(101 days)
Not Found
No
The summary describes navigation instruments used with a stereotactic system, focusing on mechanical instruments and their compatibility with existing navigation technology. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No.
The device is a set of navigation instruments used during spinal surgery to assist surgeons in precisely locating anatomical structures. It is an accessory to a surgical procedure, not a device that directly treats a condition or restores function.
No.
The device assists the surgeon in precisely locating anatomical structures during surgery, which is an intraoperative guidance function, not a diagnostic one. It is used for "preparation and placement of Globus screws" and to "assist the surgeon in precisely locating anatomical structures." The device functions as a surgical aid/guidance system, not to identify or determine a disease or condition.
No
The device description explicitly states that the device consists of "nonsterile, reusable instruments including awls, probes, drill bits, drill guides, taps, and drivers," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Globus Navigation Instruments are surgical tools used during spinal surgery to assist the surgeon in precisely locating anatomical structures. They are used in conjunction with a navigation system that utilizes imaging data (CT, MR, fluoroscopy) of the patient's anatomy.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from the patient. Its function is entirely related to guiding surgical procedures based on imaging and anatomical reference.
Therefore, the intended use and function of the Globus Navigation Instruments clearly fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Globus Navigation Instruments are intended to be used during the preparation and placement of Globus screws (QUARTEX®, CREO®, REVERE®, REVOLVE®, ELLIPSE®, PROTEX® CT, and SI-LOK®) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic 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.
Product codes
OLO
Device Description
Navigation Instruments are nonsterile, reusable instruments including awls, probes, drill bits, drill guides, taps, and drivers that can be operated manually or with a power drill such as POWEREASE™. These instruments are intended to be used with the Medtronic Synergy Spine and Trauma StealthStation® System (v 2.1.0).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model, fluoroscopy images
Anatomical Site
skull, a long bone, or vertebra (for the Medtronic StealthStation® System)
spinal surgery (for the Globus Navigation Instruments)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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
Design validation testing, including registration, and accuracy, was conducted to ensure the Navigation Instruments are acceptable for their intended use, to ensure functionality and compatibility with the Medtronic StealthStation® using the NavLock tracker, and to demonstrate substantial equivalence to the predicate instruments. Registration testing was performed to ensure that the instruments can be registered to the StealthStation®. Accuracy testing was completed for comparison to the predicate instruments.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is a symbol of a stylized human figure. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Globus Medical Inc. Lori Burns Director, Regulatory Affairs 2560 General Armistead Avenue Audubon, Pennsylvania 19403
Re: K180690
Trade/Device Name: Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: May 22, 2018 Received: May 23, 2018
Dear Lori Burns:
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 (QS) regulation (21 CFR Part 820);
June 25, 2018
1
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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Navigation Instruments
Indications for Use (Describe)
Globus Navigation Instruments are intended to be used during the preparation and placement of Globus screws (QUARTEX®, CREO®, REVERE®, REVOLVE®, ELLIPSE®, PROTEX® CT, and SI-LOK®) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medronic 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.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use |
|---|---|
| ----------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------- |
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: Navigation Instruments
| Company: | Globus Medical Inc. |
|---|---|
| 2560 General Armistead Ave. | |
| Audubon, PA 19403 | |
| 610-930-1800 |
| Primary Contact: | Lori Burns
Director, Regulatory Affairs |
| ------------------ | -------------------------------------------- |
|---|
April 3, 2018 Date Prepared:
Device Name: Navigation Instruments
- Classification: Per 21 CFR as follows: §882.4560 Stereotaxic Instrument Product Code: OLO Regulatory Class: II, Panel Code: 84
Primary Predicate: Navigation Instruments (K153203)
Predicate(s): Medtronic instruments (K143628) QUARTEX™ Occipito-Cervico-Thoracic Spinal System (K161591)
Purpose:
The purpose of this submission is to request clearance for additional instruments for use with Medtronic StealthStation® System.
Device Description:
Navigation Instruments are nonsterile, reusable instruments including awls, probes, drill bits, drill guides, taps, and drivers that can be operated manually or with a power drill such as POWEREASE™. These instruments are intended to be used with the Medtronic Synergy Spine and Trauma StealthStation® System (v 2.1.0).
Indications for Use:
Globus Navigation Instruments are intended to be used during the preparation and placement of Globus screws (QUARTEX®, CREO®, REVERE®, REVOLVE®, ELLIPSE® PROTEX® CT, and SI-LOK®) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic 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
4
relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
Performance Data:
Design validation testing, including registration, and accuracy, was conducted to ensure the Navigation Instruments are acceptable for their intended use, to ensure functionality and compatibility with the Medtronic StealthStation® using the NavLock tracker, and to demonstrate substantial equivalence to the predicate instruments. Registration testing was performed to ensure that the instruments can be registered to the StealthStation®. Accuracy testing was completed for comparison to the predicate instruments.
Technological Characteristics:
Navigation Instruments have the same technological characteristics as the predicate devices including design, intended use, material composition, function, and range of sizes. 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:
Navigation Instruments 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 instruments to the predicate devices.