use.
§ 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).