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 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.

AI/ML Overview

The provided text summarizes a 510(k) submission for the "ExcelsiusGPS High Speed Drill Instruments" for use with the ExcelsiusGPS system. However, the document does not contain explicit acceptance criteria and corresponding performance data as typically presented in a clinical study report. Instead, it states that "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."

Therefore, based on the provided text, I cannot produce the requested table of acceptance criteria and reported device performance, nor can I answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details. The document focuses on regulatory clearance based on substantial equivalence to a predicate device, rather than detailed clinical performance metrics from a specific study.

Information that is available from the text:

Device Name: ExcelsiusGPS® High Speed Drill Instruments
Intended 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.
Basis of Substantial Equivalence: Technological characteristics (design, intended use, material composition, function, and range of sizes) are the same as predicate instruments. Performance testing (Verification and Validation) was conducted to demonstrate the instruments can be used in accordance with their indications. Bacterial endotoxin testing (BET) was conducted, and biocompatibility was demonstrated by using standard materials or materials from 510(k) cleared devices.
Regulatory Clearance Document: K190653

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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: ExcelsiusGPS® High Speed Drill Instruments

Company:	Globus Medical Inc.2560 General Armistead Ave.Audubon, PA 19403610-930-1800
Contact:	Kelly J. Baker, Ph.D.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:§882.4560 Stereotaxic instrumentProduct Code(s): OLORegulatory 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:

Indications for Use:

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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.

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
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.(b)
Classification. Class II (performance standards).