Navigated INFINITY™ Instruments

K173338 · Medtronic Sofamor Danek USA, Inc. · OLO · Jan 18, 2018 · Neurology

Device Facts

• Record ID: K173338
• Device Name: Navigated INFINITY™ Instruments
• Applicant: Medtronic Sofamor Danek USA, Inc.
• Product Code: OLO · Neurology
• Decision Date: Jan 18, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Medtronic Navigated 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 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 Instruments are also compatible with the IPCTM POWEREASE™ System.

Device Story

Navigated INFINITY™ Instruments are manual or power-operated surgical tools (screwdrivers, taps, drill bits, drill tap guides) used during spinal surgery. Instruments attach to NavLock™ trackers for optical navigation via the StealthStation™ System. System inputs include CT/MR models, fluoroscopy, or digitized anatomical landmarks. Instruments facilitate precise screw placement by providing real-time navigation feedback to the surgeon. Used in OR settings by surgeons. Benefits include enhanced precision in anatomical localization during spinal procedures. Subject devices are compatible with INFINITY™ OCT System screws.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included navigation accuracy analysis, anatomical and navigation simulated use, CAD model evaluation, implant/instrument mating verification, and spine tools package functional testing.

Technological Characteristics

Reusable and single-use manual/power-operated surgical instruments. Features include NavLock™ tracker attachment for optical navigation. Includes drill bits, taps, and drill tap guides. Compatible with StealthStation™ and IPC® POWEREASE® systems. Non-sterile (drill bits).

Indications for Use

Indicated for use during spinal surgery to assist surgeons in precisely locating anatomical structures for screw preparation and placement in open or minimally invasive procedures. Compatible with StealthStation and IPC POWEREASE systems. Not intended for occipital screw placement.

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 VERTEX SELECT® Instruments (K143628)

Reference Devices

• INFINITY™ OCT System (K163375)
• IPC® POWEREASE® System (K111520, K123270)
• SteathStation® System (K050438, K170011)
• NavLock™ tracker (K124004)

Submission Summary (Full Text)

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Medtronic Sofamor Danek USA, Inc. Tejas Patel Sr. Regulatory Affairs Specialist 1800 Pvramid Place Memphis, Tennessee 38132

# Re: K173338

Trade/Device Name: Navigated INFINITY™ Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: October 20, 2017 Received: October 23, 2017

Dear Tejas Patel:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

January 18, 2018

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

# Katherine D. Kavlock -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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# Indications for Use

510(k) Number (if known)

### K173338

Device Name Navigated INFINITY™ Instruments

### Indications for Use (Describe)

Medtronic Navigated 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 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 Instruments are also compatible with the IPCTM POWEREASE™ System.

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

# January 10, 2018

- l. Company: Medtronic Sofamor Danek, USA Inc. 1800 Pyramid Place Memphis, TN 38132 Telephone Number: [phone]
- Contact: Tejas Patel Sr. Regulatory Affairs Specialist Telephone number: [phone] Email: [e-mail]
- II. Proprietary Trade Name: Navigated INFINITY™ Instruments

Common Name: Stereotaxic Instrument, Navigated Screwdriver, Navigated Tap, Navigated Drill Bit and Navigated Drill Tap (DT) Guide

Classification Name: Stereotaxic Instrument (21 CFR 882.4560)

Classification: Class II

Product Code: OLO

#### lll. Predicate Device:

Navigated VERTEX SELECT® Instruments (K143628, S.E. 02/12/2015) This predicate has not been subject to a design-related recall. This predicate is the primary predicate for this submission.

The following reference devices are also used in this submission:

- INFINITY™ OCT System (K163375, S.E. 08/21/2017) ●
- IPC® POWEREASE® System (K111520, S.E. 10/26/2011; K123270, S.E. 01/11/2013)
- SteathStation® System (K050438, S.E. 06/02/2005; K170011, S.E. 05/01/2017) ●
- NavLock™ tracker (K124004, S.E. 03/22/2013) ●

#### IV. Device Description:

The Navigated INFINITY™ Instruments are non-sterile, reusable and single use instruments that can be operated manually or under power. These instruments are intended to be used when implanting components of the INFINITY™ OCT System. The

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Navigated INFINITY™ Instruments are also compatible with the StealthStation® and IPC® POWEREASE® Systems.

Note: The subject devices are not intended to support occipital screw placement.

#### V. Indications for Use:

Medtronic Navigated 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 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 Instruments are also compatible with the IPC® POWEREASE® System.

### VI. Comparison of the Technological Characteristics with the Predicate Device:

The Navigated INFINITY™ Instruments 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 INFINITY™ Instruments 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.

The following technological differences exist between the subject and predicate devices:

- . The subject Navigated INFINITY™ Instruments are intended to be used with INFINITY™ OCT System screws whereas the predicate Navigated VERTEX SELECT® Instruments are intended to be used with the VERTEX® Reconstruction System screws.
- . The subject navigated drill bits are non-sterile and single use while the predicate drill bits are sterile and single use.
- The subject devices include an additional drill tap guide with an optional Navlock positioner feature to hold the Navlock tracker in position to face the camera throughout the drilling and tapping process.

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.

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### VII. Performance Data:

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

#### VIII. Conclusions

The Navigated INFINITY™ Instruments have shown through comparison and testing to be substantially equivalent to the identified predicate devices.