(91 days)
Excelsius3D™ Imaging System (K210912)
No
The description focuses on real-time surgical visualization, navigation, and tracking using traditional image processing and optical tracking methods. There is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML models.
No
The device is a navigation system that aids surgeons in precisely locating anatomical structures and guiding surgical instruments during procedures. It does not directly provide a therapeutic effect or treat a condition.
No
Explanation: The device is a navigation system intended to aid surgeons in precisely locating anatomical structures and guiding surgical instruments during procedures. It does not provide a medical diagnosis but rather assists in the execution of surgical tasks.
No
The device description explicitly states that the ExcelsiusHub™ is a navigation system that includes both hardware and software components. It mentions a dynamic reference base, a camera tracking system, and optical tracking, all of which are hardware elements.
Based on the provided information, the ExcelsiusHub™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, in order to provide information concerning a physiological or pathological state, a congenital abnormality, to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- ExcelsiusHub™ Function: The ExcelsiusHub™ is a surgical navigation system. Its purpose is to aid surgeons in precisely locating anatomical structures and guiding surgical instruments during a procedure on the patient's body. It uses imaging data (CT, fluoroscopy) and tracking technology to provide real-time visualization and guidance.
- No Specimen Examination: The device does not examine specimens (like blood or tissue) outside of the body. It works directly with the patient's anatomy and imaging data.
Therefore, the ExcelsiusHub™ falls under the category of a surgical navigation system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
The ExcelsiusHub™ is a navigation system that includes hardware and software that enables real time surgical visualization using radiological patient images (preoperative CT, intraoperative CT and fluoroscopy), a dynamic reference base, and a camera tracking system. The navigation system determines the registration or mapping between the virtual patient (points on the patient images) and the physical patient (corresponding points on the patient's anatomy). Once this reqistration is created, the software displays the relative position of a tracked instrument on the patient images. This visualization can help guide the surgeon's planning and approach for implant placement. The patient's scan coupled with the reqistration provides visual assistance to the surgeon when using the system for free hand navigation. During surgery, the system tracks the position of compatible instruments in or on the patient anatomy and continuously updates the instrument position on patient images utilizing optical tracking. System software is responsible for all navigation functions, data storage, network connectivity, user management, case management, and safety functions. ExcelsiusHub™ uses the same instruments as ExcelsiusGPS®.
ExcelsiusHub™ may be used in conjunction with ExcelsiusGPS® for guidance of navigated instruments along a planned trajectory using a robotic arm. When connected to ExcelsiusGPS®, ExcelsiusHub™ software is responsible for both navigation and guidance.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scans or fluoroscopy
3D preoperative exam
3D intraoperative exam
2D intraoperative exam
Excelsius3D™ CT
Excelsius3D™ fluoroscopy
Anatomical Site
Spinal and orthopedic bone (for screws and interbody fusion devices)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons / Not Found
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)
Verification and validation testing were conducted on ExcelsiusHub™ to confirm that the device meets performance requirements under the indications for use and to ensure safety and efficacy of the system:
- Non-clinical system, software, and instrument verification and validation demonstrated compliance with user needs and corresponding design inputs
- Surgical simulations conducted on phantom models
- Qualitative validation to confirm intended use
- Electrical Safety and Electromagnetic Compatibility
- 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 60601-1-6:2012 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance -Collateral standard: usability
- IEC 62304:2015 Medical device software - Software lifecycle processes
- IEC 62366:2015 Medical devices Part 1: Application of usability engineering to medical devices
- Testing was performed to assure compliance with recognized safety standards for electrical safety and electromagnetic compatibility
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ExcelsiusGPS® (K171651), ExcelsiusGPS® Spine 1.1 Interbody Module (K191100)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Excelsius3D™ Imaging System (K210912)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
0
August 25, 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 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 Senior Vice President, Regulatory and Clinical Affairs 2560 General Armistead Ave. Audubon, Pennsylvania 19403
Re: K211616
Trade/Device Name: ExcelsiusHub Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: May 25, 2021 Received: May 26, 2021
Dear Kelly 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
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 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,
For: Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211616
Device Name ExcelsiusHub™
Indications for Use (Describe)
The ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.
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: ExcelsiusHub™ System
| Company: | Globus Medical Inc.
2560 General Armistead Ave.
Audubon, PA 19403
610-930-1800 |
|--------------------|------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Kelly Baker, Ph.D.
Senior Vice President, Regulatory and Clinical Affairs |
| Date Prepared: | August 23, 2021 |
| Device Name: | ExcelsiusHub™ |
| Common Name: | Computer-assisted surgical device |
| Classification: | Per 21 CFR as follows:
§882.4560 Stereotaxic instrument
Product Code(s): OLO
Regulatory Class: II |
| Primary Predicate: | ExcelsiusGPS® (K171651) |
| Other Predicates: | ExcelsiusGPS® Spine 1.1 Interbody Module (K191100) |
- Spine 1.1 Interbody N Excelsius3D™ Imaging System (K210912)
Purpose:
The purpose of this submission is to request clearance for the ExcelsiusHub™
Device Description:
The ExcelsiusHub™ is a navigation system that includes hardware and software that enables real time surgical visualization using radiological patient images (preoperative CT, intraoperative CT and fluoroscopy), a dynamic reference base, and a camera tracking system. The navigation system determines the registration or mapping between the virtual patient (points on the patient images) and the physical patient (corresponding points on the patient's anatomy). Once this reqistration is created, the software displays the relative position of a tracked instrument on the patient images. This visualization can help guide the surgeon's planning and approach for implant placement. The patient's scan coupled with the reqistration provides visual assistance to the surgeon when using the system for free hand navigation. During surgery, the system tracks the position of compatible instruments in or on the patient anatomy and continuously updates the instrument position on patient images utilizing optical tracking. System software is responsible for all navigation functions, data storage, network connectivity, user management, case management, and safety functions. ExcelsiusHub™ uses the same instruments as ExcelsiusGPS®.
4
ExcelsiusHub™ may be used in conjunction with ExcelsiusGPS® for guidance of navigated instruments along a planned trajectory using a robotic arm. When connected to ExcelsiusGPS®, ExcelsiusHub™ software is responsible for both navigation and guidance.
Indications for Use:
The ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.
Technological Characteristics:
The ExcelsiusHub™ has similar technological characteristics to the predicate devices including the main system components, workflow, user interface, software features, and design. ExcelsiusHub™ is comparable to the predicates in terms of intended use, fundamental scientific technology, technological characteristics and principle of operation.
| Device | Subject
ExcelsiusHub™ | Predicate
ExcelsiusGPS®
(K171651, K191100) |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Principle of
operation | - Intraoperative/ preoperative images
- Patient registration
- Surgical planning (optional)
- Real-time tracking of navigated
instruments - Manual, free hand guidance of
instruments | - Intraoperative/ preoperative images - Patient registration
- Surgical planning (optional)
- Real-time tracking of navigated
instruments - Manual, free hand guidance of
instruments - Guidance of instruments |
| Input images | 3D preoperative exam
3D intraoperative exam
2D intraoperative exam
Excelsius3D™ CT*
Excelsius3D™ fluoroscopy* | 3D preoperative exam
3D intraoperative exam
2D intraoperative exam |
| Integrated
planning
software | ExcelsiusGPS® Planning and
Navigation Application Software | ExcelsiusGPS® Planning and
Navigation Application Software |
| Save/load
planning | Yes | Yes |
| Merge images
functionality | Yes | Yes |
| Image-guided | Yes | Yes |
| Patient
registration
method | Intra-Op CT: Registration Fixture
Pre-Op CT: Fluoroscopic to Pre-Op
CT Merge
Fluoroscopy: Registration Fixture
Excelsius3D™ CT*
Excelsius3D™ fluoroscopy* | Intra-Op CT: Registration Fixture
Pre-Op CT: Fluoroscopic to Pre-Op
CT Merge
Fluoroscopy: Registration Fixture |
Comparison of Principles of Operation and Technological Characteristics
5
| Device | Subject
ExcelsiusHub™ | Predicate
ExcelsiusGPS®
(K171651, K191100) |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Accuracy
verification | Yes | Yes |
| Real time
display of
instrument
position | Yes | Yes |
| Patient
fixation | Reference is fixed to patient's bony
structure such as a long bone, iliac
crest, spinous process, vertebra, etc.
for tracking system | Reference is fixed to patient's bony
structure such as a long bone, iliac
crest, spinous process, vertebra, etc.
for tracking system |
*Excelsius3D 510(k) under FDA review (remove *s and this note upon clearance)
Performance Testing:
Verification and validation testing were conducted on ExcelsiusHub™ to confirm that the device meets performance requirements under the indications for use and to ensure safety and efficacy of the system:
- . Non-clinical system, software, and instrument verification and validation demonstrated compliance with user needs and corresponding design inputs
- Surgical simulations conducted on phantom models ●
- Qualitative validation to confirm intended use ●
- 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 60601-1-6:2013 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance -Collateral standard: Usabilitv
- 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
Software Verification and Validation Testing:
Software validation and verification testing was performed in accordance 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.
Basis of Substantial Equivalence:
ExcelsiusHub™ has been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use.
6
The information provided within this premarket notification supports substantial equivalence to the predicate devices.