NextAR™ Spine Platform

K210859 · Medacta International S.A. · SBF · Nov 5, 2021 · Neurology

Device Facts

• Record ID: K210859
• Device Name: NextAR™ Spine Platform
• Applicant: Medacta International S.A.
• Product Code: SBF · Neurology
• Decision Date: Nov 5, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended 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.

Device Story

CT-based computer-assisted surgical navigation platform; aids precise location of anatomical structures during open/percutaneous spine surgery. Inputs: pre-operative CT scans and/or intra-operative 3D C-arm scans. Operation: active infrared camera tracks active sensors (targets) attached to patient bone; system registers anatomy to navigation elements via Direct 3D or 3D-3D registration. Outputs: real-time visualization of instrument position/orientation relative to anatomy on primary monitor; optional auxiliary view via AR smart glasses. Used in OR by surgeons. Benefits: assists execution of surgical plan; improves accuracy of pedicle/iliosacral screw placement.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including software validation, accuracy testing, biocompatibility (ISO 10993-1), sterilization validation, shelf-life, shipping, electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and a cadaver study to evaluate mechanical and optical performance.

Technological Characteristics

CT-based navigation platform; active infrared camera and active trackers. Components: PC hardware, optical tracking system, fiducial blocks, surgical instruments, AR glasses. Biocompatibility per ISO 10993-1. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2. Registration via Direct 3D (intra-operative 3D C-arm) or 3D-3D (pre-operative CT + intra-operative 3D C-arm).

Indications for Use

Indicated for patients requiring stereotaxic surgery for spinal implant procedures, including pedicle screw placement (thoracic/lumbosacral) and iliosacral screw placement, where rigid anatomical structures (vertebrae/pelvis) can be referenced to imaging.

Regulatory Classification

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.

Predicate Devices

• Stealth Station System (K170011)
• NextAR™ TKA Platform (K193559)
• NextAR™ TKA Platform (K202152)

Reference Devices

• M.U.S.T. Pedicle Screw System (K121115)
• M.U.S.T. Pedicle Screw System (K132878)
• M.U.S.T. Pedicle Screw System (K141988)
• M.U.S.T. Pedicle Screw System (K162061)
• M.U.S.T. Pedicle Screw System (K171170)
• M.U.S.T. Pedicle Screw System (K171369)
• M.U.S.T. Pedicle Screw System (K171595)
• M.U.S.T. Pedicle Screw System (K193365)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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## 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) | |
|------------------------------------------------------------|-----------------------------------------------------------|
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED | |

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# 510(k) Summary

#### I. Submitter

Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone [phone] Fax [phone]

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 ●

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- 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.

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#### 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:

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- 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.