(14 days)
No
The document describes a mobile x-ray system with 2D and 3D imaging capabilities and a Computer Aided Surgery (CAS) feature. There is no mention of AI, ML, deep learning, or any related concepts in the device description, intended use, or performance studies. The focus is on hardware, imaging, and basic computer-aided features, not advanced algorithmic processing typically associated with AI/ML in medical imaging.
No
Explanation: The device is an x-ray system used for visualization during surgical procedures, primarily providing imaging rather than direct therapeutic treatment or intervention.
No
Explanation: The device is described as an x-ray system for visualizing anatomical structures during surgical procedures, aiding in surgical imaging rather than diagnosing conditions.
No
The device description clearly states that the system consists of two mobile interconnected units: a mobile C-arm and a mobile viewing Workstation, both containing significant hardware components (high voltage generator, X-ray tube, detector, computer, monitors, etc.). This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The SURGIVISIO device is an X-ray system used during surgical procedures to provide visualization of anatomical structures and objects within the body. It generates images based on X-ray attenuation, not by analyzing biological samples.
- Intended Use: The intended use clearly states it's for "visualization of 2D medical imaging and/or intraoperatively generated 3D medical imaging of anatomical structures or objects with high x-ray attenuation". This is a diagnostic imaging function, not an in vitro diagnostic test.
The device is a medical imaging system used for diagnostic and guidance purposes during surgery, which falls under a different regulatory category than 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 Device 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 end 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
Yes
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
Nonclinical tests: The following nonclinical tests were performed on the SURGIVISIO Device to demonstrate substantial equivalence of safety and efficacy with the predicate device:
- Software Verification testing verifying the software requirements perform as intended -
Clinical tests: No clinical tests were conducted to demonstrate substantial equivalence.
Conclusions drawn from Performance Data: The SURGIVISIO Device 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 SURGIVISIO system (K202547) and that the SURGIVISIO Device does not raise different questions of safety and effectiveness when compared to this predicate.
Key Metrics
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 18, 2022
Image /page/0/Picture/1 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services - USA, which features a stylized human figure. To the right of that is the logo for the U.S. Food & Drug Administration (FDA). The FDA logo has the letters FDA in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Ecential Robotics % Mathilde Saulpic Ouality Assurance & Regulatory Affairs Engineer Zone Mayencin II, Parc Equation - Bâtiment 1, 2 avenue de Vignate Gieres, 38610 FRANCE
Re: K220627
Trade/Device Name: SURGIVISIO Device Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, OXO, JAA Dated: March 2, 2022 Received: March 4, 2022
Dear Mathilde Saulpic:
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,
Laurel Burk, Ph.D. Assistant Director Diagnostic X-ray Systems Team 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) K220627
Device Name SURGIVISIO Device
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) | |
|---|---|
| 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
Zone Mayencin II, Parc Equation – Bâtiment 1
2 avenue de Vignate
38610 Gières
France |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mathilde SAULPIC
Quality Assurance & Regulatory Affairs Enginee
Phone : 0033 4 58 00 35 86
Email: mathilde.saulpic@ecential-robotics.com |
| Date Summary Prepared: | 02 MAR 2022 |
Device Information
| Trade or proprietary name: | SURGIVISIO Device |
|---|---|
| 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: | K202547 - SURGIVISIO system - Manufacturer: eCential Robotics (previously SURGIVISIO) |
| Device Description: | The SURGIVISIO Device 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 |
4
| Special 510(k)
| 510(k) Summary | SURGIVISIO Device |
|---|---|
| mounting the X-ray tube assembly and the flat X-ray detector on | |
| distal end 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. | |
| Technology comparison | The technology has not changed. This is an x-ray system that |
| generates 2D and 3D images of anatomical structures. | |
| Biocompatibility | Same as the predicate. |
| Electrical Safety Testing | Same as the predicate. |
| Performance Testing | Same as the predicate. |
| Software Testing | Change of the software version from 1.5.1 to 1.8.1. |
| SURGIVISIO software was verified and validated according to | |
| IEC 62304 Medical Device Software. | |
| Results of these validations and verifications confirm that the | |
| SURGIVISIO software complies with its specifications. | |
| Clinical images | Same as predicated |
5
Conclusion
Based upon comparison of devices and performance testing results, SURGIVISIO software is substantially equivalent to the predicate device.
Summary of the technological characteristics of the device compared to the predicate device
There has been no modifications on indications for use on SURGIVISIO Device since the previously approved submission K202547.
| Devices | SURGIVISIO Device | SURGIVISIO System (K202547) |
|---|---|---|
| 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 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. | ||
| 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 43.5cm | |
| Horizontal: Up to 28cm | ||
| Orbital: 200° | ||
| Angulation: 180° | ||
| Movement | ||
| control | Motor-driven | Motor-driven |
| kV Range | 40 – 120 kV | 40 – 120 kV |
| mA Range | 1 – 120 mA | 1 – 120 mA |
| Pulse frequency | 1 – 12.5 fps | 1 – 12.5 fps |
6
| Devices | SURGIVISIO Device | SURGIVISIO System (K202547) |
|---|---|---|
| Detector | ||
| technology | Flat panel, 287mm x 265mm | Flat panel, 287mm x 265mm |
| Image Matrix | 1560x1440 pixels | 1560x1440 pixels |
| Size | 780x720 pixels | 780x720 pixels |
| X-ray tube | ||
| technology | Rotating anode | |
| 0.3 - 0.8 focal spot | Rotating anode | |
| 0.3 - 0.8 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° | 180° |
| 3D Imaging | ||
| characteristics | Cylindrical volume: 15 x Ø13 cm | |
| Elliptic cylindrical volume: 15 x Ø116 x Ø218 cm | ||
| Resolution 400 x 400 x 400 voxels | Cylindrical volume: 15 x Ø13 cm | |
| Elliptic cylindrical volume: 15 x Ø116 x Ø218 cm | ||
| Resolution 400 x 400 x 400 voxels | ||
| Monitor | ||
| cart/Workstation | Yes | Yes |
| Screen displays | 2 Monitors 22" tactile Screen Displays | 2 Monitors 22" tactile Screen Displays |
| Image output | ||
| format | DICOM | DICOM |
| LAN network | ||
| connection | Yes | Yes |
| Computer Aided | ||
| Surgery (CAS) | ||
| interface | Yes, integrated | Yes, integrated |
7
Performance Data
Nonclinical tests: The following nonclinical tests were performed on the SURGIVISIO Device to demonstrate substantial equivalence of safety and efficacy with the predicate device:
- Software Verification testing verifying the software requirements perform as intended -
Clinical tests: No clinical tests were conducted to demonstrate substantial equivalence.
Conclusions drawn from Performance Data
The SURGIVISIO Device 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 SURGIVISIO system (K202547) and that the SURGIVISIO Device does not raise different questions of safety and effectiveness when compared to this predicate.
8
| 1. Device Name | |
|---|---|
| Device Trade Name | Common/Class |
| Device Trade Name | Common/Classification Name |
|---|---|
| SURGIVISIO | |
| Device | Common or usual name: Mobile interventional Fluoroscopic X-ray system |
| Classification name: Interventional Fluoroscopic X-ray system, | |
| 21 CFR 892.1650 Image-intensified fluoroscopic x-ray system |
2. Address and registration
The address of the manufacturer for the SURGIVISIO device is: ECENTIAL ROBOTICS Zone Mayencin II, Parc Equation - Bâtiment 1 2 avenue de Vignate 38610 Gières FRANCE
3. Device class
SURGIVISIO device is a class II device.
4. Predicate device information
The predicate device is SURGIVISIO system, K202547.
5. Labeling and intended use
Labeling is same as predicated.
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.
This is the same intended use as previously cleared for the SURGIVISIO system, K202547.
6. Device description and comparison
A device description can be found in Section 8. The modification that has been made is a change in software version from 1.5.1 to 1.8.1.
7. Substantial equivalence
9
The modified SURGIVISIO device is substantially equivalent to the previously SURGIVISIO system K202547 because both devices have the same indication for use and intended use, similar principle of operation, similar technical characteristics, and design.
8. Summary of design control activities
A summary of design control activities for the SURGIVISIO device can be found in section 10.
9. 510(k) summary
A 510(k) summary for the SURGIVISIO device can be found in section 6.
10. Truthful and accuracy certification
A certification of the truthfulness and accuracy of the SURGIVISIO device described in this submission can be found in section 7.