(50 days)
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device description indicates that it consists of screws, hooks, rods, and other components used for immobilization and stabilization of spinal segments, which are mechanical functions rather than therapeutic.
No
The device is an orthopedic implant system designed to provide immobilization and stabilization of spinal segments, acting as an adjunct to fusion for various spinal conditions. It does not perform any diagnostic function.
No
The device description explicitly lists hardware components such as screws, hooks, rods, and instruments, indicating it is a physical implant system, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system for stabilizing spinal segments. This is a therapeutic device used in vivo (within the body).
- Device Description: The description details physical components like screws, hooks, rods, and plates, which are typical of surgical implants.
- No mention of in vitro testing: There is no indication that this device is used to examine specimens (like blood, tissue, or urine) outside of the body to provide diagnostic information.
IVD devices are used to perform tests on samples taken from the body to diagnose diseases or conditions. This device is a surgical implant used to treat a physical condition.
N/A
Intended Use / Indications for Use
The NuVasive® VuePoint® II OCT System is 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 to 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 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. The VuePoint II OCT System is 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, the VuePoint II OCT System may be connected to the NuVasive® SpheRx® Spinal System, Precept® Spinal System, Armada® Spinal System and Reline® 4.5-5.0 System via the rod to rod connectors or transition rods.
Product codes
NKG, KWP
Device Description
The NuVasive VuePoint II OCT System consists of screws, hooks, rods, offset connectors, rod to rod connectors, set screws, cross connectors, occipital plates and associated general instruments. Implant components are available in a variety sizes and can be rigidly locked into a variety of configurations to suit the individual pathology and anatomical conditions of the patient. The scope of this submission includes the introduction of 5.0 and 5.5 mm diameter multi axial bone screws, sterile implants, as well as minor modifications to the implant design since clearance of reference device NuVasive VuePoint II OCT System (K150474).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniocervical junction, the cervical spine (C1 to C7), the thoracic spine (T1-T3)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Nonclinical testing was performed to demonstrate that the subject NuVasive VuePoint II OCT System is substantially equivalent to the predicate device. The following testing was performed:
- Static and dynamic compression bending testing per ASTM F1717
- Static torsion testing per ASTM F1717
- Static tulip pull-off testing
- Static and Dynamic tulip shank interconnection strength testing per ASTM F1798
The results demonstrate that the subject NuVasive VuePoint II OCT System is substantially equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K150474, K093319, K142838, K161014
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
NuVasive, Incorporated Ms. Michelle Cheung Sr. Specialist, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121
Re: K180198
Trade/Device Name: NuVasive® VuePoint® II OCT System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: January 23, 2018 Received: January 24, 2018
Dear Ms. Cheung:
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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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.
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,
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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) K180198
Device Name NuVasive® VuePoint® II OCT System
Indications for Use (Describe)
The NuVasive® VuePoint® II OCT System is 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 to 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 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. The VuePoint II OCT System is 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, the VuePoint II OCT System may be connected to the NuVasive® SpheRx® Spinal System, Precept® Spinal System, Armada® Spinal System and Reline® 4.5-5.0 System via the rod to rod connectors or transition rods.
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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NuVasive® VuePoint® II OCT System January 23, 2018
510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:
Submitted by: A.
Michelle Cheung Senior Regulatory Affairs Associate NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-3360
Date Prepared: January 23, 2018
B. Device Information
NuVasive® VuePoint® II OCT System Orthosis, Cervical Pedicle Screw Spinal Fixation Product Code: NKG Unclassified, Pre-Amendment Spinal interlaminar fixation Regulation Number: § 888.3050 Product Code: KWP Class II
C. Predicate Devices
The subject device is substantially equivalent to the primary predicate VuePoint II OCT System (K150474), and additional predicates VuePoint OCT System (K093319), Synthes SYNAPSE OCT System (K142838), and Reline® System (K161014).
Device Description D.
The NuVasive VuePoint II OCT System consists of screws, hooks, rods, offset connectors, rod to rod connectors, set screws, cross connectors, occipital plates and associated general instruments. Implant components are available in a variety sizes and can be rigidly locked into a variety of configurations to suit the individual pathology and anatomical conditions of the patient. The scope of this submission includes the introduction of 5.0 and 5.5 mm diameter multi axial bone screws, sterile implants, as well as minor modifications to the implant design since clearance of reference device NuVasive VuePoint II OCT System (K150474).
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Image /page/4/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized purple and gray graphic to the left of the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Board of Innovation" in a smaller, stylized font, also in purple.
E. Intended Use
The NuVasive® VuePoint® II OCT System is 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 to 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 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. The VuePoint II OCT System is 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, the VuePoint II OCT System may be connected to the NuVasive® SpheRx® Spinal System, Precept® Spinal System, Armada® Spinal System, Reline® System and Reline® 4.5-5.0 System via the rod to rod connectors or transition rods.
F. Technological Characteristics
The NuVasive VuePoint II OCT System is introducing a large diameter multi axial bone screw, sterile implants, and design modifications to components that have been modified since their clearance in reference device VuePoint II OCT System (K150474). Modifications include minor changes to multi axial, favoured angle, and occipital bone screws, additional rod lengths and intermediate rod diameters, lasermarking updates, and minor tolerance updates to improve manufacturability of existing implants. Overall, the subject device was shown to be substantially equivalent and have equivalent technological characteristics to its predicate and reference devices through comparison in areas including design, labeling/intended use, material composition, function, and packaging.
Performance Data G.
Nonclinical testing was performed to demonstrate that the subject NuVasive VuePoint II OCT System is substantially equivalent to the predicate device. The following testing was performed:
- Static and dynamic compression bending testing per ASTM F1717 ●
- Static torsion testing per ASTM F1717 ●
- Static tulip pull-off testing ●
- Static and Dynamic tulip shank interconnection strength testing per ASTM F1798
The results demonstrate that the subject NuVasive VuePoint II OCT System is substantially equivalent to the predicate.
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Image /page/5/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a purple and gray abstract shape on the left, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller font and purple color.
H. Conclusions
The subject NuVasive VuePoint II OCT System has been shown to be substantially equivalent to legally marketed predicate devices for its intended use.