Choice Spine Navigation System

K182721 · Choicespine, LP · OLO · Jan 8, 2019 · Neurology

Device Facts

• Record ID: K182721
• Device Name: Choice Spine Navigation System
• Applicant: Choicespine, LP
• Product Code: OLO · Neurology
• Decision Date: Jan 8, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Choice Spine Navigation reusable instruments are intended to be used during preparation and placement of Choice Spine Lancer™ and Thunderbolt™ system screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Choice Spine Navigation 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 of the anatomy.

Device Story

Choice Spine Navigation System consists of non-sterile, reusable instruments; designed for use with Medtronic StealthStation and SureTrak II systems. Instruments function as navigation-compatible tools for preparation and placement of Lancer and Thunderbolt pedicle screws. Used in spinal surgery (open or minimally invasive) by surgeons to precisely locate anatomical structures. System relies on integration with Medtronic navigation platform to track instruments relative to patient anatomy (CT/MR/fluoroscopy/digitized landmarks). Output provides real-time visualization of instrument position relative to patient anatomy, assisting surgeon in screw placement. Benefits include improved surgical precision and navigation-guided accuracy during spinal instrumentation.

Clinical Evidence

Bench testing only. Performance of the Navigation System was evaluated per ASTM F2554-10, 'Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems'. Results demonstrate performance is sufficient for intended use and equivalent to predicate devices.

Technological Characteristics

Reusable orthopedic stereotaxic instruments. Materials: medical grade stainless steel, Radel, Ketaspire KT-820 CF30, Ti-6Al-4V (ASTM F136), and PTFE. Designed for integration with Medtronic StealthStation/SureTrak II navigation systems. Non-sterile. Mechanical design for surgical navigation.

Indications for Use

Indicated for use during spinal surgery to assist surgeons in locating anatomical structures for the preparation and placement of Choice Spine Lancer and Thunderbolt screws in open or minimally invasive procedures. Designed for use with the Medtronic StealthStation System for conditions where stereotactic surgery is appropriate using CT, MR, fluoroscopy, or digitized landmarks.

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

• Navigated Disc Prep Instruments (K150231)
• Thunderbolt and Lancer Pedicle Screw System (K132049)

Reference Devices

• Navigated CD HORIZON® SOLERATM Screwdrivers, CD HORIZON® SOLERATM Taps, CD HORIZON® SOLERATM Iliac Taps and CD HORIZON® LEGACY™ Taps (K124004)

Submission Summary (Full Text)

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January 8, 2019

Choice Spine, LP. % Meredith May Regulatory and Quality Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K182721

Trade/Device Name: Choice Spine Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: December 19, 2018 Received: December 20, 2018

Dear Meredith May:

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Shumaya Ali -S

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement on last page. |
|-------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|

| Indications for Use | |
|--------------------------------|--------------------------------|
| 510(k) Number (if known) | K182721 |
| Device Name | Choice Spine Navigation System |
| Indications for Use (Describe) | |

The Choice Spine Navigation reusable instruments are intended to be used during preparation
and placement of Choice Spine Lancer™ and Thunderbolt™ system screws during spinal
surgery to assist the surgeon in precisely locating anatomical structures in either open or
minimally invasive procedures. The Choice Spine Navigation 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
of the anatomy.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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| Submitter's Name | Choice Spine, LP. |
|------------------------------|------------------------------------------------------------------------------------------|
| Submitter's Address | 400 Erin Dr.<br>Knoxville, TN 37919 |
| Submitter's Phone | 865.246.3333 |
| Contact Person | Meredith Lee May<br>Empirical Consulting<br>719.337.7579<br>[e-mail] |
| Date Summary was<br>Prepared | 03 January 2019 |
| Trade or Proprietary Name | Choice Spine Navigation System |
| Common or Usual Name | Orthopedic Stereotaxic Instrument |
| Classification | Class II per 21 CFR §882.4560 |
| Product Code | OLO |
| Classification Panel | Orthopedic |

#### 510(K) SUMMARY

### DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The Choice Spine Navigation instruments are non-sterile, reusable instruments designed to function with the Medtronic® StealthStation® System and SureTrak® II System. The Choice Spine Navigation instruments are for use with Choice Spine pedicle screw systems, specifically, the Lancer™ and Thunderbolt™ Pedicle Screw Systems. The instruments are manufactured from medical grade titanium and stainless steel.

#### INDICATIONS FOR USE

The Choice Spine Navigation reusable instruments are intended to be used during preparation and placement of Choice Spine Lancer™ and Thunderbolt™ system screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Choice Spine Navigation 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 of the anatomy.

The indications for use for the Choice Spine Navigation is similar to that of the predicate devices noted in Table 5-1: Predicate Devices.

## TECHNOLOGICAL CHARACTERISTICS

The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:

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- Indications for Use ●
- Principle of Operation ●
- Technical Characteristics
- Sterility o
- Interfacing о
- Sizes O

The only difference between the subject and predicate device is the subject device utilizes different materials than the predicate device, which manufactured only from stainless steels. In addition to stainless steel, the subject device has Radel, Ketaspire KT-820 CF30, Ti-6Al-4V per ASTM F136 and PTFE.

Table 5-1: Predicate Devices

| 510k Number | Trade or Proprietary or<br>Model Name | Manufacturer | Predicate Type |
|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|----------------|
| K150231 | Navigated Disc Prep<br>Instruments | Medtronic | Primary |
| K132049 | Thunderbolt and Lancer<br>Pedicle Screw System | Choice Spine,<br>LP | Additional |
| K124004 | Navigated CD HORIZON®<br>SOLERATM<br>Screwdrivers, CD<br>HORIZON® SOLERATM<br>Taps, CD HORIZON®<br>SOLERATM<br>Iliac Taps and CD<br>HORIZON® LEGACY™<br>Taps | Medtronic<br>Navigation, Inc | Reference |

#### 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.