Who is the manufacturer of ROSA ONE Brain application?

Medtech S.A filed the 510(k) submission for ROSA ONE Brain application (K200511).

What is the FDA product code for ROSA ONE Brain application?

HAW. It is classified under 21 CFR 882.4560 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for ROSA ONE Brain application?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ROSA ONE Brain application?

ROSA ONE Brain application (K182417).

Who can help prepare an FDA 510(k) submission like ROSA ONE Brain application?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ROSA ONE Brain application

K200511 · Medtech S.A · HAW · May 29, 2020 · Neurology

Device Facts

Record ID	K200511
Device Name	ROSA ONE Brain application
Applicant	Medtech S.A
Product Code	HAW · Neurology
Decision Date	May 29, 2020
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 instruments holders or tool guides to be used by trained 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

ROSA ONE Brain application is a robotized, image-guided system assisting neurosurgeons in the OR. It uses preoperative/intraoperative 3D MRI/CT images for surgical planning, allowing users to define trajectories (entry/target points). The system registers the patient's spatial position using fiducial markers, optical registration, or stereotactic frames. A robotic arm, controlled by a supervisor module and axis controllers, provides stable, accurate guidance for surgical instruments (biopsy needles, electrodes, endoscopes). The surgeon interacts with the system via a touchscreen and foot pedal. By providing precise, reproducible instrument positioning based on pre-planned parameters, the device assists in complex neurosurgical procedures, potentially improving accuracy and procedural outcomes.

Clinical Evidence

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

Technological Characteristics

Robotized electromechanical arm with absolute encoders; mobile stand with stabilization feet. Integrates with ROSANNA BRAIN software for 3D image fusion (MRI/CT). Optical registration uses Class 2 laser (658 nm, 1 mW). Connectivity via DICOM. Software classified as major level of concern. Sterilization via moist heat (ISO 17665-1).

Indications for Use

Indicated for trained neurosurgeons performing neurosurgical procedures where stereotactic neurosurgery is appropriate, including biopsy, stimulation, recording, or endoscopy.

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 ONE Brain application (K182417)

Related Devices

K231103 — ROSA ONE Brain Application · Medtech S.A.S · Jul 20, 2023
K151359 — ROSA Brain · Medtech S.A · Dec 18, 2015
K172444 — ROSA BRAIN (v3.0.0.5) · Medtech S.A · Mar 28, 2018
K182417 — ROSA ONE Brain Application · Medtech S.A · Feb 7, 2019
K092239 — ROSA SURGICAL DEVICE, MODEL ROSA 1.1 · Medtech S.A · Nov 17, 2009

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. May 29, 2020 Medtech S.A. Serge Tabet QARA Manager ZAC Eureka - 900 Rue du Mas de Verchant Montpellier, 34000 France # Re: K200511 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: February 27, 2020 Received: March 2, 2020 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 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 {1}------------------------------------------------ https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Adam D. Pierce. Ph.D. Acting Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K200511 Device Name ROSA ONE Brain application The device is intended for the spationing and orientation of instruments holders or tool guides to be used by trained 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) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| 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." Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. {3}------------------------------------------------ # 510(k) Summary This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part 8807.92. l SUBMITTER 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 : Serge Tabet Quality & Regulatory Affairs Manager-Zimmer Biomet Robotics serge.tabet@zimmerbiomet.com Dated: May 28, 2020 #### 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 #: | K200511 | #### PREDICATE DEVICES �� ROSA ONE Brain application, manufactured by Medtech S.A., K182417, cleared on February 7, 2019 {4}------------------------------------------------ #### IV DEVICE DESCRIPTION The ROSA One Brain application device is a robotized image-quided device that assists the surgeon during brain surgeries. It provides guidance of any surgical instruments compatible with the diameter of the adaptors supplied by Medtech. It allows the user to plan the position of instruments 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 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/Figure/6 description: The image shows four views of a brain scan with electrodes. The top left panel shows a 3D view of a head with electrodes attached. The top right panel shows an axial view of the brain with the electrodes. The bottom left panel shows a sagittal view of the brain with the electrodes. The bottom right panel shows a coronal view of the brain with the electrodes. Image /page/4/Figure/7 description: The image is a title for a figure. The title is "Figure 5.1: Example planning for recording electrodes in a stereo electroencephalography (SEEG) procedure with the ROSA ONE Brain application". The title describes the figure as an example of planning for recording electrodes in a stereo electroencephalography (SEEG) procedure. The procedure is performed 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. {5}------------------------------------------------ #### V INDICATIONS FOR USE The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained 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. ### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE VI DEVICE | Device | ROSA ONE Brain application 3.1.0.4 (K182417) | ROSA ONE 3.1.3.2 Brain application (K200511) | Comparison Analysis | |--------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------| | | Device description and indications for use | | | | General device description | Computer controlled electromechanical arm providing guidance of neurosurgical instruments | Computer controlled electromechanical arm providing guidance of neurosurgical instruments | Identical | | 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. | The device is intended for the spatial positioning and orientation of instruments or tool guides to be used by trained 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. | Identical with the addition of explicit information on the level of training of the surgeons using the device | | Where used | Neurosurgical operating room | Neurosurgical operating room | Identical | | User | Neurosurgeon | Neurosurgeon | Identical | | Anatomical site | Head | Head | Identical | | Principle of operation | Preoperative imagesSurgical planningPatient registrationGuidance of instruments | Pre & intraoperative imagesSurgical planningPatient registrationGuidance of instruments | Identical | | Preoperative images & surgical planning | | | | | Images type | 3D MRI / CT | 3D MRI / CT | Identical | | DICOM compliance | Yes | Yes | Identical | | Merge images (multimodality image fusion capability) | Yes | Yes | Identical | | Device | ROSA ONE Brain application 3.1.0.4 (K182417) | ROSA ONE 3.1.3.2 Brain application (K200511) | Comparison Analysis | | Integrated planning software | ROSANNA BRAIN (Medtech) | ROSANNA BRAIN (Medtech) | Identical | | Define regions of interest (ROI) | Yes | Yes | Identical | | Trajectory planning parameters | Entry point, target point, length of the instrument, diameter, name, color | Entry point, target point, length of the instrument, diameter, name, color | Identical | | Trajectory definition (endoscopy module) | Parameters for planning trajectories: entry point, target point, length of the instrument, 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 Kinematic transformation between the Cartesian space and joint space Supervisor module | Axis controller for each joint Kinematic transformation between the Cartesian space and joint space 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 with pointer probe | Yes | Yes | Identical | | Surface matching registration with optical distance sensor | Yes | Yes | Identical | | Laser class for optical registration | Class 2 laser Wavelength - 658 nm, Maximum output - 1 mW (complies with 21 CFR 1040.10) | Class 2 laser Wavelength - 658, Maximum output - 1 mW (complies with 21 CFR 1040.10) | Identical | | Cooperative movement | Yes | Yes | Identical | | Device | ROSA ONE Brain application 3.1.0.4 (K182417) | ROSA ONE 3.1.3.2 Brain application (K200511) | Comparison Analysis | | Accuracy verification on anatomical landmarks | Yes | Yes | Identical | | | Instruments guidance | | | | Image-guided | Yes | Yes | Identical | | Real time display of the instrument position | Yes | Yes | Identical | | Provide guidance for surgical instruments | Yes | Yes | Identical | | Instrument guide position adjustment | Automatic (robotized) | Automatic (robotized) | Identical | | Surgeon carries out final gesture through the instrument guide with traditional surgical instrument | Yes - through the instrument guide | Yes - through the instrument guide | Identical | | Instrument fixation | Instruments are mounted onto robot arm's flange | Instruments are mounted onto robot arm's flange | Identical | | Instruments | Instrument holder, endoscope holder and adaptors, optical sensor | Instrument holder, endoscope holder and adaptors, optical sensor | Identical | | 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 ●CRW Frame | Navigation probe ●Standard tool holder ●Endoscope holder ●Microdrive holder ●Optical sensor ●Fiducial markers ●Head holder ●Leksell frame registration ●plates ●CRW Frame | Identical | | Patient immobilization | Yes - The device is attached to the head holder or the frame via an adaptor. | Yes - The device is attached to the head holder or the frame via an adaptor | Identical | | Device mobility | Yes - Mobile stand with wheels, immobilized with 4 stabilization feet | Yes - Mobile stands with wheels; Robot stand immobilized with stabilization feet | Identical | | Vigilance system | Yes - foot pedal | Yes - foot pedal | Identical | | Sterility | Non-sterile and sterile instruments Disposable sterile drapes for the robot arm and touch screen | Non-sterile and sterile instruments Disposable sterile drapes for the robot arm and touch screen | Identical | | Device | ROSA ONE Brain application 3.1.0.4 (K182417) | ROSA ONE 3.1.3.2 Brain application (K200511) | Comparison Analysis | | Device mobility | Yes - Mobile stand with wheels, immobilized with 4 stabilization feet | Yes - Mobile stands with wheels; Robot stand immobilized with stabilization feet | Identical | | Vigilance system | Yes - foot pedal | Yes - foot pedal | Identical | | Sterility | Non-sterile and sterile instruments Disposable sterile drapes for the robot arm and touch screen | Non-sterile and sterile instruments Disposable sterile drapes for the robot arm and touch screen | Identical | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ #### 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 guidelines - Unit test reports - · Integration test reports {9}------------------------------------------------ - · Overall software test report - · Verification test reports - · Overall software verification report Code inspections and software tests at the unit and integration 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 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 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. ### VIII ### SUMMARY OF NON CLINICAL PERFORMANCE TESTING | Test | Test Method Summary | Results | |-----------------------------------------------------------|----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | System applicative accuracy In vitro testing | Performance bench compliance with Medtech/Zimmer robotics procedures Testing in internal Biomet | Testing were performed on the predicate device. The subject devices were evaluated against the predicate testing and determined to be substantially equivalent: Robot arm positioning accuracy <0.75 mm RMS Device applicative accuracy <2mm | | Electrical safety and electromagnetic compatibility (EMC) | Testing in compliance with the IEC 60601-1:2005/A1:2012 and IEC 60601-1-2:2014 | Evaluation and testing were performed on the predicate device. The subject device was evaluated against the predicate testing and determined to be substantially equivalent. | {10}------------------------------------------------ | Biocompatibility testing | Testing in compliance with FDA Guidance "Use of International Standard IS10993, Biological evaluation of medical Devices Part 1". | The following non clinical tests were performed on the predicate device: Cytotoxicity, Sensitization, Irritation and Acute systemic toxicity. The subject devices were evaluated against the predicate testing and determined to be substantially equivalent. | |-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Software Verification and Validation Testing | Software verification testing in compliance with FDA guidance "General Principles of Software Validation" and IEC 62304: 2015 | Evaluation and testing were performed on the subject device and demonstrated substantially equivalent performance to identified predicate device. | | Cleaning- and Sterilization Validation | Testing in compliance with FDA Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" and the following standards: ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices and ISO 17664 Sterilization of medical devices --Information to be provided by the manufacturer for the processing of re- sterilizable medical devices | Evaluation and testing were performed on the predicate device. The subject device was evaluated against the predicate testing and determined to be substantially equivalent. | | Animal studies | Not applicable | Not applicable | | Clinical Studies | Not applicable | Not applicable | #### CONCLUSIONS IX ROSA ONE Brain application (v.3.1.3.2) is substantially equivalent in design and intended use to the predicate device – ROSA ONE Brain application (v.3.1.0.4) (K182417). 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 (v.3.1.3.2). raises no new issues of safety or effectiveness when compared to the predicate device.