(183 days)
No
The description focuses on real-time surgical navigation using image registration, optical tracking, and trajectory planning, which are standard techniques in image-guided surgery and do not inherently require AI/ML. The document explicitly states "Mentions AI, DNN, or ML: Not Found".
No.
Explanation: The device is a surgical navigation system that aids surgeons in precisely locating anatomical structures and guiding instruments; it does not directly treat a disease or condition.
No
The device is described as a surgical navigation system that aids in precisely locating anatomical structures and guiding surgical instruments for placement of devices. It does not provide a diagnosis or identify the presence or nature of a medical condition.
No
The device description explicitly states that the ExcelsiusGPS® Cranial Module includes both hardware and software components, and the performance studies include verification and validation of hardware components like instruments.
Based on the provided information, the ExcelsiusGPS is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used in vivo (within the living patient) to aid surgeons in precisely locating anatomical structures and guiding surgical instruments during procedures. IVD devices are used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a surgical navigation system that tracks instruments in or on the patient anatomy and displays their position on patient images. This is a surgical guidance system, not a diagnostic test performed on patient samples.
- Anatomical Site: The device is used on cranial, spinal, and orthopedic bone sites within the patient's body.
- Key Metrics: The key metrics provided are related to navigational accuracy (position and angle), which are relevant to surgical guidance systems, not diagnostic performance metrics like sensitivity, specificity, PPV, or NPV.
In summary, the ExcelsiusGPS is a surgical navigation and guidance system used during surgical procedures on living patients. This falls under the category of medical devices used for treatment or procedural assistance, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The ExcelsiusGPS is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of an instrument holder or guide to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous 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 spacers, and intracranial devices including biopsy needles, electrodes, and tubes.
Product codes
OLO, HAW
Device Description
The ExcelsiusGPS® Cranial Module includes hardware and software that enables real time surgical navigation using radiological patient images (MRI, CT, and fluoroscopy), using a dynamic reference base and positioning camera. 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 registration is created, the software displays the relative position of a tracked instrument on the patient images. As an aid to visualization, the surgeon can plan trajectories for instrument placement on the patient images prior to surgery. Registration provides the necessary information to provide visual assistance to the surgeon during freehand navigation. During surgery, the system tracks the position of GPS 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. ExcelsiusGPS® surgical instruments include non-sterile, re-usable instruments and sterile instruments that are operated manually or with the use of the positioning system.
The ExcelsiusGPS® Cranial Module is designed to assist with stereotactic procedures that include quidance to cranial targets for instrument navigation and device placement. Instruments consist of end effector instruments, registration instruments, navigated instruments, patient positioning instruments, and surgical instruments. End effector instruments include instruments to the Interchangeable Guide End Effector. Registration and navigated instruments incorporate unique array patterns with reflective markers, and are used to track patient anatomy and surgical instruments. Patient positioning instruments aid in patient fixation. Surgical instruments are used to access and prepare the local site and place devices, such as needles, electrodes, and tubes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
3D preoperative exam, 3D intraoperative exam, 2D intraoperative exam
Anatomical Site
cranial, spinal, orthopedic bone
Indicated Patient Age Range
adult and pediatric patient populations
Intended User / Care Setting
surgeons, clinical setting (inferred)
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)
- Non-clinical system, software, and instrument verification and validation - demonstrated compliance with user needs and corresponding design inputs
- Surgical simulations conducted on phantom models cranial sawbone models and registration matrix were used to quantify accuracy in a controlled setting
- Human cadaveric quantitative validation under clinically relevant scenarios - demonstrated system accuracy in navigating cranial devices to the desired location on patient images
- Compliance conformity assessments per: IEC 60601-1 Medical electrical equipment. General requirements for basic safety and essential performance, 2005, Amendment 1, 2012; IEC 60601-1-6 Medical Electrical Equipment Part 1-6, General Requirements for Basic Safety and Essential Performance - Usability
- Navigational accuracy of the subject device system with mean, standard deviation, and 99% confidence interval (CI). Results demonstrate the subject device meets the accuracy acceptance criteria for position and angle.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Navigational accuracy:
Position: Mean
§ 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
July 10, 2020
Globus Medical Inc. Jennifer Antonacci Group Manager, Regulatory Affairs 2560 General Armistead Ave. Audubon, Pennsylvania 19403
Re: K200047
Trade/Device Name: ExcelsiusGPS Cranial 1.0 Module Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, HAW Dated: June 11, 2020 Received: June 12, 2020
Dear Jennifer Antonacci:
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 (OS) 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,
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices 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) K200047
Device Name ExcelsiusGPS Cranial 1.0 Module
Indications for Use (Describe)
The ExcelsiusGPS is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of an instrument holder or guide to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous 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 spacers, and intracranial devices including biopsy needles, electrodes, and tubes.
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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510(k) Summary: ExcelsiusGPS Cranial 1.0 Module
| Company: | Globus Medical Inc.
2560 General Armistead Ave.
Audubon, PA 19403
610-930-1800 |
|------------------|-----------------------------------------------------------------------------------------|
| Primary Contact: | Jennifer Antonacci, Ph.D.
Group Manager, Regulatory Affairs |
| Date Prepared: | July 10, 2020 |
| Device Name: | ExcelsiusGPS® Cranial 1.0 Module |
| Common Name: | Computer-assisted surgical device |
-
Classification: Per 21 CFR as follows: §882.4560 Stereotaxic instrument Product Code(s): OLO, HAW Regulatory Class: II
Primary Predicate: ExcelsiusGPS® (K171651) -
Other Predicates: ExcelsiusGPS® Spine 1.1 Interbody Module (K191100) Medtronic StealthStation S8 (K162309) ROSA ONE Brain (K182417)
Purpose:
The purpose of this submission is to request clearance of the ExcelsiusGPS® Cranial 1.0 Module software and navigated instruments for access, preparation, and placement of cranial devices.
Device Description:
The ExcelsiusGPS® Cranial Module includes hardware and software that enables real time surgical navigation using radiological patient images (MRI, CT, and fluoroscopy), using a dynamic reference base and positioning camera. 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 registration is created, the software displays the relative position of a tracked instrument on the patient images. As an aid to visualization, the surgeon can plan trajectories for instrument placement on the patient images prior to surgery. Registration provides the necessary information to provide visual assistance to the surgeon during freehand navigation. During surgery, the system tracks the position of GPS 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
4
navigation functions, data storage, network connectivity, user management, case management, and safety functions. ExcelsiusGPS® surgical instruments include non-sterile, re-usable instruments and sterile instruments that are operated manually or with the use of the positioning system.
The ExcelsiusGPS® Cranial Module is designed to assist with stereotactic procedures that include quidance to cranial targets for instrument navigation and device placement. Instruments consist of end effector instruments, registration instruments, navigated instruments, patient positioning instruments, and surgical instruments. End effector instruments include instruments to the Interchangeable Guide End Effector. Registration and navigated instruments incorporate unique array patterns with reflective markers, and are used to track patient anatomy and surgical instruments. Patient positioning instruments aid in patient fixation. Surgical instruments are used to access and prepare the local site and place devices, such as needles, electrodes, and tubes. The ExcelsiusGPS® Cranial Module is suitable for use in adult and pediatric patient populations in which the use of stereotactic neurosurgery may be appropriate.
Indications for Use:
The ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of an instrument holder or quide tube to be used by surgeons for navigating and/or quiding compatible surqical 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 spacers, and intracranial devices including biopsv needles, electrodes, and tubes.
Technological Characteristics:
The ExcelsiusGPS® Cranial Module and associated instruments have similar technological characteristics to the predicate devices including the main system components, workflow, user interface, software features, and design. The ExcelsiusGPS® Cranial Module is comparable to the predicates in terms of intended use, fundamental scientific technology, technological characteristics and principle of operation.
| Device | Subject
ExcelsiusGPS®
Cranial Module | Predicate
ExcelsiusGPS®
(K171651, K191100) | Predicate
StealthStation S8
(K162309) | Predicate
ROSA ONE Spine
(K182417) |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Principle of
operation | - Intraoperative/
preoperative
images
- Patient registration
- Surgical planning
- Real-time tracking
of navigated
instruments | - Intraoperative/
preoperative
images - Patient registration
- Surgical planning
- Real-time tracking
of navigated
instruments | - Intraoperative/
preoperative
images - Patient
registration - Surgical planning | - Intraoperative/
preoperative
images - Patient registration
- Surgical planning
- Guidance of
instruments |
| Device | Subject
ExcelsiusGPS®
Cranial Module | Predicate
ExcelsiusGPS®
(K171651, K191100) | Predicate
StealthStation S8
(K162309) | Predicate
ROSA ONE Spine
(K182417) |
| | - Guidance of
instruments | - Guidance of
instruments | - Real-time tracking
of navigated
instruments | |
| Input images | 3D preoperative
exam
3D intraoperative
exam
2D intraoperative
exam | 3D preoperative
exam
3D intraoperative
exam
2D intraoperative
exam | 3D preoperative
exam
3D intraoperative
exam
2D intraoperative
exam | 3D preoperative
exam
3D intraoperative
exam
2D intraoperative
exam |
| Integrated
planning
software | ExcelsiusGPS®
Planning and
Navigation
Application Software | ExcelsiusGPS®
Planning and
Navigation
Application Software | Stealthstation
Cranial | ROSANNA BRAIN |
| Save/load
planning | Yes | Yes | Yes | Yes |
| Merge images
functionality | Yes | Yes | Yes | Yes |
| Image-guided | Yes | Yes | Yes | Yes |
| Patient
registration
method | Intra-Op CT:
Registration
Fixture
Fluoroscopy:
Registration
Fixture
Stereotactic
Localizer
Registration | Intra-Op CT:
Registration
Fixture
Pre-Op CT:
Fluoroscopic to
Pre-Op CT Merge
Fluoroscopy:
Registration
Fixture | Point-to-point
registration with
anatomical
markers or
skin/bone
fiducials
Optical or
electromagnetic
trace merge
Intra-Op CT:
Calibrated CT
gantry to camera
merge
Stereotactic
Localizer
Registration | Point-to-point
registration with
anatomical markers
or skin/bone
fiducials
Stereotactic Localizer
Registration
Optical surface
registration |
| Accuracy
verification on
anatomical
landmarks | Yes | Yes | Yes | Yes |
| Real time
display of
instrument
position | Yes | Yes | Yes | Yes |
| Patient
fixation | Reference is
attached to patient
head holder - Head is fixed to
patient stabilization
stand | Reference is fixed to
patient's bony
structure such as a
long bone, iliac
crest, spinous
process, vertebra,
etc. for tracking
system | Reference is
attached to patient
head holder | Head is fixed onto
robot arm's flange |
Comparison of Principles of Operation and Technological Characteristics
5
6
Performance Testing:
Verification and validation testing was conducted on ExcelsiusGPS® Cranial Module 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 cranial sawbone . models and registration matrix were used to quantify accuracy in a controlled setting
- Human cadaveric quantitative validation under clinically relevant scenarios - demonstrated system accuracy in navigating cranial devices to the desired location on patient images
- . Compliance conformity assessments per:
- o IEC 60601-1 Medical electrical equipment. General requirements for basic safety and essential performance, 2005, Amendment 1, 2012
- o IEC 60601-1-6 Medical Electrical Equipment Part 1-6, General Requirements for Basic Safety and Essential Performance - Usability
- Navigational accuracy of the subject device system with mean, standard . deviation, and 99% confidence interval (CI). Results demonstrate the subject device meets the accuracy acceptance criteria for position and angle as follows:
| Position | Angle | ||
|---|---|---|---|
| Mean | 99% CI | Mean | 99% CI |