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.

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.

AI/ML Overview

The provided text describes the SURGIVISIO Device, which is a mobile interventional fluoroscopic x-ray system, and states that it relies on the substantial equivalence to a previously cleared predicate device (SURGIVISIO system K202547). The primary change in the current submission is a software version update from 1.5.1 to 1.8.1.

While the document mentions "Software Verification testing verifying the software requirements perform as intended," it does not explicitly state specific acceptance criteria or provide a detailed study report that proves the device meets particular acceptance criteria beyond the software verification. The core of the argument for acceptance is substantial equivalence to the predicate device, implying that since the software update maintains the same intended use and performance, it meets the inherent criteria of the predicate.

Given this, I will infer the implied acceptance criteria from the claim of substantial equivalence and the listed comparison of technological characteristics.

1. A table of acceptance criteria and the reported device performance

Since specific numerical acceptance criteria for performance are not explicitly stated for this 510(k), and the device essentially claims "same as predicate" for performance, the acceptance criteria are implicitly that the software update does not degrade the performance characteristics of the predicate device.

Acceptance Criteria (Implied from Substantial Equivalence to K202547)	Reported Device Performance (SURGIVISIO Device)
Functional Equivalence:
- Same 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. (Same as predicate)
- Same Principle of Operation	Similar principle of operation as the predicate device. (Stated in Section 7: Substantial equivalence)
- Similar Technical Characteristics	All technical characteristics (e.g., Mechanical configuration, Movement range, kV Range, mA Range, Pulse frequency, Detector technology, Image Matrix, X-ray tube technology, 2D Imaging, 3D Imaging characteristics, Monitor cart/Workstation, Screen displays, Image output format, LAN network connection, Computer Aided Surgery (CAS) interface) are identical to the predicate device.
Safety and Effectiveness:
- Biocompatibility maintained	Same as the predicate.
- Electrical Safety Testing maintained	Same as the predicate.
- Performance Testing maintained	Same as the predicate.
- Software functionality as intended	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 unchanged	Same as predicated.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states, "No clinical tests were conducted to demonstrate substantial equivalence." Therefore, there is no test set of patient data mentioned for evaluating performance in the context of this software update. The verification focused on software requirements and compliance with IEC 62304.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Since no clinical tests using patient data were conducted, no experts were used to establish ground truth for a test set. The validation was against software specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable as no clinical test set requiring adjudication was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done, as no clinical tests or human reading evaluations are mentioned for this software update. The device itself is an imaging system with an integrated Computer Aided Surgery (CAS) feature, but the submission doesn't detail performance studies of this CAS feature, instead focusing on the equivalence of the overall system after a software update.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The "Software Verification testing verifying the software requirements perform as intended" and "Results of these validations and verifications confirm that the SURGIVISIO software complies with its specifications" indicate that standalone software testing was performed against specified requirements. However, the specifics of what those requirements are (e.g., accuracy, precision of specific measurements or detections if any) are not detailed. It's a general statement of software verification and validation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the software verification and validation, the ground truth would be the software specifications and requirements themselves. The software was tested to ensure it met its predefined functional and non-functional requirements.

8. The sample size for the training set

Not applicable/Not provided. This submission is for a software update to an existing imaging system, claiming substantial equivalence based on verification and validation against specifications, not a new AI algorithm that would typically involve a distinct training set. The device description does not imply a machine learning component requiring a training set in the conventional sense for this submission.

9. How the ground truth for the training set was established

Not applicable as no training set is mentioned in the context of this submission.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K220627

Device Name SURGIVISIO Device

Indications for Use (Describe)

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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510(k) Summary

Submitter Information

Submitter:	eCential RoboticsZone Mayencin II, Parc Equation – Bâtiment 12 avenue de Vignate38610 GièresFrance
Contact Person:	Mathilde SAULPICQuality Assurance & Regulatory Affairs EngineePhone : 0033 4 58 00 35 86Email: 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

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Special 510(k)510(k) Summary	SURGIVISIO Device
	mounting the X-ray tube assembly and the flat X-ray detector ondistal end of the 'C'.The mobile viewing workstation comprises a computer, an imagedetector process unit, the main power supply, radiation indicator,dual viewing monitors and a user interface for patientmanagement and image handling.The system integrates a Computer Aided Surgery (CAS) featurethat supports instruments positioning during surgical procedures.
Indication for use:	The SURGIVISIO medical device is intended to be used duringsurgical procedures in which the physician would benefit from thevisualization of 2D medical imaging and/or intraoperativelygenerated 3D medical imaging of anatomical structures or objectswith high x-ray attenuation such as bony anatomy or metallicobjects. Such procedures include procedures during which thespine, pelvis or articulation structures are visualized.
Technology comparison	The technology has not changed. This is an x-ray system thatgenerates 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 toIEC 62304 Medical Device Software.Results of these validations and verifications confirm that theSURGIVISIO software complies with its specifications.
Clinical images	Same as predicated

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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 foruse	The SURGIVISIO medical deviceis intended to be used duringsurgical procedures in which thephysician would benefit from thevisualization of 2D medicalimaging and/or intraoperativelygenerated 3D medical imaging ofanatomical structures or objectswith high x-ray attenuation suchas bony anatomy or metallicobjects. Such procedures includeprocedures during which thespine, pelvis or articulationstructures are visualized.	The SURGIVISIO medical deviceis intended to be used duringsurgical procedures in which thephysician would benefit from thevisualization of 2D medicalimaging and/or intraoperativelygenerated 3D medical imaging ofanatomical structures or objectswith high x-ray attenuation suchas bony anatomy or metallicobjects. Such procedures includeprocedures during which thespine, pelvis or articulationstructures are visualized.
Primary productcode	OWB	OWB
Mechanicalconfiguration	Mobile C-Arm	Mobile C-Arm
Movementrange	Vertical: Up to 43.5cmHorizontal: Up to 28cmOrbital: 200°Angulation: 180°	Vertical: Up to 43.5cmHorizontal: Up to 28cmOrbital: 200°Angulation: 180°
Movementcontrol	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

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Devices	SURGIVISIO Device	SURGIVISIO System (K202547)
Detectortechnology	Flat panel, 287mm x 265mm	Flat panel, 287mm x 265mm
Image Matrix	1560x1440 pixels	1560x1440 pixels
Size	780x720 pixels	780x720 pixels
X-ray tubetechnology	Rotating anode0.3 - 0.8 focal spot	Rotating anode0.3 - 0.8 focal spot
2D Imaging	2D Fluoroscopic	2D Fluoroscopic
PulsedFluoroscopy	Yes	Yes
AERC system	Yes, kv/mA curve types	Yes, kv/mA curve types
3D Imaging	Yes	Yes
Rotatingmovement for3D imaging	180°	180°
3D Imagingcharacteristics	Cylindrical volume: 15 x Ø13 cmElliptic cylindrical volume: 15 x Ø116 x Ø218 cmResolution 400 x 400 x 400 voxels	Cylindrical volume: 15 x Ø13 cmElliptic cylindrical volume: 15 x Ø116 x Ø218 cmResolution 400 x 400 x 400 voxels
Monitorcart/Workstation	Yes	Yes
Screen displays	2 Monitors 22" tactile Screen Displays	2 Monitors 22" tactile Screen Displays
Image outputformat	DICOM	DICOM
LAN networkconnection	Yes	Yes
Computer AidedSurgery (CAS)interface	Yes, integrated	Yes, integrated

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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.

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1. Device Name
Device Trade Name	Common/Class

Device Trade Name	Common/Classification Name
SURGIVISIODevice	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.

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

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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.

Regulation Number and Section

§ 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.