(277 days)
No
The description focuses on inertial sensors, real-time calculations based on sensor data, and display of measurements. There is no mention of AI, ML, or image processing, which are common indicators of AI/ML use in medical devices. The performance studies also describe traditional verification and validation methods, not AI/ML specific evaluations.
No.
The device provides measurements to aid in the selection and positioning of orthopedic implant components, but it does not directly treat or alleviate a medical condition.
No
The device is intended to provide intra-operative measurements and aid in the selection and positioning of orthopedic implant system components. While it provides information, it does not diagnose a medical condition or disease.
No
The device description explicitly states that the system consists of "Orientation Sensing Modules (OSM)" which are "battery-powered devices containing inertial sensors" that communicate wirelessly to a computer. This indicates the presence of hardware components beyond just software.
Based on the provided information, the GALILEO™ Spine Alignment Monitoring System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- GALILEO™'s Function: The GALILEO™ system directly interacts with the patient's body (attached to vertebrae) and provides real-time measurements of anatomical alignment during surgery. It does not analyze biological specimens.
- Intended Use: The intended use is to aid the surgeon in selecting and positioning orthopedic implants and controlling spinal alignment intra-operatively. This is a surgical guidance and monitoring function, not an in vitro diagnostic function.
Therefore, the GALILEO™ Spine Alignment Monitoring System falls under the category of a surgical guidance or monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The GALILEO™ Spine Alignment Monitoring System is intended to provide intra-operative measurements to a surgeon to aid in the selection and positioning of orthopedic implant system components, relative to anatomical structures and reference axes.
The GALILEO™ Spine Alignment Monitoring System is indicated for patients undergoing orthopedic spine surgery where the use of stereotactic surgery is considered safe and effective, and where a reference to a rigid spinal anatomical structure, such as a vertebral body, can be identified relative to the anatomy. The system aids the surgeon in controlling spinal sagittal alignment.
Example spine surgical procedures include:
- Spinal deformity correction
- Spinal fusion
Product codes
OLO
Device Description
The GALILEO™ Spine Alignment Monitoring System provides intra-operative real-time measurement of sagittal plane spine alignment parameters such as Lordosis and Kyphosis. The system consists of Orientation Sensing Modules (OSM) that are attached to vertebrae of interest with the patient in prone position. The OSM's are battery-powered devices containing inertial sensors that measure vertebral alignment changes and communicate the information wirelessly to a computer. The computer software calculates sagittal plane spinal alignment parameters in real-time based on the OSM measurements and displays the information on a touch screen tablet.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vertebrae, spinal anatomical structure, vertebral body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, intra-operative
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)
The following performance data supports the safety and substantial equivalence of the GALILEO™ Spine Alianment Monitoring System.
-
- Performance tests were performed under simulated bench test conditions to verify the implementation of the software algorithms and overall system accuracy covering all functional steps including: calibration, sagittal plane registration, vertebral registration, and sagittal plane spine alignment measurements.
-
- Simulated use testing involving sawbones and cadaver specimen were performed to verify and validate the overall system performance and to compare system measurements with clinically accepted standardized radiographic measurements. The results demonstrated that the GALILEO™ Spine Alignment Monitoring System satisfied all user needs and intended use requirements.
-
- Electrical, electromagnetic compatibility, and wireless telecommunication tests were performed to demonstrate compliance to IEC 60601-1-2, and FCC 47 CFR part 15.
-
- Software tests were performed to ensure that the required functionalities and features were implemented without the introduction of hazardous anomalies.
-
- Biocompatibility was achieved by using materials with established biocompatibility for characteristics for all patient contacting instruments and components.
-
- Sterilization and packaging validation tests were performed for single-use components in compliance with ISO 14937 and ISO 11607 to ensure a SAL of 10-9 over the shelf life of the product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Intellijoint HIP™ System (K133759)
Reference Device(s)
Zimmer iASSIST® Knee System (K122326)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
June 15, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
MiRus, LLC Jordan Bauman Director of Regulatory Affairs and Quality 2150 Newmarket Parkway Suite 108 Marietta, Georgia 30067
Re: K182524
Trade/Device Name: GALILEO Spine Alignment Monitoring System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO
Dear Jordan Bauman:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated June 17, 2019. Specifically, FDA is updating this SE Letter as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Shumaya Ali, M.P.H., OHT6: Office of Orthopedic Devices, (301) 796-2356, Shumaya.Ali(@fda.hhs.gov.
Sincerely,
Jesse Muir -S
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
1
Image /page/1/Picture/0 description: The image contains 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. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 18, 2019
MiRus, LLC Jordan Bauman Director of Regulatory Affairs and Ouality 2150 Newmarket Parkway Suite 108 Marietta, Georgia 30067
Re: K182524
Trade/Device Name: GALILEO Spine Alignment Monitoring System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: May 13, 2019 Received: May 16, 2019
Dear Jordan Bauman:
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
2
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.
Jesse Muir-S
For; Shumaya Ali, MPH 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
3
Indications for Use Statement
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020
See PRA Statement below.
510(k) Number (if known)
Device Name
GALILEO™ Spine Alignment Monitoring System
Indications for Use (Describe)
The GALILEO™ Spine Alignment Monitoring System is intended to provide intra-operative measurements to a surgeon to aid in the selection and positioning of orthopedic implant system components, relative to anatomical structures and reference axes.
The GALILEO™ Spine Alignment Monitoring System is indicated for patients undergoing orthopedic spine surgery where the use of stereotactic surgery is considered safe and effective, and where a reference to a rigid spinal anatomical structure, such as a vertebral body, can be identified relative to the anatomy. The system aids the surgeon in controlling spinal sagittal alignment.
Example spine surgical procedures include:
- Spinal deformity correction
- Spinal fusion
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)
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."
| FORM FDA 3881 (7/17) | |||
|---|---|---|---|
| ---------------------- | -- | -- | -- |
4
510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92(c).
| I. SUBMITTER | MiRus, LLC
2150 Newmarket Parkway
Suite 108
Marietta, Georgia 30067
Tel: (844) 367-0078
Fax: (844) 367-2348 |
|--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| II. OFFICIAL CORRESPONDENT | Jordan Bauman
Director of Regulatory Affairs and Quality
MiRus, LLC
2150 Newmarket Parkway
Suite 108
Marietta, Georgia 30067
Tel: (844) 367-0078
Fax: (844) 367-2348 |
| III. DATE PREPARED | May 13, 2019 |
| IV. DEVICE | |
| Name of Device
Common Name
Classification Name
Regulatory Class
Product Codes
Submission Type | GALILEO™ Spine Alignment Monitoring System
Orthopedic Stereotaxic Instrument
21 CFR §882.4560
Class II
OLO
Traditional 510(k) |
| V. PREDICATE DEVICE | Primary:
Intellijoint HIP™ System (K133759)
Reference:
Zimmer iASSIST® Knee System (K122326) |
VI. DEVICE DESCRIPTION
The GALILEO™ Spine Alignment Monitoring System provides intra-operative real-time measurement of sagittal plane spine alignment parameters such as Lordosis and Kyphosis. The system consists of Orientation Sensing Modules (OSM) that are attached to vertebrae of interest with the patient in prone position. The OSM's are battery-powered devices containing inertial sensors that measure vertebral alignment changes and communicate the information wirelessly to a computer. The computer software calculates sagittal plane spinal alignment parameters in real-time based on the OSM measurements and displays the information on a touch screen tablet.
5
VII. INTENDED USE/ INDICATIONS FOR USE:
The GALILEO™ Spine Alignment Monitoring System is intended to provide intra-operative measurements to a surgeon to aid in the selection and positioning of orthopedic implant system components, relative to anatomical structures and reference axes,
The GALILEO™ Spine Alignment Monitoring System is indicated for patients undergoing orthopedic spine surgery where the use of stereotactic surgery is considered safe and effective, and where a reference to a rigid spinal anatomical structure, such as a vertebral body, can be identified relative to the anatomy. The system aids the surgeon in controlling spinal sagittal alignment.
Example spine surgical procedures include:
- Spinal deformity correction
- Spinal fusion
VIII. TECHNOLOGICAL COMPARISONS TO THE PREDICATE
Both the predicate and subject devices provide intra-operative measurements to a surgeon to aid in the selection and positioning of orthopedic implant system components. Differences in tracking technology between the subject and predicate do not raise any new questions of safety and effectiveness. The reference device - iASSIST® Knee System (K122326) - is a legally marketed device that utilizes similar battery-powered inertial sensing technology as the subject device to track the orientation of instruments and anatomy.
IX. PERFORMANCE DATA
The following performance data supports the safety and substantial equivalence of the GALILEO™ Spine Alianment Monitoring System.
-
- Performance tests were performed under simulated bench test conditions to verify the implementation of the software algorithms and overall system accuracy covering all functional steps including: calibration, sagittal plane registration, vertebral registration, and sagittal plane spine alignment measurements.
-
- Simulated use testing involving sawbones and cadaver specimen were performed to verify and validate the overall system performance and to compare system measurements with clinically accepted standardized radiographic measurements. The results demonstrated that the GALILEO™ Spine Alignment Monitoring System satisfied all user needs and intended use requirements.
-
- Electrical, electromagnetic compatibility, and wireless telecommunication tests were performed to demonstrate compliance to IEC 60601-1-2, and FCC 47 CFR part 15.
-
- Software tests were performed to ensure that the required functionalities and features were implemented without the introduction of hazardous anomalies.
-
- Biocompatibility was achieved by using materials with established biocompatibility for characteristics for all patient contacting instruments and components.
-
- Sterilization and packaging validation tests were performed for single-use components in compliance with ISO 14937 and ISO 11607 to ensure a SAL of 10-9 over the shelf life of the product.
6
X. CONCLUSION
Based on the intended use, performance testing, and comparison to the predicate device, the GALILEO™ Spine Alignment Monitoring System has been shown to be substantially equivalent to the legally marketed predicate device and does not present any new questions of safety and effectiveness.