Excelsius3D

K210912 · Globus Medical, Inc. · OWB · Aug 12, 2021 · Radiology

Device Facts

• Record ID: K210912
• Device Name: Excelsius3D
• Applicant: Globus Medical, Inc.
• Product Code: OWB · Radiology
• Decision Date: Aug 12, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Excelsius3D™ is a mobile X-ray system designed for 2D fluoroscopy, 2D digital radiography, and 3D imaging of adult and pediatric patients. The system is indicated for use where a physician benefits from 2D and 3D information on anatomic structures and high contrast objects with high x-ray attenuation such as bony anatomy and metallic objects. Excelsius3D™ images are compatible with image guided systems such as ExcelsiusGPS®.

Device Story

Mobile X-ray system; performs 2D fluoroscopy, 2D digital radiography, and 3D imaging. Inputs: X-ray radiation; outputs: 2D/3D images for visualization and DICOM storage. Used in clinical/surgical settings by physicians to localize pathology for preoperative, intraoperative, and postoperative analysis. Assists in complex procedures like spinal deformity correction or deep brain stimulation (DBS) placement. Integrates with ExcelsiusGPS® image-guided systems. Provides real-time image capture and post-capture processing to aid clinical decision-making and surgical navigation.

Clinical Evidence

No clinical trials performed. Evidence consists of non-clinical system and software verification/validation, electrical safety/EMC testing per IEC standards (60601 series, 62304, 62366), image quality assessment compared to predicates, and qualitative human cadaveric validation in clinically relevant scenarios.

Technological Characteristics

Mobile X-ray system; isocentric gantry with 360° rotation; rotating anode X-ray tube; cone-beam collimation with x-y shutters. Connectivity via industry-standard protocols for DICOM storage. Software lifecycle per IEC 62304. Safety compliance: IEC 60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 60601-2-43, 60601-2-54, IEC 60825-1.

Indications for Use

Indicated for adult and pediatric patients requiring 2D fluoroscopy, 2D digital radiography, or 3D imaging of anatomic structures and high-contrast objects (bony anatomy, metallic objects).

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

• Medtronic O-Arm Imaging System (K092564)
• Medtronic O-Arm O2 Imaging System (K200074)

Reference Devices

• GE Optima XR220amx/XR200amx (K142383)

Submission Summary (Full Text)

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August 12, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that 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.

Globus Medical Inc. % Kelly Baker, Ph.D. Senior Vice President, Regulatory and Clinical Affairs 2560 General Armistead Ave. AUDUBON PA 19403

### Re: K210912

Trade/Device Name: Excelsius3D™ Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, OXO, JAA Dated: July 20, 2021 Received: July 21, 2021

Dear Dr. Baker:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 ([e-mail]) or phone [phone] 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

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# Indications for Use

510(k) Number (if known) K210912

Device Name Excelsius3D™

#### Indications for Use (Describe)

Excelsius3D™ is a mobile X-ray system designed for 2D fluoroscopy, 2D digital radiography, and 3D imaging of adult and pediatric patients. The system is indicated for use where a physician benefits from 2D and 3D information on anatomic structures and high contrast objects with high x-ray attenuation such as bony anatomy and metallic objects. Excelsius3D™ images are compatible with image guided systems such as ExcelsiusGPS®.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| <span style="font-family: Arial;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: Arial;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary: Excelsius3D™

| Company: | Globus Medical Inc.<br>2560 General Armistead Ave.<br>Audubon, PA 19403<br>610-930-1800 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kelly Baker, Ph.D.<br>Senior Vice President, Regulatory and Clinical Affairs |
| Date Prepared: | July 20, 2021 |
| Device Name: | Excelsius3D™ |
| Common Name: | Computer-assisted mobile image-intensified fluoroscopic and<br>X-ray system |
| Classification: | Per 21 CFR as follows:<br>§892.1650 Image-intensified Fluoroscopic X-ray System,<br>Mobile<br>Product Code(s): OWB, OXO, JAA<br>Regulatory Class: II |

Primary Predicate: Medtronic O-Arm Imaging System (K092564) Other Predicates: Medtronic O-Arm O2 Imaging System (K200074) Reference Device: GE Optima XR220amx/XR200amx (K142383)

#### Purpose:

The purpose of this submission is to request clearance of the Excelsius3D™

### Device Description:

Excelsius3D™ is a mobile X-ray imaging system that combines 2D fluoroscopy, 2D digital radiography, and 3D imaging into one unit for acquisition and visualization of 2D or 3D images of patient anatomy. Excelsius3D™ provides real-time image capture, post-capture processing and visualization, and DICOM storage of images.

Visualization of patient anatomy assists in localizing regions of pathology for preoperative examination, in vivo surgical procedures, and post-surgical analysis. The three imaging modalities can assist physicians with performing complex surqical procedures, such as spinal deformity correction or deep brain stimulation (DBS) placement.

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### Indications for Use:

Excelsius3D™ is a mobile X-ray system designed for 2D fluoroscopy, 2D digital radiography, and 3D imaging of adult and pediatric patients. The system is indicated for use where a physician benefits from 2D and 3D information on anatomic structures and high contrast objects with high x-ray attenuation such as bony anatomy and metallic objects. Excelsius3D™ images are compatible with image quided systems such as ExcelsiusGPS®.

### Technological Characteristics:

The Excelsius3D™ has similar technological characteristics to the predicate devices including the main system components, workflow, user interface, software features, and design. The Excelsius3D™ is comparable to the predicates in terms of intended use, fundamental scientific technology, technological characteristics and principle of operation.

| | Subject<br>Excelsius3D™ | Predicate<br>O-Arm<br>(K092564, K200074) | Reference<br>Optima XR220amx<br>(K142383) |
|------------------------------------|--------------------------------------------------------|------------------------------------------|----------------------------------------------------------------------|
| Intended<br>Applications | Orthopaedic, cranial | Orthopaedic, cranial | Orthopaedic, cranial<br>(& gastrointestinal,<br>thoracic, pulmonary) |
| Imaging<br>Modalities | 2D fluoroscopy<br>3D imaging<br>2D digital radiography | 2D fluoroscopy<br>3D imaging | 2D digital radiography |
| Gantry<br>Motion | Isocentric | Isocentric | N/A |
| Gantry<br>Rotation | 360° | 360° | N/A |
| Gantry Stored<br>Positions | Yes | Yes | N/A |
| X-ray Tube<br>Type | Rotating anode | Rotating anode | Rotating anode |
| X-ray Beam/<br>Collimation<br>Type | Cone beam with x-y<br>shutters | Cone beam with x-y<br>shutters | Cone beam with x-y<br>shutters |
| Image<br>Acquisition<br>Presets | Yes | Yes | Yes |
| Method of<br>Image<br>Acquisition | Hand switch<br>or foot pedal | Hand switch<br>or foot pedal | Hand switch |
| Image<br>Transfer | Yes | Yes | Yes |
| Cybersecurity | Industry standard<br>protocols | Industry standard<br>protocols | Industry standard<br>protocols |

#### Comparison of Principles of Operation and Technological Characteristics

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# Performance Testing:

Verification and validation testinq were conducted on Excelsius3D™ to confirm that the device meets performance requirements under the indications for use and to ensure the system performs as intended.

- Non-clinical system and software verification and validation. ●
- Software validation and verification testing was performed in accordance o with the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005). The software for this device is considered a "MAJOR" level of concern.
- Electrical Safety and Electromagnetic Compatibility ●
- o Testing was performed to assure compliance with recognized safety standards for electrical safety and electromagnetic compatibility
- IEC 60601-1:2012 Medical electrical equipment Part 1: General . requirements for basic safety and essential performance
- . IEC 60601-1-2:2014 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances
- IEC 60601-1-3:2013 Medical electrical equipment – Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
- l IEC 60601-1-6:2013 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- .. IEC 60601-2-43:2010 Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of Xray equipment for interventional procedures
- IEC 60601-2-54:2015 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
- I IEC 60825-1:2007 Safety of laser products - Part 1: Equipment classification, and requirements
- . IEC 62304:2015 Medical device software - Software lifecycle processes
- . IEC 62366:2015 Medical devices - Part 1: Application of usability engineering to medical devices
- Image quality assessment comparison and paired image analysis to ● predicates
- Human cadaveric qualitative validation under clinically relevant scenarios ●

# Basis of Substantial Equivalence:

Excelsius3D™ has been found to be substantially equivalent to the predicate devices with respect to technological characteristics, imaging performance, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate devices.