ROSA Brain
Device Facts
| Record ID | K151359 |
|---|---|
| Device Name | ROSA Brain |
| Applicant | Medtech S.A |
| Product Code | HAW · Neurology |
| Decision Date | Dec 18, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.4560 |
| Device Class | Class 2 |
Indications for Use
The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.
Device Story
ROSA Brain is a robotized, image-guided platform for neurosurgical instrument positioning. Input: preoperative MRI/CT images. Surgeon performs surgical planning (target/entry points, instrument length) using ROSANNA BRAIN 3.0 software. During surgery, the device uses a 6-axis robotic arm to provide rigid, accurate mechanical guidance for instruments (biopsy needles, electrodes, endoscopes) based on the plan. The system includes a touch screen for user communication and commands. The device is used in the neurosurgical operating room by neurosurgeons. It provides real-time visualization of instrument position relative to preoperative images, ensuring reproducible guidance. Benefits include increased accuracy and stability in stereotactic procedures.
Clinical Evidence
No clinical data or animal studies were provided. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993), electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and comprehensive software verification and validation.
Technological Characteristics
6-axis electromechanical robotic arm; mobile stand with 4 stabilization feet; touch screen interface; 1-pedal footswitch. Integrates with preoperative 3D MRI/CT (DICOM 3.0). Registration via fiducial markers, optical laser telemeter (Class 2), or stereotactic frame. Software: ROSANNA BRAIN 3.0. Sterilization: Not specified (standard surgical instrument guidance).
Indications for Use
Indicated for neurosurgical procedures where stereotactic surgery is appropriate, including biopsy, stimulation/recording electrode placement, and endoscopy. For use 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 (K101797)
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" 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
December 18, 2015
Medtech S.A. Ms. Colette Maurin Regulatory Affairs Director ZAC Eurêka 900 rue du Mas de Verchant 34000 Montpellier, France
Re: K151359
Trade/Device Name: ROSA Brain Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: November 16, 2015 Received: November 20, 2015
Dear Ms. Colette Maurin:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
{1}------------------------------------------------
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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
{2}------------------------------------------------
# Indications for Use
510(k) Number (if known) K151359
Device Name ROSA Brain
### Indications for Use (Describe)
The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.
Type of Use (Select one or both, as applicable)
| <span style="font-family: Arial;"> <svg height="15" width="15"> <rect fill="none" height="15" stroke="black" width="15" x="0" y="0"></rect> <path d="M2,2 L13,13 M13,2 L2,13" stroke="black"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial;"> <svg height="15" width="15"> <rect fill="none" height="15" stroke="black" width="15" x="0" y="0"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for Medtech. The logo is in blue and consists of the word "medtech" in a sans-serif font. Below the word "medtech" is the phrase "INNOVATIVE SURGICAL TECHNOLOGY" in a smaller font. The logo is simple and modern.
# 510(k) Summary
This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part §807.92.
#### SUBMITTER I
Medtech S.A. ZAC Eurêka 900 rue du Mas de Verchant 34000 Montpellier, France Tel +33 (0)4 67 10 77 40 Fax +33 (0)4 67 59 74 18
Contact Person: Colette Maurin Requlatory Affairs Director c.maurin@medtechsurgical.com
Dated prepared: December 17, 2015
#### II DEVICE
Name of device: ROSA Brain Common Name: Computer-assisted surgical device Classification name: Stereotaxic Instrument (21CFR 882.4560) Requlatory class: II Code product: HAW
# III PREDICATE DEVICE
ROSA Surgical Device, manufactured by Medtech S.A., K101797, cleared September 23, 2010
#### DEVICE DESCRIPTION IV
The ROSA Brain device is a robotized platform providing quidance of any neurosurqical instruments compatible with the diameter of the adaptors supplied by Medtech (for example, a biopsy needle).
The device is composed of a compact robotic arm and a touch screen mounted on a robot stand. Different types of instruments may be attached to the robot arm and changed according to the requirements of the procedure to be completed.
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for Medtech. The logo is in blue and consists of the word "medtech" in a stylized font. Below the word "medtech" is the phrase "INNOVATIVE SURGICAL TECHNOLOGY" in a smaller font. The logo is simple and modern, and it conveys a sense of innovation and technology.
The touch screen ensures the communication between the device and its user by indicating the actions to be done as well as by offering various commands.
ROSA Brain is an image-quided device that assists the surgeon in planning the position of instruments or implants on preoperative or intraoperative images. It provides a stable, accurate and reproducible mechanical guidance in accordance with the planning.
An image acquisition of the patient's head (MRI / CT images) is performed prior to surgery and loaded into the device.
In the preoperative phase, the surgeon carries out the surgical planning on the patient images using the device software. The desired surgical parameters for positioning of the surgical instruments are defined (for example: target point, entry point and instrument length).
During surgery, the device provides accurate and rigid quidance of the required instrument according to the previously completed planning.
#### > INDICATIONS FOR USE
The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurqical procedure in which the use of stereotactic surgery may be appropriate.
#### VI COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Device | ROSA Surgical Device<br>(K101791) | ROSA Brain<br>(submission subject) |
|-----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Intended to be used in the operating<br>room for the spatial positioning and<br>orientation of an instrument holder or<br>tool guide. The system is intended to<br>be used by neurosurgeons to guide<br>standard neurosurgical instruments<br>(biopsy needle, stimulation or<br>recording electrode, endoscope).<br>Indicated for any neurosurgical<br>condition in which the use of<br>stereotactic surgery may be<br>appropriate. | Different<br>Justification:<br>Minor rewording<br>Intended for the spatial positioning and<br>orientation of instrument holders or tool<br>guides to be used by neurosurgeons to<br>guide standard neurosurgical instruments<br>(biopsy needle, stimulation or recording<br>electrode, endoscope). The device is<br>indicated for any neurosurgical procedure<br>in which the use of stereotactic surgery<br>may be appropriate |
| Where used | Neurosurgical operating room | Identical |
| User | Neurosurgeon | Identical |
| General device description | Computer controlled<br>electromechanical 6-axis multi-<br>jointed arm | Identical |
| Device | ROSA Surgical Device<br>(K101791) | ROSA Brain<br>(submission subject) |
| Principle of operation | • Preoperative images<br>• Surgical planning<br>• Patient registration<br>• Guidance of instruments | Identical |
| | Preoperative images & surgical planning | |
| Preoperative images | 3D MRI / CT | Identical |
| DICOM compliance | DICOM 3.0 | Identical |
| Multimodality fusion | Yes (MRI/CT) | Identical |
| Planning software | ROSANNA 2.0 (Medtech) | Different<br>Justification:<br>Minor changes – Upgraded version<br>ROSANNA BRAIN 3.0 (Medtech) |
| Integrated planning<br>software | Yes | Identical |
| Define regions of interest<br>(ROI) | Yes | Identical |
| Trajectory definition<br>(stereotactic module) | Parameters for planning trajectories:<br>entry point, target point, instrument<br>length, diameter, name, color | Identical |
| Trajectory definition<br>(endoscopy module) | Parameters for planning trajectories:<br>entry point, target point, instrument<br>length, diameter, name, security<br>radius (10mm by default), security<br>aperture (10° by default) | Identical |
| Save/load planning | Yes | Identical |
| | Patient registration | |
| Localization means | Robot arm absolute encoders | Identical |
| Controller | Axis controller for each joint<br>Kinematic transformation between<br>the Cartesian space and joint space<br>Supervisor module | Identical |
| Registration methods | • Fiducial markers<br>• Optical registration device | Different<br>Justification:<br>• Fiducial markers<br>• Optical registration device<br>• Stereotactic frame (fiducials mounted<br>on the frame) |
| Fiducial markers<br>registration with pointer<br>probe | Yes | Identical |
| Optical registration with<br>laser telemeter | Yes | Identical |
| Laser class for optical<br>registration | 2 (complies with 21 CFR 1040.10) | Identical |
| Cooperative movement | Yes | Identical |
| Accuracy verification on<br>anatomical landmarks | Yes (navigation probe, laser beam) | Identical |
| Device | ROSA Surgical Device<br>(K101791) | ROSA Brain<br>(submission subject) |
| Instruments guidance | | |
| Image-guided | Yes | Identical |
| Display real-time<br>instrument position on<br>preoperative images | Yes | Identical |
| Mechanical guidance for<br>surgical instruments | Yes | Identical |
| Instrument guide position<br>adjustment | Automatic (robotized) | Identical |
| Surgeon carries out final<br>gesture through the<br>instrument guide with<br>traditional surgical<br>instrument | Yes | Identical |
| Instrument fixation | Instruments are mounted onto robot<br>arm's flange | Identical |
| Instrument calibration<br>method | Factory calibration | Identical |
| Components | Navigation probe Standard tool holder Endoscope holder Optical sensor Fiducial markers Head holder Stereovision system 3D visualization headset Light source | Different<br>Justification:<br>Navigation probe Standard tool holder Endoscope holder Optical sensor Fiducial markers Head holder Microdrive holder Leksell frame registration plates The stereovision system, headset and<br>light source are not part of the device.<br>Registration plates were designed for the<br>stereotactic frame registration method. |
| Patient immobilization | Yes - The device is attached to the<br>head holder or the frame via an<br>adaptor | Different<br>Justification:<br>Same principle with minor redesign of the<br>head holder and frame adaptors |
| Device mobility | Yes - Mobile stand with wheels,<br>immobilized with 3 stabilization feet | Different<br>Justification:<br>Same principle with 4 stabilization feet<br>instead of 3 |
| Vigilance system | Yes - hand control | Different<br>Justification:<br>1-pedal footswitch |
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for Medtech. The logo is in blue and consists of the word "medtech" in a sans-serif font. Below the word "medtech" is the phrase "INNOVATIVE SURGICAL TECHNOLOGY" in a smaller, sans-serif font. The logo is simple and modern.
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for Medtech. The logo is in blue and consists of the word "medtech" in a stylized font. Below the word "medtech" is the phrase "INNOVATIVE SURGICAL TECHNOLOGY" in a smaller font. The logo is simple and modern, and it conveys a sense of innovation and technology.
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for Medtech, a company that specializes in innovative surgical technology. The logo is in blue and features the company name in a bold, sans-serif font. Below the company name is the tagline "Innovative Surgical Technology" in a smaller font. The logo is simple and modern, and it conveys a sense of innovation and expertise.
#### PERFORMANCE DATA VII
The following performance data were provided in support of the substantial equivalence determination.
# Biocompatibility testing
The biocompatibility evaluation for ROSA Brain device has been conducted in accordance with blue book memorandum #G95-1 entitled "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part-1: Evaluation and Testing", May 1, 1995. The evaluation reveals that biocompatibility requirements are met by the ROSA Brain device.
### Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on ROSA Brain. The device complies with recognized electrical safety standards: IEC 60601-1 standard for electrical safety and IEC 60601-1-2 standard for electromagnetic compatibility.
### Software Verification and Validation Testing
Software tests were conducted to satisfy the requirements of the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304 Standard (Medical Device Software - Life Cycle Process). The software was considered as a "major" level of concern, since a failure of the software could result in serious injury or death to the patient.
Software verification activities were performed during the "Design, coding & testing" and "Verification" phases of software lifecycle. Outputs generated during these phases include:
- Code walkthroughs ●
- Unit test reports
- Integration test reports
- . System test reports
- Overall software test report ●
- Verification test reports
- Overall software verification report (see ROSA3-052A)
Code inspections and software tests at the unit, integration and system levels were performed according to the Software Test Plan. Verification tests were performed for each software requirements according to the Software Verification Plan.
Conformity of software with the user needs and intended use of the device were performed through the "Validation" phase of the ROSA Brain device.
## Mechanical and acoustic testing
The 510(k) does not contain clinical information for the ROSA Brain.
## Animal study
The 510(k) does not contain animal study test results for the ROSA Brain.
## Clinical Studies
The 510(k) does not contain clinical information for the ROSA Brain.
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for Medtech. The logo is in blue and consists of the word "medtech" in a sans-serif font. Below the word "medtech" is the phrase "INNOVATIVE SURGICAL TECHNOLOGY" in a smaller font. The logo is simple and modern.
#### CONCLUSIONS VI
The non-clinical data support the safety of the device and the hardware verification and validation demonstrate that the ROSA Brain Device should perform as intended in the specified use conditions. The non-clinical data demonstrate that the ROSA Brain Device performs comparably to the predicate device that is currently marketed for the same intended use.
