(14 days)
No
The summary does not mention AI, ML, or any related terms, and the description focuses on standard imaging and navigation technology.
No
The device is an imaging system and a computer-aided surgery guidance system, which aids in visualization and instrument positioning during surgical procedures. It does not perform a therapeutic function itself.
No
This device is an imaging system designed for visualization during surgical procedures and for guiding instruments, not for diagnosing medical conditions.
No
The device description explicitly details multiple hardware components, including a mobile C-arm with an X-ray tube and detector, a mobile viewing workstation with a computer and monitors, and dedicated SPX1 instruments. While software is mentioned for image handling and a CAS feature, the core of the device is a physical X-ray system with associated hardware.
Based on the provided information, the SURGIVISIO device is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for use during surgical procedures to visualize 2D and 3D medical imaging of anatomical structures (spine, pelvis, articulation structures) and metallic objects. This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description details a mobile X-ray system, a C-arm, a workstation, and surgical instruments. These are all tools used for imaging and guidance during surgery, not for testing biological samples outside the body.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The SURGIVISIO device does not perform these functions. It provides imaging and guidance for surgical procedures.
Therefore, the SURGIVISIO device falls under the category of a medical imaging and surgical guidance 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 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.
The SPX1 Instruments are a set of dedicated accessories intended to be used in conjunction with the SURGIVISIO Device in order to enable stereotaxic guidance. More specifically, and when used with the 3D imaging, they support the registration of patient anatomy with the 3D reconstructed image. the Submissions K202547/ K220627 consider SPX1 instruments set with the standard 3D Imaging Set SPX1 accessory.
This submission aims at clearing a new imaging set accessory possibility: the 3D Offset Imaging Set SPX1 accessory, containing same patient reference and wedges as 3D imaging Set SPX1 accessory already 510(k) cleared, and an offset phantom (new instrument). The principle of use of the Offset Phantom SPX1 is identical to the already 510(k) cleared Phantom SPX1 (belonging to 3D Imaging set). However, the Offset Phantom SPX1 additional value is to offset the imaging area that will be navigated during surgery by 10 cm from the standard configuration. The 3D Imaging Set SPX1 accessory will be considered as the predicate for the 3D Offset Imaging Set SPX1 accessory.
Mentions image processing
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 structures or objects with high x-ray attenuation such as bony anatomy or metallic objects.
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 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 using 3D Offset Imaging Set SPX1 accessory to demonstrate substantial equivalence of safety and efficacy with the predicate device:
- -Design verification activities have been performed for the Offset Phantom SPX1
- -Accuracy verification has been conducted at the system level with the 3D Offset Imaging Set SPX1 accessory as intended
- -Software verification testing verifying the software requirements has been performed as intended and are already taken into account by the previous 510(k) cleared version (Submission K220627).
- Packaging process validation and verification activities, including Shelf-life validation, have been conducted as intended
Clinical tests: No clinical tests were conducted to demonstrate substantial equivalence.
Key results: The SURGIVISIO Device using 3D Offset Imaging Set SPX1 accessory is identical 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 Device (K202547/ K220627) and that the SURGIVISIO Device using 3D Offset Imaging Set SPX1 accessory does not raise different questions of safety and effectiveness when compared to this predicate.
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
April 15, 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: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is the Department of Health & Human Services logo. The right side of the logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Ecential Robotics % Mathilde Saulpic Quality Assurance & Regulatory Affairs Engineer Zone Mayencin II, Parc Equation - Bâtiment 1, 2 avenue de Vignate Gieres, 38610 FRANCE
Re: K220946
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 29, 2022 Received: April 1, 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
1
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 (OS) 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,
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) K220946
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 imaging and/or intraoperatively generated 3D medical 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.
| 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
Submitter Information
| Submitter: | ECENTIAL ROBOTICS
2 avenue de Vignate
Zone Mayencin II, Parc Equation – Bâtiment 1
38610 Gières
France |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mathilde SAULPIC
Quality Assurance & Regulatory Affairs Engineer
Phone : 0033 4 58 00 35 86
Email: mathilde.saulpic@ecential-robotics.com |
| Date Summary Prepared: | 08 April 2022 |
4
Summary of the technological characteristics of the device compared to the predicate device
There have been no modifications on indication for use on SURGIVISIO Device since the previously approved submission K202547 & K220627.
This submission aims at adding a new Imaging set: 3D Offset Imaging Set SPX1 accessory, which enables to deport imaging zone regarding the already cleared 3D Imaging Set SPX1 accessory, giving user more flexibility by freeing space around the Patient reference SPX1 and the zone of interest. The new 3D Offset Imaging Set SPX1 accessory will not replace the already cleared 3D Imaging Set SPX1 accessory.
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 & K220627 - SURGIVISIO device - 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 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. |
5
The system integrates a Computer Aided Surgery (CAS) feature that supports instruments positioning during surgical procedures.
The SPX1 Instruments are a set of dedicated accessories intended to be used in conjunction with the SURGIVISIO Device in order to enable stereotaxic guidance. More specifically, and when used with the 3D imaging, they support the registration of patient anatomy with the 3D reconstructed image. the Submissions K202547/ K220627 consider SPX1 instruments set with the standard 3D Imaging Set SPX1 accessory.
This submission aims at clearing a new imaging set accessory possibility: the 3D Offset Imaging Set SPX1 accessory, containing same patient reference and wedges as 3D imaging Set SPX1 accessory already 510(k) cleared, and an offset phantom (new instrument). The principle of use of the Offset Phantom SPX1 is identical to the already 510(k) cleared Phantom SPX1 (belonging to 3D Imaging set). However, the Offset Phantom SPX1 additional value is to offset the imaging area that will be navigated during surgery by 10 cm from the standard configuration. The 3D Imaging Set SPX1 accessory will be considered as the predicate for the 3D Offset Imaging Set SPX1 accessory.
- Indication 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. Indication for use is the same as the predicate.
- Technology comparison Same as the predicate. The technology is not impacted by the discussed device change, object of this Special 510(K) submission. This is an x-ray system that generates 2D and 3D images of anatomical structures. The 3D Offset Imaging Set accessory is used in combination with the imaging system in the same way than the 3D Imaging Set SPX1 accessory.
- 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 processes are the same for 3D Imaging Set SPX1 accessory than for 3D Offset Imaging Set SPX1 accessory.
6
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.
Software Testing Same as the predicate.
Software change to enable the identification of the Offset Phantom SPX1 were already taken into account in submission K220627. The clearance of the present Special 510(k) would enable to release the associated functionalities by clearing the associated required instrument.
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 the predicate. The discussed device change, object of this Special 510(K) submission does not impact clinical images.
- Conclusion Based upon comparison of devices and performance testing results, SURGIVISIO Device using 3D Offset Imaging Set SPX1 accessory is substantially equivalent to the predicate device.
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| Devices | SURGIVISIO Device used
with 3D Offset Imaging
Set SPX1 accessory | SURGIVISIO Device
(K202547 & K220627)
used with 3D Imaging
Set SPX1 accessory |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use / Indication 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 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 |
| Detector technology | Flat panel, 287mm x 265mm | Flat panel, 287mm x 265mm |
| Image Matrix Size | 1560x1440 pixels
780x720 pixels | 1560x1440 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° |
| Devices | SURGIVISIO Device used
with 3D Offset Imaging
Set SPX1 accessory | SURGIVISIO Device
(K202547 & K220627)
used with 3D Imaging
Set SPX1 accessory |
| 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 |
| 3D Imaging set accessory
components | Offset Phantom SPX1 with
its ID card
Patient reference SPX1
with its ID card
Associated wedges | Phantom SPX1 with its ID
card
Patient reference SPX1
with its ID card
Associated wedges |
| 3D Imaging set accessory
components packaging | Offset Phantom SPX1 and
patient reference with
associated wedges
packaged in one unique
blister
Blister Material and
reference:
PETG & Tyvek 1073B | Phantom SPX1 and
patient reference
packaged in its own Blister
Patient reference SPX1
with associated wedges
packaged in its own Blister
Blister Material and
reference:
PETG & Tyvek 1073B |
| Software workflow | 3D Spine Universal
workflow | 3D Spine Universal
workflow |
8
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Performance Data
For further information about testing, standards, acceptance criteria and results, please refer to section Design Control Activities Summary.
Nonclinical tests: The following nonclinical tests were performed on the SURGIVISIO Device using 3D Offset Imaging Set SPX1 accessory to demonstrate substantial equivalence of safety and efficacy with the predicate device:
- -Design verification activities have been performed for the Offset Phantom SPX1
- -Accuracy verification has been conducted at the system level with the 3D Offset Imaging Set SPX1 accessory as intended
- -Software verification testing verifying the software requirements has been performed as intended and are already taken into account by the previous 510(k) cleared version (Submission K220627).
- Packaging process validation and verification activities, including Shelf-life validation, have been conducted as intended
Clinical tests: No clinical tests were conducted to demonstrate substantial equivalence.
Conclusions drawn from Performance Data
The SURGIVISIO Device using 3D Offset Imaging Set SPX1 accessory is identical 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 Device (K202547/ K220627) and that the SURGIVISIO Device using 3D Offset Imaging Set SPX1 accessory does not raise different questions of safety and effectiveness when compared to this predicate.