(92 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. It provides quidance of any surqical 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 touchscreen positioned close the operating table. 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 quidance 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, a robotized image-guided device for neurosurgery. It's an FDA 510(k) submission seeking substantial equivalence to a previously cleared version of the same device. The submission focuses on non-clinical performance data to demonstrate this equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" for each test in a formal table with pass/fail. However, it does outline the tests performed and the results, implying that the predicate device's performance levels define the acceptance criteria for the new version. The most specific performance metric provided is for accuracy.
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| System applicative accuracy (In vitro) | Robot arm positioning accuracy <0.75 mm RMS; Device applicative accuracy <2mm (based on predicate device testing) | Robot arm positioning accuracy <0.75 mm RMS; Device applicative accuracy <2mm |
| Electrical safety and EMC | Compliance with IEC 60601-1 and IEC 60601-1-2 standards (based on predicate device) | Complies with IEC 60601-1 and IEC 60601-1-2 standards |
| Biocompatibility testing | Compliance with FDA guidance ISO 10993-1 (Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity performed on predicate device) | Requirements met; Evaluated against predicate testing |
| Software Verification and Validation Testing | Compliance with FDA guidance "General Principles of Software Validation" and IEC 62304: 2015 for "major" level of concern software | Demonstrated substantially equivalent performance |
| Cleaning- and Sterilization Validation | Compliance with FDA guidance "Reprocessing Medical Devices..." and standards like ISO 17665-1, ISO 17664, ANSI/AAMI ST79, AAMI TIR 12 (based on predicate device) | Evaluated against predicate testing |
2. Sample size used for the test set and the data provenance
- System applicative accuracy: The text states "Performance bench Testing in compliance with internal Medtech/Zimmer Biomet robotics procedures." No specific sample size (number of tests or cases) for this in vitro testing is mentioned. The data provenance is internal company testing.
- For other tests (Electrical safety, EMC, Biocompatibility, Cleaning- and Sterilization Validation), the testing was largely performed on the predicate device. The subject device (ROSA ONE Brain application v. 3.1.7.0) was then evaluated against these predicate testing results, implying a comparison or re-evaluation rather than new, extensive testing on a new sample set for clinical endpoints.
- For Software Verification and Validation Testing, testing was performed on the subject device. No specific sample size (number of test cases or runs) is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The studies listed are non-clinical (bench testing, software testing, electrical safety, biocompatibility, cleaning/sterilization), which do not typically involve experts establishing ground truth in the same way clinical studies with image interpretation or patient outcomes do.
4. Adjudication method for the test set
This information is not applicable as the studies are non-clinical performance and engineering tests, not involving human interpretation of data that would require an adjudication method.
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
No MRMC comparative effectiveness study was done. 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, there is no information about human reader improvement with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
While the device is a "robotized image-guided device," the performance data presented is for the entire system's accuracy and various engineering aspects. The "Software Verification and Validation Testing" does cover the algorithm's performance within the broader software system. The statement that "Robot arm positioning accuracy <0.75 mm RMS Device applicative accuracy <2mm" can be considered a standalone performance metric for the device's mechanical and software-guided capabilities, demonstrating its ability to meet a precision target independently of a human's final surgical action. However, it's not an "algorithm-only" performance in the sense of an AI diagnostic tool.
7. The type of ground truth used
- System applicative accuracy: The ground truth would be precise, known physical measurements and positions in a controlled bench test environment.
- Electrical safety and EMC: Ground truth is defined by the absolute limits and requirements of the IEC 60601-1 and IEC 60601-1-2 standards.
- Biocompatibility testing: Ground truth is established by the specified biological responses (e.g., cell viability for cytotoxicity, skin reaction for irritation) determined according to ISO 10993-1.
- Software Verification and Validation Testing: Ground truth is defined by the software requirements and design specifications, against which the software's behavior is verified and validated.
- Cleaning- and Sterilization Validation: Ground truth is defined by the absence of viable microorganisms or acceptable residual soil levels, determined according to standards like ISO 17665-1, ISO 17664, ANSI/AAMI ST79, and AAMI TIR 12.
8. The sample size for the training set
This information is not provided and is not applicable to this submission. The device is a robotized stereotaxic instrument, not an AI/ML device that requires a distinct "training set" for model development. The software verification and validation are against pre-defined requirements, not derived from a training dataset.
9. How the ground truth for the training set was established
This question is not applicable as there is no mention of a training set for an AI/ML model in this submission.
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July 20, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a blue square and the full name written in a sans-serif font.
Medtech S.A.S. Paul Hardy Regulatory Affairs Director 432 Rue du Rajol Mauguio, Languedoc-Roussillon 34130 France
Re: K231103
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 14, 2023 Received: April 19, 2023
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 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).
Sincerelv.
Adam D. Digitally signed by Adam D. Pierce -S Pierce -> 14:24:34 -04'00'
Adam D. Pierce, Ph.D. 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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Indications for Use
510(k) Number (if known) K231103
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X 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 క్తి807.92.
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 Director paul.hardy@zimmerbiomet.com
Dated prepared: June 20, 2023
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 #: | K231103 |
PREDICATE DEVICES llll
ROSA ONE Brain application, manufactured by Medtech S.A.S, K214065, cleared on May 4, 2022
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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 quidance of any surqical 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 touchscreen positioned close the operating table.
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 lines and markers overlaid. The top left panel displays a 3D view of a head with lines projecting from the scalp. The top right panel shows an axial view of the brain with colorful markers and lines intersecting at various points. The bottom panels display sagittal and coronal views of the brain, also with lines and markers indicating specific locations or pathways within the brain structure.
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 quidance 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.
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VI COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Device | ROSA ONE Brain applicationv.3.1.6.0(K214065) | ROSA ONE Brain applicationv. 3.1.7.0(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.3.1.6.0(K214065) | ROSA ONE Brain applicationv. 3.1.7.0(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 mounted●on the frame) | Fiducial markers (skin, bone)●Optical registration device●Stereotactic frame (fiducials mounted●on 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, Maximum output - 1mW (complies with 21 CFR 1040.10) | Identical |
| Device | ROSA ONE Brain applicationv.3.1.6.0(K214065) | ROSA ONE Brain applicationv. 3.1.7.0(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 | SimilarDrill adaptor modified as part of thissubmission |
| 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 adaptor• Leksell frame registration plates• CRW Frame | • Pointer probe• Standard tool holder• Endoscope holder• Microdrive holder• Optical sensor• Fiducial markers• Head holder adaptor• Leksell frame registration plates• CRW Frame | Identical |
| Device | ROSA ONE Brain applicationv.3.1.6.0(K214065) | ROSA ONE Brain applicationv. 3.1.7.0(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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K231103 Page 5 of 10
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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".
Software Verification and Validation Testing
Software tests were conducted to satisfy the requirements of the FDA quidance 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.
| Test | Test Method Summary | Results |
|---|---|---|
| System applicative accuracyIn vitro testing | Performance bench Testing incompliance with internalMedtech/Zimmer Biometrobotics procedures | Testing were performed on the predicatedevice.The subject device was evaluated againstthe predicate testing and determined to besubstantially 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 ISO10993, Biologicalevaluation of medical DevicesPart 1". | The following non clinical tests wereperformed on the predicate device:Cytotoxicity, Sensitization, Irritation andAcute systemic toxicity.The subject device was evaluated againstthe predicate testing and determined to besubstantially 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. |
VIII SUMMARY OF NON CLINICAL PERFORMANCE TESTING
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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. 3.1.7.0) is substantially equivalent in design and intended use to the predicate device - ROSA ONE Brain application (v.3.1.6.0) (K214065).
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. 3.1.7.0). 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).