(26 days)
No
The summary does not mention AI, ML, or related terms, and the device description focuses on mechanical components and navigation based on imaging and fiducial markers.
No
The device is described as an aid for precisely locating anatomical structures and for guiding surgical instruments, which are tools for surgical procedures rather than devices that provide therapy directly.
No
The device is intended for navigating and guiding surgical instruments, which is a procedural/treatment function, not a diagnostic one.
No
The device description explicitly mentions hardware components like "array, array sleeves, a drill guard, and drill bits" made from materials like stainless steel and PEEK, which are physical instruments, not software.
Based on the provided information, the ExcelsiusGPS® device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for surgical navigation and guidance during open or percutaneous procedures, specifically for placing spinal and orthopedic bone screws. This involves interacting directly with the patient's anatomy during a surgical procedure.
- Device Description: The description focuses on the physical components used in surgery (drill instruments, array, etc.).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. The ExcelsiusGPS® is used in vivo (within the body) to assist in surgical procedures.
N/A
Intended Use / 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.
Product codes
OLO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scans or fluoroscopy
Anatomical Site
spinal and orthopedic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ExcelsiusGPS® (K171651)
Reference Device(s)
AQrate™ Robotic Assistance System (K182000)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains 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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
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
1
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
2
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)
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| --------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------- |
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3
510(k) Summary: ExcelsiusGPS® High Speed Drill Instruments
| Company: | Globus Medical Inc.
2560 General Armistead Ave.
Audubon, PA 19403
610-930-1800 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------|
| 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 instrument
Product Code(s): OLO
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.
4
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.