ROSA BRAIN (v3.0.0.5)

K172444 · Medtech S.A · HAW · Mar 28, 2018 · Neurology

Device Facts

• Record ID: K172444
• Device Name: ROSA BRAIN (v3.0.0.5)
• Applicant: Medtech S.A
• Product Code: HAW · Neurology
• Decision Date: Mar 28, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended 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 patient MRI/CT images. Operation: surgeon performs surgical planning on images via device software, defining target/entry points and instrument parameters; device uses a 6-axis robotic arm to provide stable, accurate mechanical guidance for instruments during surgery. Used in neurosurgical OR by neurosurgeons. Output: real-time instrument position displayed on preoperative images; physical guidance of surgical tools. Benefits: provides accurate, reproducible mechanical guidance for stereotactic procedures. The device includes a touch screen for user communication and commands. It is compatible with various head holders, including a new CRW frame adaptor. Anti-static sterile drapes are required to mitigate ESD susceptibility of the optical sensor.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical bench testing, including system applicative accuracy (<2mm), robot arm positioning accuracy (<0.75mm RMS), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), biocompatibility (ISO 10993-1), and software verification/validation (IEC 62304).

Technological Characteristics

6-axis electromechanical robotic arm; touch screen interface; optical registration (laser telemeter, Class 2); DICOM 3.0 compliant; software-based planning module; compatible with MRI/CT imaging. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2. Sterilization per ISO 17665-1. Software classified as major level of concern.

Indications for Use

Indicated for neurosurgical patients requiring stereotactic surgery for guidance of standard instruments including biopsy needles, stimulation/recording electrodes, or endoscopes.

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 BRAIN (v3.0.0.0) (K151359)

Submission Summary (Full Text)

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March 28, 2018

Medtech S.A. Elise Lagacherie RA/QA Manager ZAC Eureka 900 rue du Mas de Verchant 34000 Montpellier, France

Re: K172444

Trade/Device Name: ROSA BRAIN (v3.0.0.5) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: February 22, 2018 Received: February 26, 2018

Dear Elise Lagacherie:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

# Sincerely, Michael J. Hoffmann -S

Carlos L. Peña. PhD. MS for 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) K172444

Device Name ROSA BRAIN (v3.0.0.5)

### 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)

| Prescription Use (Part 21 CFR 801 Subpart D) | <div> <span style="font-size: 20px;"><b>×</b></span> </div> |
|----------------------------------------------|-------------------------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | |

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Image /page/3/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 the company's focus on technology and innovation.

# 510(k) Summary

This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part §807.92.

#### l SUBMITTER

Medtech S.A. ZAC Eurêka 900 rue du Mas de Verchant 34000 Montpellier, France Tel [phone] Fax [phone]

# Contact Person :

Serge Tabet, Quality & Regulatory Affairs Manager-Zimmer Biomet Robotics [e-mail]

Dated prepared: August 7, 2017

#### ll DEVICE

Name of Device: ROSA BRAIN (v3.0.0.5) Common Name: Computer-assisted surgical device Classification Name: Stereotaxic Instrument (21CFR 882.4560) Classification Panel: Neurology Regulatory Class: II Product Code: HAW 510k #: K172444

#### ��� PREDICATE DEVICE

ROSA BRAIN (v3.0.0.0), manufactured by Medtech S.A., K151359, cleared December 19, 2015

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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 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.

#### DEVICE DESCRIPTION IV

The ROSA BRAIN device is a robotized platform providing guidance 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.

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 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 lenath).

During surgery, the device provides accurate and rigid guidance of the required instrument according to the previously completed planning.

The optical distance sensor used with the ROSA BRAIN is susceptible to Electrostatic Discharge (ESD).

The ROSA BRAIN device is intended to be used with anti-static sterile drapes which are designed for the device and listed in the list of compatible devices. The anti-static sterile drapes are mitigations to ROSA Brain device ESD immunity.

#### V 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.

#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE VI DEVICE

| Device | ROSA BRAIN 3.0.0.0<br>(K151359) | ROSA BRAIN 3.0.0.5<br>(submission subject) |
|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | ROSA BRAIN 3.0.0.0<br>(K151359) | ROSA BRAIN 3.0.0.5<br>(submission subject) |
| Indications for use | Intended for the spatial positioning<br>and orientation of instrument holders<br>or tool guides to be used by<br>neurosurgeons to guide standard<br>neurosurgical instruments (biopsy<br>needle, stimulation or recording<br>electrode, endoscope). The device is<br>indicated for any neurosurgical<br>procedure in which the use of<br>stereotactic surgery may be<br>appropriate. | Identical |
| Where used | Neurosurgical operating room | Identical |
| User | Neurosurgeon | Identical |
| General device description | Computer controlled<br>electromechanical 6-axis multi-jointed<br>arm | Identical |
| Principle of operation | Preoperative images Surgical planning Patient registration 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 BRAIN (v3.0.0.0)<br>(product version)(Medtech) | ROSANNA BRAIN (v3.0.0.5)<br>(product version) (Medtech)<br>Justification:<br>Upgraded version. |
| 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,<br>security<br>radius (10mm by default),<br>security<br>aperture (10° by default) | Identical |
| Save/load planning | Yes | Identical |
| | Patient registration | |
| Localization means | Robot arm absolute encoders | Identical |
| Device | ROSA BRAIN 3.0.0.0<br>(K151359) | ROSA BRAIN 3.0.0.5<br>(submission subject) |
| Controller | Axis controller for each joint<br>Kinematic transformation between the<br>Cartesian space and joint space<br>Supervisor module | Identical |
| Registration methods | Fiducial markers<br>Optical registration device<br>Stereotactic frame (fiducials<br>mounted on the frame) | Identical |
| 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) | Identical |
| | Instruments guidance | |
| Image-guided | Yes | Identical |
| Display real-time instrument<br>position on preoperative<br>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<br>Standard tool holder<br>Endoscope holder<br>Microdrive holder<br>Optical sensor<br>Fiducial markers<br>Head holder adaptor<br>Leksell frame registration plates | Navigation probe<br>Standard tool holder<br>Endoscope holder<br>Microdrive holder<br>Optical sensor<br>Fiducial markers<br>Head holder adaptor<br>Leksell frame registration plates<br>CRW Frame<br>Justification:<br>Addition of a compatibility to a new head<br>holder ("CRW Frame") by adding a<br>mechanical component the "CRW Frame<br>Adaptor" to immobilize the patient's head<br>specifically during DBS surgery procedure |
| Patient immobilization | Yes - The device is attached to the<br>head holder or the frame via an | Yes - The device is attached to a head<br>holder or a frame via an adaptor |
| Device | ROSA BRAIN 3.0.0.0<br>(K151359) | ROSA BRAIN 3.0.0.5<br>(submission subject) |
| | adaptor | |
| | | Different -<br>Same principle with addition of a new<br>head holder CRW Frame |
| Device mobility | Yes - Mobile stand with wheels,<br>immobilized with 4 stabilization<br>feet | Identical |
| Vigilance system | Yes - pedal | Identical |

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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 font. The logo is simple and modern.

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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 sans-serif font, with the "t" and "e" connected. Below the word "medtech" is the phrase "INNOVATIVE SURGICAL TECHNOLOGY" in a smaller, sans-serif font.

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Image /page/7/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.

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Image /page/8/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.

# VII PERFORMANCE DATA

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 FDA Guidance Document: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process." 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. The EMC testing was performed according to the FDA EMC guidance document "Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices" issued in July 11, 2016.

# 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

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 requirement 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.

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Image /page/9/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 stylized font. The words "INNOVATIVE SURGICAL TECHNOLOGY" are written in smaller letters below the company name. The logo is simple and modern, and it conveys the company's focus on technology and innovation.

# Cleaning- and Sterilization Validation

MEDTECH has performed an automated cleaning validation according to FDA Guidance Document Reprocessing of Reusable Medical Devices: Information for Manufacturers and AAMI TIR 30 Technical report. Additionally, the sterilization validation was performed according to ISO 17665-1, ISO 17664, ANSI/AAMI ST79, and AAMI TIR 12 Technical report using two cycles.

# Animal studies

Data from animal studies were not required to support the safety and effectiveness of ROSA Brain.

# Clinical Studies

Clinical data were not required to support the safety and effectiveness of ROSA Brain. All validation was performed based on non-clinical performance tests.

#### SUMMARY OF NON CLINICAL PERFORMANCE TESTING vi

| Test | Test Method Summary | Results |
|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| System applicative accuracy<br>In vitro testing | Performance bench Testing in compliance with internal Biomet<br>medtech /Zimmer<br>robotics procedures | Testing on the subject device was performed and demonstrated to be<br>substantially equivalent to the predicate<br>device:<br>Robot arm positioning accuracy< 0.75 mm RMS Device applicative accuracy< 2mm |
| Electrical safety and<br>electromagnetic compatibility<br>(EMC) | Testing in compliance with the<br>IEC 60601-1:2005/A1:2012 and<br>IEC 60601-1-2:2014 | Evaluation and testing were performed on<br>the subject device and demonstrated to<br>be substantially equivalent to the<br>predicate device. |
| Biocompatibility testing | Testing in compliance with FDA<br>Guidance "Use of International<br>Standard IS10993, Biological<br>evaluation of medical Devices<br>Part 1". | The following non clinical tests were<br>performed on the predicate device :<br>Cytotoxicity, Sensitization , Irritation and<br>Acute systemic toxicity<br><br>The subject devices were evaluated<br>against the predicate testing and<br>determined to be substantially equivalent. |
| Software Verification and<br>Validation Testing | Software verification testing in<br>compliance with FDA guidance<br>"General Principles of Software<br>Validation" and IEC 62304:<br>2006 | Evaluation and testing were performed on<br>the subject device and demonstrated<br>substantially equivalent performance to<br>identified predicate device |
| Cleaning- and Sterilization<br>Validation | Testing in compliance with FDA<br>Guidance "Reprocessing<br>Medical Devices in Health Care<br>Settings: Validation Methods<br>and Labeling" and the following<br>standards: ISO 17665-1<br>Sterilization of health care | Evaluation was performed of the subject<br>device and demonstrated to be<br>substantially equivalent to the identified<br>predicate devices. |

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Image /page/10/Picture/0 description: The image shows the logo for Medtech, a company that specializes in innovative surgical technology. The logo is composed of the word "medtech" in a bold, sans-serif font, with the "h" stylized to resemble a surgical instrument. Below the company name is the tagline "INNOVATIVE SURGICAL TECHNOLOGY" in a smaller font.

| | products -Moist heat - Part 1:<br>Requirements for<br>the Development, Validation<br>and Routine Control of a<br>Sterilization Process for Medical<br>Devices and ISO 17664-<br>Sterilization of medical devices -<br>-Information to be provided by<br>the manufacturer for the<br>processing of re-sterilizable<br>medical devices | |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Animal studies | Not applicable | Not applicable |
| Clinical Studies | Not applicable | Not applicable |

# VII CONCLUSIONS

ROSA BRAIN (v3.0.0.5) is substantially equivalent in design and intended use to the predicate device – ROSA BRAIN (3.0.0.0) (K151359). Any differences between the subject and predicate device have no significant influence on safety or effectiveness as established through performance testing. Therefore, ROSA BRAIN (v3.0.0.5) raises no new issues of safety or effectiveness when compared to the predicate device.