(128 days)
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.
The ROSA One Brain application device is a robotized image-guided device that assists the surgeon during brain surgeries. lt 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 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 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 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 510(k) summary for the ROSA ONE Brain Application (K214065), a robotized image-guided device assisting in brain surgeries. The document highlights the substantial equivalence of the new version (v.3.1.6.0) to its predicate device (v.3.1.3.2) (K200511).
However, the provided document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria beyond general safety and equivalence. Instead, it refers to performance testing completed for the predicate device and states that the subject device was evaluated against that predicate testing and determined to be "substantially equivalent."
Therefore, I cannot provide a table of acceptance criteria or details about a study proving the device meets those criteria directly from the provided text, as the document explicitly states: "All validation was performed based on non-clinical performance tests." and "Clinical data were not required to support the safety and effectiveness of ROSA ONE Brain application."
Based on the provided document, here's what can be inferred and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents the following performance data as part of the summary, largely relying on the predicate device's testing and then asserting equivalence for the new device. It does not explicitly state "acceptance criteria" but rather "results" from testing.
| Acceptance Criteria (Implied from Results) | Reported Device Performance and Remarks |
|---|---|
| Biocompatibility: | Conformity with FDA guidance document Use of International Standard ISO 10993-1. |
| Electrical Safety and EMC: | Compliance with IEC 60601-1 and IEC 60601-1-2 standards and FDA EMC guidance. |
| Software Verification and Validation: | Satisfaction of FDA guidance for Software in Medical Devices and IEC 62304 standard. Software considered "major" level of concern. |
| Cleaning- and Sterilization Validation: | Compliance with FDA guidance "Reprocessing of Reusable Medical Devices," ISO 17665-1, ISO 17664, ANSI/AAMI ST79, and AAMI TIR 12. |
| System Applicative Accuracy (In vitro testing): | Robot arm positioning accuracy < 0.75 mm RMS; Device applicative accuracy < 2mm. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a quantitative "sample size" for a test set in the traditional sense of a clinical or human-in-the-loop study. The performance data presented are primarily from bench testing and evaluations related to software, electrical safety, biocompatibility, and cleaning/sterilization. These tests are generally conducted on representative units of the device or its components.
- Data Provenance: The document does not explicitly state the country of origin for the data for all tests. It mentions "internal Biomet Medtech/Zimmer robotics procedures" for a system accuracy test. The studies mentioned (biocompatibility, electrical safety, software V&V, cleaning/sterilization, and system accuracy) are non-clinical performance tests. They are retrospective in the sense that they refer to data typically collected during product development and validation phases, rather than prospective clinical trials.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable: The document describes non-clinical performance tests. There is no mention of human experts being used to establish ground truth for a test set in the context of image interpretation or diagnostic accuracy, as this is a device for surgical guidance, not diagnostic interpretation.
4. Adjudication Method for the Test Set
- Not Applicable: As there's no mention of human experts establishing ground truth for a test set for diagnostic or interpretative purposes, adjudication methods are not relevant here.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- No: The document explicitly states: "Clinical data were not required to support the safety and effectiveness of ROSA ONE Brain application." Therefore, no MRMC comparative effectiveness study was performed.
6. Standalone (Algorithm Only) Performance
- Not Applicable in the traditional sense: The device is a robotized surgical guidance system. Its "performance" is inherently tied to its mechanical and software accuracy in positioning. The software verification and validation is a standalone assessment of the software's functionality, but there isn't an "algorithm only without human-in-the-loop performance" study in the way one would assess an AI diagnostic algorithm's standalone performance. The system's output is guidance for a human surgeon.
7. Type of Ground Truth Used
- Engineering/Physical Ground Truth: For the system applicative accuracy, the ground truth would be established by precise measurements using metrology equipment on a bench setup, comparing the device's guided positions against known, true positions or planned trajectories. For other tests (biocompatibility, electrical safety, software, cleaning/sterilization), the "ground truth" is compliance with established international standards and internal protocols.
8. Sample Size for the Training Set
- Not Applicable: The ROSA ONE Brain Application is a robotized surgical guidance system, not an AI/ML model that would typically have a "training set" in the context of machine learning. The software is developed through standard engineering practices (design, coding, unit testing, integration testing, verification, validation) rather than being "trained" on a dataset like a deep learning model.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As there's no "training set" in the machine learning sense, this question is not relevant based on the provided document. The device's "knowledge" or functionality is engineered and programmed, not learned from a dataset.
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May 4, 2022
Image /page/0/Picture/1 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Medtech S.A.S Paul Hardy Regulatory Affairs Associate Director 432 rue du Rajol Mauguio, Languedoc-Roussillon 34130 France
Re: K214065
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: April 28, 2022 Received: May 4, 2022
Dear Paul Hardy:
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
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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/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 mediation-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,
Xiaolin Zheng, Ph.D. 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name ROSA ONE Brain Application
Indications for Use (Describe)
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.
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------ | ---------------------------------------------------------------------------------- |
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Type of Use (Select one or both, as applicable)
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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.
SUBMITTER l
Medtech S.A.S 432 rue du Rajol 34130 Mauguio, France Tel +33 (0)4 67 10 77 40
Contact Person :
Paul HARDY Regulatory Affairs Associate Director paul.hardy@zimmerbiomet.com
Dated prepared: May 4, 2022
ll DEVICE
| Name of Device: | ROSA ONE Brain application |
|---|---|
| Common Name : | Neurological Stereotaxic Instrument |
| Classification Name: | Stereotaxic Instrument (21 CFR 882.4560) |
| Classification Panel: | Neurology |
| Regulatory Class: | II |
| Product Code: | HAW |
| 510k #: | K214065 |
PREDICATE DEVICES ���
ROSA ONE Brain application, manufactured by Medtech S.A., K200511, cleared on May 29, 2020
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IV DEVICE DESCRIPTION
The ROSA One Brain application device is a robotized image-guided device that assists the surgeon during brain surgeries.
lt 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 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 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 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 colored lines and markers overlaid on them. The top left panel shows a 3D view of a head with lines extending from the scalp. The top right panel displays an axial view of the brain, while the bottom left panel shows a sagittal view. The bottom right panel presents a coronal view, all with the same colored lines and markers indicating specific points or regions of interest within the brain.
Figure 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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INDICATIONS FOR USE V
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.
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VI COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| ROSA ONE Brain application | ROSA ONE Brain application | ||
|---|---|---|---|
| Device | v.3.1.3.2(K200511) | v.3.1.6.0(submission subject) | 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 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 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. | Identical |
| Where used | Neurosurgical operating room | Neurosurgical operating room | Identical |
| User | Neurosurgeon | Neurosurgeon | Identical |
| Anatomical site | Head | Head | Identical |
| Principle of operation | Pre & intraoperative 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 |
| Device | ROSA ONE Brain applicationv.3.1.3.2(K200511) | ROSA ONE Brain applicationv.3.1.6.0(submission subject) | Comparison Analysis |
| Merge images (multimodalityimage fusion capability) | Yes | Yes | Identical |
| Integrated planning software | ROSANNA BRAIN(Medtech) | ROSANNA BRAIN(Medtech) | SimilarSoftware modified as part of thissubmission |
| Define regions of interest(ROI) | Yes | Yes | Identical |
| Trajectory planningparameters | Entry point, target point, length of theinstrument, diameter, name, color | Entry point, target point, length of theinstrument, diameter, name, color | Identical |
| Trajectory definition(endoscopy module) | Parameters for planning trajectories: entrypoint, target point, length of the instrument,diameter, name, security radius (10mm bydefault), security aperture (10° by default) | Parameters for planning trajectories: entrypoint, target point, length of the instrument,diameter, name, security radius (10mm bydefault), 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 jointKinematic transformation between theCartesian space and joint spaceSupervisor module | Axis controller for each jointKinematic transformation between theCartesian space and joint spaceSupervisor module | Identical |
| Patient registration methods | • Fiducial markers• Optical registration device• Stereotactic frame (fiducials mountedon the frame) | • Fiducial markers (skin, bone)• Optical registration device• Stereotactic frame (fiducials mountedon the frame) | Identical |
| Fiducial markers registrationwith pointer probe | Yes | Yes | Identical |
| Surface matching registrationwith optical distance sensor | Yes | Yes | Identical |
| Laser class for opticalregistration | Class 2 laserWavelength – 658 nm, Maximum output – 1mW (complies with 21 CFR 1040.10) | Class 2 laserWavelength – 658 nm, Maximum output – 1mW (complies with 21 CFR 1040.10) | Identical |
| Device | ROSA ONE Brain applicationv.3.1.3.2(K200511) | ROSA ONE Brain applicationv.3.1.6.0(submission subject) | Comparison Analysis |
| Cooperative movement | Yes | Yes | Identical |
| Accuracy verification onanatomical landmarks | Yes | Yes | Identical |
| Instruments guidance | |||
| Image-guided | Yes | Yes | Identical |
| Real time display of theinstrument position | Yes | Yes | Identical |
| Provide guidance for surgicalinstruments | Yes | Yes | Identical |
| Instrument guide positionadjustment | Automatic (robotized) | Automatic (robotized) | Identical |
| Surgeon carries out finalgesture through theinstrument guide withtraditional surgicalinstrument | Yes - through the instrument guide | Yes - through the instrument guide | Identical |
| Instrument fixation | Instruments are mounted onto robot arm'sflange | Instruments are mounted onto robot arm'sflange | Identical |
| Instruments | Instrument holder, endoscope holder andadaptors, optical sensor | Instrument holder, endoscope holder andadaptors, optical sensor | Identical |
| Instrument calibration method | Factory calibration | Factory calibration | Identical |
| Associated equipment | Pointer probe•Standard tool holder•Endoscope holder•Microdrive holder•Optical sensor•Fiducial markers•Head holder•Leksell frame registration plates•CPW Frame | Pointer probe•Standard tool holder•Endoscope holder•Microdrive holder•Optical sensor•Fiducial markers•Head holder•Leksell frame registration plates•CPW Frame | Identical |
| Device | ROSA ONE Brain applicationv.3.1.3.2(K200511) | ROSA ONE Brain applicationv.3.1.6.0(submission subject) | Comparison Analysis |
| Patient immobilization | Yes - The device is attached to the headholder or the frame via an adaptor. | Yes - The device is attached to the headholder or the frame via an adaptor | Identical |
| Device mobility | Yes - Mobile stand with wheels,immobilized with 4 stabilization feet | Yes - Mobile stands with wheels; Robotstand immobilized with stabilizationfeet | Identical |
| Vigilance system | Yes - foot pedal | Yes - foot pedal | Identical |
| Sterility | Non-sterile and sterile instrumentsDisposable sterile drapes for the robot armand touch screen | Non-sterile and sterile instrumentsDisposable sterile drapes for the robot armand 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 quidance 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".
Software Verification and Validation Testing
Software tests were conducted to satisfy the requirements of the FDA guidance document 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
- · 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.
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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 PERFORM ANCE TESTING
| Test | Test Method Summary | Results |
|---|---|---|
| System applicative accuracyIn vitro testing | Performance bench Testing incompliance with internal BiometMedtech/Zimmerrobotics procedures | Testing were performed on the predicatedevice.The subject devices were evaluatedagainst the predicate testing anddetermined to be substantially equivalent:• 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 predicate device.The subject device was evaluated againstthe predicate testing and determined to besubstantially equivalent. |
| 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 toxicity.The 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: 2015 | 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 Methods | Evaluation and testing were performed onthe predicate device. |
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| and Labeling" and the followingstandards: ISO 17665-1Sterilization of health careproducts -Moist heat - Part 1:Requirements forthe Development, Validation andRoutine Control of a SterilizationProcess for Medical Devices andISO 17664 Sterilization ofmedical devices --Information tobe provided by the manufacturerfor the processing of re-sterilizable medical devices | The subject device was evaluated againstthe predicate testing and determined to besubstantially equivalent. | |
|---|---|---|
| Animal studies | Not applicable | Not applicable |
| Clinical Studies | Not applicable | Not applicable |
IX CONCLUSIONS
ROSA ONE Brain application (v.3.1.6.0) is substantially equivalent in design and intended use to the predicate device - ROSA ONE Brain application (v.3.1.3.2) (K200511).
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.3.1.6.0). 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).