(128 days)
Not Found
No
The description focuses on robotic guidance based on pre-operative planning and registration, without mentioning any AI/ML algorithms for image analysis, planning, or real-time adjustments.
No.
The device assists the surgeon during brain surgeries by providing guidance for surgical instruments; it does not directly treat a condition or disease.
No
The device is described as a "robotized image-guided device that assists the surgeon during brain surgeries" by providing "guidance of any surgical instruments." It aids in the "spatial positioning and orientation of instruments holders or tool guides." Its primary function is to provide stable, accurate, and reproducible guidance for surgical instruments based on pre-operative planning, not to diagnose medical conditions.
No
The device description explicitly states it is composed of a "robot stand with a compact robotic arm and a touch screen," indicating significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "spatial positioning and orientation of instruments holders or tool guides to be used by trained neurosurgeons to guide standard neurosurgical instruments". This describes a surgical guidance system used during a procedure on a patient.
- Device Description: The description reinforces this by explaining it's a "robotized image-guided device that assists the surgeon during brain surgeries" and provides "guidance of any surgical instruments".
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide diagnostic information. IVDs are specifically designed for this purpose.
The device is a surgical robot designed to assist in neurosurgical procedures by providing guidance based on medical images. This falls under the category of surgical or procedural devices, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
HAW
Device Description
The ROSA One Brain application device is a robotized image-guided 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
3D MRI / CT
Anatomical Site
Head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
User: Neurosurgeon
Where used: Neurosurgical operating room
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
System applicative accuracy In vitro testing:
- Test Method Summary: Performance bench Testing in compliance with internal Biomet Medtech/Zimmer robotics procedures
- Results: 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
§ 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).
0
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
1
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
2
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.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete.
the complete instructions, search existing data sources, gather and maintain the data needed and and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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Type of Use (Select one or both, as applicable)
3
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
4
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.
5
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.
6
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 application | ||
| v.3.1.3.2 | |||
| (K200511) | ROSA ONE Brain application | ||
| v.3.1.6.0 | |||
| (submission subject) | Comparison Analysis | ||
| Merge images (multimodality | |||
| image fusion capability) | Yes | Yes | Identical |
| Integrated planning software | ROSANNA BRAIN | ||
| (Medtech) | ROSANNA BRAIN | ||
| (Medtech) | Similar | ||
| Software modified as part of this | |||
| submission | |||
| Define regions of interest | |||
| (ROI) | Yes | Yes | Identical |
| Trajectory planning | |||
| parameters | Entry point, target point, length of the | ||
| instrument, diameter, name, color | Entry point, target point, length of the | ||
| instrument, diameter, name, color | Identical | ||
| Trajectory definition | |||
| (endoscopy module) | Parameters for planning trajectories: entry | ||
| point, target point, length of the instrument, | |||
| diameter, name, security radius (10mm by | |||
| default), security aperture (10° by default) | Parameters for planning trajectories: entry | ||
| point, target point, length of the instrument, | |||
| diameter, name, security radius (10mm by | |||
| default), security aperture (10° by default) | Identical | ||
| Save/load planning | Yes | Yes | Identical |
| Patient Registration | |||
| Localization means | Robot arm absolute encoders | Robot arm absolute encoders | Identical |
| Controller | Axis controller for each joint | ||
| Kinematic transformation between the | |||
| Cartesian space and joint space | |||
| Supervisor module | Axis controller for each joint | ||
| Kinematic transformation between the | |||
| Cartesian space and joint space | |||
| Supervisor module | Identical | ||
| Patient registration methods | • Fiducial markers | ||
| • Optical registration device | |||
| • Stereotactic frame (fiducials mounted | |||
| on the frame) | • Fiducial markers (skin, bone) | ||
| • Optical registration device | |||
| • Stereotactic frame (fiducials mounted | |||
| on the frame) | Identical | ||
| Fiducial markers registration | |||
| with pointer probe | Yes | Yes | Identical |
| Surface matching registration | |||
| with optical distance sensor | Yes | Yes | Identical |
| Laser class for optical | |||
| registration | Class 2 laser | ||
| Wavelength – 658 nm, Maximum output – 1 | |||
| mW (complies with 21 CFR 1040.10) | Class 2 laser | ||
| Wavelength – 658 nm, Maximum output – 1 | |||
| mW (complies with 21 CFR 1040.10) | Identical | ||
| Device | ROSA ONE Brain application | ||
| v.3.1.3.2 | |||
| (K200511) | ROSA ONE Brain application | ||
| v.3.1.6.0 | |||
| (submission subject) | Comparison Analysis | ||
| Cooperative movement | Yes | Yes | Identical |
| Accuracy verification on | |||
| anatomical landmarks | Yes | Yes | Identical |
| Instruments guidance | |||
| Image-guided | Yes | Yes | Identical |
| Real time display of the | |||
| instrument position | Yes | Yes | Identical |
| Provide guidance for surgical | |||
| instruments | Yes | Yes | Identical |
| Instrument guide position | |||
| adjustment | Automatic (robotized) | Automatic (robotized) | Identical |
| Surgeon carries out final | |||
| gesture through the | |||
| instrument guide with | |||
| traditional surgical | |||
| instrument | Yes - through the instrument guide | Yes - through the instrument guide | Identical |
| Instrument fixation | Instruments are mounted onto robot arm's | ||
| flange | Instruments are mounted onto robot arm's | ||
| flange | Identical | ||
| Instruments | Instrument holder, endoscope holder and | ||
| adaptors, optical sensor | Instrument holder, endoscope holder and | ||
| adaptors, optical sensor | Identical | ||
| Instrument calibration method | Factory calibration | Factory calibration | Identical |
| Associated equipment | 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 application | ||
| v.3.1.3.2 | |||
| (K200511) | ROSA ONE Brain application | ||
| v.3.1.6.0 | |||
| (submission subject) | Comparison Analysis | ||
| Patient immobilization | Yes - The device is attached to the head | ||
| holder or the frame via an adaptor. | Yes - The device is attached to the head | ||
| holder or the frame via an adaptor | Identical | ||
| Device mobility | Yes - Mobile stand with wheels, | ||
| immobilized with 4 stabilization feet | Yes - Mobile stands with wheels; Robot | ||
| stand immobilized with stabilization | |||
| feet | Identical | ||
| Vigilance system | Yes - foot pedal | Yes - foot pedal | Identical |
| Sterility | Non-sterile and sterile instruments | ||
| Disposable sterile drapes for the robot arm | |||
| and touch screen | Non-sterile and sterile instruments | ||
| Disposable sterile drapes for the robot arm | |||
| and touch screen | Identical |
7
8
9
ર
10
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.
11
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 accuracy | ||
| In vitro testing | Performance bench Testing in | |
| compliance with internal Biomet | ||
| Medtech/Zimmer | ||
| robotics procedures | 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