(90 days)
Not Found
No
The device description focuses on optical position determination technology and standard navigation system principles, with no mention of AI or ML.
No.
This device is an intraoperative guidance system used during surgical procedures to aid physicians in visualizing anatomical structures, performing computer-assisted surgery, and positioning instruments, rather than directly treating a disease or condition itself.
No
Explanation: The device provides imaging and guidance for surgical procedures. While it generates images that could be used for diagnosis, its primary stated purpose is for intraoperative visualization and guidance, not for diagnosing conditions.
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 IVD (In Vitro Diagnostic) device.
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 patient's body. This is an in vivo application, not an in vitro (outside the body) diagnostic test performed on biological samples.
- Device Description: The description details a system for medical imaging and stereotaxic guidance using optical tracking technology to determine the position of instruments relative to the patient's anatomy. This is consistent with surgical navigation and guidance systems.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is to aid the surgeon during the procedure itself.
Therefore, the SURGIVISIO Device falls under the category of a surgical guidance or navigation system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SURGIVISIO Device is intended 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 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 guidance feature is intended 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 SPX1InstrumentsSPX1 Instrument and Spine CoBot instruments are intended 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 guidance 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 guidance feature utilizes the same principle of optical position determination technology. The system componentss 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, 3D CT scans (predicate device)
Anatomical Site
spine, pelvis, or articulation structures, thoracolumbar region (vertebrae)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician, surgeons, surgical procedures, computer-assisted surgery
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
Nonclinical tests:
- Design verification tests were performed based on risk management activities and product requirements.
- Software development and testing activites were conducted in accordance with IEC 62304 Medical device software – Life cycle processes and FDA guidance.
- Biocompatibility was evaluated and testing in accordance with ISO 10993 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process..
- Electrical safety and electromagnetic compatibility (EMC) testing were conducted in accordance with IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance and IEC 60601-1-1 Medical electrical equipment – Part 1- 1: General requirements for safety – Collateral standard: Safety requirements for medical electrical systems.
- The SURGIVISIO Device was validated with intended users in cadaver labs and simulated use testing to ensure the users' needs and intended use requirements were met.
All test requirements were met, no new issues of safety or effectiveness were raised, and substantial equivalence was demonstrated.
Clinical tests:
No clinical tests were conducted to demonstrate substantial equivalence.
Key Metrics
Mean navigation accuracy of ± 2mm point (tip) displacement and ± 2° angular axis displacement
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
July 6, 2022
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 with the full name of the agency on the right. The seal features an eagle with outstretched wings, while the FDA part has the acronym in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
Ecential Robotics Sarah Lefevre-Billard Zone Mayencin II, Parc Equation - Bâtiment 1, 2 avenue de Vignate Gieres. 38610 France
Re: K221028
Trade/Device Name: SURGIVISIO Device Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: April 4, 2022 Received: April 7, 2022
Dear Sarah Lefevre-Billard:
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,
For: Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221028
Device Name SURGIVISIO Device
Indications for Use (Describe)
The SURGIVISIO Device is intended 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 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 guidance feature is intended 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 SPX1InstrumentsSPX1 Instrument and Spine CoBot instruments are intended to be used with the SURGIVISIO Device.
| 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
Submitter Information
| Submitter: | ECENTIAL ROBOTICS
2 avenue de Vignate
Zone Mayencin II, Parc Equation – Bâtiment 1
38610 Gières
France |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mathilde SAULPIC
Quality and Regulatory Affairs Engineer
Phone: +33 4 58 00 57 21
Email: mathilde.saulpic@ecential-robotics.com |
| Date Summary Prepared: | April 4th, 2022 |
| Device Information | |
| Trade or proprietary name: | SURGIVISIO Device |
| Common or usual name: | Orthopedic Stereotaxic Instrument |
| Classification Name: | Stereotaxic Instrument |
| Regulation Number: | 21 CFR 882.4560 |
| Regulatory class: | II |
| Primary product code: | OLO |
| Legally marketed device to which equivalence is claimed: | K141941 Stryker SpineMap® 3D Navigation System
(available with SpineMask™ tracking device) by Stryker
Leibinger GmbH & Co for the free hand navigation feature of the SURGIVISIO Device [Primary], and
K182848 ROSA® ONE Spine application by Medtech
S.A.(Zimmer Biomet) for the robotic guidance feature of the SURGIVISIO Device. |
| Device Description: | The SURGIVISIO Device is a medical device that
provides 2D/3D medical imaging and stereotaxic
guidance. The subject device offers two stereotaxic
guidance 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 |
| Traditional 510(k)
Section 05 – 510(k) Summary | SURGIVISIO
Device |
| | 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 guidance feature utilizes the same principle
of optical position determination technology. The system
componentss 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 intended 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 intended 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 guidance
feature is intended 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 instruments and Spine CoBot instruments are
intended to be used with the SURGIVISIO Device. |
4
5
Summary of Technological Characteristics and Comparison to Predicate Device
There are no new technological characteristics in the SURGIVISIO Device as compared to the predicate device. A comparison of the technological characteristics of the SURGIVISIO Device freehand navigation feature to the predicate, the Stryker SpineMap® 3D Navigation System (available with the SpineMask™ tracking device) is provided below:
| Characteristics | Free Hand Navigation Feature of
the SURGIVISIO Device | The Stryker SpineMap® 3D
Navigation System with
SpineMask™ tracking device
(K141941) |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (Subject device) | (Predicate device) |
| Intended use | The SURGIVISIO Device through its
freehand navigation feature is
intended as an intraoperative
guidance system to enable open or
percutaneous computer-assisted
surgery.
It is indicated for conditions of the | The Stryker SpineMap® 3D Navigation
System, when used with a Stryker
computer workstation, is intended as a
planning and intraoperative guidance
system to enable open or percutaneous
computer-assisted surgery.
The system is indicated for any medical |
| | 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. | condition in which the use of computer-
assisted planning and surgery may be
appropriate. The system can be used
for intraoperative guidance where a
reference to a rigid anatomical structure
can be identified.
The Stryker SpineMap® 3D Navigation
System assists in the precise
positioning of instruments for
procedures on the spine, including:
• Pedicle screw placement
Stryker SpineMask™ Tracker
Indications for Use
The Stryker SpineMask™ Tracker is
intended to be used as an accessory to
the Stryker SpineMap® 3D Navigation
System. It is placed onto the patient's
skin dorsal to the spine.
• In combination with
intraoperative imaging devices, it
enables automatic patient registration |
| | | Device |
| | | for open or percutaneous computer-
assisted surgery.
• When used for patient tracking,
the Stryker SpineMask™ Tracker
supports minimally invasive procedures
on the lumbar and thoracic spine |
| Principle of
operation | Uses established computer-assisted
orthopedic surgery technologies to
navigate targeting needles. | Uses established computer-assisted
orthopedic surgery technologies to
navigate targeting needles. |
| | Optical localization technology is used
to collect intraoperative data and track
the relative position of the navigated
targeting needle during surgery | Optical localization technology is used
to collect intraoperative data and track
the relative position of the navigated
targeting needle during surgery |
| | Uses infrared optical passive sensing
technology to collect intraoperative
data and track the relative position of
the navigated targeting needle during
surgery | Uses infrared optical active sensing
technology to collect intraoperative
data and track the relative position of
the navigated targeting needle during
surgery |
| | Uses Automatic Intraoperative
Registration | Uses Automatic intraoperative
registration or anatomical registration
or 3D C-Arm registration |
| | If the computer unit or camera fails,
the user reverts to conventional
manual | If the computer unit or camera fails, the
user reverts to conventional manual |
| System
accuracy
Statement | Mean navigation accuracy of ± 2mm
point (tip) displacement and ± 2°
angular axis displacement | Mean navigation accuracy of ± 2mm
point (tip) displacement and ± 2°
angular axis displacement |
| Dedicated
Software | Dedicated freehand spine navigation
application software | Dedicated freehand spine navigation
application software |
| Characteristics | Robotic guidance feature of the
Surgivisio Device
(Spine CoBot Solution)
(Subject device) | ROSA One Spine application
(K182848)
(Predicate device) |
| Intended use | The SURGIVISIO Device through its
robotic guidance feature is intended
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 instruments and Spine
CoBot instruments are intended to be
used with the SURGIVISIO Device. | The ROSA one spine application is
intended for the spatial positioning and
orientation of instrument holders or tool
guides to be used by surgeons to guide
standard surgical instruments during
spine surgeries. Guidance is based on
an intraoperative plan developed with
three-dimensional imaging software
provided that the required fiducial
markers and rigid patient anatomy can
be identified on 3D CT scans. The
device is intended for the placement of
pedicle screws in vertebrae with a
posterior approach in the
thoracolumbar region |
| General device
technology
description | Computer-controlled
electromechanical arm guiding
neurosurgical instruments | Computer-controlled
electromechanical arm guiding
neurosurgical instruments |
| 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) |
| Device
accuracy | - Device accuracy: