(63 days)
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are nonclinical mechanical tests.
Yes.
The device is intended to provide immobilization of spinal segments as an adjunct to fusion for various acute and chronic instabilities and conditions, including traumatic fractures, instability, deformity, failed fusions, tumors, and degenerative diseases. This restorative function for physical ailments is indicative of a therapeutic device.
No
The device is described as an immobilization system for spinal segments, an adjunct to fusion, and for restoring spinal column integrity. Its purpose is structural support and stabilization, not to diagnose medical conditions or identify diseases.
No
The device description explicitly states it is a system of physical components made from Titanium and Cobalt Chromium alloys, including screws, rods, and plates, which are hardware.
Based on the provided information, 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 the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a system of physical components (screws, rods, plates, etc.) made of metal alloys. This aligns with a surgical implant, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
- Performance Studies: The performance studies described are mechanical tests (compression, torsion, pull-off) to assess the structural integrity of the implant, which is typical for surgical devices.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The NuVasive Reline Cervical System is intended to provide immobilization 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 Reline Cervical 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 Reline Cervical System may be connected to the Nu Vasive® 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 Reline Cervical System is an occipito-cervico-thoracic posterior system manufactured from Titanium alloy (Ti6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3 and Cobalt Chromium alloy conforming to ASTM F90 or ASTM F1537. The Reline Cervical System consists of a variety of components including screws, rods, offset connectors, rod to rod connectors, set screws, cross connectors, hooks, eyelets, and occipital plates which can be rigidly locked in a variety of configurations to accommodate patient anatomy.
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) and the thoracic spine (T1-T3)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 Reline Cervical System is substantially equivalent to the predicate device. The following testing was performed:
- Static and dynamic compression bending testing per ASTM F2706
- Static torsion testing per ASTM F2706 ●
- Static tulip pull-off testing
- Dynamic Torsion testing per ASTM F2706
The results demonstrate that the subject NuVasive Reline Cervical System is substantially equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
VuePoint II OCT System (K180198), VuePoint OCT System (K071435), VuePoint OCT System (K093319), DePuy Summit OCT Spinal System (K002733)
Reference Device(s)
NuVasive Reline System (K160989), NuVasive Reline 4.5-5.0 System (K170126), NuVasive SpheRx II System (K091502), NuVasive Long Lateral Spinal System (K122081), NuVasive Camber Laminoplasty System (K191169), NuVasive Reline System (K182974)
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.
August 14, 2019
NuVasive, Incorporated Ms. Michelle Cheung Associate Manager, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121
Re: K191553
Trade/Device Name: NuVasive® Reline® Cervical System Regulation Number: 21 CFR 888.3075 Regulation Name: Posterior cervical screw system Regulatory Class: Class II Product Code: NKG, KWP Dated: June 11, 2019 Received: June 12, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ronald P. Jean, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K191553
Device Name NuVasive® Reline® Cervical System
Indications for Use (Describe)
The NuVasive Reline Cervical System is intended to provide immobilization 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 Reline Cervical 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 Reline Cervical System may be connected to the Nu Vasive® 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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Image /page/3/Picture/1 description: The image shows the Nuvasive logo. The logo consists of a stylized leaf shape on the left and the word "NUVASIVE" on the right. The leaf shape is split into two parts, with the top part being purple and the bottom part being gray. The word "NUVASIVE" is written in gray, sans-serif font.
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:
A. Submitted by:
Michelle Cheung Associate Manager, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-3360 Date Prepared: August 12, 2019
B. Device Information
NuVasive® Reline® Cervical System Orthosis, Cervical Pedicle Screw Spinal Fixation Product Code: NKG, KWP Classification Name: Posterior cervical screw system (21 CFR 888.3075); Spinal interlaminar fixation orthosis (21 CFR 888.3050) Regulatory Class: Class II
C. Predicate Devices
The subject device is substantially equivalent to the primary predicate VuePoint II OCT System (K180198). Additional predicates include VuePoint OCT System (K071435), VuePoint OCT System (K093319), and DePuy Summit OCT Spinal System (K002733). Reference devices include NuVasive Reline System (K160989), NuVasive Reline 4.5-5.0 System (K170126), NuVasive SpheRx II System (K091502), NuVasive Long Lateral Spinal System (K122081), NuVasive Camber Laminoplasty System (K191169) and the NuVasive Reline System (K182974).
D. Device Description
The NuVasive Reline Cervical System is an occipito-cervico-thoracic posterior system manufactured from Titanium alloy (Ti6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3 and Cobalt Chromium alloy conforming to ASTM F90 or ASTM F1537. The Reline Cervical System consists of a variety of components including screws, rods, offset connectors, rod to rod connectors, set screws, cross connectors, hooks, eyelets, and occipital plates which can be rigidly locked in a variety of configurations to accommodate patient anatomy.
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Image /page/4/Picture/1 description: The image shows the Nuvasive logo. The logo consists of a stylized purple and gray leaf-like shape on the left, followed by the word "NUVASIVE" in gray, sans-serif font. The logo is clean and modern, with a focus on the company name.
E. Intended Use
The NuVasive Reline Cervical 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 Reline Cervical 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 Reline Cervical System may be connected to the NuVasive® 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 Reline Cervical System is an occipito-cervico-thoracic posterior system manufactured from Titanium alloy (Ti6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3 and Cobalt Chromium alloy conforming to ASTM F90 or ASTM F1537. The Reline Cervical System consists of a variety of components including screws, rods, offset connectors, rod to rod connectors, set screws, cross connectors, hooks, eyelets, and occipital plates which can be rigidly locked in a variety of configurations to accommodate patient anatomy. 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.
G. Performance Data
Nonclinical testing was performed to demonstrate that the subject NuVasive Reline Cervical System is substantially equivalent to the predicate device. The following testing was performed:
- Static and dynamic compression bending testing per ASTM F2706
- Static torsion testing per ASTM F2706 ●
- Static tulip pull-off testing
- Dynamic Torsion testing per ASTM F2706
The results demonstrate that the subject NuVasive Reline Cervical 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 stylized leaf shape on the left, with the word "NUVASIVE" in gray letters to the right of the leaf. The leaf is split into two colors, purple and gray.
H. Conclusions
The subject NuVasive Reline Cervical System has been shown to be substantially equivalent to legally marketed predicate devices for its intended use.