SPINEART Navigation Instrument System

K210472 · Spineart · OLO · Mar 19, 2021 · Neurology

Device Facts

• Record ID: K210472
• Device Name: SPINEART Navigation Instrument System
• Applicant: Spineart
• Product Code: OLO · Neurology
• Decision Date: Mar 19, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The SPINEART® Navigation Instrument System reusable instruments are intended to be used during the preparation and placement of Spineart screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SPINEART® Navigation Instrument System reusable instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

Device Story

Reusable surgical instruments (screwdrivers, taps, drills, drill guides) used in spinal surgery; designed for use with Medtronic StealthStation System and NavLock Tracker System. Instruments track anatomical structures relative to CT/MR models or fluoroscopy; assist surgeons in precise placement of pedicle screw implants (Romeo 2, Romeo 2 MIS, Perla Cervico-thoracic, Perla TL, Perla TL MIS). Operated by surgeons in OR; provides visual guidance via navigation system to improve accuracy of screw placement; benefits patient through potentially increased precision during spinal fixation.

Clinical Evidence

No clinical data. Substantial equivalence established via design features, technological characteristics, and dimensional/tolerance stack-up analysis.

Technological Characteristics

Stainless steel per ASTM F899. Reusable, non-sterile. Includes screwdrivers, taps, drills, and drill guides. Compatible with Medtronic StealthStation (V2.1.0) and NavLock Tracker System. Mechanical navigation interface.

Indications for Use

Indicated for patients undergoing spinal surgery requiring preparation and placement of Spineart screws in open or minimally invasive procedures, where stereotactic navigation is appropriate.

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

• SPINEART Navigation Instrument System (K183630)

Reference Devices

• Medtronic StealthStation System (V2.1.0)
• Medtronic NavLock Tracker System

Submission Summary (Full Text)

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March 19, 2021

Image /page/0/Picture/1 description: The image shows 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Spineart Franck Pennesi Chief Technical Officer 3 chemin du pré Fleuri Plan Les Ouates, Geneva 1228 Switzerland

Re: K210472

Trade/Device Name: SPINEART Navigation Instrument System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: February 11, 2021 Received: February 17, 2021

Dear Franck Pennesi:

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

### K210472

Device Name

SPINEART® Navigation Instrument System

#### Indications for Use (Describe)

The SPINEART® Navigation Instrument System reusable instruments are intended to be used during the preparation and placement of Spineart screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SPINEART® Navigation Instrument System reusable instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

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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FORM FDA 3881 (6/20)

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# Special 510k - Device Modification SPINEART NAVIGATION Instrument System

Image /page/3/Picture/2 description: The image shows the logo for Spineart. The logo consists of the word "spineart" in a stylized font, with the first five letters in black and the last three letters in purple. Above the word "spineart" is a purple butterfly.

## 510(k) SUMMARY

| 510k | Special 510(k): Device Modification |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Basis for submission | Product Line Extension of the SPINEART Navigation Instrument System (K183630) |
| Submitted by | SPINEART<br>3 Chemin du Pré Fleuri<br>1228 PLAN LES OUATES<br>GENEVA SWITZERLAND |
| Contacts | Franck PENNESI Chief Technical Officer<br>Phone: [phone] Fax: [phone]<br>Mail: [e-mail]<br>Regulatory contact: Dr Isabelle DRUBAIX (PhD) [e-mail] |
| Date Prepared | February 8, 2021 |
| Common Name | Orthopedic Stereotaxic Instrument |
| Trade Name | SPINEART Navigation Instrument System |
| Classification Name | Orthopedic Stereotaxic Instrument |
| Class | II |
| Product Code | OLO |
| CFR section | 882.4560 |
| Device panel | ORTHOPEDIC |
| Legally marketed predicate device(s) | Primary predicate: SPINEART Navigation Instrument System manufactured by<br>SPINEART (K183630) |
| Indications for use | The SPINEART® Navigation Instrument System reusable instruments are intended to be used during the preparation and placement of Spineart screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SPINEART® Navigation Instrument System reusable instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy. |

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| Description of the device | The SPINEART® Navigation Instrument System reusable instruments are surgical<br>instruments for use with the Medtronic StealthStation® Navigation System to<br>assist surgeons in precisely locating anatomical structures in either open,<br>minimally invasive, or percutaneous procedures for preparation and placement of<br>pedicle screw system implants.<br>The SPINEART® Navigation Instrument System includes the following:<br>Screwdrivers, Taps, Drills, and Drill Guides.<br>The SPINEART® Navigation Instrument System are to be used with the following<br>Spineart Systems:<br>- Romeo® 2<br>- Romeo® 2 MIS<br>- Perla® Cervico-thoracic Fixation System<br>All instruments are made of stainless steel per ASTM F899. All instruments are<br>reusable instruments provided not sterile.<br>The SPINEART® Navigation Instrument System instruments are not compatible<br>with implants from other manufacturers.<br>The SPINEART® Navigation Instrument System are designed for use only with<br>Medtronic StealthStation® System (V2.1.0) and the Medtronic NavLock® Tracker<br>System. |
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| Technological<br>characteristics<br>compared to the<br>predicate devices | The subject product line extension of the SPINEART Navigation Instrument System<br>(K183630) consists of addition of taps, drill and screwdrivers for the Perla TL and<br>Perla TL MIS Posterior Osteosynthesis Systems.<br>As was established in this submission, the SPINEART Navigation added instruments<br>are substantially equivalent and have the same technological characteristics to<br>predicate devices in areas including indications for use, function, material<br>composition, design, range of sizes and accuracy performance. Verification and<br>validation activities conducted on the added navigated instruments demonstrate<br>that these navigated instruments are suitable to be used with the Medtronic®<br>StealthStation® System (V2.1.0) and the Medtronic® NavLock Tracker System<br>when implanting screws part of the Perla TL and Perla TL MIS Posterior<br>Osteosynthesis Systems. |
| Discussion of Testing | Addition of navigated instruments to SPINEART Navigation Instrument System<br>(K183630) does not require testing. |
| Conclusion | Based on the design features, technological characteristics, feature comparisons,<br>indications for use, and dimensional and tolerance stack-up analysis, the added<br>SPINEART Navigation Instruments have demonstrated substantial equivalence to |