ChoiceSpine Navigation System

K203561 · Choice Spine, LLC · OLO · Jan 4, 2021 · Neurology

Device Facts

• Record ID: K203561
• Device Name: ChoiceSpine Navigation System
• Applicant: Choice Spine, LLC
• Product Code: OLO · Neurology
• Decision Date: Jan 4, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The ChoiceSpine Navigation reusable instruments are intended to be used during preparation and placement of ChoiceSpine Lancer™, Thunderbolt™, and Blackbird™ system during spinal surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The ChoiceSpine Navigation reusable instruments are specifically designed for use with the Medtronic Stealth Station System (V2.1.0), 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, along bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

Device Story

ChoiceSpine Navigation instruments are non-sterile, reusable surgical tools; designed for use with Medtronic StealthStation System and SureTrak II System. Instruments interface with navigation system to track position relative to patient anatomy; surgeon uses system to precisely locate structures during spinal preparation and screw placement (Lancer, Thunderbolt, Blackbird systems). System utilizes CT/MR models, fluoroscopy, or digitized landmarks for registration. Output provides real-time visual guidance to surgeon; assists in accurate instrument placement; potentially reduces surgical error and improves patient outcomes in cervical, thoracic, and lumbar spinal procedures.

Clinical Evidence

Bench testing only. The device was tested per ASTM F2554-10, "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems," during the original submission. No new clinical data was required for this submission as the technological characteristics and function remain identical to the predicate.

Technological Characteristics

Instruments manufactured from medical-grade titanium and stainless steel. Designed for use with Medtronic StealthStation System (V2.1.0). Principle of operation involves stereotactic navigation using CT/MR models, fluoroscopy, or digitized landmarks. Complies with ASTM F2554-10 for positional accuracy. Reusable, non-sterile.

Indications for Use

Indicated for patients undergoing spinal surgery requiring precise anatomical localization for preparation and placement of ChoiceSpine Lancer, Thunderbolt, and Blackbird systems in open or minimally invasive procedures.

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

• Navigation System (K182721)
• Blackbird™ Spinal System (K133214)
• Medtronic Navigated Disc Prep Instruments and CAPSTONE Trials (K150231)

Submission Summary (Full Text)

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January 4th, 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 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.

ChoiceSpine, LLC Kim Finch Director of Regulatory Affairs 400 Erin Drive Knoxville, Tennessee 37919

Re: K203561

Trade/Device Name: ChoiceSpine Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: December 2, 2020 Received: December 7, 2020

Dear Kim Finch:

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 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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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K203561

#### Device Name

ChoiceSpine Navigation System

### Indications for Use (Describe)

The ChoiceSpine Navigation reusable instruments are intended to be used during preparation and placement of ChoiceSpine Lancer", Thunderbolt", and Blackbird™ system during spinal surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The ChoiceSpine Navigation reusable instruments are specifically designed for use with the Medtronic Stealth Station System (V2.1.0), 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, along bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 7. 510(k) Summary

| Date: | December 2, 2020 |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | ChoiceSpine, LLC<br>400 Erin Drive<br>Knoxville, TN 37919 |
| Phone: | 865-243-3969 |
| Fax: | 865-246-3334 |
| Contact Person: | Kim Finch, Director of Regulatory Affairs |
| Proposed<br>Proprietary Trade<br>Name: | ChoiceSpine Navigation System |
| Product Class: | Class II |
| Classification<br>Name: | ChoiceSpine Navigation System<br>• 882.4560 Neurological Stereotaxic Instrument |
| Device Product<br>Code: | ChoiceSpine Navigation System<br>• OLO |
| Purpose of Submission: | The purpose of this submission is to add Blackbird instruments to the<br>ChoiceSpine Navigation system. |
| Device Description: | The ChoiceSpine Navigation instruments are non-sterile, reusable instruments<br>designed to function with the Medtronic® StealthStation® System and SureTrak®<br>II System. Refer to the appropriate navigation system Instructions for Use<br>and/or Surgical Technique Guide for details regarding navigation system use.<br>The ChoiceSpine Navigation instruments are for use with ChoiceSpine screw<br>systems, specifically, Lancer™, Thunderbolt™, and Blackbird™ Spinal Systems. |
| Indications for Use: | The ChoiceSpine Navigation reusable instruments are intended to be used<br>during preparation and placement of ChoiceSpine Lancer™, Thunderbolt™, and<br>Blackbird™ system during spinal surgery to assist the surgeon in precisely<br>locating anatomical structures in either open or minimally invasive procedures.<br>The ChoiceSpine Navigation reusable instruments are specifically designed for<br>use with the Medtronic Stealth Station System (V2.1.0), which is indicated for<br>any medical condition in which the use of stereotactic surgery may be<br>appropriate, and where reference to a rigid anatomical structure, such as a<br>skull, along bone, or vertebra, can be identified relative to a CT or MR based<br>model, fluoroscopy images, or digitized landmarks for the anatomy. |
| Materials: | The instruments are manufactured from medical grade titanium and stainless<br>steel. |
| Non-clinical Testing: | Addition of Blackbird to Choicespine Navigation does not require testing. The<br>subject and predicate devices have nearly identical technological characteristics<br>the minor difference does not raise any new issues of safety and effectiveness.<br>Specifically, the following characteristics are identical between the subject and |

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predicate; Principle of operation and technical characteristics such as design, sterility, and interfacing. The only difference between the subject and predicate device is anatomical location of surgical use. The predicate submission names system used in the thoracic lumbar region of the spine (Lancer™)Thunderbolt™) whereas this subject submission will add usage in the cervical region (Blackbird™) as well as the thoracic lumbar region of the spine (Lancer™/Thunderbolt™). The Choice Spine Navigation 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. Thus the Medtronic® StealthStation® System inherently has the ability for stereotactic surgery of the cervical spine, such as the proposed usage of the ChoiceSpine Blackbird™ system in an identical or similar registration, calibration and application to that of the existing ChoiceSpine Navigation system. Testing is not required since the subject device has identical and unchanged technological characteristics and function as the predicate which was tested per ASTM F2554-10, "Standard Practice for Measurement of Positional Accuracy of Computer assisted Surgical Systems" as part of the original submission.

- Predicate Devices: Primary Predicate: Navigation System (K182721) Additional Predicates: Blackbird™ Spinal System (K133214) Medtronic Navigated Disc Prep Instruments and CAPSTONE Trials (K150231)
Substantial Equivalence

Conclusion: The addition of Blackbird to Navigation is within scope of the primary and secondary predicates. The Primary predicate submission names system used in the thoracic lumbar region of the spine (Lancer™/Thunderbolt™) whereas this subject submission will add usage in the cervical region (Blackbird™) as well as the thoracic lumbar region of the spine (Lancer™/Thunderbolt™). The secondary predicate (K150231) includes usage in both the Cervical and thoracic lumbar region. So, subject submission is within scope of both the primary and secondary predicates. This subject submission has identical and unchanged technological characteristics and function as the primary predicate.

# PERFORMANCE DATA:

The Navigation System has been tested per ASTM F2554-10, "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems". The results of this non-clinical testing show that performance of the Navigation System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

# CONCLUSION:

The overall technology characteristics and performance data lead to the conclusion that the Navigation System is substantially equivalent to the predicate device.