(29 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the device description focuses on traditional image-guided navigation components.
No
The device is described as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or guide to be used by surgeons for navigating and/or guiding compatible surgical instruments. It assists surgeons in placing pedicle screws but does not directly treat a disease or condition.
No
The device is described as an "aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or guide," and "for navigating and/or guiding compatible surgical instruments." This indicates it is a surgical navigation and guidance system, not a device used to diagnose a medical condition.
No
The device description explicitly states that the system is comprised of a computer workstation, software, a trajectory system (including a targeting platform), a camera, and various image guided instruments, indicating it includes significant hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Fusion Robotic Navigation System is a surgical navigation system. Its purpose is to aid surgeons in precisely locating anatomical structures and guiding surgical instruments during a surgical procedure, based on pre-operative imaging. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or guide to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous spinal procedures." This is an intra-operative function, not an in vitro diagnostic one.
- Device Description: The description mentions a computer workstation, software, a trajectory system, camera, and instruments for assisting the surgeon in the pedicles of the lumbar spine. This aligns with a surgical navigation system, not an IVD.
Therefore, based on the provided information, the Fusion Robotic Navigation System falls under the category of a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Fusion Robotic Navigation System is indicated for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or guide to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous spinal procedures in reference to rigid patient anatomy and fiducials that can be identified on a 3D imaging scan. The Fusion System is indicated for assisting the surgeon in placing pedicle screws in the posterior lumbar region (L1-S1). The system is designed for lumbar pedicle screw placement with the prone position and is compatible with the ATEC Invictus® Spinal Fixation System.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
The Fusion Robotic Navigation System is an image guided system primarily comprised of a computer workstation, software, a trajectory system, including a targeting platform, a camera, and various image guided instruments intended for assisting the surgeon in the pedicles of the lumbar spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
3D imaging scan
Anatomical Site
posterior lumbar region (L1-S1)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons / open or percutaneous spinal procedures
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)
An engineering analysis was conducted comparing the Invictus Guide Tube, Invictus 8mm Guide Tube Sleeve and Invictus MIS to the predicate Guide Tube, 8mm Guide Tube Sleeve and MIS Driver. Invictus® Spinal Fixation System instruments maintain all the same critical features as the predicate designs. The stackup of the tolerances do not create any new worst-case conditions. The Invictus® Spinal Fixation System instruments are used in an identical manner to the predicate versions using the same software.
The results of this engineering analysis show that the Invictus® Spinal Fixation System instruments are substantially equivalent to the predicate. Therefore, no additional verification testing is required.
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.
REMI Robotic Navigation System (K223070), Accelus LineSider Navigation Instruments (K231098)
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.
Not Found
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
September 8, 2023
Image /page/0/Picture/1 description: The image contains 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 text logo on the right. The text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
Alphatec Spine, Inc. Sarah Braun Senior Regulatory Affairs Specialist 168 Centennial Parkway, Unit 170 Louisville, Colorado 80027
Re: K232413
Trade/Device Name: Fusion Robotic Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: August 10, 2023 Received: August 10, 2023
Dear Sarah Braun:
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.
1
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 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.
Tejen D. Soni -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
2
Indications for Use
510(k) Number (if known) K232413
Device Name Fusion Robotic Navigation System
Indications for Use (Describe)
The Fusion Robotic Navigation System is indicated for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or guide to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous spinal procedures in reference to rigid patient anatomy and fiducials that can be identified on a 3D imaging scan. The Fusion System is indicated for assisting the surgeon in placing pedicle screws in the posterior lumbar region (L1-S1). The system is designed for lumbar pedicle screw placement with the prone position and is compatible with the ATEC Invictus® Spinal Fixation System.
| 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."
3
Image /page/3/Picture/0 description: The image shows the word "atec" in a stylized font. The "a" is green, while the "tec" is a dark blue color. There is a trademark symbol to the right of the "c". The font is sans-serif and the letters are connected.
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
| 510(k) Owner | Alphatec Spine, Inc.
1950 Camino Vida Roble
Carlsbad, CA 92008 |
|-----------------------------|---------------------------------------------------------------------------------------------------------|
| Contact Person | Sarah Braun
Senior Regulatory Affairs Specialist
Tel: 423-838-4454
Email: sbraun@atecspine.com |
| Date Prepared | September 8, 2023 |
| Classification Reference | 21 CFR 882.4560 |
| Product Code | OLO |
| Common/Usual Name | Stereotaxic Instrument |
| Trade/Proprietary Name | Fusion Robotic Navigation System |
| Primary Predicate Device(s) | REMI Robotic Navigation System (K223070) |
| Additional Predicate Device | Accelus LineSider Navigation Instruments
(K231098) |
The Fusion Robotic Navigation System is an image guided system primarily comprised of a computer workstation, software, a trajectory system, including a targeting platform, a camera, and various image guided instruments intended for assisting the surgeon in the pedicles of the lumbar spine.
Indications for Use
The Fusion Robotic Navigation System is indicated for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous spinal procedures in reference to rigid patient anatomy and fiducials that can be identified on a 3D imaging scan. The Fusion Robotic Navigation System is indicated for assisting the surgeon in placing pedicle screws in the posterior lumbar region (L1-S1). The system is designed for lumbar pedicle screw placement with the prone position and is compatible with the ATEC Invictus Spinal Fixation System.
Comparison of the Technological Characteristics
The proposed Fusion Robotic Navigation System is considered substantially equivalent to the REMI Robotic Navigation System (K223070). The only change to the indications for use is the replacement of Accelus LineSider with ATEC Invictus® Spinal Fixation System. The IFU is also updated with the addition of the Invictus Guide Tube, Invictus 8mm Guide Tube Sleeve and Invictus MIS Driver. The principles of operation, mode of operation, and performance are the same as the predicate.
4
Additional Instruments
To facilitate the use of the ATEC Invictus® Spinal Fixation System with the Fusion Robotic Navigation System three additional instruments were added: the Invictus Guide Tube (P1012), Invictus 8mm Guide Tube Sleeve (P1021), and Invictus MIS Screwdriver (P1067). All of these instruments are manufactured from the same materials used in the predicate system and also follow the same manufacturing processes.
The new instruments do not introduce a worst case for biocompatibility, cleaning, or sterilization. No new risks were identified, and no existing risks were impacted by the addition of the Invictus® Spinal Fixation System instruments. No requirements were added to the design requirement as a part of this change. The design requirements document was updated to standardize nomenclature for existing instrumentation and replace "Remi" with "SGS" (Surgical Guidance System) where appropriate. Other minor clerical changes were made to the design requirements document.
Performance Testing
An engineering analysis was conducted comparing the Invictus Guide Tube, Invictus 8mm Guide Tube Sleeve and Invictus MIS to the predicate Guide Tube, 8mm Guide Tube Sleeve and MIS Driver. Invictus® Spinal Fixation System instruments maintain all the same critical features as the predicate designs. The stackup of the tolerances do not create any new worst-case conditions. The Invictus® Spinal Fixation System instruments are used in an identical manner to the predicate versions using the same software.
The results of this engineering analysis show that the Invictus® Spinal Fixation System instruments are substantially equivalent to the predicate. Therefore, no additional verification testing is required.
Conclusion
The subject device, Fusion Robotic Navigation System, described in this submission has the same intended use and the same technological characteristics as the predicate device, REMI Robotic Navigation System (K223070). The primary difference between the subject device and the predicate is the use with the Invictus® Spinal Fixation System and the introduction of Invictus® Spinal Fixation System instruments.
The engineering analysis performed on the new instrumentation demonstrated that the characteristics of the subject Fusion Robotic Navigation System is substantially equivalent to the predicate device. The subject device continues to meet design requirements, is as safe and effective as the predicate device, and performs according to its intended use. The information presented in this 510(k) premarket notification demonstrates that the subject device is substantially equivalent to the predicate REMI Robotic Navigation System (K223070).