(226 days)
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.
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.
The provided text is a 510(k) summary for a medical device called ROSA BRAIN (v3.0.0.5), a computer-assisted surgical device (stereotaxic instrument). This document describes the device, its intended use, and the testing conducted to demonstrate its substantial equivalence to a predicate device (ROSA BRAIN v3.0.0.0).
Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document focuses on demonstrating substantial equivalence to a predicate device rather than setting new, specific acceptance criteria for this version's performance at a detailed algorithmic level. The performance data provided are primarily for safety and general functional aspects, and a key 'performance' metric mentioned is system applicable accuracy.
| Test Category | Acceptance Criteria (Implied / Stated) | Reported Device Performance |
|---|---|---|
| System Applicative Accuracy (In vitro) | Performance demonstrated to be substantially equivalent to the predicate device. Specific numerical targets for accuracy are given for the predicate and are implicitly the acceptance criteria for the new device. | - Robot arm positioning accuracy: < 0.75 mm RMS - Device applicative accuracy: < 2mm(These results are stated to be "substantially equivalent to the predicate device") |
| Electrical Safety and EMC | Compliance with recognized electrical safety standards: IEC 60601-1 and electromagnetic compatibility standard IEC 60601-1-2. | "Evaluation and testing were performed on the subject device and demonstrated to be substantially equivalent to the predicate device." Device complies with IEC 60601-1:2005/A1:2012 and IEC 60601-1-2:2014. |
| Biocompatibility Testing | Compliance with FDA Guidance Document: Use of International Standard ISO 10993-1. (Specifically, the predicate device had passed Cytotoxicity, Sensitization, Irritation, and Acute systemic toxicity tests, which implied the new device should not introduce new risks). | "The biocompatibility evaluation for ROSA BRAIN device has been conducted in accordance with FDA Guidance Document... The evaluation reveals that biocompatibility requirements are met by the ROSA BRAIN device." "The subject devices were evaluated against the predicate testing and determined to be substantially equivalent." |
| Software Verification and Validation | Compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304 Standard (Medical Device Software - Life Cycle Process). Software considered "major" level of concern. | "Evaluation and testing were performed on the subject device and demonstrated substantially equivalent performance to identified predicate device." Includes code walkthroughs, unit, integration, and system test reports, and verification/validation activities. |
| Cleaning and Sterilization Validation | Compliance with FDA Guidance Document Reprocessing of Reusable Medical Devices and standards such as ISO 17665-1, ISO 17664, ANSI/AAMI ST79, and AAMI TIR 12. | "Evaluation was performed of the subject device and demonstrated to be substantially equivalent to the identified predicate devices." Automated cleaning validation and sterilization validation (using two cycles) were performed. |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states: "Clinical data were not required to support the safety and effectiveness of ROSA Brain. All validation was performed based on non-clinical performance tests."
Therefore:
- Test Set Sample Size: Not applicable in the context of human patient data or studies. The "test set" refers to the non-clinical bench testing conducted to verify accuracy and other engineering specifications. For physical accuracy, the entry "System applicative accuracy In vitro testing" indicates "Testing on the subject device was performed." This would imply multiple runs or repetitions, but a specific numerical sample size (e.g., number of test cases or measurements) is not provided.
- Data Provenance: Not applicable as no human data was used. The testing was in vitro (bench testing) and non-clinical. Given the manufacturer is Medtech S.A. in Montpellier, France, the testing would presumably have been conducted in a controlled lab environment at or by the manufacturer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable, as no human-in-the-loop clinical or reader studies were performed, and the evaluation was based on non-clinical performance tests against engineering specifications. The "ground truth" for the accuracy test would have been established by precise measurement tools and calibration standards (e.g., coordinate measuring machines, optical tracking systems) rather than human experts in an interpretive sense.
4. Adjudication Method for the Test Set:
Not applicable, as no human-in-the-loop or interpretive studies requiring adjudication were performed.
5. MRMC Comparative Effectiveness Study:
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The submission explicitly states: "Clinical data were not required to support the safety and effectiveness of ROSA Brain." The device's clearance is based on substantial equivalence to a predicate, primarily through non-clinical performance testing.
6. Standalone (Algorithm Only) Performance:
The device is a robotized platform providing guidance, not an AI algorithm that generates diagnostic outputs or interpretations. Its primary "performance" is in terms of the physical accuracy and reliability of its robotic positioning and guidance, as well as its software's ability to plan and execute these movements. The "System applicative accuracy" testing (Robot arm positioning accuracy < 0.75 mm RMS, Device applicative accuracy < 2mm) represents the standalone mechanical and software performance accuracy.
7. Type of Ground Truth Used:
For the "System applicative accuracy" test, the ground truth was metrological/engineering ground truth, established through precise physical measurements using calibrated equipment (e.g., optical tracking systems, mechanical benchmarks) in an in-vitro testing environment, and compared against predefined engineering tolerances.
8. Sample Size for the Training Set:
Not applicable. This device is a robotic surgical assistance system, not a machine learning model that requires a "training set" in the conventional sense of AI/ML. The software itself undergoes verification and validation, but this refers to traditional software engineering practices, not AI model training.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" for an AI/ML model for this device. The software development and testing follow standard software verification and validation procedures (IEC 62304).
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | × |
|---|---|
| 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 +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 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(K151359) | ROSA BRAIN 3.0.0.5(submission subject) |
|---|---|---|
| Device | ROSA BRAIN 3.0.0.0(K151359) | ROSA BRAIN 3.0.0.5(submission subject) |
| Indications for use | Intended for the spatial positioningand orientation of instrument holdersor tool guides to be used byneurosurgeons to guide standardneurosurgical instruments (biopsyneedle, stimulation or recordingelectrode, endoscope). The device isindicated for any neurosurgicalprocedure in which the use ofstereotactic surgery may beappropriate. | Identical |
| Where used | Neurosurgical operating room | Identical |
| User | Neurosurgeon | Identical |
| General device description | Computer controlledelectromechanical 6-axis multi-jointedarm | 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)(product version)(Medtech) | ROSANNA BRAIN (v3.0.0.5)(product version) (Medtech)Justification:Upgraded version. |
| Integrated planningsoftware | Yes | Identical |
| Define regions of interest(ROI) | Yes | Identical |
| Trajectory definition(stereotactic module) | Parameters for planning trajectories:entry point, target point, instrumentlength, diameter, name, color | Identical |
| Trajectory definition(endoscopy module) | Parameters for planning trajectories:entry point, target point, instrumentlength, diameter, name,securityradius (10mm by default),securityaperture (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(K151359) | ROSA BRAIN 3.0.0.5(submission subject) |
| Controller | Axis controller for each jointKinematic transformation between theCartesian space and joint spaceSupervisor module | Identical |
| Registration methods | Fiducial markersOptical registration deviceStereotactic frame (fiducialsmounted on the frame) | Identical |
| Fiducial markersregistration with pointerprobe | Yes | Identical |
| Optical registration withlaser telemeter | Yes | Identical |
| Laser class for opticalregistration | 2 (complies with 21 CFR 1040.10) | Identical |
| Cooperative movement | Yes | Identical |
| Accuracy verification onanatomical landmarks | Yes (navigation probe) | Identical |
| Instruments guidance | ||
| Image-guided | Yes | Identical |
| Display real-time instrumentposition on preoperativeimages | Yes | Identical |
| Mechanical guidance forsurgical instruments | Yes | Identical |
| Instrument guide positionadjustment | Automatic (robotized) | Identical |
| Surgeon carries out finalgesture through theinstrument guide withtraditional surgicalinstrument | Yes | Identical |
| Instrument fixation | Instruments are mounted onto robotarm's flange | Identical |
| Instrument calibrationmethod | Factory calibration | Identical |
| Components | Navigation probeStandard tool holderEndoscope holderMicrodrive holderOptical sensorFiducial markersHead holder adaptorLeksell frame registration plates | Navigation probeStandard tool holderEndoscope holderMicrodrive holderOptical sensorFiducial markersHead holder adaptorLeksell frame registration platesCRW FrameJustification:Addition of a compatibility to a new headholder ("CRW Frame") by adding amechanical component the "CRW FrameAdaptor" to immobilize the patient's headspecifically during DBS surgery procedure |
| Patient immobilization | Yes - The device is attached to thehead holder or the frame via an | Yes - The device is attached to a headholder or a frame via an adaptor |
| Device | ROSA BRAIN 3.0.0.0(K151359) | ROSA BRAIN 3.0.0.5(submission subject) |
| adaptor | ||
| Different -Same principle with addition of a newhead holder CRW Frame | ||
| Device mobility | Yes - Mobile stand with wheels,immobilized with 4 stabilizationfeet | 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 accuracyIn vitro testing | Performance bench Testing in compliance with internal Biometmedtech /Zimmerrobotics procedures | Testing on the subject device was performed and demonstrated to besubstantially equivalent to the predicatedevice:Robot arm positioning accuracy< 0.75 mm RMS Device applicative accuracy< 2mm |
| Electrical safety andelectromagnetic compatibility(EMC) | Testing in compliance with theIEC 60601-1:2005/A1:2012 andIEC 60601-1-2:2014 | Evaluation and testing were performed onthe subject device and demonstrated tobe substantially equivalent to thepredicate device. |
| Biocompatibility testing | Testing in compliance with FDAGuidance "Use of InternationalStandard IS10993, Biologicalevaluation of medical DevicesPart 1". | The following non clinical tests wereperformed on the predicate device :Cytotoxicity, Sensitization , Irritation andAcute systemic toxicityThe subject devices were evaluatedagainst the predicate testing anddetermined to be substantially equivalent. |
| Software Verification andValidation Testing | Software verification testing incompliance with FDA guidance"General Principles of SoftwareValidation" and IEC 62304:2006 | Evaluation and testing were performed onthe subject device and demonstratedsubstantially equivalent performance toidentified predicate device |
| Cleaning- and SterilizationValidation | Testing in compliance with FDAGuidance "ReprocessingMedical Devices in Health CareSettings: Validation Methodsand Labeling" and the followingstandards: ISO 17665-1Sterilization of health care | Evaluation was performed of the subjectdevice and demonstrated to besubstantially equivalent to the identifiedpredicate 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:Requirements forthe Development, Validationand Routine Control of aSterilization Process for MedicalDevices and ISO 17664-Sterilization of medical devices --Information to be provided bythe manufacturer for theprocessing of re-sterilizablemedical 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.
§ 882.4560 Stereotaxic instrument.
(a)
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.(b)
Classification. Class II (performance standards).