(134 days)
Not Found
No
The summary describes a physical implantable device for spinal fusion and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is described as an intervertebral body fusion system intended to treat symptomatic disc degeneration and degenerative spondylolisthesis, which aims to alleviate pain and restore function.
No
This device is an interbody fusion system designed for the surgical treatment of spinal conditions, not for diagnosing them. It is a therapeutic implant.
No
The device description clearly states it is an "expandable interbody system manufactured from titanium alloy" and "nickel-cobalt-chromium-molybdenum," indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The NuVasive XLX Interbody System is a surgical implant designed for spinal fusion. It is a physical device implanted into the body to provide structural support and facilitate bone growth.
- Lack of Specimen Analysis: The description does not mention the device being used to analyze any biological specimens. Its function is mechanical and biological (promoting fusion).
Therefore, the NuVasive XLX Interbody System falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The NuVasive® XLX Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. When used with or without the XLX internal fixation, the system is intended for use with supplemental spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. XLX interbody devices expanded to ≥20° lordosis must be used with the XLX internal fixation and additional supplemental fixation. The devices are to be used in patients who have had at least six months of non-operative treatment.
The XLX Interbody System is intended for use in interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The NuVasive XLX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
Product codes (comma separated list FDA assigned to the subject device)
MAX, PHM, OVD
Device Description
The NuVasive XLX Interbody System is an expandable interbody system manufactured from titanium alloy Ti-6A1-4V ELI per ASTM F136 and ISO 5832-3, and nickel-cobaltchromium-molybdenum (MP35N) conforming to ASTM F562. XLX interbodies are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The XLX Interbody intervertebral fusion device is designed to address thoracolumbar pathologies utilizing interbody placement through a standard lateral (XLIF) approach. The hollow core, or graft aperture, allows for packing of autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to aid in the promotion of a solid fusion. An internal fixation plate with bone screw manufactured from titanium alloy (Ti-6A1-4V ELI) conforming ASTM F136 or ISO 5832-3 and MP35N conforming to ASTM F562 may be affixed to the adjacent vertebral body to provide additional migration resistance and stability. When used with or without the internal fixation plate and bone screw, the device is intended to be used with supplemental spinal fixation systems that are cleared by the FDA for use in the thoracolumbar spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and the lumbar spine, from L1 to S1
Indicated Patient Age Range
skeletally mature patients
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 XLX Interbody System is substantially equivalent to other predicate devices. The following testing was performed:
- Static and dynamic axial compression testing per ASTM F2077
- Static and dynamic compression-shear testing per ASTM F2077
- Dynamic torsion testing per ASTM F2077
- Static push-out testing per ASTM draft standard F-04.25.02.02 (work item Z8423Z)
- Screw push-out analysis
- Subsidence analysis
The results demonstrate that the subject XLX Interbody System presents no new worst-case for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate devices.
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.
K172123, K171633, K140770, K161230, K163506
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
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
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May 4, 2018
NuVasive, Incorporated Manthan Damani Senior Regulatory Affairs Specialist 7475 Lusk Blvd. San Diego, California 92121
Re: K173892
Trade/Device Name: NuVasive® XLX Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, PHM, OVD Dated: April 4, 2018 Received: April 5, 2018
Dear Manthan Damani:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 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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Indications for Use
510(k) Number (if known) K173892
Device Name NuVasive® XLX Interbody System
Indications for Use (Describe)
The NuVasive XLX Interbody System is intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. When used with or without the XLX internal fixation, the system is intended for use with supplemental spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. XLX interbody devices expanded to ≥20° lordosis must be used with the XLX internal fixation and additional supplemental fixation. The devices are to be used in patients who have had at least six months of non-operative treatment.
The XLX Interbody System is intended for use in interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The NuVasive XLX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
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® XLX Interbody System
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:
Manthan J. Damani Senior Regulatory Affairs Specialist NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 458-2272
Date Prepared: April 4, 2018
B. Device Name
| Trade or Proprietary Name: | NuVasive® XLX Interbody System |
|---|---|
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Body Fusion Device |
| Device Class: | Class II |
|---|---|
| Classification: | 21 CFR § 888.3080 |
| Product Code: | MAX, PHM, OVD |
C. Predicate Devices
The subject XLX Interbody System is substantially equivalent to multiple predicate devices. NuVasive Modulus XLIF Interbody System (K172123) serves as the primary predicate device, while NuVasive TLX Interbody System (K171633), NuVasive MLX - Medial Lateral Expandable Lumbar Interbody System (K140770), NuVasive Lumbar Interbody Implants (K161230) and Vertera Coalesce Lumbar Interbody Fusion System (K163506) are additional predicate devices.
D. Device Description
The NuVasive XLX Interbody System is an expandable interbody system manufactured from titanium alloy Ti-6A1-4V ELI per ASTM F136 and ISO 5832-3, and nickel-cobaltchromium-molybdenum (MP35N) conforming to ASTM F562. XLX interbodies are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The XLX Interbody intervertebral fusion device is designed to address thoracolumbar pathologies utilizing interbody placement through a standard lateral (XLIF) approach. The hollow core, or graft aperture, allows for packing of autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to aid in the promotion of a solid fusion. An internal fixation plate with bone screw manufactured from titanium alloy (Ti-6A1-4V ELI) conforming ASTM F136 or ISO 5832-3 and MP35N conforming to ASTM F562 may be affixed to the adjacent vertebral body to provide additional migration resistance and stability. When used with or without the internal fixation plate and bone screw, the device is intended to be used with supplemental spinal fixation systems that are cleared by the FDA for use in the thoracolumbar spine.
4
Indications for Use E.
The NuVasive® XLX Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. When used with or without the XLX internal fixation, the system is intended for use with supplemental spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. XLX interbody devices expanded to ≥20° lordosis must be used with the XLX internal fixation and additional supplemental fixation. The devices are to be used in patients who have had at least six months of non-operative treatment.
The XLX Interbody System is intended for use in interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The NuVasive XLX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
F. Technological Characteristics
As was established in this submission, the subject XLX Interbody System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, and function.
G. Performance Data
Nonclinical testing was performed to demonstrate that the subject XLX Interbody System is substantially equivalent to other predicate devices. The following testing was performed:
- Static and dynamic axial compression testing per ASTM F2077 ●
- Static and dynamic compression-shear testing per ASTM F2077 ●
- Dynamic torsion testing per ASTM F2077 ●
- Static push-out testing per ASTM draft standard F-04.25.02.02 (work item Z8423Z)
- Screw push-out analysis
- Subsidence analysis ●
The results demonstrate that the subject XLX Interbody System presents no new worst-case for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate devices.
H. Conclusions
Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject XLX Interbody System has been shown to be substantially equivalent to legally marketed predicate devices.