ROSA SURGICAL DEVICE

K101791 · Medtech S.A.S · HAW · Sep 23, 2010 · Neurology

Device Facts

• Record ID: K101791
• Device Name: ROSA SURGICAL DEVICE
• Applicant: Medtech S.A.S
• Product Code: HAW · Neurology
• Decision Date: Sep 23, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended 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 instrument holder or 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.

Device Story

ROSA Surgical Device is a computer-controlled, multi-jointed electromechanical arm used in the operating room by neurosurgeons. It functions as a stereotactic instrument for spatial positioning and orientation of tool guides. Input data consists of pre-operative CT or MRI DICOM 3.0 images; the surgeon defines entry and target points using 3D planning software. Registration is achieved via fiducial markers or optical laser telemeter. The system features a 'cooperative mode' allowing the surgeon to manually move the arm to collect markers or digitize anatomical landmarks. The robot then automatically scans the patient's head surface. The device provides stable, reproducible mechanical guidance for standard neurosurgical instruments. By aligning the tool guide with the pre-operative plan, the device assists the surgeon in reaching target anatomical structures, potentially increasing accuracy and optimizing surgical access.

Clinical Evidence

Bench testing only. In vitro validation performed using a phantom skull with metallic balls and a portable CMM (FARO Titanium arm). Accuracy evaluated for both fiducial marker and optical registration methods across 45 measurements each. Results demonstrated mean target localization accuracy below 2 mm, consistent with predicate devices.

Technological Characteristics

Computer-controlled electromechanical multi-jointed arm. Features include absolute encoders for localization, fiducial marker/optical registration, and a laser telemeter. Connectivity supports DICOM 3.0 image input. Software follows IEC 62304 lifecycle processes. Electrical safety complies with IEC 60601-1 and electromagnetic compatibility with IEC 60601-1-2.

Indications for Use

Indicated for any neurosurgical condition where stereotactic surgery is appropriate, requiring spatial positioning and orientation of instruments (e.g., biopsy needles, electrodes, endoscopes) by neurosurgeons.

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 (K092239)
• StealthStation Treatment Guidance Platform (K001801)
• VectorVision Cranial / ENT (K023651)
• Frameless Neuromate Stereotactic System (K991081)

Submission Summary (Full Text)

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# PREMARKET NOTIFICATION 510(K) SUBMISSION

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ROSA SURGICAL DEVICE

5 - 510(K) SUMMARY

[As Required by 21 CFR 807.92] Summary of Safety and Effectiveness

| 1 | Submitter | MedTech S.A Parc Euromédecine Bâtiment 8 1006 rue de la Croix Verte 34090 Montpellier France | K101791 SEP 23 2010 |
|---|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| | Contact Person | Bertin NAHUM, President Phone number : ([phone] Fax number : ([phone] | |
| | Preparation date | June 10, 2010 | |
| | Revision date | July 20, 2010 | |
| | Revision date | August 18, 2010 | |
| | Revision date | September 02, 2010 | |
| 2 | Device name | | |
| | Trade Name | ROSA Surgical Device | |
| | Common Name | Computer-assisted surgical device | |
| | Code product and classification name | Stereotaxic Instrument (HAW), 21 CFR Section 882.4560 | |
| 3 | Predicate devices | ROSA Surgical Device, manufactured by MedTech SAS, K092239, cleared November 17, 2009 | |
| | | StealthStation Treatment Guidance Platform, manufactured by Medtronic Surgical Navigation Technologies, K001801, cleared June 30, 2000 | |
| | | VectorVision Cranial / ENT, manufactured by BrainLAB AG, K023651, cleared February 17, 2004 | |
| | | Frameless Neuromate Stereotactic System, manufactured by Integrated Surgical Systems, Inc., K991081, cleared June 25, 1999 | |
| 4 | Description | 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 instrument holder or 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. | |

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## PREMARKET NOTIFICATION 510(K) SUBMISSION ROSA SURGICAL DEVICE

Explanation of how the device operates

ROSA Surgical Device assists the neurosurgeon in planning the position of instruments relative to preoperative images.

Adequate position of the instrument holder is obtained from three-dimensional calculations performed from desired surgical planning parameters and registration of spatial positions of patient head with fiducial markers or a laser telemeter.

When using the fiducial markers registration, ROSA Surgical Device can be shifted into a "cooperative mode" during which the surgeon can manually move the arm anywhere in the operating field by simply grabbing the tip. Pinpoint collection of fiducial markers is carried out with ROSA and its navigation probe with the cooperative mode.

When using the optical registration, ROSA Surgical Device can be shifted into a "cooperative mode" during which the surgeon can manually move the arm with the laser telemeter at its end and digitize selected anatomical landmarks on the patient's head. Then, the robot arm automatically scans an appropriate surface of the patient's head.

ROSA Surgical Device provides a stable, accurate and reproducible mechanical guidance of neurosurgical instruments in accordance with a preoperative planning.

a computer-controlled ROSA Surgical Device is electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or 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.

Intended use

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Performance data 6

Testing was carried out to assure compliance with recognized electrical safety standards: IEC 60601-1 standard for electrical safety and IEC 60601-1-2 standard for electromagnetic compatibility.

Tests were also carried out to satisfy the requirements of the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304 (Medical Device Software - Life Cycle Process).

Device performance tests were performed to validate the absolute accuracy and repeatability of the device (robot arm).

Device performance tests were performed to validate the application accuracy of the device for fiducial markers and optical registration.

The test bench permits to simulate a neurosurgical procedure. Test consists in thoroughly following the ROSA stereotactic procedure and measuring the distance between the targeted point and the attained instrument tip position. Equipment for this test includes a phantom skull featuring small metallic balls that materialize target points and a portable CMM for the measures (FARO Titanium arm, 50 um single point accuracy). Application accuracy is computed as the mean distance error for the N targets.

Expected results for ROSA surgical device for an in vitro application should yield a mean accuracy equivalent to other commonly used surgical localization systems: below 2 mm.

For fiducial markers: The mean target localization accuracy was evaluated in vitro on a total of 45 measurements collected by approaching nine targets distributed within a volume comparable to a human head. Average in vitro application accuracy is below than 2 mm.

For optical registration: The mean target localization accuracy was evaluated in vitro on a total of 45 measurements collected by approaching various targets distributed within a volume comparable to a human head. Average in vitro application accuracy is below than 2 mm.

ROSA application accuracy with optical registration ાંક equivalent to the application accuracy of the previous cleared ROSA (below than 2 mm).

Testing protocol

Tests results .

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## PREMARKET NOTIFICATION 510(K) SUBMISSION ROSA SURGICAL DEVICE

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## 7 summary

Substantial equivalence The technological characteristics, features, specifications, materials, mode of operation, and intended use of the ROSA Surgical Device are substantially equivalent to the predicate devices cited above.

> The differences that exist between the devices do not raise new issues of safety or effectiveness regarding the ROSA Surgical Device.

| COMPARISON TABLE | | | | | |
|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reference | Frameless<br>Neuromate<br>Stereotactic<br>System<br>K991081 | VectorVision<br>Cranial / ENT<br>K023651 | ROSA Surgical<br>Device<br>K092239 | StealthStation<br>Treatment<br>Guidance<br>Platform<br>K001801 | ROSA Surgical<br>Device (for new<br>submission) |
| Design | | | | | |
| General device<br>description | Computer controlled<br>electromechanical<br>multi-jointed arm<br>indicated for use as a<br>stereotactic<br>instrument | Neuronavigation<br>system providing<br>localization means for<br>neurosurgical<br>instruments | Computer<br>controlled<br>electromechanical<br>multi-jointed arm<br>indicated for use as<br>a stereotactic<br>instrument | Neuronavigation<br>system providing<br>localization means for<br>neurosurgical<br>instruments | Computer<br>controlled<br>electromechanical<br>multi-jointed arm<br>indicated for use as<br>a stereotactic<br>instrument |
| Localization means | Robot arm absolute<br>encoders | Infrared cameras | Robot arm absolute<br>encoders | Infrared cameras<br>(NDI Polaris system) | Robot arm absolute<br>encoders |
| Image-guided | Yes | Yes | Yes | Yes | Yes |
| Integrated planning<br>software | No<br>(third-party software) | Yes | Yes | Yes | Yes |
| Registration<br>method | Bone-mounted<br>ultrasound device | Fiducial markers<br>"Softouch"<br>mechanical probe<br>system<br>Laser scanning<br>device (Z-touch<br>system) | Fiducial markers | Fiducial markers<br>"Tracer" mechanical<br>probe system<br>Laser registration<br>device (Fazer) | Fiducial markers<br>Optical registration<br>device |
| Instrumentation | Laser pointer<br>Tool holder | Probes<br>Frameless biopsy<br>system | Navigation probe<br>Tool holder | Probes<br>Frameless biopsy<br>system | Navigation probe<br>Tool holder<br>Laser pointer |
| Instrument fixation | Instruments are<br>mounted onto robot<br>arm's flange. | Freehand<br>instruments.<br>A localizer is attached<br>to each navigated<br>instrument. | Instruments are<br>mounted onto robot<br>arm's flange. | Freehand<br>instruments.<br>A localizer is attached<br>to each navigated<br>instrument. | Instruments are<br>mounted onto robot<br>arm's flange. |
| Instrument<br>calibration method | Factory calibration | Intra operative | Factory calibration | Intra operative | Factory calibration |
| System<br>immobilization<br>between the patient<br>and the device | Yes | Not necessarily<br>A localizer is attached<br>to the head holder as<br>a reference | Yes | Not necessarily<br>A localizer is attached<br>to the head holder as<br>a reference | Yes |
| Patient<br>Immobilization<br>(head holder) | Yes | Yes | Yes | Yes | Yes |
| Planning & Navigation Software | | | | | |
| Path planning and<br>control Software | VoXimTM<br>(IVS Solutions AG) | VectorVision Flex<br>(BrainLAB) | ROSANNA<br>(MedTech) | StealthStation<br>(Medtronic) | ROSANNA<br>(MedTech) |
| CT, & MRI<br>modalities | Yes | Yes | Yes | Yes | Yes |
| Merge images | Yes | Yes | No | Yes | Yes |
| Save/load path | Yes | Yes | Yes | Yes | Yes |
| Reference | Frameless<br>Neuromate<br>Stereotactic<br>System<br>K991081 | VectorVision<br>Cranial / ENT<br>K023651 | ROSA Surgical<br>Device<br>K092239 | StealthStation<br>Treatment<br>Guidance<br>Platform<br>K001801 | ROSA Surgical<br>Device (for new<br>submission) |
| Fiducial markers<br>registration with<br>pointer probe | No | Yes | Yes | Yes | Yes |
| Optical registration<br>with laser<br>telemeter | No | Yes | No | Yes | Yes |
| Registration based<br>on ultrasound<br>measures | Yes | no | No | No | No |
| Cooperative<br>movement | No | No | Yes | No | Yes |
| Accuracy<br>verification on<br>anatomical<br>landmarks | Yes (laser pointer) | Yes (pointer probe) | Yes (navigation<br>probe) | Yes (pointer probe) | Yes (navigation<br>probe, laser beam) |
| Display real-time<br>instrument position<br>on preoperative<br>images | Yes | Yes | Yes | Yes | Yes |
| Provide mechanical<br>guidance for<br>surgical<br>instruments | Yes | No | Yes | Only with the<br>frameless biopsy | Yes |
| Instrument guide<br>position adjustment | Automatic (robotized) | Manual | Automatic<br>(robotized) | Manual | Automatic<br>(robotized) |
| Surgeon carries out<br>final gesture<br>through the<br>instrument guide | Yes | Yes | Yes | Yes | Yes |
| Indication(s) for use | | | | | |
| Indication for use | Stereotactic spatial<br>positioning and<br>orientation of an<br>instrument holder or<br>tool guide to be used<br>by a surgeon to<br>manually guide<br>standard<br>neurosurgical<br>instruments (biopsy<br>needle, stimulation or<br>recording electrode,<br>endoscope). | Intended as an aid for<br>precisely locating<br>anatomical structures<br>in either open or<br>percutaneous<br>procedures. Indicated<br>for any medical<br>condition in which the<br>use of stereotactic<br>surgery may be<br>appropriate, and<br>where a reference to<br>a rigid anatomical<br>structure can be<br>identified to a CT or<br>MR based model. | Intended to be used<br>in the operating<br>room for the spatial<br>positioning and<br>orientation of an<br>instrument holder<br>or tool guide. The<br>system is intended<br>to be used by<br>neurosurgeons to<br>guide standard<br>neurosurgical<br>instruments (biopsy<br>needle, stimulation<br>or recording<br>electrode).<br>Indicated for any<br>neurosurgical<br>condition in which<br>the use of<br>stereotactic surgery<br>may be<br>appropriate. | Intended as an aid for<br>precisely locating<br>anatomical structures<br>in either open or<br>percutaneous<br>procedures. Indicated<br>for any medical<br>condition in which the<br>use of stereotactic<br>surgery may be<br>appropriate, and<br>where a reference to<br>a rigid anatomical<br>structure can be<br>identified to a CT or<br>MR based model. | Intended to be used<br>in the operating<br>room for the spatial<br>positioning and<br>orientation of an<br>instrument holder<br>or tool guide. The<br>system is intended<br>to be used by<br>neurosurgeons to<br>guide standard<br>neurosurgical<br>instruments (biopsy<br>needle, stimulation<br>or recording<br>electrode,<br>endoscope).<br>Indicated for any<br>neurosurgical<br>condition in which<br>the use of<br>stereotactic surgery<br>may be<br>appropriate. |
| Anatomical site | Head | Head, ENT | Head | Head, Spine, ENT | Head |
| User | Neurosurgeon | Neurosurgeon | Neurosurgeon | Neurosurgeon | Neurosurgeon |
| Associated<br>equipments | Sterile drapes | Sterile drapes<br>Fiducial markers<br>Neurosurgical head<br>holder | Sterile drapes<br>Fiducial markers<br>Neurosurgical head<br>holder<br>Light source (for<br>visualization) | Sterile drapes<br>Fiducial markers<br>Neurosurgical head<br>holder<br>Surgical microscope | Sterile drapes<br>Fiducial markers<br>Neurosurgical head<br>holder<br>Light source (for<br>visualization) |

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# PREMARKET NOTIFICATION 510(K) SUBMISSION ROSA SURGICAL DEVICE

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#### SIMILARITIES AND DIFFERENCES

#### Similarities

All five devices are intraoperative stereotactic instruments used by neurosurgeons for assisting in the spatial positioning and orientation of a neurosurgical instrument.

ROSA Surgical device is substantially equivalent to:

- the Neuromate, StealthStation and VectorVision devices for assisting the spatial positioning and orientation of an endoscope (neurosurgical instrument).

the cleared ROSA, Neuromate, StealthStation and VectorVision devices concerning the preoperative planning process. All five take as input data CT or MRI DICOM 3.0 medical images. The neurosurgeon performs its preoperative plan by defining entry and target points on 3D and 2D views. Preoperative plan can be performed the day before surgery.

- the cleared ROSA, StealthStation and VectorVision devices concerning the manual registration processes. It uses the same Image Guided Surgery multi-modality fiducial markers and is based on the same mathematical computations (3D rigid transformation). The application accuracy is substantially equivalent.

- the StealthStation and VectorVision devices with regard to the optical registration processes. It uses the same Image Guided Surgery multi-modality and is based on the same mathematical computations (3D rigid transformation). The application accuracy is substantially equivalent.

- the StealthStation which uses a laser telemeter for the optical registration.

- the Neuromate device which provides a laser system for the navigation and accuracy verification.

- the cleared ROSA and Neuromate devices as it provides mechanical guidance for neurosurgical instruments and allows optimal access according to patient anatomy. Both are computer controlled electromechanical multi-jointed arms with factory calibrated instruments.

- the cleared ROSA Surgical Device as it provides cooperative movement where the surgeon can - the cleared ROOA Ourgour Dowlod in preating field simply by directing the surgical instrument attached to the robot arm.

ROSA Surgical Device combines the planning and registration functionalities of the Neuromate, NOOA Gurgiour Donio combines the pechanical guidance functionality of the cleared ROSA system and Neuromate.

#### DIFFERENCES

StealthStation and Vector…