SYMBIS Surgical System

K143420 · Imris, Inc. · HAW · Oct 30, 2015 · Neurology

Device Facts

• Record ID: K143420
• Device Name: SYMBIS Surgical System
• Applicant: Imris, Inc.
• Product Code: HAW · Neurology
• Decision Date: Oct 30, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended 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.

Device Story

SYMBIS Surgical System is a computer-controlled electromechanical arm for spatial positioning/orientation of biopsy instrument guides in the OR. System components: Surgeon Console, Surgical Cart, Manipulator (6-DOF master/slave robot), Robot Control Cabinet (RCC), Vision System, and Platform Room Integration Kit. Surgeon, seated at console, uses hand controller and foot pedal to manipulate the arm; tremor filtering and motion scaling provided. Vision System provides 3D view of patient/site/manipulator; integrated with third-party Medtronic StealthStation navigation for trajectory planning. System uses fiducial markers/optical registration to align with pre-operative CT/MRI plans. Output: mechanical guidance for biopsy needle insertion. Benefits: precise, image-guided trajectory positioning for neurosurgical biopsies.

Clinical Evidence

No clinical data provided. Bench testing only: design verification of console/cart/manipulator, software verification (IEC 62304), electrical safety (IEC 60601-1), EMC/EMI (IEC 60601-1-2), biocompatibility (ISO 10993), and sterilization validation (ISO 11137). Human factors summative validation study conducted with 15 neurosurgeons in simulated surgical procedures to confirm safety and effectiveness.

Technological Characteristics

6-DOF electromechanical arm; absolute encoders for localization; rigid linkage to patient head holder. Connectivity: networked with Medtronic StealthStation. Software: control software for robot movement. Biocompatibility: ISO 10993. Sterilization: Radiation (ISO 11137). Electrical safety: IEC 60601-1. EMC: IEC 60601-1-2. Usability: IEC 62366.

Indications for Use

Indicated for neurosurgeons and trained physicians performing needle-based biopsies in neurosurgical conditions where stereotactic surgery is appropriate.

Regulatory Classification

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.

Predicate Devices

• ROSA Surgical device (K101791)

Reference Devices

• Medtronic StealthStation (K133444)
• Medtronic Biopsy instrument Kit (K971247)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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) | |
|---------------------------------------------------------------------------------|-----------------------------------------------------------|
| <div style="display:inline-block;">☒</div> Research and/or Educational Use Only | <div style="display:inline-block;">☐</div> 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: | [e-mail] |
| Alternate Contact<br>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: | [e-mail] |
| 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 SAS<br>1006 Rue De La Croix Verte<br>Parc Euromedecine (Bat8)<br>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) | Decision<br>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<br>Characteristic | MEDTECH<br>ROSA Surgical Device<br>(K101791) | IMRIS<br>SYMBIS Surgical System<br>(submission subject) | Comparison | | | |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------|-----------|
| Indications for<br>Use | ROSA Surgical Device is a<br>computer-controlled<br>electromechanical arm. It is<br>intended to be used in the<br>operating room for the<br>spatial positioning and<br>orientation of an tool guide.<br>Guidance is based on a pre-<br>operative plan developed<br>with three-dimensional<br>imaging software, and uses<br>fiducial markers or optical<br>registration. The system is<br>intended for use by<br>neurosurgeons to guide<br>standard neurosurgical<br>instruments.<br>It is indicated for any<br>neurosurgical condition in<br>which the use of stereotactic<br>surgery may be appropriate. | The SYMBIS Surgical System is a<br>computer-controlled<br>electromechanical arm. The<br>manipulation of the arm is<br>performed by the<br>neurosurgeon. It is intended to<br>be used in the operating room<br>for the spatial positioning and<br>orientation of a biopsy<br>instrument guide.<br>Guidance is based on a pre-<br>operative plan developed using<br>the Medtronic StealthStation®<br>along with fiducial marker or<br>optical registration. The system<br>is intended for use by<br>neurosurgeons to guide a<br>biopsy needle.<br>It is intended for use by trained<br>physicians for needle based<br>biopsy. | Identical meaning<br>(Different Trade<br>name/component name,<br>we would like to have more<br>focus on training so we<br>have added word for use by<br>trained physicians) | | | |
| Where Used | Hospital | Hospital | Identical | | | |
| Users | Surgeon | Surgeon | Identical | | | |
| General<br>Device | Computer controlled<br>electromechanical multi-<br>jointed arm indicated for | Computer controlled<br>electromechanical multi-jointed<br>arm indicated for use as a | Identical | | | |
| System<br>Characteristic | MEDTECH<br>ROSA Surgical Device<br>(K101791) | IMRIS<br>SYMBIS Surgical System<br>(submission subject) | Comparison | | | |
| Description | use as a stereotactic<br>instrument | stereotactic instrument | | | | |
| Localization<br>means | Robot arm absolute<br>encoders | Robot arm absolute encoders | Identical | | | |
| Path Planning<br>and control<br>Software | ROSANNA from Medtech | Path planning using the<br>StealthStation®<br>from Medtronic, and control<br>using the SYMBIS control<br>software | Different<br>Justification<br>ROSA uses the path<br>planning capabilities<br>offered by the ROSANNA<br>navigation system.<br>SYMBIS uses the path<br>planning capabilities<br>offered by the Medtronic<br>StealthStation (K133444)<br>navigation system.<br>The control software for<br>the ROSA robot and for the<br>SYMBIS robot are similar in<br>that both respond to<br>movement commands, and<br>map the movement<br>commands to the<br>corresponding movement<br>of the joints of the arm. | | | |
| Image-guided | Surgeon positions ROSA to<br>desired biopsy trajectory<br>using path planning<br>software | Surgeon positions SYMBIS to<br>desired biopsy trajectory using<br>path planning software | Identical | | | |
| Registration<br>Method | Fiducial Markers<br>Optical Registration device | Fiducial Markers<br>Optical Registration device | Identical | | | |
| Instrumentati<br>on | Navigation probe, Tool<br>holder Laser Pointer | Navigation probe, Tool holder | Different<br>Justification: | | | |
| System<br>Characteristic | MEDTECH<br>ROSA Surgical Device<br>(K101791) | IMRIS<br>SYMBIS Surgical System<br>(submission subject) | Comparison | | | |
| | | | SYMBIS uses the<br>registration method<br>provided by the Medtronic<br>StealthStation (K133444),<br>which does not require a<br>laser pointer. | | | |
| | | | Instrument<br>fixation | Instruments are mounted<br>onto robot arm's end<br>effector | Instruments are mounted onto<br>robot arm's end effector | Identical |
| | | | Instrument<br>calibration<br>method | Calibrated at the factory | Calibrated at the factory | Identical |
| | System<br>immobilization between<br>the patient<br>and the device | Coupled to patient HFD via<br>rigid, adjustable linkage | Coupled to patient HFD via<br>rigid, adjustable linkage | Identical | | |
| | Patient<br>Immobilization (head<br>holder) | HFD Employed for Head<br>Fixation | HFD Employed for Head<br>Fixation | Identical | | |
| | CT & MRI<br>modalities | CT and MRI modalities used<br>for pre-operative planning<br>and navigation through the<br>path planning software | CT and MRI modalities used for<br>pre-operative planning and<br>navigation through the path<br>planning software | Identical | | |
| | | Merge images | No support for Biopsy<br>procedures for merging of<br>multi-modal images in the<br>path planning software | No support for Biopsy<br>procedures for merging of<br>multi-modal images in the path<br>planning software | Identical | |
| | | Save/load<br>path planning | Path planning can be saved<br>and loaded using the path<br>planning software | Path planning can be saved and<br>loaded using the path planning<br>software | Identical | |

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| System | MEDTECH | IMRIS | Comparison |
|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | ROSA Surgical Device<br>(K101791) | SYMBIS Surgical System<br>(submission subject) | |
| Fiducial<br>markers<br>registration<br>and pointer<br>probe | Optical registration<br>accomplished with fiducial<br>markers and registration<br>probe using the path<br>planning software | Optical registration<br>accomplished with fiducial<br>markers and registration probe<br>using the path planning<br>software | Identical |
| Optical<br>registration<br>with<br>laser<br>telemeter | Optical registration via laser<br>telemeter supported on<br>ROSA system | Not Supported | Different<br>Justification:<br>SYMBIS uses the<br>registration method<br>provided by the Medtronic<br>StealthStation (K133444),<br>which does not require a<br>laser pointer. |
| Registration<br>based<br>on ultrasound<br>measures | Ultrasound based<br>registration with patient is<br>not supported with the path<br>planning software | Ultrasound based registration<br>with patient is not supported<br>with the path planning software | Identical |
| Cooperative<br>movement | Cooperative movement<br>supported by manually<br>guiding the instrument to<br>the entry point | Cooperative movement<br>supported through<br>teleoperation at the surgeon<br>console. Surgeon uses the hand<br>controller to manually guide the<br>instrument to the entry point | Different<br>Justification:<br>In both cases the user<br>manually guides the<br>position of the instrument. |
| 3D<br>Stereoscopic<br>Camera for<br>Situational<br>Awareness | Not Supported | 3D Stereoscopic camera for<br>situational awareness<br>supported by SYMBIS | Different<br>Justification:<br>A 3D Camera is used to<br>visualize the Manipulator<br>and patient surgical site, to<br>aid the surgeon in<br>positioning instruments<br>near the patient head |
| Support for<br>drilling<br>through robot- | Drilling through the robot-<br>held instrument guide is<br>supported with the ROSA | Not supported | Different<br>Justification: |

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| System | MEDTECH | IMRIS | Comparison |
|-------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | ROSA Surgical Device<br>(K101791) | SYMBIS Surgical System<br>(submission subject) | |
| held<br>instrument<br>guide | system | | The SYMBIS system is used<br>after the burr hole is<br>created. Therefore support<br>of drilling through a robot-<br>held instrument guide is<br>not required. |
| Deadman<br>switch for<br>cooperative<br>movement | Deadman switch employed<br>for robotic arm movement | Deadman switch employed for<br>robotic arm movement | Identical |
| Accuracy<br>verification on<br>anatomical<br>landmarks | Accuracy verification<br>performed on anatomical<br>landmarks via a navigation<br>probe | Accuracy verification performed<br>on anatomical landmarks via a<br>navigation probe | Identical |
| Application<br>Accuracy | <2 mm | <2 mm | Identical |
| Display real-<br>time<br>instrument<br>position on<br>preoperative<br>images | Real-time instrument<br>position displayed on pre-<br>operative images in the path<br>planning software | Real-time instrument position<br>displayed on pre-operative<br>images in the path planning<br>software | Identical |
| Provide<br>mechanical<br>guidance<br>for surgical<br>instruments | Surgeon manually inserts<br>the biopsy needle through<br>the instrument guide | Surgeon manually inserts the<br>biopsy needle through the<br>instrument guide | Identical |
| Surgeon<br>carries out<br>final gesture<br>through the<br>instrument<br>guide | Surgeon manually advances<br>biopsy needle through<br>instrument guide | Surgeon manually advances<br>biopsy needle through<br>instrument guide | Identical |

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| System<br>Characteristic | MEDTECH<br>ROSA Surgical Device<br>(K101791) | IMRIS<br>SYMBIS Surgical System<br>(submission subject) | Comparison |
|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Associated<br>equipment | Sterile drapes, Fiducial<br>markers<br>and Neurosurgical head<br>holder. | Sterile drapes, Fiducial markers<br>Neurosurgical head holder,<br>Stealth Station | Different<br>Justification for the Stealth<br>Station:<br>SYMBIS uses the Medtronic<br>StealthStation (K133444)<br>for biopsy navigation. |
| Electrical,<br>Mechanical,<br>Thermal<br>Safety | Industry recognized<br>standards (IEC series of the<br>standards) | Industry recognized standards<br>(IEC series of the standards) | Identical |
| EMC/EMI<br>compatibility | Industry recognized<br>standards (IEC series of the<br>standards) | Industry recognized standards<br>(IEC series of the standards) | Identical |
| Human<br>Factors | Unknown | Industry recognized standards<br>(IEC 62366:2007) | Different<br>Justification:<br>The Human Factors study<br>conducted for the SYMBIS<br>robot concluded that there<br>are no significant Human<br>Factors risks with the use of<br>the SYMBIS robot. |
| Cleaning,<br>Disinfection,<br>and<br>Sterilization<br>applicability | Manipulator arm draped<br>before use with sterile<br>drape, which is disposed<br>after use.<br>Biopsy instrument guide is<br>reprocessed (sterilized)<br>before use | Manipulator arm draped before<br>use with sterile drape, which is<br>disposed after use.<br>Biopsy instrument guide is<br>sterile and disposed after use | Different<br>Justification:<br>The SYMBIS instrument<br>guide is single use<br>(disposable) to reduce the<br>risk on contamination<br>and/or functional<br>degradation from<br>reprocessing. |
| Biocompatibili<br>ty | Industry recognized<br>standards (IEC series of the<br>standards) | Industry recognized standards<br>(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-<br>1:2005/C1:2009/A2:2010 | Medical electrical equipment – Part 1: General requirements<br>for basic safety and essential performance (IEC 60601-<br>1:2005, MOD). |
| 19-1 | IEC 60601-1-2:2007 | Medical Electrical Equipment – Part 1-2: General<br>Requirements for Basic Safety and Essential Performance –<br>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:<br>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:<br>Establishing the sterilization dose |
| 14-355 | ISO 11607-1:2006 | Packaging for terminally sterilized medical devices – Part 1:<br>Requirements for materials, sterile barrier systems, and packaging systems |
| 14-356 | ISO 11607-2:2006 | Packaging for terminally sterilized medical devices - Part 2:<br>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.