(205 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the performance studies focus on standard imaging and reconstruction quality, not AI/ML model validation.
No
This device is an imaging system (mobile x-ray system) that provides visualization for diagnostic and surgical guidance purposes, not directly delivering therapy.
Yes
Explanation: The device is intended for the "visualization of 2D medical imaging and/or intraoperatively generated 3D medical imaging of anatomical structures" to inform a physician during surgical procedures, which is a diagnostic function.
No
The device description explicitly states the system consists of two mobile interconnected units: a mobile C-arm and a mobile viewing Workstation, both of which contain significant hardware components (high voltage generator, X-ray tube, detector, computer, monitors, etc.). It is a hardware system with integrated software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- SURGIVISIO Function: The SURGIVISIO system is an imaging device used during surgical procedures to visualize anatomical structures and objects within the body using X-rays. It does not analyze samples taken from the body.
The description clearly indicates it's a mobile X-ray system for intraoperative imaging and surgical guidance, which falls under the category of medical imaging and surgical support devices, not IVDs.
N/A
Intended Use / Indications for Use
The SURGIVISIO medical 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.
Product codes
OWB, OXO, JAA
Device Description
The Surgivisio system is a mobile x-ray system which provides 2D imaging and allows the generation of intraoperative 3D information of high contrast objects and anatomical structures.
The system consists of two mobile interconnected units: a mobile C-arm and a mobile viewing Workstation. These units are moved manually and are interconnected by a single cable that provides power and transfer of data and controls.
The mobile C-arm comprises a high voltage generator, foot switches for radiation release, laser target devices, electronics cabinet, collision avoidance system, and a C-shaped structure mounting the X-ray tube assembly and the flat X-ray detector on distal ends of the 'C'.
The mobile viewing workstation comprises a computer, an image detector process unit, the main power supply, radiation indicator, dual viewing monitors and a user interface for patient management and image handling.
The system integrates a Computer Aided Surgery (CAS) feature that supports instruments positioning during surgical procedures.
Mentions image processing
The mobile viewing workstation comprises a computer, an image detector process unit, the main power supply, radiation indicator, dual viewing monitors and a user interface for patient management and image handling.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
spine, pelvis or articulation structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician / 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)
The following nonclinical tests were performed on the Surgivisio system to demonstrate substantial equivalence of safety and efficacy with the predicate device:
- IEC 60601-1 (Edition 3.1): Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2 (Edition 4.0): Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-3 (Edition 2.1): Medical electrical equipment Part 1-3 : General requirements for basic safety and essential performance - Collateral Standard : Radiation protection in diagnostic X-ray equipment
- IEC 60601-2-43 (Edition 2.1): Medical electrical equipment Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures
- IEC 60601-2-54 (Edition 1.1): Medical electrical equipment Part 2-54: Particular i requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy [Including: Amendment 2 (2018)]
- 2D Image Quality Assessment of the Surgivisio system provides a quantitative image quality assessment of subject device in comparison to the predicate device
- Basic CBCT bench testing using phantoms and based on standard IEC 60601-2-44 (Edition 3.2) Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography. to demonstrate the effectiveness and safety of the subject device
- Concurrence study using a distortion phantom to demonstrate the ability of the subject device to provide 3D images equivalent to those of the predicate device
- Quality characterization of the iterative 3D reconstruction algorithm to demonstrate the effectiveness of the 3D imaging feature
- 3D image quality assessment with breathing simulation to demonstrate the effectiveness of the 3D imaging feature
- Sample clinical images evaluated by a qualified expert to support the intended use of the 2D and 3D imaging features
- Comparison of radiation doses associated with clinical image data provided by the subject device to literature
- Software Verification testing verifying the software requirements perform as intended -
Clinical tests: No clinical tests were conducted to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
March 26, 2021
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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Surgivisio % Elodie Bouillet Quality and Regulatory Affairs Engineer Zone Mayencin II, Parc Equation - Bâtiment 1 2 Avenue de Vignate Gières, 38610 FRANCE
Re: K202547
Trade/Device Name: Surgivisio system Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, OXO, JAA Dated: February 23, 2021 Received: March 1, 2021
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.
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).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202547
Device Name Surgivisio system
Indications for Use (Describe)
The SURGIVISIO medical 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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☑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 K202547
Submitter Information
| Submitter: | Surgivisio
Zone Mayencin II, Parc Equation – Bâtiment 1
2 avenue de Vignate
38610 Gières
France |
|------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Vincent Leré
Quality/Regulatory Affairs Director
Phone : 33-4-58 00 57 21
Email: vincent.lere@surgivisio.com |
| Date Summary Prepared: | July 31st, 2020 |
Device Information
| Trade or proprietary name: | Surgivisio system |
|---|---|
| Common or usual name: | Mobile Interventional Fluoroscopic X-ray System |
| Classification Name: | Interventional Fluoroscopic X-Ray System |
| Regulation Number: | 21 CFR 892.1650 - Image-intensified fluoroscopic x-ray system |
| Regulatory class: | II |
| Primary product code: | OWB |
| Legally marketed device to which equivalence is claimed: | K042793 - Arcadis Orbic (available with options 3D and 3D navigation interface) - Manufacturer: Siemens Medical Solutions, Inc |
| Device Description: | The Surgivisio system is a mobile x-ray system which provides 2D imaging and allows the generation of intraoperative 3D information of high contrast objects and anatomical structures. |
| The system consists of two mobile interconnected units: a mobile C-arm and a mobile viewing Workstation. These units are moved manually and are interconnected by a single cable that provides power and transfer of data and controls. |
4
The mobile C-arm comprises a high voltage generator, foot switches for radiation release, laser target devices, electronics cabinet, collision avoidance system, and a C-shaped structure mounting the X-ray tube assembly and the flat X-ray detector on distal ends of the 'C'.
The mobile viewing workstation comprises a computer, an image detector process unit, the main power supply, radiation indicator, dual viewing monitors and a user interface for patient management and image handling.
The system integrates a Computer Aided Surgery (CAS) feature that supports instruments positioning during surgical procedures.
- Indication for use: The SURGIVISIO medical 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.
Summary of the technological characteristics of the device compared to the predicate device
The Surgivisio system is substantially equivalent to the Arcadis Orbic (available with options 3D and 3D navigation interface) - K042793
| Devices | Surgivisio system | The Arcadis Orbic with options
3D and 3D navigation interface
(K042793) |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use /
Indication for
use | The SURGIVISIO medical 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 Arcadis Orbic is a mobile X-ray
system designed to provide
fluoroscopic and digital spot-film
imaging of the patient during
surgical and interventional
procedures. Clinical application
may include, but are not limited to,
cholangiography, endoscopic,
urologic, pain management,
orthopedic, neurologic, vascular,
cardiac, critical care and
emergency room procedures.
The Arcadis Orbic 3D option
provides 3D imaging and is
intended to be used whenever the
physician benefits form
intraoperatively-generated 3D
information of high contrast objects
and anatomical structures. |
| Device | Surgivisio system | The Arcadis Orbic with options 3D and 3D navigation interface (K042793) |
| Primary product code | OWB | OWB |
| Mechanical configuration | Mobile C-Arm | Mobile C-Arm |
| Movement range | Vertical: Up to 43.5cm
Horizontal: Up to 28cm
Orbital: 200°
Angulation: 180° | Vertical: Up to 40cm
Horizontal: Up to 20cm
Orbital: 190°
Angulation: 190° |
| Movement control | Motor-driven | Manual
Motor-driven |
| kV Range | 40 – 120 kV | 40-110 kV |
| mA Range | 1 – 120 mA | 0.2 – 15.2 mA, pulsed up to 23 mA
mAs up to 150 |
| Pulse frequency | 1 – 12.5 fps | Up to 15 fps |
| Detector technology | Flat panel, 287mm x 265mm | X-ray Image intensifier Ø23cm |
| Image Matrix Size | 1560x1440 pixels
780x720 pixels | 1024x1024 pixels |
| X-ray tube technology | Rotating anode
0.3 – 0.8 focal spot | Stationary anode
0.6 focal spot |
| 2D Imaging | 2D Fluoroscopic | 2D Fluoroscopic |
| Pulsed Fluoroscopy | Yes | Yes |
| AERC system | Yes, kv/mA curve types | Yes, kv/mA curve types |
| 3D Imaging | Yes | Yes |
| Rotating movement for 3D imaging | 180° | [120° - 190°] |
| 3D Imaging characteristics | Cylindrical volume: 15 x Ø13 cm
Elliptic cylindrical volume: 15 x Ø16 x Ø218 cm
Resolution 400 x 400 x 400 voxels | Cubic volume: 11 x 11 x 11 cm |
| Monitor cart/Workstation | Yes | Yes |
| Screen displays | 2 Monitors 22" tactile Screen Displays | 2 Monitors 19" Screen Displays |
| Image output format | DICOM | DICOM |
| LAN network connection | Yes | Yes |
| Computer Aided Surgery (CAS) interface | Yes, integrated | Yes, provides the 3D navigation interface that enables interoperability with navigation |
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6
Performance Data
The following nonclinical tests were performed on the Surgivisio system Nonclinical tests: to demonstrate substantial equivalence of safety and efficacy with the predicate device:
- IEC 60601-1 (Edition 3.1): Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2 (Edition 4.0): Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-3 (Edition 2.1): Medical electrical equipment Part 1-3 : General requirements for basic safety and essential performance - Collateral Standard : Radiation protection in diagnostic X-ray equipment
- IEC 60601-2-43 (Edition 2.1): Medical electrical equipment Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures
- IEC 60601-2-54 (Edition 1.1): Medical electrical equipment Part 2-54: Particular i requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy [Including: Amendment 2 (2018)]
- 2D Image Quality Assessment of the Surgivisio system provides a quantitative image । quality assessment of subject device in comparison to the predicate device
- । Basic CBCT bench testing using phantoms and based on standard IEC 60601-2-44 (Edition 3.2) Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography. to demonstrate the effectiveness and safety of the subject device
- । Concurrence study using a distortion phantom to demonstrate the ability of the subject device to provide 3D images equivalent to those of the predicate device
- Quality characterization of the iterative 3D reconstruction algorithm to demonstrate the effectiveness of the 3D imaqing feature
- 3D image quality assessment with breathing simulation to demonstrate the i effectiveness of the 3D imaging feature
- Sample clinical images evaluated by a qualified expert to support the intended use of the 2D and 3D imaging features
- । Comparison of radiation doses associated with clinical image data provided by the subject device to literature
- Software Verification testing verifying the software requirements perform as intended -
Clinical tests: No clinical tests were conducted to demonstrate substantial equivalence.
7
Conclusions drawn from Performance Data
The Surgivisio system is similar in indications for use and technological characteristics as the proposed predicate device. These aspects, along with the performance testing conducted, demonstrate the substantial equivalence to the Arcadis Orbic system (K042793) and that the Surgivisio system does not raise different questions of safety and effectiveness when compared to this predicate.