Navigated Disc Prep Instruments and CAPSTONE Trials

K150231 · Medtronic Sofamor Danek USA, Inc. · OLO · Jun 16, 2015 · Neurology

Device Facts

• Record ID: K150231
• Device Name: Navigated Disc Prep Instruments and CAPSTONE Trials
• Applicant: Medtronic Sofamor Danek USA, Inc.
• Product Code: OLO · Neurology
• Decision Date: Jun 16, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Navigated Disc Preparation Instruments are intended to be used to facilitate a discectomy during spinal surgery. The Navigated Trials are intended to be used to facilitate implant size selection of Medtronic intervertebral body fusion devices during spinal surgery. Navigated 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.

Device Story

Navigated Disc Prep Instruments (Cobb Elevator, Combo Tool, Curette, Osteotome, Rotating Shaver) and CAPSTONE Trials are manual surgical accessories for StealthStation System; used during spinal surgery. Instruments track anatomical structures via optical navigation relative to CT/MR models, fluoroscopy, or digitized landmarks. Surgeon uses instruments to perform discectomy or determine optimal implant size by selecting trial with best fit in prepared disc space. System provides real-time visual feedback on instrument position relative to patient anatomy, aiding surgical precision and implant placement. Devices are reusable, non-sterile stainless steel tools.

Clinical Evidence

Bench testing only. Testing included navigation accuracy analysis, anatomical and navigation simulated use, CAD model evaluation, implant/instrument mating verification, and spine tools package functional testing to confirm interface requirements with application software.

Technological Characteristics

Materials: Stainless steel conforming to ASTM F899, ASTM A693, and ASTM A564. Principle: Optical navigation via StealthStation System. Form factor: Manual surgical instruments (Cobb Elevator, Combo Tool, Curette, Osteotome, Rotating Shaver, Trials). Sterilization: Provided non-sterile, reusable. Connectivity: Compatible with StealthStation optical navigation system.

Indications for Use

Indicated for patients undergoing spinal surgery requiring discectomy or intervertebral body fusion implant size selection, 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

• Navigated CD HORIZON® SOLERA® Instruments (K140454)
• Navigated CAPSTONE Trials, CLYDESDALE Trials, CAPSTONE & CLYDESDALE Inserter (K131425)

Submission Summary (Full Text)

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

Medtronic Sofamor Danek USA, Incorporated Mr. Nicholas Tabrizi Principal Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

June 16, 2015

Re: K150231

Trade/Device Name: Navigated Disc Prep Instruments and CAPSTONE Trials Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: May 13, 2015 Received: May 14, 2015

Dear Mr. Tabrizi:

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 - Mr. Nicholas Tabrizi

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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 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 vours.

# 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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# Indications for Use

510(k) Number (if known) K150231

Device Name

Navigated Disc Prep Instruments and CAPSTONE Trials

Indications for Use (Describe)

The Navigated Disc Preparation Instruments are intended to be used to facilitate a discectomy during spinal surgery. The Navigated Trials are intended to be used to facilitate implant size selection of Medtronic intervertebral body fusion devices during spinal surgery.

Navigated 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.

| 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)

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## 510(k) Summary

### June 2015

| I. | Company: | Medtronic Sofamor Danek, USA Inc.<br>1800 Pyramid Place<br>Memphis, TN 38132<br>Telephone Number: [phone] |
|----|----------|------------------------------------------------------------------------------------------------------------------|
|----|----------|------------------------------------------------------------------------------------------------------------------|

- Contact: Nicholas Tabrizi Principal Regulatory Affairs Specialist Telephone: [phone] Fax: [phone]
- II. Proprietary Trade Name: Navigated Disc Prep Instruments and CAPSTONE Trials

Common Name: Stereotaxic Instrument, Navigated Instruments

Classification Name: Stereotaxic Instruments (21 CFR 882.4560)

Classification: Class II

Product Code: OLO

#### III. Product Description:

The Cobb Elevator. Combo Tool, Curette, Osteotome, and Rotating Shaver are instruments that are manual accessories to the StealthStation System. These instruments can be used to facilitate a discectomy during a spinal surgery procedure. These devices are offered in non-sterile form and are reusable.

The stainless steel material used in the Disc Prep Instruments conforms to ASTM F899, ASTM A693 and ASTM A564 standards.

### CAPSTONE Trials

Implant size and placement is determined by selecting the trial which provides the most satisfactory fit in the prepared disc space. Once trialing is complete, the implant of corresponding size is positioned. The new trials are designed specifically to be used with CAPSTONE and are also compatible with StealthStation. The trials will be provided non-sterile and are reusable.

The stainless steel material used in the CAPSTONE Trials conforms to ASTM F899, ASTM A693 and ASTM A564 standards.

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#### IV. Indications for Use:

The Navigated Disc Preparation Instruments are intended to be used to facilitate a discectomy during spinal surgery. The Navigated Trials are intended to be used to facilitate implant size selection of Medtronic intervertebral body fusion devices during spinal surgery.

Navigated 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.

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

- Navigated CD HORIZON® SOLERA® Instruments (K140454) ● This predicate has not been subject to a design-related recall. This predicate is the primary predicate for this submission.
- Navigated CAPSTONE Trials, CLYDESDALE Trials, CAPSTONE & . CLYDESDALE Inserter (K131425) This predicate has not been subject to a design-related recall. This predicate is an additional predicate for this submission.

#### VI. Comparison of the Technological Characteristics:

The Navigated Disc Preparation Instruments are intended to be used to facilitate a discectomy during spinal surgery. The Navigated Trials are intended to be used to facilitate implant size selection of Medtronic intervertebral body fusion devices during spinal surgery. These instruments are specifically designed for use with the StealthStation® System, 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 capabilities. 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® System.

#### VII. 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 |
|------|-------------|
|------|-------------|

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| 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<br>conditions. |
| CAD Model<br>Evaluation | Verified that the CAD models are accurately reflected in the<br>application software. |
| Implant/Instrument<br>Mating Conditions | Verified that the instruments can be assembled with the appropriate<br>devices according to their intended use. |
| Spine Tools<br>Package<br>Functional Testing | Verified that the Spine Tools package has met the required interface<br>needs of the spine application software. |

### VIII. Conclusions

The Navigated Disc Prep Instruments and CAPSTONE Trials have been shown through comparison and testing to be substantially equivalent to the identified predicate devices.