VERZA™ High Speed Drills are indicated for drilling, burring, removing, and otherwise manipulating hard tissue, bone, bone cement, prosthesis, implant, and other bone related tissue during spinal and orthopedic procedures.

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 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 and interbody fusion devices.

ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating 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 and interbody fusion devices.

Device Description

VERZA™ High Speed Drills are electrical drill handpieces/attachments powered by a motor with a control unit and foot pedal, and may be navigated using ExcelsiusGPS® or ExcelsiusHub™. The navigated components are provided nonsterile and are reusable. Burs are provided sterile and are single-use.

AI/ML Overview

I am sorry, but the provided text is a 510(k) Premarket Notification from the FDA regarding a medical device called "VERZA™ High Speed Drills". This document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance. It does not contain the detailed information necessary to answer your specific questions about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment for an AI/ML-based medical device.

The document mentions that "The navigation and guidance accuracy of VERZA™ High Speed Drills was evaluated using intra-operative imaging and accuracy verification testing. Testing confirmed that accuracy values meet the product requirement specification." However, it does not provide:

A table of acceptance criteria and reported device performance.
Sample size used for the test set or data provenance.
Number of experts or their qualifications for establishing ground truth.
Adjudication method.
Information about multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
Details about standalone (algorithm-only) performance.
The type of ground truth used (beyond "accuracy verification testing" and meeting "product requirement specification").
Sample size for the training set.
How ground truth for the training set was established.

This device appears to be a surgical tool (drills) that may be navigated using existing systems (ExcelsiusGPS® or ExcelsiusHub™), rather than a new AI/ML software device that diagnoses or predicts outcomes based on data. Therefore, the types of studies and information you are requesting are not typically found in a 510(k) for this kind of physical medical device.

Summary

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February 9, 2024

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Globus Medical, Inc. Jennifer Antonacci Group Manager, Regulatory Affairs Valley Forge Business Center 2560 General Armistead Ave Audubon, Pennsylvania 19403

Re: K233638

Trade/Device Name: VERZA™ High Speed Drills Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: November 13, 2023 Received: November 13, 2023

Dear Jennifer Antonacci:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumaya Ali-S

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

Device Name VERZATM High Speed Drills

Indications for Use (Describe)

VERZATM High Speed Drills are indicated for drilling, burring, removing, and otherwise manipulating hard tissue, bone, bone cement, prosthesis, implant, and other bone related tissue during spinal and orthopedic procedures.

Type of Use (Select one or both, as applicable)
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❌ Prescription Use (Part 21 CFR 801 Subpart D)	▢ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary: VERZA™ High Speed Drills

Company:	Globus Medical Inc.2560 General Armistead Ave.Audubon, PA 19403610-930-1800
Primary Contact:	Jennifer Antonacci, Ph.D.Group Manager, Regulatory Affairs
Date Prepared:	February 9, 2024
Device Name:	VERZA™ High Speed Drills
Common Name:	Orthopedic Stereotaxic Instrument
Classification:	Per 21 CFR as follows:§882.4560 Stereotaxic instrumentProduct Code(s): OLORegulatory Class: II, Panel Code: 87

Primary Predicate: ExcelsiusGPS® High Speed Drill Instruments (K190653)

Additional

Predicates:	Primado2 Total Surgical System (K132264)
	Medtronic Stealth-Midas MR8 (K183644)
	ExcelsiusGPS® (K171651, K191100)
	ExcelsiusHub™ (K211616)

Purpose:

The purpose of this submission is to request clearance of VERZA™ High Speed Drills for use with ExcelsiusGPS® and ExcelsiusHub™.

Device Description:

Indications for Use:

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

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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 and interbody fusion devices.

Technological Characteristics:

Subject VERZA™ High Speed Drills have the same technological characteristics as predicate instruments including design, intended use, material composition, function, and range of sizes.

Features	Subject	Predicates
	VERZA™™ High Speed Drills
Indications	VERZA™™ High Speed Drills are indicated for drilling,burring, removing, and otherwise manipulating hardtissue, bone, bone cement, prosthesis, implant, andother bone related tissue during spinal andorthopedic procedures.	Similar
	ExcelsiusGPS is intended for use as an aid forprecisely locating anatomical structures and for thespatial positioning and orientation of an instrumentholder or guide tube to be used by surgeons fornavigating and/or guiding compatible surgicalinstruments in open or percutaneous proceduresprovided that the required fiducial markers and rigidpatient anatomy can be identified on CT scans orfluoroscopy. The system is indicated for theplacement of spinal and orthopedic bone screws andinterbody fusion devices.
	ExcelsiusHub is intended for use as an aid forprecisely locating anatomical structures to be usedby surgeons for navigating compatible surgicalinstruments in open or percutaneous proceduresprovided that the required fiducial markers and rigidpatient anatomy can be identified on CT scans orfluoroscopy. The system is indicated for theplacement of spinal and orthopedic bone screws andinterbody fusion devices.
Instruments	Navigated and guided instruments	Same
Materials	Stainless steel, Aluminum alloy, Diamond coating	Same

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Features	SubjectVERZA™ High Speed Drills	Predicates
Biocompatibility	Stainless steel, aluminum alloy and diamond coatinghave a history of biocompatibility as instrumentmaterials per ASTM specifications and predicatedevices.	Same
Performance	The navigation and guidance accuracy of VERZA™ High SpeedDrills was evaluated using intra-operative imaging and accuracyverification testing. Testing confirmed that accuracy values meet theproduct requirement specification.
ElectricalSafety/EMC	Electrical safety and EMC testing were conducted on the predicatePrimado2 system. No new testing is necessary.

Performance Testing:

The navigation and guidance accuracy of VERZA™ High Speed Drills was evaluated using intra-operative imaging and accuracy verification testing. Testing confirmed that accuracy values meet the product requirement specification. Verification and validation testing and comparison to the predicate devices demonstrate that the subject VERZA™ High Speed Drills can be used in accordance with their indications.

Basis of Substantial Equivalence:

VERZA™ High Speed Drills have been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject device 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).