Spineology Navigation Instruments

K182345 · Spineology, Inc. · OLO · Sep 21, 2018 · Neurology

Device Facts

• Record ID: K182345
• Device Name: Spineology Navigation Instruments
• Applicant: Spineology, Inc.
• Product Code: OLO · Neurology
• Decision Date: Sep 21, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

Spineology Navigation Instruments are intended to be used during the preparation and placement of Spineology's Fortress, Threshold V2, and Palisade pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, long bone, or vertebra, can be identified relative to a CT- or MR-based model. fluoroscopic images, or digitalized landmarks of the anatomy.

Device Story

Spineology Navigation Instruments consist of manual, reusable surgical tools including awls, bone taps, drills, and screwdrivers; used to prepare and place pedicle screws during spinal surgery. Instruments interface with Medtronic StealthStation System to provide real-time navigation; surgeon uses system to track instrument position relative to patient anatomy (CT/MR/fluoroscopy models). Output is visual guidance on navigation display; assists surgeon in precise anatomical localization. Used in OR by surgeons; facilitates minimally invasive or open procedures. Benefits include improved accuracy in screw placement and stabilization of spinal segments.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing and design verification activities, including assessment of instrument mating and performance confirmation.

Technological Characteristics

Non-sterile, reusable manual instruments (awls, taps, drills, screwdrivers). Materials: stainless steel per ASTM F899. Principle: mechanical navigation interface for use with Medtronic StealthStation System. No electronic components; purely mechanical instruments.

Indications for Use

Indicated for use during preparation and placement of Fortress, Threshold V2, and Palisade pedicle screws in spinal surgery to assist surgeons in locating anatomical structures in open or minimally invasive procedures. Designed for use with Medtronic StealthStation System for conditions where stereotactic surgery is appropriate and rigid anatomical structures (skull, long bone, vertebra) can be referenced via CT, MR, fluoroscopy, or digitalized 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

• Spineology Navigation Instruments (K180796)
• Spineology Navigation Instruments (K172518)

Reference Devices

• Medtronic Synergy Experience StealthStation® System S7 (v2.1.0)

Submission Summary (Full Text)

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September 21, 2018

Spineology Inc Karen Roche VP, Operations & Technologies 7800 Third Street N., Suite 600 St. Paul, Minnesota 55128

# Re: K182345

Trade/Device Name: Spineology Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: August 27, 2018 Received: August 28, 2018

Dear Karen Roche:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 medical devices and radiation-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,

# Mark N. Melkerson -S

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

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

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

## Indications for Use

510(k) Number (if known)

### K182345

Device Name Spineology Navigation Instruments

## Indications for Use (Describe)

Spineology Navigation Instruments are intended to be used during the preparation and placement of Spineology's Fortress, Threshold V2, and Palisade pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, long bone, or vertebra, can be identified relative to a CT- or MR-based model. fluoroscopic images, or digitalized landmarks of 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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# Spineology ***

# 510(k) Summary

| Date Prepared: | September 18, 2018 |
|------------------------------------|-----------------------------------------------------------------------------|
| Submitter: | Spineology Inc.<br>7800 3rd Street North, Suite 600<br>Saint Paul, MN 55128 |
| Establishment Registration Number: | 2135156 |
| Contact Person: | Karen Roche<br>Vice President, Operations & Technology |
| | Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Device Name and Classification | |
| Trade Name: | Spineology Navigation Instruments |
| Common Name: | Orthopedic Stereotaxic instrument |
| Classification Name: | Stereotaxic Instrument |
| Product Codes: | OLO |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 882.4560 |

Predicate Device

K180796, K172518 Spineology Navigation Instruments (Spineology Inc.)

Orthopedic

#### Purpose 1.

Panel:

The purpose of this Premarket Notification is to obtain FDA clearance for the addition of an Adapter to Spineology's FDA cleared Spineology Navigation Instrument set.

#### Device Description 2.

#### A. Spineology Navigation Instruments

Spineology Navigation Instruments are non-sterile, reusable instruments; including awls, bone taps, drills, and screwdrivers that are operated manually. These instruments are manufactured from stainless steel in accordance with ASTM F899 and are intended to be used within the context and limitations of the indications for use for Spineology's FDA-cleared Fortress™, Threshold™, Threshold™ V2, and Palisade™ Pedicular Fixation Systems and the Medtronic Synergy Experience StealthStation® System S7 (v2.1.0).

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#### B. Spineology Pedicular Fixation Systems

Spineology Fortress, Threshold V2, and Palisade Pedicular Fixation Systems consist of screws, curved and straight rods, and Connex Connector devices to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. All screws are available with or without a hydroxyapatite coating. These systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The screws can be placed in the pedicles in a variety of trajectories ranging from the standard anatomic transpedicular path projected medially toward the ventral vertebral body, to a caudocephalad path sagittally and a laterally directed path in the transverse plane.

#### 3. Indications for Use

Spineology Navigation Instruments are intended to be used during the preparation and placement of Spineology's Fortress, Threshold V2, and Palisade pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are 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, long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitalized landmarks of the anatomy.

#### 4. Technological Characteristics

When compared to the predicate device, Spineology Navigation Instruments have the same intended use and equivalent technological characteristics, including:

- Primary Design Features, including but not limited to, critical dimensions, distal (functional) end features (i.e., implant/inserter interface), and proximal end mating features
- . Materials of Construction
- Fundamental Scientific Technology
- Function/Performance
- .
-
- Use with Medtronic StealthStation System
- Principle of Operation

#### 5. Non-Clinical Testing

Spineology performed design verification activities to demonstrate that the design outputs of the subject Spineology Navigation Instruments met the design input requirements. Testing of the Adapter included, but was not limited to, assessment of instrument mating and confirmation that performance of Spineology Navigation Instruments is unaffected by use of the Adapter.

Spineology conducted a risk assessment to confirm that the subject Adapter for Spineology Navigation Instruments does not introduce new issues of safety or effectiveness.

#### 6. Clinical Testing

Clinical testing was not performed or required to establish the substantial equivalence of Spineology Navigation Instruments to the predicate device.

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#### 7. Conclusion

Spineology has demonstrated the substantial equivalence of the subject Spineology Navigation Instruments through the comparison of these devices to the legally marketed predicate device and confirmed that the intended use is the same and any differences in technological characteristics between the subject and predicate device do not raise new issues of safety and effectiveness.