(91 days)
Not Found
No
The summary describes navigation instruments used with a stereotactic system, focusing on mechanical and compatibility testing. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device aids in precise navigation during surgery but does not directly treat a disease or condition. It is an instrument used with a surgical system.
No
The device, "Globus Navigation Instruments," is described as instruments used during spinal surgery to assist in locating anatomical structures and placing screws. It functions as a surgical aid to guide the surgeon and is not used to diagnose a medical condition.
No
The device description explicitly states that the Navigation Instruments are nonsterile, reusable instruments including 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 medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Globus Navigation Instruments are described as surgical instruments (probes, drill bits, etc.) used during spinal surgery to assist the surgeon in precisely locating anatomical structures. They are used in conjunction with a navigation system (Medtronic StealthStation®) that utilizes imaging data (CT, MR, fluoroscopy) and digitized landmarks.
- Lack of Sample Testing: There is no mention of these instruments being used to test samples taken from the body. Their function is to guide surgical procedures based on anatomical information.
Therefore, the intended use and description clearly indicate a surgical navigation tool, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Globus Navigation Instruments are intended to be used in the preparation and placement of Globus screws (CREO, REVERE, REVOLVE, ELLIPSE and PROTEX CT Stabilization Systems) 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 (comma separated list FDA assigned to the subject device)
OLO
Device Description
Navigation Instruments are nonsterile, reusable instruments including probes, drill bits, drill quides, taps, and drivers that can be operated manually. These instruments are intended to be used with the Medtronic Synergy Spine and Trauma StealthStation® System (v 2.1.0) and are manufactured from stainless steel, as specified in ASTM F899.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, fluoroscopy images
Anatomical Site
skull, a long bone, or vertebra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, spinal surgery
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)
Design validation testing, including rigidity, 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®, and to demonstrate substantial equivalence to the predicate instruments. Rigidity testing evaluated the connection between the NavLock Tracker and the 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 (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 3, 2016
Globus Medical, Incorporated Kelly J. Baker, Ph.D. Senior Vice President, Regulatory and Clinical Affairs 2560 General Armistead Avenue Audubon, Pennsylvania 19403
Re: K153203
Trade/Device Name: Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: January 5, 2016 Received: January 6, 2016
Dear Dr. 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. 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153203
Device Name Navigation Instruments
Indications for Use (Describe)
Globus Navigation Instruments are intended to be used in the preparation and placement of Globus screws (CREO, REVERE, REVOLVE, ELLIPSE and PROTEX CT Stabilization Systems) 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CER 801 Subpart D) | □ Over-The-Counter Use (21 CER 801 Subpart C) |
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510(k) Summary: Navigation 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 & Clinical Affairs |
| Date Prepared: | January 5, 2016 |
| 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: Medtronic instruments (K143628, K143375, K140454)
Purpose:
The purpose of this submission is to request clearance for the Globus Navigation Instruments for use with the Medtronic StealthStation® System.
Device Description:
Navigation Instruments are nonsterile, reusable instruments including probes, drill bits, drill quides, taps, and drivers that can be operated manually. These instruments are intended to be used with the Medtronic Synergy Spine and Trauma StealthStation® System (v 2.1.0) and are manufactured from stainless steel, as specified in ASTM F899.
Indications for Use:
Globus Navigation Instruments are intended to be used in the preparation and placement of Globus screws (CREO, REVERE, REVOLVE, ELLIPSE and PROTEX CT Stabilization Systems) 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.
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Technological Characteristics as Compared to the Predicates:
The Globus Navigation Instruments and the predicate instruments are intended to be used with the Medtronic StealthStation® System to assist the surgeon in locating anatomical structures. These instruments have similar designs, are made from the same materials, and function in the same manner as the predicates. Performance testing shows that the Globus Navigation Instruments are substantially equivalent to the predicate instruments.
Performance Data:
Design validation testing, including rigidity, 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®, and to demonstrate substantial equivalence to the predicate instruments. Rigidity testing evaluated the connection between the NavLock Tracker and the 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.
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 devices to the predicate devices. Globus Navigation Instruments are as safe, as effective, and perform equivalent to the predicate devices.