(92 days)
Not Found
No
The description focuses on robotized image-guided assistance and 3D calculations for guidance, without mentioning AI or ML algorithms for image analysis, planning, or control.
No
The device aids surgeons in guiding instruments but does not directly treat or diagnose a disease or condition itself.
No
The device is described as an image-guided robot that assists surgeons in positioning and orienting surgical instruments. It provides "guidance of any surgical instruments" and enables "stable, accurate and reproducible guidance" for procedures like biopsies or electrode placement. It does not perform diagnostic functions itself, but rather aids in surgical interventions where diagnostic samples (like biopsies) might be taken or therapeutic devices (like electrodes) might be placed.
No
The device description explicitly states it is a "robotized image-guided device" composed of a "robot stand with a compact robotic arm and a touchscreen," indicating significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states the device is a robotized image-guided system intended for the spatial positioning and orientation of surgical instruments during neurosurgical procedures. It assists the surgeon in guiding instruments into the patient's body based on pre-operative planning and patient registration.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples or performing any tests on samples taken from the patient. Its function is purely mechanical guidance and positioning within the surgical field.
Therefore, the device's purpose and operation fall outside the scope of In Vitro Diagnostics. It is a surgical assistance device.
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 (comma separated list FDA assigned to the subject device)
HAW
Device Description
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.
Mentions image processing
Yes
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
Neurosurgeon / 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
System applicative accuracy In vitro testing: Performance bench Testing in compliance with internal Medtech/Zimmer Biomet robotics procedures. Testing were performed on the predicate device. The subject device was 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
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
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 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
2
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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3
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
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 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.
5
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.
6
VI COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Device | ROSA ONE Brain application
v.3.1.6.0
(K214065) | ROSA ONE Brain application
v. 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 application
v.3.1.6.0
(K214065) | ROSA ONE Brain application
v. 3.1.7.0
(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, Maximum output - 1
mW (complies with 21 CFR 1040.10) | Identical |
| Device | ROSA ONE Brain application
v.3.1.6.0
(K214065) | ROSA ONE Brain application
v. 3.1.7.0
(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 | Similar
Drill adaptor modified as part of this
submission |
| 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 application
v.3.1.6.0
(K214065) | ROSA ONE Brain application
v. 3.1.7.0
(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
K231103 Page 5 of 10
8
9
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 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.
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.
| Test | Test Method Summary | Results |
|---|---|---|
| System applicative accuracy | ||
| In vitro testing | Performance bench Testing in | |
| compliance with internal | ||
| Medtech/Zimmer Biomet | ||
| robotics procedures | Testing were performed on the predicate | |
| device. | ||
| The subject device was evaluated against | ||
| the predicate testing and determined to be | ||
| substantially equivalent: | ||
| Robot arm positioning accuracy |