(104 days)
No
The description focuses on the mechanical components of the spinal system and navigation instruments used with a separate, predicate navigation system (Medtronic StealthStation® System). There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes.
The device, the QUARTEX™ Occipito-Cervico-Thoracic Spinal System, is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for a variety of acute and chronic instabilities and deformities, including traumatic fractures, tumors, and degenerative diseases. These are medical conditions that the device is designed to treat or alleviate.
No
The device, QUARTEX™ Occipito-Cervico-Thoracic Spinal System, is an implant system and associated surgical navigation instruments used for immobilization and stabilization of spinal segments. Their purpose is therapeutic (fusion, stabilization, and restoration of spinal column integrity), not diagnostic. While it mentions the use of imaging data (CT/MR/fluoroscopy), this data is used for surgical planning and navigation, not for diagnosing a condition.
No
The device description clearly outlines physical implants (rods, screws, hooks, etc.) and manual surgical instruments made of metal alloys. While it mentions navigation instruments used with a separate navigation system (Medtronic StealthStation® System), the core device being described and cleared is a physical spinal implant system and associated manual instruments.
Based on the provided text, 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, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the QUARTEX™ system is a spinal implant system used for immobilization and stabilization of spinal segments. The Globus Navigation Instruments are used during surgery to assist in placing these implants.
- No Mention of Samples or Testing: There is no mention of collecting samples from the body or performing any kind of diagnostic test on those samples. The device is a surgical implant and associated navigation tools.
Therefore, the QUARTEX™ Occipito-Cervico-Thoracic Spinal System and the Globus Navigation Instruments are surgical devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The QUARTEX™ Occipito-Cervico-Thoracic Spinal System implants are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations: instability or deformity: failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. These implants are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, rods may be connected to occipital cervical thoracic or thoracolumbar stabilization systems ranging in diameter from 3.2mm to 6.5mm, using corresponding connectors.
Globus Navigation Instruments are intended to be used during the preparation and placement of Globus screws (QUARTEX, 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)
NKG, KWP, OLO
Device Description
The QUARTEX™ Occipito-Cervico-Thoracic Spinal System consists of 3.5mm-4.0mm jointed, straight and pre-bent rods, tapered rods, polyaxial screws, hooks, locking caps, t-connectors, lateral connectors, parallel connectors, in-line connectors, rod-to-rod connectors, rod extension clamps, QUARTEX™ H-LINK™ Integrated Rod and occipital plates. The implants are composed of titanium alloy (per ASTM F136, F1472, or F1295), stainless steel (per ASTM F138) or cobalt chromium molybdenum alloy (CoCr) (per ASTM F1537).
QUARTEX™ constructs may be connected to stabilization systems including ELLIPSE®, PROTEX® CT, PROTEX® , CREO®, REVERE®, or BEACON® Systems using corresponding connectors.
The QUARTEX™ System include manual surgical instruments manufactured from stainless steel, as specified in ASTM F899. Globus Navigation Instruments are nonsterile, reusable instruments that can be operated manually and are intended to be used with the Medtronic StealthStation® System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model, fluoroscopy images
Anatomical Site
Craniocervical junction, the cervical spine (C1-C7) and the thoracic spine (T1-T3)
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)
Performance of the QUARTEX™ Occipito-Cervico-Thoracic Spinal System was evaluated in accordance with ASTM F1717, ASTM F2706, and the "Guidance for Industry and FDA Staff, Guidance for Spinal Systems 510(k)s," May 3, 2004. Performance data demonstrate substantial equivalence to the predicate devices. A comparative analysis was provided for the Globus Navigation Instruments and its predicate device. Bacterial endotoxin testing was also provided.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
ELLIPSE® OCT Spinal System (K150552), Synapse OCT System (K142838), Globus Navigation Instruments (K153203)
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.
H-LINK™ Integrated Rod (K073517), PROTEX CT® (K050391)
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
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 21, 2016
Globus Medical, Inc. Kelly J. Baker, Ph.D. Senior Vice President. Regulatory and Clinical Affairs 2560 General Armistead Avenue Audubon, Pennsylvania 19403
Re: K161591
Trade/Device Name: QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments
Regulatory Class: Unclassified Product Code: NKG, KWP, OLO Dated: September 7, 2016 Received: September 8, 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" (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 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,
Vincent J. Devlin -S
for 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) K161591
Device Name
QUARTEX™ Occipito-Cervico-Thoracic Spinal System
Indications for Use (Describe)
The QUARTEX™ Occipito-Cervico-Thoracic Spinal System implants are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); turnors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. These implants are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage turnors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, rods may be connected to occipital cervical thoracic or thoracolumbar stabilization systems ranging in diameter from 3.2mm to 6.5mm, using corresponding connectors.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995,
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K161591
Device Name Globus 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, 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 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)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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| 510(k) Summary: QUARTEX™ Occipito-Cervico-Thoracic Spinal System | |||||
|---|---|---|---|---|---|
| and Globus 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, Requlatory and Clinical Affairs Date Prepared: September 15, 2016 QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Device Name: Globus Navigation Instruments Classification: QUARTEX™ Occipito-Cervico-Thoracic Spinal System Pre-Amendment Device Cervical Pedicle Screw Spinal Fixation Orthosis Product Code: NKG Regulatory Class: Unclassified Per 21 CFR as follows: §888.3050 Spinal Interlaminal Fixation Orthosis Product Code: KWP Regulatory Class: II, Panel Code: 87 Globus Navigation Instruments Per 21 CFR as follows: §882.4560 Stereotaxic Instrument Product Code: OLO Regulatory Class: II; Panel Code: 87 QUARTEX™ Occipito-Cervico-Thoracic Spinal System Predicates: Primary predicate: ELLIPSE® OCT Spinal System (K150552) Additional predicates: Synapse OCT System (K142838) Reference: H-LINK™ Integrated Rod (K073517) PROTEX CT® (K050391) Globus Navigation Instruments Additional predicate: Globus Navigation Instruments (K153203)
5
Purpose:
The purpose of this submission is to request clearance for QUARTEX™ Occipito-Cervico-Thoracic Spinal System implants and instruments, and Globus Navigation instruments for use with the Medtronic StealthStation® System.
Device Description:
The QUARTEX™ Occipito-Cervico-Thoracic Spinal System consists of 3.5mm-4.0mm jointed, straight and pre-bent rods, tapered rods, polyaxial screws, hooks, locking caps, t-connectors, lateral connectors, parallel connectors, in-line connectors, rod-to-rod connectors, rod extension clamps, QUARTEX™ H-LINK™ Integrated Rod and occipital plates. The implants are composed of titanium alloy (per ASTM F136, F1472, or F1295), stainless steel (per ASTM F138) or cobalt chromium molybdenum alloy (CoCr) (per ASTM F1537).
QUARTEX™ constructs may be connected to stabilization systems including ELLIPSE®, PROTEX® CT, PROTEX® , CREO®, REVERE®, or BEACON® Systems using corresponding connectors.
The QUARTEX™ System include manual surgical instruments manufactured from stainless steel, as specified in ASTM F899. Globus Navigation Instruments are nonsterile, reusable instruments that can be operated manually and are intended to be used with the Medtronic StealthStation® System.
Indications for Use:
QUARTEX™ Occipito-Cervico-Thoracic Spinal System
The QUARTEX™ Occipito-Cervico-Thoracic Spinal System implants are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations: instability or deformity: failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. These implants are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, rods may be connected to occipital cervical thoracic or thoracolumbar stabilization systems ranging in diameter from 3.2mm to 6.5mm, using corresponding connectors.
Globus Navigation Instruments
Globus Navigation Instruments are intended to be used during the preparation and placement of Globus screws (QUARTEX, CREO, REVERE, REVOLVE, ELLIPSE, and PROTEX CT Stabilization Systems) during spinal surgery to assist
6
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.
Performance Data:
Performance of the QUARTEX™ Occipito-Cervico-Thoracic Spinal System was evaluated in accordance with ASTM F1717, ASTM F2706, and the "Guidance for Industry and FDA Staff, Guidance for Spinal Systems 510(k)s," May 3, 2004. Performance data demonstrate substantial equivalence to the predicate devices. A comparative analysis was provided for the Globus Navigation Instruments and its predicate device. Bacterial endotoxin testing was also provided.
Basis of Substantial Equivalence:
The QUARTEX™ Occipito-Cervico-Thoracic Spinal System and Globus Navigation Instruments have been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use. The subject devices perform as well as or better than the predicate devices.