(88 days)
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.
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. 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.
The provided text describes the ROSA ONE Brain application and its substantial equivalence to a predicate device. However, it does not include detailed acceptance criteria and a study proving the device meets those criteria in the way typically expected for an AI/ML medical device submission (e.g., performance metrics like sensitivity, specificity, AUC for a diagnostic algorithm).
Instead, this document focuses on demonstrating substantial equivalence based on engineering and quality control tests rather than clinical performance of an AI algorithm making diagnostic or treatment recommendations. The "performance data" section primarily discusses electrical safety, EMC, software verification, and biocompatibility, along with a statement about system applicative accuracy derived from the predicate device's testing.
Given the information provided, here's a breakdown of what is and is not available in the document regarding your request:
1. A table of acceptance criteria and the reported device performance
Based on the document, the primary "performance data" that could be interpreted as a performance criterion is the "System applicative accuracy."
| Acceptance Criteria (Implied from Predicate) | Reported Device Performance (Inherited from Predicate) |
|---|---|
| Robot arm positioning accuracy < 0.75 mm RMS | < 0.75 mm RMS |
| Device applicative accuracy < 2 mm | < 2 mm |
Note: The document explicitly states: "Testing were performed on the predicate device. The subject devices were evaluated against the predicate testing and determined to be substantially equivalent." This implies that the current device is expected to meet these same performance levels, rather than providing new, independent test results for the current device's accuracy.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided text. The accuracy testing was "in vitro" and performed on the predicate device, not necessarily on a "test set" of clinical cases or data in the context of an AI/ML algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not available. The document does not describe the establishment of ground truth by experts in the context of clinical image interpretation or AI performance evaluation. The accuracy testing mentioned is an engineering performance bench test.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available. Adjudication methods are typically relevant for clinical studies involving human readers or expert consensus on clinical data, which is not described here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not available. The document explicitly states "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." Therefore, an MRMC comparative effectiveness study was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance test in the typical AI/ML sense (e.g., evaluating an algorithm's diagnostic accuracy on images) was not done or at least not described. The "System applicative accuracy" is a standalone test of the robot's physical positioning capabilities, not an AI algorithm's interpretive performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "System applicative accuracy," the ground truth would be precise physical measurements or a known, highly accurate reference system on a test bench. It is not based on expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set
This information is not available. The device describes a "robotized image-guided device" that assists surgeons; it does not explicitly mention an AI algorithm that is "trained" on a dataset in the way a diagnostic AI would be. The software verification and validation are for the overall embedded software system, not specifically for an AI model's training.
9. How the ground truth for the training set was established
This information is not available, for the same reasons as point 8. No specific AI training set or its ground truth establishment is described in this document.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" referenced in the document is a series of non-clinical performance tests, primarily conducted on the predicate device, and the new device (ROSA ONE 3.1.3.2) was evaluated for substantial equivalence against these established tests and performance levels.
- System Applicative Accuracy In vitro testing: This was a performance bench test designed to evaluate the physical accuracy of the robotic arm's positioning. The results stated were "<0.75 mm RMS" for robot arm positioning accuracy and "<2mm" for device applicative accuracy. These tests were performed on the predicate device, and the subject device was deemed substantially equivalent. The specific methodology would involve measuring the robot's ability to reach planned targets with precision using specialized measurement tools, but the details of the "Medtech/Zimmer robotics procedures" are not provided.
- Electrical safety and electromagnetic compatibility (EMC): Testing against IEC 60601-1 and IEC 60601-1-2 standards.
- Biocompatibility testing: Evaluation according to ISO 10993-1, including cytotoxicity, sensitization, irritation, and acute systemic toxicity performed on the predicate device.
- Software Verification and Validation Testing: Conducted according to FDA guidance and IEC 62304 standards, with the software designated as "major" concern level. This involved code inspections, unit tests, integration tests, and verification tests against requirements, followed by validation against user needs.
- Cleaning- and Sterilization Validation: Performed according to FDA guidance and ISO/AAMI standards.
In essence, the document confirms that the ROSA ONE Brain application (v.3.1.3.2), as a stereotactic instrument, relies on demonstrating its performance through engineering and quality control tests, showing substantial equivalence to a previously cleared predicate device, rather than a clinical study evaluating an AI's interpretive performance.
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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
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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
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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) |
|---|---|
| ------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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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
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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.
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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 application3.1.0.4 (K182417) | ROSA ONE 3.1.3.2Brain application(K200511) | Comparison Analysis |
|---|---|---|---|
| Device description and indications for use | |||
| General devicedescription | Computer controlledelectromechanical armproviding guidance ofneurosurgical instruments | Computer controlledelectromechanical armproviding guidance ofneurosurgical instruments | Identical |
| Indications for use | The device is intended for thespatial positioning andorientation of instrument holdersor tool guides to be used byneurosurgeons to guidestandard neurosurgicalinstruments (biopsy needle,stimulation or recordingelectrode, endoscope). Thedevice is indicated for anyneurosurgical procedure inwhich the use of stereotacticneurosurgery may beappropriate. | The device is intended for thespatial positioning andorientation of instrumentsor tool guides to be used by trained neurosurgeonsto guide standard neurosurgicalinstruments (biopsy needle,stimulation or recordingelectrode, endoscope). Thedevice is indicated for anyneurosurgical procedure inwhich the use of stereotacticneurosurgery may beappropriate. | Identical with the addition ofexplicit information on the levelof training of the surgeonsusing 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(multimodalityimage fusioncapability) | Yes | Yes | Identical |
| Device | ROSA ONE Brain application3.1.0.4 (K182417) | ROSA ONE 3.1.3.2Brain application(K200511) | Comparison Analysis |
| Integrated planningsoftware | ROSANNA BRAIN(Medtech) | ROSANNA BRAIN(Medtech) | Identical |
| Define regions ofinterest(ROI) | Yes | Yes | Identical |
| Trajectory planningparameters | Entry point, target point, lengthof the instrument, diameter,name, color | Entry point, target point, lengthof the instrument, diameter,name, color | Identical |
| Trajectorydefinition(endoscopymodule) | Parameters for planningtrajectories: entry point, targetpoint, length of the instrument,diameter, name, securityradius (10mm by default),security aperture (10° bydefault) | Parameters for planningtrajectories: entry point, targetpoint, length of the instrument,diameter, name, securityradius (10mm by default),security aperture (10° bydefault) | 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 jointKinematic transformationbetween the Cartesian spaceand joint space Supervisormodule | Axis controller for each jointKinematic transformationbetween the Cartesian spaceand joint space Supervisormodule | Identical |
| Patient registrationmethods | Fiducial markersOptical registration deviceStereotacticframe (fiducialsmounted on the frame) | Fiducial markers (skin,bone)Optical registration deviceStereotacticframe (fiducialsmounted on the frame) | Identical |
| Fiducial markersregistration withpointer probe | Yes | Yes | Identical |
| Surface matchingregistration withoptical distance sensor | Yes | Yes | Identical |
| Laser class foroptical registration | Class 2 laserWavelength - 658 nm,Maximum output- 1 mW (complies with 21 CFR1040.10) | Class 2 laserWavelength - 658, Maximumoutput - 1 mW (complies with21 CFR 1040.10) | Identical |
| Cooperativemovement | Yes | Yes | Identical |
| Device | ROSA ONE Brain application3.1.0.4 (K182417) | ROSA ONE 3.1.3.2Brain application(K200511) | Comparison Analysis |
| Accuracyverification onanatomicallandmarks | Yes | Yes | Identical |
| Instruments guidance | |||
| Image-guided | Yes | Yes | Identical |
| Real time display oftheinstrument position | Yes | Yes | Identical |
| Provide guidance forsurgical instruments | Yes | Yes | Identical |
| Instrument guidepositionadjustment | Automatic (robotized) | Automatic (robotized) | Identical |
| Surgeon carries outfinal gesture throughthe instrument guidewith traditionalsurgicalinstrument | Yes - through the instrumentguide | Yes - through the instrumentguide | Identical |
| Instrument fixation | Instruments are mounted ontorobotarm's flange | Instruments are mounted ontorobotarm's flange | Identical |
| Instruments | Instrument holder, endoscopeholder and adaptors, opticalsensor | Instrument holder, endoscopeholder and adaptors, opticalsensor | Identical |
| Instrument calibrationmethod | 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 tothe head holder or the frame viaan adaptor. | Yes - The device is attached tothe head holder or the frame viaan adaptor | Identical |
| Device mobility | Yes - Mobile stand with wheels,immobilized with 4 stabilizationfeet | Yes - Mobile stands withwheels; Robot standimmobilized with stabilizationfeet | Identical |
| Vigilancesystem | Yes - foot pedal | Yes - foot pedal | Identical |
| Sterility | Non-sterile and sterileinstrumentsDisposable sterile drapes forthe robot arm and touch screen | Non-sterile and sterileinstrumentsDisposable sterile drapes forthe robot arm and touch screen | Identical |
| Device | ROSA ONE Brain application3.1.0.4 (K182417) | ROSA ONE 3.1.3.2Brain application(K200511) | Comparison Analysis |
| Device mobility | Yes - Mobile stand with wheels,immobilized with 4 stabilizationfeet | Yes - Mobile stands withwheels; Robot standimmobilized with stabilizationfeet | Identical |
| Vigilancesystem | Yes - foot pedal | Yes - foot pedal | Identical |
| Sterility | Non-sterile and sterileinstrumentsDisposable sterile drapes forthe robot arm and touch screen | Non-sterile and sterileinstrumentsDisposable sterile drapes forthe robot arm and touch screen | Identical |
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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
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- · 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 proceduresTesting 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. |
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| 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 andValidation 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 SterilizationValidation | 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.
§ 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).