Navigated INFINITY Instruments

K181111 · Medtronic Sofamor Danek USA, Inc. · OLO · May 17, 2018 · Neurology

Device Facts

• Record ID: K181111
• Device Name: Navigated INFINITY Instruments
• Applicant: Medtronic Sofamor Danek USA, Inc.
• Product Code: OLO · Neurology
• Decision Date: May 17, 2018
• Decision: SESE
• Submission Type: Special
• 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 IPC™ POWEREASETM System.

Device Story

Navigated INFINITY™ drill bit; sterile, single-use instrument for spinal surgery. Used with StealthStation® System for stereotactic navigation and IPC® POWEREASE® System for power. Surgeon uses device to prepare bone and place screws; navigation tracks instrument position relative to patient anatomy (CT/MR/fluoroscopy). Provides precise anatomical localization; assists in screw placement during open or minimally invasive procedures. Benefits include improved surgical accuracy and guidance. Not intended for occipital screw placement.

Clinical Evidence

Bench testing only. Sterilization validation provided to support the transition to a sterile, single-use device, confirming equivalence to the existing product family.

Technological Characteristics

Stainless steel drill bit; manual or power-driven; compatible with StealthStation® and IPC® POWEREASE® systems. Sterile, single-use form factor. Sterilization validated to SAL 10^-6.

Indications for Use

Indicated for patients undergoing spinal surgery requiring preparation and placement of Medtronic screws; used in open or minimally invasive procedures where stereotactic navigation is appropriate; compatible with CT, MR, or fluoroscopy-based anatomical referencing.

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 INFINITY™ Instruments (K173338)
• Navigated VERTEX SELECT® Instruments (K143628)

Reference Devices

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

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

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

Re: K18111

Trade/Device Name: Navigated INFINITY TM Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: April 26, 2018 Received: April 27, 2018

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.

May 17, 2018

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K181111

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,

# 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) K181111

### Device Name Navigated INFINITYTM 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 IPC™ POWEREASETM 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

# April 26, 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]
- ll. Proprietary Trade Name: Navigated INFINITY™ Instruments

Classification Name: Stereotaxic Instrument (21 CFR 882.4560)

Common Name: Navigated Drill Bit

Classification: Class II

Product Code: OLO

#### lll. Predicate Device:

Primary Predicate:

- Navigated INFINITY™ Instruments (K173338, S.E. 01/18/2018) .
Additional Predicate:

- . Navigated VERTEX SELECT® Instruments (K143628, S.E. 02/12/2015)
These predicates have not been subject to a design-related recall

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)
- NavLockTM tracker (K124004, S.E. 03/22/2013)

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#### IV. Device Description:

The subject Navigated INFINITY™ drill bit is a sterile, single-use instrument that can be operated manually or under power. This instrument is intended to be used when implanting components of the INFINITY™ OCT System. The Navigated INFINITY™ Drill bit is 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 subject drill bit has identical indications, intended use, fundamental scientific technology, materials, dimensions and design features as the Navigated INFINITY™ Instruments recently cleared in K173338 (S.E. 01/18/2018). Identical to the predicate drill bit, the subject drill bit is available in stainless steel. The only technological difference between the subject and predicate Navigated INFINITY™ Instrument is as below:

- The subject navigated drill bit is sterile and single use while the predicate drill bit is non-sterile and single use.
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.

### VII. Performance Data:

The following information is provided in support of substantial equivalence.

# Sterilization:

The addition of the sterile drill bit does not create a new "worst case" and it was adopted in to the existing product family as detailed in the sterilization rationale provided in this submission since the design, material, manufacturing process, and

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manufacturing facilities of the sterile subject devices are equivalent to that of the referenced product family. The sterilization justification supports an SAL of 10-6. Based on the information provided in this submission, Medtronic believes that adequate evidence has been provided to show that we have fully validated the sterilization parameters.

#### VIII. Conclusions

Based on the sterilization assessment and additional supporting documentation provided in this pre-market notification, the subject Navigated INFINITY™ Instrument demonstrates substantially equivalent to the identified predicate devices.