(30 days)
Not Found
No
The description focuses on optical position determination technology and standard navigation system principles, with no mention of AI or ML.
No.
The device is an intraoperative guidance system that provides imaging and navigation capabilities during surgical procedures; it does not directly treat or cure a disease or condition.
No
The device is an intraoperative guidance system that provides visualization and navigation during surgical procedures. It does not provide a diagnosis of a disease or condition.
No
The device description explicitly lists hardware components such as a stereoscopic camera (SURGIVISIO Camera Pole), a computer platform with monitors (SURGIVISIO Station), and a robotic arm (CoBot) in addition to the software.
Based on the provided information, the SURGIVISIO Device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly describes the device as being used during surgical procedures for visualization and guidance of instruments within the body. This is an in vivo application, meaning it interacts directly with the patient's body.
- Device Description: The description details a system involving cameras, computers, software, and robotic arms used for tracking and guiding instruments during surgery. This aligns with a surgical navigation and guidance system, not a device used to examine specimens outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological specimens (blood, tissue, urine, etc.) or to provide information about a patient's health status based on such analysis. IVDs are designed for testing samples in vitro (in glass or outside the body).
Therefore, the SURGIVISIO Device falls under the category of a surgical navigation and guidance system, which is a type of medical device used in vivo, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The SURGIVISIO Device is indicated to be used during surgical procedures in which the physician would benefit from the visualization of 2D medical intraoperatively generated 3D medical imaging of anatomical structures or objects with high x-ray attenuation such as bony anatomy or metallic objects. Such procedures during which the spine, pelvis, or articulation structures are visualized
The SURGIVISIO Device through its freehand navigation feature is indicated as an intraoperative guidance system to enable open or percutaneous computer-assisted surgery.
It is indicated for conditions of the spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical bony structure can be identified relative to the intraoperatively generated 3D image of the anatomy provided by the SURGIVISIO Device.
It is indicated to precisely position the Navigated Targeting Needle SPX I during general spinal procedures with a posterior approach.
The SURCIVISIO Device through its robotic guidance feature is indicated for the positioning of instrument holders or tool guides to be used by surgeons to guide the Spine CoBot instruments during general spinal surgery. Guidance is based on an intra-operative plan developed with three-dimensional imaging software based on intra-operative 3D images provided by the SURGIVISIO Device.
It is indicated for positioning of surgical instruments in vertebrae with a posterior approach in the thoracolumbar region.
The SPX1 Instrument and Spine CoBot instruments are designed to be used with the SURGIVISIO Device.
Product codes
OLO
Device Description
The SURGIVISIO Device is a medical device that provides 2D/3D medical imaging and stereotaxic guidance. The subject device offers two stereotaxic quidance features: freehand navigation and robotic guidance. The freehand navigation feature is based on the standard and established technique of navigation systems utilizing optical position determination technology. Like currently marketed optical tracking navigation systems, the operating principle of the freehand navigation feature is based upon the use of a stereoscopic camera emitting infrared light which can determine a 3D position of reflective marker spheres. This allows for real-time tracking of the marker spheres. The system components include a stereoscopic camera (SURGIVISIO Camera Pole), a computer platform with monitors (SURGIVISIO Station) and navigation software (3D Spine Universal Workflow software application) and instruments equipped with marker spheres to enable an exact localization in space. The robotic quidance feature utilizes the same principle of optical position determination technology. The system components include a stereoscopic camera (SURGIVISIO Camera Pole), a computer platform with monitors (SURGIVISIO Station) and a navigation software (3D Spine Robotic Workflow software application), a robotic arm (CoBot), and instruments equipped with marker spheres to enable an exact localization in space.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
2D medical imaging, intraoperatively generated 3D medical imaging
Anatomical Site
spine, pelvis, or articulation structures, thoracolumbar region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / during surgical procedures.
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)
Nonclinical tests: The following nonclinical tests were performed on the SURGIVISIO Device to demonstrate substantial equivalence of safety and efficacy with the predicate device:
- The Sterilization validation part of the reprocessing validation of the Spine CoBot Instruments has been performed.
- A cadaveric study has been performed to assess:
- The accuracy of the robotic quidance feature
- The safety of the robotic guidance feature
Clinical tests: No clinical tests were conducted to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Device 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
Image /page/0/Picture/0 description: The image shows the date July 27, 2023. The month is July, the day is 27, and the year is 2023. The date is written in a clear, legible font. The text is black on a white background.
Ecential Robotics Elodie Bouillet Design Process & Regulatory Affaires Manager Zone Mayencin II, Parc Equation - Bâtiment 1
Gieres, 38610 France
tance
Re: K231886
2 avenue de Vignate
Trade/Device Name: SURGIVISIO Device Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: June 27, 2023 Received: June 27, 2023
Dear Elodie Bouillet:
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see 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.
Shumaya Ali -S
Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231886
Device Name SURGIVISIO Device
Indications for Use (Describe)
The SURGIVISIO Device is indicated to be used during surgical procedures in which the physician would benefit from the visualization of 2D medical intraoperatively generated 3D medical imaging of anatomical structures or objects with high x-ray attenuation such as bony anatomy or metallic objects. Such procedures during which the spine, pelvis, or articulation structures are visualized
The SURGIVISIO Device through its freehand navigation feature is indicated as an intraoperative guidance system to enable open or percutaneous computer-assisted surgery.
It is indicated for conditions of the spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical bony structure can be identified relative to the intraoperatively generated 3D image of the anatomy provided by the SURGIVISIO Device.
It is indicated to precisely position the Navigated Targeting Needle SPX I during general spinal procedures with a posterior approach.
The SURCIVISIO Device through its robotic guidance feature is indicated for the positioning of instrument holders or tool guides to be used by surgeons to guide the Spine CoBot instruments during general spinal surgery.
Guidance is based on an intra-operative plan developed with three-dimensional imaging software based on intra-operative 3D images provided by the SURGIVISIO Device.
It is indicated for positioning of surgical instruments in vertebrae with a posterior approach in the thoracolumbar region.
The SPX1 Instrument and Spine CoBot instruments are designed to be used with the SURGIVISIO Device.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 区 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
Submitter Information
| Submitter: | ECENTIAL ROBOTICS
2 avenue de Vignate
Zone Mayencin II, Parc Equation – Bâtiment 1
38610 Gières
France |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Elodie BOUILLET
Project Quality & Regulatory Affairs Manager
Phone : 0033 6 37 82 07 90
Email: elodie.bouillet@ecential-robotics.com |
Date Summary Prepared: June 27, 2022
Device Information
| Trade or proprietary
| name | SURGIVISIO Device |
|---|---|
| Common or usual name | |
| Classification Name | |
| Regulation Number | |
| Regulatory class | |
| Primary product code | Orthopedic Stereotaxic Instrument |
| Stereotaxic Instrument | |
| 21 CFR 882.4560 | |
| II | |
| OLO | |
| Legally marketed device | |
| to which equivalence is | |
| claimed | SURGIVISIO Device by ECENTIAL ROBOTICS: |
- Primary predicate K221028
- Other predicates
o K202547
o K220946
o K220627 |
| Scope of the
submission | The subject device is the SURGIVISIO Device which
enables 2D/3D medical imaging and stereotaxic guidance.
The 2D/3D medical imaging feature was cleared originally
via 510(k) K202547 and via Special 510(k) K220946 and
K220627. The stereotaxic guidance including freehand
navigation and robotic guidance feature was cleared via
510(k) K221028.
The scope of this current submission is limited to the design
modification of the Spine CoBot instruments which are used
for the Robotic Guidance feature. |
| Device Description | The SURGIVISIO Device is a medical device that provides
2D/3D medical imaging and stereotaxic guidance. The |
4
subject device offers two stereotaxic quidance features: freehand navigation and robotic guidance.
The freehand navigation feature is based on the standard and established technique of navigation systems utilizing optical position determination technology. Like currently marketed optical tracking navigation systems, the operating principle of the freehand navigation feature is based upon the use of a stereoscopic camera emitting infrared light which can determine a 3D position of reflective marker spheres. This allows for real-time tracking of the marker spheres. The system components include a stereoscopic camera (SURGIVISIO Camera Pole), a computer platform with monitors (SURGIVISIO Station) and navigation software (3D Spine Universal Workflow software application) and instruments equipped with marker spheres to enable an exact localization in space.
The robotic quidance feature utilizes the same principle of optical position determination technology. The system components include a stereoscopic camera (SURGIVISIO Camera Pole), a computer platform with monitors (SURGIVISIO Station) and a navigation software (3D Spine Robotic Workflow software application), a robotic arm (CoBot), and instruments equipped with marker spheres to enable an exact localization in space.
Indications for use The SURGIVISIO Device is indicated to be used during surgical procedures in which the physician would benefit from the visualization of 2D medical imaging and/or intraoperatively generated 3D medical imaging of anatomical structures or objects with high x-ray attenuation such as bony anatomy or metallic objects. Such procedures include procedures during which the spine, pelvis, or articulation structures are visualized.
The SURGIVISIO Device through its freehand navigation feature is indicated as an intraoperative guidance system to enable open or percutaneous computer-assisted surgery. It is indicated for conditions of the spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical bony structure can be identified relative to the intraoperatively generated 3D image of the anatomy provided by the SURGIVISIO Device. It is indicated to precisely position the Navigated Targeting Needle SPX1 during general spinal procedures with a posterior approach.
The SURGIVISIO Device through its robotic quidance feature is indicated for the positioning of instrument holders or tool guides to be used by surgeons to guide the Spine CoBot instruments during general spinal surgery. Guidance
5
is based on an intra-operative plan developed with threedimensional imaging software based on intraoperative 3D images provided by the SURGIVISIO Device. It is indicated for positioning of surgical instruments in vertebrae with a posterior approach in the thoracolumbar region.
The SPX1 Instruments and Spine CoBot instruments are designed to be used with the SURGIVISIO Device.
- Technology comparison Increase of instruments diameters, modification of the shape of the CoBot, Drill Guide - Sleeve teeth, CoBot, Drill Bit tip and CoBot, Drill Bit connection to power tool. The technology is not impacted by the discussed device change.
- Biocompatibility Same as the predicate. The discussed device change, object of this Special 510(K) submission does not require to re-perform Biocompatibility testing as the raw material, manufacturing additives as well as manufacturing processes are not modified following the design change.
- Electrical Safety Testing Same as the predicate. The discussed device change, object of this Special 510(K) submission does not impact Electrical Safety.
- Performance Testing Same as the predicate. The accuracy and safety assessment (cadaveric study) were redone in order to ensure that the design modification on the Spine CoBot Instruments do not impact the accuracy and the safety of the Robotic Guidance Feature of the SURGIVISIO Device.
Software Testing Same as the predicate
- Based upon comparison of devices and performance Conclusion testing results. SURGIVISIO Device is substantially equivalent to the predicate device.
Summary of the technological characteristics of the device compared to the predicate device
| Characteristics | Robotic guidance feature
of the SURGIVISIO Device
(Subject device) | Robotic guidance feature
of the SURGIVISIO Device
(K221028)
(Predicate device) | Discussion |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The SURGIVISIO Device
through its robotic guidance
feature is indicated for the | The SURGIVISIO Device
through its robotic guidance
feature is intended for the | Similar: word "intended"
replaced by "indicated", |
| Characteristics | Robotic guidance feature
of the SURGIVISIO Device
(Subject device) | Robotic guidance feature
of the SURGIVISIO Device
(K221028)
(Predicate device) | Discussion |
| | positioning of instrument
holders or tool guides to be
used by surgeons to guide
the Spine CoBot instruments
during general spinal
surgery.
Guidance is based on an
intra-operative plan
developed with three-
dimensional imaging
software based on intra-
operative 3D images
provided by the
SURGIVISIO Device.
It is indicated for positioning
of surgical instruments in
vertebrae with a posterior
approach in the
thoracolumbar region.
The SPX1 instruments and
Spine CoBot instruments
are designed to be used
with the SURGIVISIO
Device. | positioning of instrument
holders or tool guides to be
used by surgeons to guide
the Spine CoBot instruments
during general spinal
surgery.
Guidance is based on an
intra-operative plan
developed with three-
dimensional imaging
software based on intra-
operative 3D images
provided by the
SURGIVISIO Device.
It is indicated for positioning
of surgical instruments in
vertebrae with a posterior
approach in the
thoracolumbar region.
The SPX1 instruments and
Spine CoBot instruments
are intended to be used with
the SURGIVISIO Device. | "intended" replaced by
"designed" while the
statement of indications
for use is the same. Safety
and performance of the
system are not questioned. |
| Anatomical site | The SURGIVISIO Device
through its robotic guidance
feature is indicated for
positioning of surgical
instruments in vertebrae
with a posterior approach in
the thoracolumbar region. | The SURGIVISIO Device
through its robotic guidance
feature is indicated for
positioning of surgical
instruments in vertebrae
with a posterior approach in
the thoracolumbar region. | Identical |
| Patient population | The SURGIVISIO Device
through its robotic guidance
feature is indicated for a
population with medical
conditions requiring the
treatment of diseases with
the placement of spinal
instruments and for which
the use of stereotactic
surgery may be considered
to be appropriate and after
consideration of the
compatibility of patient
spinal anatomy with
dimensions of the Spine
CoBot Instruments and
dimensions of virtual
implants proposed by the 3D
Spine Robotics workflow
surgical plan. | The SURGIVISIO Device
through its robotic guidance
feature is indicated for a
population with medical
conditions requiring the
treatment of diseases with
the placement of spinal
instruments and for which
the use of stereotactic
surgery may be considered
to be appropriate and after
consideration of the
compatibility of patient
spinal anatomy with
dimensions of the Spine
CoBot Instruments and
dimensions of virtual
implants proposed by the 3D
Spine Robotics workflow
surgical plan. | Identical |
| Characteristics | Robotic guidance feature
of the SURGIVISIO Device
(Subject device) | Robotic guidance feature
of the SURGIVISIO Device
(K221028)
(Predicate device) | Discussion |
| General device
technology description | Computer-controlled
electromechanical arm
guiding neurosurgical
instruments | Computer-controlled
electromechanical arm
guiding neurosurgical
instruments | Identical |
| Global system
functional principal | Stereotactic robotic
navigation guidance of spine
surgical instrument based
on an intra-operative plan
developed with three-
dimensional imaging
software which is based on
intraoperative 3D images
using an optical system
(infrared camera) | Stereotactic robotic
navigation guidance of spine
surgical instrument based
on an intra-operative plan
developed with three-
dimensional imaging
software which is based on
intraoperative 3D images
using an optical system
(infrared camera) | Identical |
| Surgical work Flow | 1. Patient and device
installation
2. Intraoperative image
acquisition
3. Registration
4. Intraoperative planning
5. Spine instrument holder
positioning
6. Instrument guidance
7. Screw implantation | 1. Patient and device
installation
2. Intraoperative image
acquisition
3. Registration
4. Intraoperative planning
5. Spine instrument holder
positioning
6. Instrument guidance
7. Screw implantation | Identical |
| Graphical User
Interface | System-specific GUI | System-specific GUI | Identical |
| Surgeon control | - The surgeon
controls the motion
of the robotic arm
from one screw
position to the next
by pressing the foot
pedal and the
manual button. | - The surgeon
controls the motion
of the robotic arm
from one screw
position to the next
by pressing the foot
pedal and the
manual button. | Identical |
| | The surgeon carries out the
final positioning through the
instrument guide with a
traditional surgical
instrument. | The surgeon carries out the
final positioning through the
instrument guide with a
traditional surgical
instrument. | |
| Device accuracy | - Device accuracy: