(209 days)
Not Found
No
The document describes a computer-assisted surgical navigation platform using stereotaxic technology and optical tracking. It does not mention AI, ML, or related concepts in the device description, intended use, or performance studies.
No.
The device is a surgical navigation platform intended as an aid for precisely locating anatomical structures and for planning tools, not for directly treating a medical condition or restoring function.
No
The device is described as a "surgical navigation platform" intended to aid surgeons in precisely locating anatomical structures and executing surgical plans during spine procedures. It provides real-time visualization of instrumentation relative to intra-operative data and offers planning tools for screw positioning and rod selection. It does not diagnose medical conditions.
No
The device description explicitly lists multiple hardware components including Augmented Reality glasses, an optical tracking system, a PC based hardware platform, a Fiducial Block, an Adaptor for sensor, Spine attachment instruments, and Reusable surgical instruments.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The NextAR Spine platform is a surgical navigation system. It uses imaging data (CT scans) and optical tracking to help surgeons precisely locate anatomical structures and guide instruments during spine procedures. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's an "aid for precisely locating anatomical structures in either open or percutaneous spine procedures" and provides "planning tools for measuring and selecting the fixation rod". This is a surgical assistance tool, not a diagnostic tool based on in vitro analysis.
- Device Components: The components listed (software, augmented reality glasses, optical tracking system, PC hardware, fiducial block, instruments) are consistent with a surgical navigation system, not an IVD.
Therefore, the NextAR Spine platform falls under the category of a surgical navigation system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NextAR Spine platform is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. It is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate, when reference to a rigid anatomical structure, such as vertebrae or pelvis, can be identified relative to images of the anatomy. This can include posterior approach spinal procedures, such as:
- · Pedicle Screw Placement (Thoracic and Lumbosacral spine)
- · Iliosacral Screw Placement
NextAR Spine is also intended to provide planning tools for measuring and selecting the fixation rod for the thoracic and lumbosacral spine.
The NextAR Spine platform is intended to be used in combination with NextARTM Stereotaxic instruments and / or Medacta preoperative planning. In the case of pre-operative planning software is used pre-operatively to plan the surgical placement of pedicle screws based upon radiological images of the patient. As an optional display, the NextAR Smart Glasses can be used auxiliary to the NextAR Spine Platform to view stereotaxic information as presented by the NextAR Spine Platform. The NextAR Smart Glasses should not be relied upon solely and should always be used in conjunction with the primary computer display.
Product codes (comma separated list FDA assigned to the subject device)
OLO, JWH, PBF
Device Description
The NextARTM Spine Platform is a CT based computer-assisted surgical navigation platform used in either open/mini open or percutaneous spine surgery procedure and includes the following components:
- navigation software which displays information to the surgeon; ●
- Augmented Reality glasses; ●
- optical tracking system; ●
- PC based hardware platform; ●
- Fiducial Block;
- Adaptor for sensor: ●
- . Spine attachment instruments
- Reusable surgical instruments for spine surgery procedures. .
The system operates on the common principle of stereotaxic technology in which markers are mounted on the bones and an infrared camera is used to monitor the spatial location of the instruments. Tracking sensors attached to the bones enable the surgeon to view the position and orientation of the instrumentation relative to the intra-operative data in real-time while performing the surgical procedure. The tracking sensors, the fiducial block and a group of pins and drills are provided sterile.
The NextAR™ Spine Platform aid the surgeon in executing the surgical plan by visualizing all the information in real time in a screen monitor.
The NextAR Spine system is a surgical navigation platform which uses the information of either an intra-operative scan or pre-operative CT in combination with an intra-operative 3D scan in order to register the spine to navigation elements.
The registration can be performed with one of the following approaches:
- Direct 3D: based on the use of an intra-operative 3D scan
- 3D-3D: based on the use of a pre-operative CT scan and an intra-operative 3D scan .
NextAR gives the possibility of planning the screw positioning on the intraoperative DICOM images of the patient, in case of the 3D direct approach, just before the system setup. The application allows for navigating the spine with a screw planning superimposed on the acquired scan.
The NextAR Spine Platform includes also the rod planning that is intended to provide information on the length and geometry of the pre-bend rod that would fit with each screw position.
The system's navigation technology is based on an active infrared camera coupled with an active tracker (Target). These elements allow, by means of the different registration approaches and use of compatible instruments, to accurately prepare trajectories in the vertebrae and/or to implant screws while visualizing information in real time on a screen monitor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
intra-operative scan, pre-operative CT, intraoperative DICOM images (in case of 3D direct approach)
Anatomical Site
Spine (Thoracic, Lumbosacral, vertebrae, pelvis)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon
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)
Testing was conducted according to written protocols with acceptance criteria that were based on standards. The following studies were performed in support of a substantial equivalence determination:
- software validation;
- Accuracy test ●
- performance testing
- cadaver study. ●
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.
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
April 24, 2024
Image /page/0/Picture/1 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. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Medacta International S.A. % Chris Lussier Senior Director, Quality, Regulatory and Clinical Research Medacta USA 3973 Delp Street Memphis, Tennessee 38118
Re: K233172
Trade/Device Name: NextAR™ Spine Platform Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, JWH, PBF Dated: September 27, 2023 Received: September 28, 2023
Dear Chris Lussier:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
2
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
2
Indications for Use
510(k) Number (if known)
Device Name NextAR™ Spine Platform
Indications for Use (Describe)
The NextAR Spine platform is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. It is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate, when reference to a rigid anatomical structure, such as vertebrae or pelvis, can be identified relative to images of the anatomy. This can include posterior approach spinal procedures, such as:
- · Pedicle Screw Placement (Thoracic and Lumbosacral spine)
- · Iliosacral Screw Placement
NextAR Spine is also intended to provide planning tools for measuring and selecting the fixation rod for the thoracic and lumbosacral spine.
The NextAR Spine platform is intended to be used in combination with NextARTM Stereotaxic instruments and / or Medacta preoperative planning. In the case of pre-operative planning software is used pre-operatively to plan the surgical placement of pedicle screws based upon radiological images of the patient. As an optional display, the NextAR Smart Glasses can be used auxiliary to the NextAR Spine Platform to view stereotaxic information as presented by the NextAR Spine Platform. The NextAR Smart Glasses should not be relied upon solely and should always be used in conjunction with the primary computer display.
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
K233172 510(k) Summary
I. Submitter
Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66
Contact Person: Stefano Baj, Regulatory Affairs Director, Medacta International SA Applicant Correspondent: Christopher Lussier, Sr. Director of Quality and Regulatory, Medacta USA Date Prepared: September 25, 2023 Date Modified: April 24, 2024
II. Device
| Device Proprietary Name: | NextAR™ Spine Platform |
|---|---|
| Common or Usual Name: | Navigation System |
| Total Joint Replacement | |
| Classification Name: | Stereotaxic Instrument |
| Primary Product Code: | OLO |
| JWH | |
| PBF | |
| Regulation Number: | 21 CFR 882.4560, 21 CFR 888.3560, 21 CFR 888.3030 |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following devices:
Primary predicate device:
- NextARTM Spine Platform K223769 Medacta International SA .
4
IV. Device Description
The NextARTM Spine Platform is a CT based computer-assisted surgical navigation platform used in either open/mini open or percutaneous spine surgery procedure and includes the following components:
- navigation software which displays information to the surgeon; ●
- Augmented Reality glasses; ●
- optical tracking system; ●
- PC based hardware platform; ●
- Fiducial Block;
- Adaptor for sensor: ●
- . Spine attachment instruments
- Reusable surgical instruments for spine surgery procedures. .
The system operates on the common principle of stereotaxic technology in which markers are mounted on the bones and an infrared camera is used to monitor the spatial location of the instruments. Tracking sensors attached to the bones enable the surgeon to view the position and orientation of the instrumentation relative to the intra-operative data in real-time while performing the surgical procedure. The tracking sensors, the fiducial block and a group of pins and drills are provided sterile.
The NextAR™ Spine Platform aid the surgeon in executing the surgical plan by visualizing all the information in real time in a screen monitor.
The NextAR Spine system is a surgical navigation platform which uses the information of either an intra-operative scan or pre-operative CT in combination with an intra-operative 3D scan in order to register the spine to navigation elements.
The registration can be performed with one of the following approaches:
- Direct 3D: based on the use of an intra-operative 3D scan
- 3D-3D: based on the use of a pre-operative CT scan and an intra-operative 3D scan .
NextAR gives the possibility of planning the screw positioning on the intraoperative DICOM images of the patient, in case of the 3D direct approach, just before the system setup. The application allows for navigating the spine with a screw planning superimposed on the acquired scan.
The NextAR Spine Platform includes also the rod planning that is intended to provide information on the length and geometry of the pre-bend rod that would fit with each screw position.
The system's navigation technology is based on an active infrared camera coupled with an active tracker (Target). These elements allow, by means of the different registration approaches
5
and use of compatible instruments, to accurately prepare trajectories in the vertebrae and/or to implant screws while visualizing information in real time on a screen monitor.
V. Indications for Use
The NextAR Spine platform is intended as an aid for precisely locating anatomical structures in either open/mini-open or percutaneous spine procedures. It is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate, when reference to a rigid anatomical structure, such as vertebrae or pelvis, can be identified relative to images of the anatomy. This can include posterior approach spinal procedures, such as:
- · Pedicle Screw Placement (Thoracic and Lumbosacral spine)
- Iliosacral Screw Placement
NextAR Spine is also intended to provide planning tools for measuring and selecting the fixation rod for the thoracic and lumbosacral spine.
The NextAR Spine platform is intended to be used in combination with NextAR™ Stereotaxic instruments and / or Medacta preoperative planning. In the case of pre-operative planning. surgical planning software is used pre-operatively to plan the surgical placement of pedicle screws based upon radiological images of the patient. As an optional display, the NextAR Smart Glasses can be used auxiliary to the NextAR Spine Platform to view stereotaxic information as presented by the NextAR Spine Platform. The NextAR Smart Glasses should not be relied upon solely and should always be used in conjunction with the primary computer display.
VI. Comparison of Technological Characteristics
The NextAR™ Spine System and the predicate NextAR™ Spine Platform, K223769, share the following characteristics:
- Intended use ●
- principle of operation; ●
- user interface: ●
- power source;
- optical tracking system ●
- platform; ●
- Displaying Technology
- Glasses communication;
- use of surgical instruments for navigation; ●
- main system components;
- use of surgical instruments for navigation; ●
- Tracking System accuracy;
- use of active optical tracking system
- . computer hardware;
- pre-operative patient anatomy data acquisition. ●
6
- intra-operative patient anatomy data acquisition ●
- . use of surgical instruments for navigation;
The subject NextAR™ Spine System differs from the predicate device with respect to:
- Rod planning feature ●
- Intra Operative Screw planning feature ●
- . Fiducial Registration Accuracy
Discussion
The differences between the subject and the primary predicate device are concerning the rod planning and intra operative screw planning features.
They do not raise different questions of safety or effectiveness when compared to the predicate device. Both navigation systems utilize stereotaxic technologies.
Minor differences are addressed by performing cadaveric testing/ rational/ test.
VII. Performance Data
Testing was conducted according to written protocols with acceptance criteria that were based on standards. The following studies were performed in support of a substantial equivalence determination:
- software validation;
- Accuracy test ●
- performance testing
- cadaver study. ●
VIII. Conclusion
The information provided above supports that the NextAR™ Spine Platform is substantially equivalent to the identified predicate devices.
Substantial equivalence has been demonstrated through a comparison of design and technological characteristics, as well as performance evaluations. The NextAR™ Spine Platform can be considered substantially equivalent to the identified predicate devices.