(101 days)
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.
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).
The provided text describes a 510(k) premarket notification for "Navigation Instruments" by Globus Medical Inc., intended for use with the Medtronic StealthStation® System in spinal surgery. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific, quantitative acceptance criteria for algorithm or AI performance.
Therefore, most of the requested information regarding acceptance criteria, study design for AI/algorithm performance (e.g., sample sizes, expert ground truth, MRMC studies, standalone performance), training data, etc., is not present in this type of regulatory submission. This document describes a medical device, not an AI/ML algorithm.
However, I can extract the relevant information that is present:
Acceptance Criteria and Device Performance (as inferred from the submission):
| Acceptance Criteria Category | Specific Criteria (Inferred from submission) | Reported Device Performance |
|---|---|---|
| Functionality & Compatibility | Instruments can be registered to the Medtronic StealthStation® System using the NavLock tracker. | "Registration testing was performed to ensure that the instruments can be registered to the StealthStation®." (Implies successful registration) |
| Accuracy | Accuracy comparable to predicate instruments. | "Accuracy testing was completed for comparison to the predicate instruments." (Implies comparable accuracy, as it supports substantial equivalence) |
| Intended Use | Acceptable for use during preparation and placement of specified Globus screws in spinal surgery to assist in precisely locating anatomical structures. | "Design validation testing... was conducted to ensure the Navigation Instruments are acceptable for their intended use..." (Implies successful validation for indicated use) |
| Substantial Equivalence | Technical characteristics, performance, and intended use are similar to predicate devices. | "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..." |
| Biocompatibility | Patient-contacting materials meet applicable standards or are used in 510(k) cleared devices. | "Biocompatibility of patient-contacting materials was demonstrated by using materials that meet applicable standards or are used in 510(k) cleared devices." |
Information Not Present in the Document:
The following requested information is not available in the provided 510(k) summary, as it pertains to AI/ML algorithm validation, which is not the subject of this device submission:
- Sample sizes used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs. without AI assistance.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
Summary of Study (as described in the document):
The study described is a design validation testing for the "Navigation Instruments" to demonstrate their functionality, accuracy, and compatibility with the Medtronic StealthStation® System, and ultimately, their substantial equivalence to existing predicate devices.
- Type of Study: Design validation and comparative testing for substantial equivalence.
- Focus: Mechanical and functional performance (registration, accuracy) of surgical instruments designed for use with a navigation system, rather than an AI algorithm's diagnostic or predictive performance.
- Ground Truth: Implicitly, the ground truth for accuracy and functionality testing would be established through engineering measurements and comparisons to known performance of predicate devices or established technical specifications. No expert consensus or outcomes data for diagnostic purposes is mentioned.
- Sample Size: Not specified for any testing.
- Data Provenance: Not specified.
- Experts/Adjudication: Not relevant for this type of mechanical device testing.
- MRMC/Standalone AI Performance: Not applicable as the device is not an AI/ML algorithm.
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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
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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
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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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510(k) Summary: Navigation Instruments
| Company: | Globus Medical Inc. |
|---|---|
| 2560 General Armistead Ave. | |
| Audubon, PA 19403 | |
| 610-930-1800 |
| Primary Contact: | Lori BurnsDirector, 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
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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.
§ 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).