(227 days)
No
The description focuses on traditional stereotaxic navigation technology using optical tracking and image registration, with no mention of AI or ML algorithms for image processing, planning, or guidance.
No
The device is a surgical navigation platform intended to aid in precisely locating anatomical structures during spine procedures, not to provide therapy or treatment itself.
No
The device is described as a "computer-assisted surgical navigation platform" intended to aid in locating anatomical structures and executing surgical plans by visualizing real-time information to the surgeon during spine procedures. It does not perform a diagnosis.
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, the NextAR Spine platform is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- NextAR Spine Platform Function: The NextAR Spine platform is a surgical navigation system. Its purpose is to aid surgeons in precisely locating anatomical structures during spine procedures using imaging data and tracking technology. 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 for "surgical placement of pedicle screws." This is a surgical guidance tool, not a diagnostic test performed on a sample.
- Device Description: The description details components like navigation software, augmented reality glasses, optical tracking, and surgical instruments. These are all related to surgical navigation and execution, not in vitro analysis.
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 indical for any medical condition in which the use of stereotaxtic 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 the following spinal implant procedures, such as:
- · Pedicle Screw Placement (Thoracic and Lumbosacral spine)
- Iliosacral Screw Placement
The NextAR Spine platform is intended to be used in combination with NextAR™M Stereotaxic instruments and / or Medacta preoperative planning. In the case of pre-operative planning software is used preoperatively 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 aids the surgeon in executing the surgical plan by visualizing all the information in real time on 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-CArm 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-CArm scan ●
- . 3D-3D: based on the use of a pre-operative CT scan and an intra-operative 3D-CArm scan
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 scan, intra-operative 3D-CArm scan
Anatomical Site
Spine, vertebrae, pelvis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
- Software validation:
- Accuracy test
- Biocompatibility per ISO 10993-1:2009;
- Sterilization validation;
- Shelf-life testing:
- Shipping test
- Electrical safety testing per IEC 60601-1:2005, COR1:2006, COR2:2007, Amd1:2012;
- Electromagnetic compatibility testing per IEC 60601-1-2:2014;
- Performance testing to evaluate mechanical and optical properties.
- 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.
K121115, K132878, K141988, K162061, K171170, K171369, K171595, K193365
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
November 5, 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: on the left, there is a seal of the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's role in protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.
Medacta International, SA % Chris Lussier Senior Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis. Tennessee 38118
Re: K210859
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 29, 2021 Received: September 30, 2021
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 (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 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.
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) K210859
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 indical for any medical condition in which the use of stereotaxtic 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 the following spinal implant procedures, such as:
- · Pedicle Screw Placement (Thoracic and Lumbosacral spine)
- Iliosacral Screw Placement
The NextAR Spine platform is intended to be used in combination with NextAR™M Stereotaxic instruments and / or Medacta preoperative planning. In the case of pre-operative planning software is used preoperatively 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 |
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3
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: Chris Lussier, Sr. Director of Quality and Regulatory, Medacta USA Date Prepared: March 22, 2021 Dave Revised: November 4, 2021
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 | |
| BPF | |
| Regulation Number: | 21 CFR 882.4560 |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following devices:
Primary predicate device:
-
Stealth Station System, K170011, Medtronic ●
Additional predicate devices: -
. NextARTM TKA Platform K193559, Medacta International SA
-
NextARTM TKA Platform K202152, Medacta International SA ●
Reference predicate devices:
- M.U.S.T. Pedicle Screw System, K121115, Medacta International SA ●
- M.U.S.T. Pedicle Screw System, K132878, Medacta International SA ●
- M.U.S.T. Pedicle Screw System, K141988, Medacta International SA ●
- M.U.S.T. Pedicle Screw System, K162061, Medacta International SA ●
- M.U.S.T. Pedicle Screw System, K171170, Medacta International SA ●
- M.U.S.T. Pedicle Screw System, K171369, Medacta International SA ●
4
- M.U.S.T. Pedicle Screw System, K171595, Medacta International SA ●
- . M.U.S.T. Pedicle Screw System, K193365, Medacta International SA
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 aids the surgeon in executing the surgical plan by visualizing all the information in real time on 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-CArm 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-CArm scan ●
- . 3D-3D: based on the use of a pre-operative CT scan and an intra-operative 3D-CArm scan
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.
5
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 stereotaxtic 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 the following spinal implant procedures, such as:
- Pedicle Screw Placement (Thoracic and Lumbosacral spine)
- Iliosacral Screw Placement
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 NextARTM Spine Platform and the predicate- Stealth Station system, K170011, share the following characteristics:
- principle of operation;
- user interface: ●
- power source; ●
- main system components; ●
- use of surgical instruments for navigation;
- accuracy; ●
- use of active optical tracking system ●
- computer hardware; ●
- pre-operative patient anatomy data acquisition.
- intra-operative patient anatomy data acquisition ●
The NextAR™ Spine Platform and the predicate NextAR™ TKA Platform K193559 and K202152 share the following characteristics:
- power source; ●
- optical tracking system ●
- platform; ●
- use of surgical instruments for navigation; ●
The NextAR™ Spine Platform and the predicate Stealth Station system, K170011, are technologically different with respect to:
6
-
Active infrared Camera Target vs Passive infrared Camera Target ●
The NextAR™ Spine Platform and the predicate NextAR™ TKA Platform K193559 and K202152 are different with respect to: -
Intended use and indication ●
-
Surgical flow ●
-
intra operative scan
-
Dedicated algorithm ●
-
Target dimension ●
Discussion
There are minor differences between the subject and predicate devices; these differences are concerning optical tracking system, dedicated algorithm and intended use. 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 and rational testing.
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 ●
- Biocompatibility per ISO 10993-1:2009; ●
- Sterilization validation; ●
- Shelf-life testing: ●
- Shipping test ●
- Electrical safety testing per IEC 60601-1:2005, COR1:2006, COR2:2007, Amd1:2012; ●
- Electromagnetic compatibility testing per IEC 60601-1-2:2014; ●
- Performance testing to evaluate mechanical and optical properties. ●
- 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 intended use, design and technological characteristics, as well as performance evaluations. The NextAR™ Spine Platform can be considered substantially equivalent to the identified predicate devices.