NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS

K140454 · Medtronic Sofamor Danek USA, Inc. · OLO · May 22, 2014 · Neurology

Device Facts

• Record ID: K140454
• Device Name: NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS
• Applicant: Medtronic Sofamor Danek USA, Inc.
• Product Code: OLO · Neurology
• Decision Date: May 22, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Medtronic Navigated Reusable Instruments are specifically designed for use with the 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. Medtronic Navigated Reusable Instruments are also compatible with the IPC® POWEREASE™ System.

Device Story

Navigated CD HORIZON® SOLERA® Screwdrivers and Taps are reusable surgical instruments for spinal screw implantation. Instruments attach to NavLock™ Trackers for optical navigation via the StealthStation® System. They function manually or with the IPC® POWEREASE™ power system. During surgery, the system tracks the instrument position relative to patient anatomy (CT/MR/fluoroscopy/digitized landmarks). Surgeons use the navigation display to guide instrument placement, improving precision in open or minimally invasive procedures. Benefits include enhanced anatomical localization during spinal instrumentation.

Clinical Evidence

Bench testing only. No clinical data presented. Testing included navigation accuracy analysis, anatomical and navigation simulated use, CAD model evaluation, implant/instrument mating verification, and spine tools package functional testing to ensure interface compatibility with application software.

Technological Characteristics

Reusable surgical instruments made of stainless steel. Features NavLock™ Tracker interface for optical navigation. Compatible with StealthStation® and IPC® POWEREASE™ systems. Manual or power-driven operation. Non-sterile.

Indications for Use

Indicated for use during spinal surgery to assist surgeons in precisely locating anatomical structures for screw placement in open or minimally invasive procedures. Compatible with StealthStation® and IPC® POWEREASE™ systems for patients requiring stereotactic surgery where rigid anatomical structures (skull, long bone, vertebra) can be referenced against 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 CD HORIZON® SOLERA® SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY™ TAPS (K124004)
• IPC® POWEREASE™ System (K111520, K123270)

Submission Summary (Full Text)

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### K140454

# 510(k) Summary

# MAY 2 2 2014

## February 2013

- Medtronic Sofamor Danek, USA Inc. l. Company: 1800 Pvramid Place Memphis, TN 38132 Telephone Number: [phone]
- Contact: Regina Holmes Sr. Regulatory Affairs Specialist Telephone: [phone] Fax: [phone]
- II. Proprietary Trade Name: Navigated CD HORIZON® SOLERA® Screwdrivers and Taps
- Common Name: Stereotaxic Instrument, Navigated Screwdriver, Navigated Tap III.
- Classification Name: Stereotaxic Instrument (21 CFR 882.4560) IV.
- Classification: Class II V.
- Product Code: OLO, HBE VI.

#### VII. Product Description:

The Navigated Screwdrivers and Taps are non-sterile, reusable surgical instruments that can be operated manually or under power. These instruments are intended to be used when implanting CD HORIZON® Spinal System devices. The Navigated Screwdrivers and Taps are also compatible with the StealthStation® and IPC® POWEREASE™ Systems.

### VIII. Indications for Use:

Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Medtronic Navigated Reusable Instruments are specifically designed for use with the 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. Medtronic Navigated Reusable Instruments are also compatible with the IPC® POWEREASE™ System.

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### IX. Identification of Legally Marketing Devices (Predicate Devices)

- NAVIGATED CD HORIZON® SOLERA® SCREWDRIVERS, TAPS, . ILIAC TAPS, LEGACY™ TAPS (K124004)
- IPC® POWEREASE™ System (K111520, K123270) .

### Comparison of the Technological Characteristics: X.

The Navigated Taps and Screwdrivers are intended to be used during the preparation and placement of Medtronic screws during spinal surgery and are specifically designed for use with the StealthStation® System. Identical to the predicates, the Navigated Screwdrivers and Taps attach to the NavLock™ Tracker, which allows for optical navigation of the surgical instruments. These devices have similar designs as the predicate devices and incorporate the same design features to enable navigation and use with the IPC® POWEREASE™ System, when desired. Like the predicate devices, the subject Navigated Taps and Screwdrivers are also made from stainless steel.

The instrument modifications detailed in this submission have no impact on the technological characteristics of either the existing instruments or the StealthStation® and IPC® POWEREASE™ Systems.

### XI. Discussion of the Performance Testing

Testing was completed to ensure the functionality and compatibility with the identified Medtronic products. The following table summarizes the performance testing completed:

| Test | Description |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Navigation<br>Accuracy Analysis | Confirmed navigated instrument accuracy. |
| Anatomical<br>Simulated Use | Confirmed instrument functionality under expected use conditions. |
| Navigation<br>Simulated Use | Confirmed navigation system functionality under expected use conditions. |
| CAD Model<br>Evaluation | Verified that the CAD models are accurately reflected in the application software. |
| Implant/Instrument<br>Mating Conditions | Verified that the instruments can be assembled with the appropriate devices according to their intended use. |
| Spine Tools<br>Package<br>Functional Testing | Verified that the Spine Tools package has met the required interface needs of the spine application software. |

### XII. Conclusions

The Navigated Screwdrivers and Taps have been shown through comparison and testing to be substantially equivalent to the identified predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 22, 2014

Medtronic Sofamor Danek USA, Incorporated Ms. Regina Holmes Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K140454

Trade/Device Name: Navigated CD HORIZON® SOLERA® Screwdrivers and Taps Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO, HBE Dated: February 20, 2014 Received: February 24, 2014

Dear Ms. Holmes:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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## Page 2 – Ms. Regina Holmes

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Ronald P. Jean -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 Food and Drug Administration

# Indications for Use

510(k) Number (if known) K140454

### Device Name

Navigated CD HORIZON® SOLERA® Screwdrivers and Taps

### Indications for Use (Describe)

Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Medtronic Navigated Reusable Instruments are specifically designed for use with the SteathStation® 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, a long bone, or vertebra, can be identified relative to a CT or MR based model. fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Navigated Reusable Instruments are also compatible with the IPC® POWEREASE™ System.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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## FOR FDA USE ONLY

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

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