ROSA ONE Brain Application

K182417 · Medtech S.A · HAW · Feb 7, 2019 · Neurology

Device Facts

• Record ID: K182417
• Device Name: ROSA ONE Brain Application
• Applicant: Medtech S.A
• Product Code: HAW · Neurology
• Decision Date: Feb 7, 2019
• 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 neurosurgery may be appropriate.

Device Story

Robotized, image-guided system assisting neurosurgeons in brain surgery; provides spatial positioning/orientation for instrument holders/tool guides. Inputs: preoperative/intraoperative 3D MRI/CT images; patient registration data (fiducial markers, optical registration, or stereotactic frame). Operation: surgeon plans trajectories (entry/target points) on images; robot arm provides stable, accurate, reproducible guidance for instruments (biopsy needles, electrodes, endoscopes). Used in neurosurgical OR; operated by neurosurgeon. Output: real-time display of instrument position relative to planned trajectory; robotized guidance of instrument holder. Benefits: enhanced accuracy and reproducibility in instrument placement for complex neurosurgical procedures.

Clinical Evidence

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

Technological Characteristics

6-axis electromechanical robotic arm; PEEK instrument adaptors; Class 2 laser (658 nm, 1 mW) for optical registration; DICOM-compliant image processing; absolute encoders for localization; mobile stand with stabilization feet; non-sterile and sterile components; moist heat sterilization (ISO 17665-1).

Indications for Use

Indicated for neurosurgical procedures requiring stereotactic guidance, including biopsy, stimulation, recording, or endoscopy. Applicable to patients undergoing neurosurgical procedures where stereotactic positioning 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 BRAIN (K172444)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 7, 2019

Medtech S.A. Serge Tabet RA Manager ZAC Eureka - 900 Rue du Mas de Verchant Montpellier, 34000 Fr

Re: K182417

Trade/Device Name: ROSA ONE Brain Application Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: November 19, 2018 Received: November 23, 2018

Dear Serge Tabet:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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,

# Matthew C. Krueger -S

- for 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) K182417

Device Name ROSA ONE Brain Application

### 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 neurosurgery may be appropriate.

Type of Use (Select one or both, as applicable)

| <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
|-----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
|-----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|

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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 a sense of innovation and expertise.

# 510(k) Summary

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

#### SUBMITTER l

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: November 19, 2018

#### ll DEVICE

| Name of Device: | ROSA ONE Brain application |
|-----------------------|------------------------------------------|
| Common Name: | Computer-assisted surgical device |
| Classification Name: | Stereotaxic Instrument (21 CFR 882.4560) |
| Classification Panel: | Neurology |
| Regulatory Class: | II |
| Product Code: | HAW (Brain) |
| 510k #: | K182417 |

### PREDICATE DEVICES ���

ROSA BRAIN, manufactured by Medtech S.A., K172444, cleared on March 28, 2018

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Image /page/4/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.

### DEVICE DESCRIPTION IV

The ROSA One Brain application device is a robotized image-guided device that assists the surgeon during brain surgeries.

It provides quidance of any surgical instruments compatible with the diameter of the adaptors supplied by Medtech. It allows the user to plan the position of instruments or implants on medical images and provides stable, accurate and reproducible guidance in accordance with the planning.

The device is composed of a robot stand with a compact robotic arm and a touch screen.

Different types of instruments may be attached to the end of the robot arm and changed according to the intended surgical procedure. For Brain applications, these neurosurgical instruments (e.g. biopsy needle, stimulation or recording electrode, endoscope) remain applicable for a variety of procedures as shown below in Figure 5.1 for the placement of recording electrodes.

Image /page/4/Picture/6 description: The image shows four different views of a brain scan with various lines and points overlaid on them. The top left panel shows a 3D view of a head with lines extending from the scalp. The top right panel shows an axial view of the brain, while the bottom left panel shows a sagittal view, and the bottom right panel shows a coronal view, all with lines and points indicating different locations or measurements within the brain.

Figure 5.1: Example planning for recording electrodes in a stereo electroencephalography (SEEG) procedure with the ROSA ONE Brain application

The touchscreen ensures the communication between the device and its user by indicating the actions to be performed with respect to the procedure.

Adequate guidance of instruments is obtained from three-dimensional calculations performed from desired surgical planning parameters and registration of spatial position of the patient.

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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, sans-serif font. The logo is simple and modern, and it conveys a sense of innovation and technology.

### 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 neurosurgery may be appropriate.

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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. Below the word "medtech" is the phrase "INNOVATIVE SURGICAL TECHNOLOGY" in a smaller font. The logo is simple and modern.

# VI COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

| Device | ROSA BRAIN<br>(K172444) | ROSA ONE 3.1<br>Brain application<br>(submission subject) | Comparison Analysis |
|--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Device description and indications for use | | | |
| General device description | Computer controlled electromechanical<br>6-axis multi-jointed arm | Computer controlled electromechanical<br>arm providing guidance of neurosurgical<br>instruments | Identical |
| Indications for use | The device is intended for the spatial<br>positioning and orientation of instrument<br>holders 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 appropriate. | The device is intended for the spatial<br>positioning and orientation of instrument<br>holders or tool guides to be used by<br>neurosurgeons to guide standard<br>neurosurgical instruments (biopsy needle,<br>stimulation or recording electrode,<br>endoscope). The device is indicated for<br>any neurosurgical procedure in which the<br>use of stereotactic neurosurgery may be<br>appropriate. | Identical |
| Where used | Neurosurgical operating room | Neurosurgical operating room | Identical |
| User | Neurosurgeon | Neurosurgeon | Identical |
| Anatomical site | Head | Head | Identical |
| Principle of operation | Preoperative images Surgical planning Patient registration Guidance of instruments | Pre & intraoperative images Surgical planning Patient registration Guidance of instruments | Identical |
| Preoperative images & surgical planning | | | |
| Images type | 3D MRI / CT | 3D MRI / CT | Identical |
| DICOM compliance | Yes | Yes | Identical |
| Merge images (multimodality<br>image fusion capability) | Yes | Yes | Identical |
| Device | ROSA BRAIN<br>(K172444) | ROSA ONE 3.1<br>Brain application<br>(submission subject) | Comparison Analysis |
| Integrated planning software | ROSANNA BRAIN<br>(Medtech) | ROSANNA BRAIN<br>(Medtech) | Identical |
| Define regions of interest<br>(ROI) | Yes | Yes | Identical |
| Trajectory planning<br>parameters | Entry point, target point, length of the<br>instrument, diameter, name, color | Entry point, target point, length of the<br>instrument, diameter, name, color | Identical |
| Trajectory definition<br>(endoscopy module) | Parameters for planning trajectories: entry point, target point, instrument length, diameter, name, security radius (10mm by default), security aperture (10° by default) | Parameters for planning trajectories: entry point, target point, length of the instrument, diameter, name, security radius (10mm by default), security aperture (10° by default) | Identical |
| Save/load planning | Yes | Yes | Identical |
| Patient Registration | | | |
| Localization means | Robot arm absolute encoders | Robot arm absolute encoders | Identical |
| Controller | Axis controller for each joint<br>Kinematic transformation between the<br>Cartesian space and joint space<br>Supervisor module | Axis controller for each joint<br>Kinematic transformation between the<br>Cartesian space and joint space<br>Supervisor module | Identical |
| Patient registration methods | Fiducial markers Optical registration device Stereotactic frame (fiducials mounted on the frame) | Fiducial markers (skin, bone) Optical registration device Stereotactic frame (fiducials mounted on the frame) | Identical |
| Fiducial markers registration<br>with pointer probe | Yes | Yes | Identical |
| Surface matching registration<br>with optical distance sensor | Yes | Yes | Identical |
| Laser class for optical<br>registration | Class 2 laser<br>Wavelength - 658 nm, Maximum output<br>- 1 mW (complies with 21 CFR 1040.10) | Class 2 laser<br>Wavelength - 658, Maximum output - 1<br>mW (complies with 21 CFR 1040.10) | Identical |
| Device | ROSA BRAIN<br>(K172444) | ROSA ONE 3.1<br>Brain application<br>(submission subject) | Comparison Analysis |
| Cooperative movement | Yes | Yes | Identical |
| Accuracy verification on<br>anatomical landmarks | Yes | Yes | Identical |
| Instruments guidance | | | |
| Image-guided | Yes | Yes | Identical |
| Real time display of the<br>instrument position | Yes | Yes | Identical |
| Provide guidance for surgical<br>instruments | Yes | Yes | Identical |
| Instrument guide position<br>adjustment | Automatic (robotized) | Automatic (robotized) | Identical |
| Surgeon carries out final<br>gesture through the<br>instrument guide with<br>traditional surgical instrument | Yes - through the instrument guide | Yes - through the instrument guide | Identical |
| Instrument fixation | Instruments are mounted onto robot<br>arm's flange | Instruments are mounted onto robot arm's<br>flange | Identical |
| Instruments | Instrument holder, endoscope holder<br>and adaptors, optical sensor | Instrument holder, endoscope holder and<br>adaptors, optical sensor | Identical with addition of two new<br>transnasal endoscopy instrument<br>holders and six new<br>PEEK instrument adaptors |
| Instrument calibration method | Factory calibration | Factory calibration | Identical |
| Associated equipment | Navigation probe Standard tool holder Endoscope holder Microdrive holder Optical sensor Fiducial markers Head holder adaptor Leksell frame registration plates | Navigation probe Standard tool holder Endoscope holder Microdrive holder Optical sensor Fiducial markers Head holder Leksell frame registration plates | Identical |
| Device | ROSA BRAIN<br>(K172444) | ROSA ONE 3.1<br>Brain application<br>(submission subject) | Comparison Analysis |
| | • CRW Frame | • CRW Frame | |
| Patient immobilization | Yes - The device is attached to the head<br>holder or the frame via an adaptor. | Yes - The device is attached to the head<br>holder or the frame via an adaptor | Identical |
| Device mobility | Yes - Mobile stand with wheels,<br>immobilized with 4 stabilization feet | Yes - Mobile stands with wheels; Robot<br>stand immobilized with stabilization<br>feet | Identical |
| Vigilance system | Yes - foot pedal | Yes - foot pedal | Identical |
| Sterility | Non-sterile and sterile instruments<br>Disposable sterile drapes for the robot<br>arm and touch screen | Non-sterile and sterile instruments<br>Disposable sterile drapes for the robot arm<br>and touch screen | Identical |

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Image /page/7/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 "t" stylized to resemble a surgical instrument. Below the company name is the tagline "INNOVATIVE SURGICAL TECHNOLOGY" in a smaller font.

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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 stylized font. Below the word "medtech" is the phrase "INNOVATIVE SURGICAL TECHNOLOGY" in a smaller font.

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Image /page/9/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 "h" stylized to look like a surgical instrument. Below the word "medtech" is the phrase "INNOVATIVE SURGICAL TECHNOLOGY" in a smaller, sans-serif font.

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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 in blue and features the company name in a modern, sans-serif font. Below the company name is the tagline "Innovative Surgical Technology" in a smaller font. The logo is simple and clean, and it conveys a sense of innovation and technology.

# VII PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

# Biocompatibility testing

The biocompatibility evaluation for the ROSA ONE Brain application 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 ONE device.

# Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on ROSA ONE Brain application. 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.

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Image /page/11/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.

Conformity of software with the user needs and intended use of the device were performed through the "Validation" phase of the ROSA ONE Brain application.

# 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 ONE Brain application.

# Clinical Studies

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

| Test | Test Method Summary | Results |
|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| System applicative accuracy<br>In vitro testing | Performance bench Testing in<br>compliance with internal<br>Medtech/Zimmer<br>Biomet<br>robotics procedures | Testing on the subject device was<br>performed and demonstrated to be<br>substantially equivalent to the predicate<br>device:<br>• Robot arm positioning accuracy<br><0.75 mm RMS<br>• Device applicative accuracy<br><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>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. |

# VIII SUMMARY OF NON CLINICAL PERFORMANCE TESTING

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Image /page/12/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.

| 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:<br>ISO 17665-1<br>Sterilization of health care<br>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 | Evaluation was performed of the subject<br>device and demonstrated to be<br>substantially equivalent to the identified<br>predicate device. |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Animal studies | Not applicable | Not applicable |
| Clinical Studies | Not applicable | Not applicable |

### CONCLUSIONS IX

ROSA ONE Brain application is substantially equivalent in design and intended use to the predicate device – ROSA BRAIN (K172444).

Any differences between the subject and the predicate device have no significant influence on safety or effectiveness as established through performance testing. Therefore, ROSA ONE Brain application raises no new issues of safety or effectiveness when compared to the predicate device.