Who is the manufacturer of Surgivisio system?

Surgivisio filed the 510(k) submission for Surgivisio system (K202547).

What is the FDA product code for Surgivisio system?

OWB. It is classified under 21 CFR 892.1650 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Surgivisio system?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Surgivisio system?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Surgivisio system

K202547 · Surgivisio · OWB · Mar 26, 2021 · Radiology

Device Facts

Record ID	K202547
Device Name	Surgivisio system
Applicant	Surgivisio
Product Code	OWB · Radiology
Decision Date	Mar 26, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1650
Device Class	Class 2

Intended 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.

Device Story

Mobile C-arm X-ray system providing 2D fluoroscopy and intraoperative 3D imaging. System comprises mobile C-arm (X-ray tube, flat panel detector, generator, collision avoidance) and mobile viewing workstation (dual monitors, computer, user interface). Operated by clinicians in surgical settings. Inputs: X-ray projections during manual or motor-driven C-arm rotation. Processing: Iterative 3D reconstruction algorithm transforms 2D projections into 3D volumes. Outputs: 2D fluoroscopic images and 3D anatomical reconstructions displayed on workstation monitors. Integrated Computer Aided Surgery (CAS) feature supports instrument positioning. Benefits: Intraoperative visualization of bony anatomy/metallic objects to guide surgical procedures; supports spine, pelvis, and articulation surgeries.

Clinical Evidence

No clinical tests were conducted. Evidence consists of bench testing: IEC 60601 series compliance, 2D image quality assessment, CBCT phantom testing (IEC 60601-2-44), distortion phantom concurrence study, iterative 3D reconstruction algorithm characterization, 3D image quality with breathing simulation, expert evaluation of sample clinical images, and radiation dose comparisons to literature.

Technological Characteristics

Mobile C-arm with flat panel detector (287mm x 265mm). Rotating anode X-ray tube (0.3–0.8 focal spot). 40–120 kV range. Motor-driven movement. Dual 22" tactile monitors. DICOM output. LAN connectivity. Iterative 3D reconstruction algorithm. Complies with IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-43, 60601-2-54, and 60601-2-44.

Indications for Use

Indicated for surgical procedures requiring visualization of 2D or intraoperative 3D images of high x-ray attenuation structures (e.g., bone, metal), specifically spine, pelvis, or articulation structures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Arcadis Orbic (K042793)

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Submission Summary (Full Text)

{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) | |-------------------------------------------------| |-------------------------------------------------| | <div style="display:flex; align-items:center;"><div style="margin-right:5px;">☑</div>Prescription Use (Part 21 CFR 801 Subpart D)</div> | |-----------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"><div style="margin-right:5px;">☐</div>Over-The-Counter Use (21 CFR 801 Subpart C)</div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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 | {5}------------------------------------------------ {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.