ExcelsiusGPS

K190653 · Globus Medical, Inc. · OLO · Apr 9, 2019 · Neurology

Device Facts

• Record ID: K190653
• Device Name: ExcelsiusGPS
• Applicant: Globus Medical, Inc.
• Product Code: OLO · Neurology
• Decision Date: Apr 9, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws.

Device Story

ExcelsiusGPS® is a stereotaxic surgical navigation system; aids surgeons in precise anatomical localization and spatial positioning of instrument holders/guide tubes. System inputs include patient CT scans or fluoroscopic images; utilizes fiducial markers to register rigid patient anatomy. Device transforms imaging data into spatial guidance for surgical instruments; enables navigation during open or percutaneous procedures. Output consists of visual guidance for instrument placement; assists surgeons in spinal and orthopedic bone screw implantation. Used in clinical/OR settings by surgeons. Benefits include increased precision in instrument orientation and anatomical targeting. This submission specifically adds high-speed drill instruments (drill bits, guards, arrays) to the existing system ecosystem.

Clinical Evidence

Bench testing only. Verification and validation testing performed to confirm performance. Biocompatibility demonstrated via material standards compliance. Bacterial endotoxin testing conducted per ANSI/AAMI ST-72:2011.

Technological Characteristics

Stereotaxic instrument system. Components: array, array sleeves, drill guard, drill bits. Materials: stainless steel (ASTM F899) and PEEK. Non-sterile (drill bits provided sterile or non-sterile). Connectivity: integrated with ExcelsiusGPS® platform.

Indications for Use

Indicated for surgeons performing open or percutaneous spinal and orthopedic bone screw placement procedures where fiducial markers and rigid patient anatomy are identifiable via CT or fluoroscopy.

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

• ExcelsiusGPS® (K171651)
• AQrate™ Robotic Assistance System (K182000)

Submission Summary (Full Text)

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Globus Medical Inc. Kelly Baker Senior Vice President, Regulatory and Clinical Affairs 2560 General Armistead Ave. Audubon, Pennsylvania 19403

April 9, 2019

## Re: K190653

Trade/Device Name: ExcelsiusGPS Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 13, 2019 Received: March 14, 2019

## Dear Kelly Baker:

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 mediation-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,

For: 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)

K190653

Device Name ExcelsiusGPS®

Indications for Use (Describe)

The ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws.

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

| <span style="font-size:10pt"><span style="font-family:Arial">☑</span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:10pt"><span style="font-family:Arial">☐</span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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# 510(k) Summary: ExcelsiusGPS® High Speed Drill Instruments

| Company: | Globus Medical Inc.<br>2560 General Armistead Ave.<br>Audubon, PA 19403<br>610-930-1800 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kelly J. Baker, Ph.D.<br>Senior Vice President, Regulatory and Clinical Affairs |
| Date Prepared: | April 3, 2019 |
| Device Name: | ExcelsiusGPS® |
| Common Name: | Orthopedic Stereotaxic Instrument |
| Classification: | Per 21 CFR as follows:<br>§882.4560 Stereotaxic instrument<br>Product Code(s): OLO<br>Regulatory Class: II, Panel Code: 84 |

Primary Predicate: ExcelsiusGPS® (K171651)

## Additional

AQrate™ Robotic Assistance System (K182000) Predicate:

## Purpose:

The purpose of this submission is to request clearance of the High Speed Drill Instruments for use with ExcelsiusGPS®.

## Device Description:

The High Speed Drill Instruments consist of an array, array sleeves, a drill guard, and drill bits. These instruments are provided non-sterile, except for the drill bits which are provided sterile or non-sterile. These instruments are intended to be used with ExcelsiusGPS® and are manufactured from stainless steel, per ASTM F899, and PEEK.

## Indications for Use:

The ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws.

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### Technological Characteristics:

Subject ExcelsiusGPS® High Speed Drill Instruments have the same technological characteristics as predicate instruments including design, intended use, material composition, function, and range of sizes.

#### Performance Testing:

Verification and Validation testing and comparison to the predicate demonstrate that the ExcelsiusGPS® High Speed Drill Instruments can be used in accordance with its indications.

Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011. Biocompatibility of patient-contacting materials was demonstrated by using materials that meet applicable standards or are used in 510(k) cleared devices.

## Basis of Substantial Equivalence:

The ExcelsiusGPS® High Speed Drill Instruments have been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided supports substantial equivalence to the predicate devices.