(136 days)
GE Optima XR220amx/XR200amx (K142383)
No
The summary describes standard image processing and visualization capabilities, but does not mention AI, ML, or related concepts like deep learning, neural networks, or algorithms trained on data.
No
The device is an imaging system designed for diagnosis and information gathering, not for treatment or therapy.
Yes
The device is an imaging system (2D fluoroscopy, 2D digital radiography, and 3D imaging) used to acquire and visualize images of patient anatomy, which are then used by a physician to obtain 2D and 3D information on anatomic structures. This process of acquiring information about a patient's condition to aid in diagnosis is a diagnostic function.
No
The device description explicitly states it is a "mobile X-ray imaging system" and mentions hardware components like "real-time image capture" and "DICOM storage of images," indicating it is a hardware device with integrated software.
Based on the provided information, the Excelsius3D™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body. The intended use and device description clearly state that the Excelsius3D™ is an X-ray system used for imaging directly on adult and pediatric patients. It captures images of anatomical structures within the body.
- The device description focuses on imaging technology and image processing. It describes capturing, processing, and visualizing images of patient anatomy, not analyzing biological samples.
- The performance studies described are related to imaging performance and clinical use on cadavers. They do not involve the analysis of biological specimens.
Therefore, the Excelsius3D™ falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 guided systems such as ExcelsiusGPS®.
Product codes
OWB, OXO, JAA
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
2D fluoroscopy, 2D digital radiography, 3D imaging
Anatomical Site
anatomic structures, bony anatomy
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
physician
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
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
- o Testing was performed to assure compliance with recognized safety standards for electrical safety and electromagnetic compatibility
- Image quality assessment comparison and paired image analysis to ● predicates
- Human cadaveric qualitative validation under clinically relevant scenarios ●
Key Metrics
Not Found
Predicate Device(s)
Medtronic O-Arm Imaging System (K092564), Medtronic O-Arm O2 Imaging System (K200074)
Reference Device(s)
GE Optima XR220amx/XR200amx (K142383)
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
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
1
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) 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) | |
|---|---|
| ☑ 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: Excelsius3D™
| Company: | Globus Medical Inc.
2560 General Armistead Ave.
Audubon, PA 19403
610-930-1800 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kelly Baker, Ph.D.
Senior Vice President, Regulatory and Clinical Affairs |
| Date Prepared: | July 20, 2021 |
| Device Name: | Excelsius3D™ |
| Common Name: | Computer-assisted mobile image-intensified fluoroscopic and
X-ray system |
| Classification: | Per 21 CFR as follows:
§892.1650 Image-intensified Fluoroscopic X-ray System,
Mobile
Product Code(s): OWB, OXO, JAA
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.
4
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
Excelsius3D™ | Predicate
O-Arm
(K092564, K200074) | Reference
Optima XR220amx
(K142383) |
|------------------------------------|--------------------------------------------------------|------------------------------------------|----------------------------------------------------------------------|
| Intended
Applications | Orthopaedic, cranial | Orthopaedic, cranial | Orthopaedic, cranial
(& gastrointestinal,
thoracic, pulmonary) |
| Imaging
Modalities | 2D fluoroscopy
3D imaging
2D digital radiography | 2D fluoroscopy
3D imaging | 2D digital radiography |
| Gantry
Motion | Isocentric | Isocentric | N/A |
| Gantry
Rotation | 360° | 360° | N/A |
| Gantry Stored
Positions | Yes | Yes | N/A |
| X-ray Tube
Type | Rotating anode | Rotating anode | Rotating anode |
| X-ray Beam/
Collimation
Type | Cone beam with x-y
shutters | Cone beam with x-y
shutters | Cone beam with x-y
shutters |
| Image
Acquisition
Presets | Yes | Yes | Yes |
| Method of
Image
Acquisition | Hand switch
or foot pedal | Hand switch
or foot pedal | Hand switch |
| Image
Transfer | Yes | Yes | Yes |
| Cybersecurity | Industry standard
protocols | Industry standard
protocols | Industry standard
protocols |
Comparison of Principles of Operation and Technological Characteristics
5
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
- o Testing was performed to assure compliance with recognized safety standards for electrical safety and electromagnetic compatibility
- 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.