(100 days)
Not Found
No
The document describes a physical spinal implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is indicated for intervertebral body fusion of the spine and treatment of symptomatic degenerative disc disease, which are therapeutic medical purposes.
No
The device description clearly states its purpose is for intervertebral body fusion of the spine, and it describes implants made of PEEK-Optima and titanium, designed to promote fusion and grip vertebrae. This is a therapeutic and implantable device, not one that gathers or analyzes data for diagnostic purposes.
No
The device description clearly states it is an interbody manufactured from PEEK-Optima® LT-1 with titanium alloy components, including integrated screws. This indicates 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 diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Description and Intended Use: The NuVasive® Interfixated 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. Its intended use is to treat conditions like degenerative disc disease and scoliosis by fusing vertebrae.
- Lack of Diagnostic Activity: The description and intended use do not involve analyzing biological samples or providing diagnostic information about a patient's condition based on such analysis.
Therefore, the NuVasive® Interfixated 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® Interfixated Interbody System is indicated for the following:
CoRoent XL-F System
The NuVasive CoRoent XL-F System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation systems (e.g., pedicle or facet screws) cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The devices are to be used in patients who have had at least six months of non-operative treatment.
The CoRoent XL-F System is intended for use in interbody fusions in the lumbar spine from L2 to L5, following discectomy in the treatment of symptomatic degenerative disc disease (DDD) with up to Grade I spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The CoRoent XL-F System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
Brigade System
The Brigade System is indicated for spinal fusion procedures in skeletally mature patients. The Brigade Standalone System (lordotic angles of 8° and 12°) is a standalone system. The Brigade Hyperlordotic System (lordotic angels of 15° to 30°) must be used with supplemental internal spinal fixation systems (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The System is designed for use with autogenous bone graft to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment.
The Brigade System is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectomy in the treatment of symptomatic degenerative disc disease (DDD) with up to Grade I spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Brigade System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis, and when used in these patients at multiple levels, the Brigade Standalone System must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.
Product codes (comma separated list FDA assigned to the subject device)
OVD
Device Description
The subject NuVasive Interfixated Interbody System are interbodies manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026 PEEK-Optima® LT-1, with radiographic markers manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136. The devices all contain integrated screws made of titanium alloy, and include a hollow core or graft aperture which allows for packing of autograft to help promote a solid fusion. The subject implants contain small spikes or teeth on each end of the device which serve to grip the adjacent vertebrae to resist migration and expulsion.
The implants are available in a variety sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. In addition to the integrated screws, the CoRoent XL-F System and Brigade Hyperlordotic System devices are intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar spine from L2 to L5, Lumbar spine from L2 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)
No new device designs for the CoRoent XL-F System and no new worst case sizes for the Brigade System are being introduced to the subject Interfixated Interbody System. Therefore, no performance testing was performed for this 510(k) submission.
A retrospective clinical analysis was performed to support the use of the subject device as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
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.
K140479, K131723, K100043, K123045, K153419
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human profile, composed of three interconnected lines or shapes.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 20, 2016
NuVasive, Incorporated Ms. Michelle Cheung Associate, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121
Re: K160051
Trade/Device Name: NuVasive® Interfixated Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: March 23, 2016 Received: March 23, 2016
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 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" (21CFR 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 yours,
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Page 1 of 1
510(k) Number (if known)
Device Name NuVasive® Interfixated Interbody System
Indications for Use (Describe)
The NuVasive® Interfixated Interbody System is indicated for the following:
CoRoent XL-F System
The NuVasive CoRoent XL-F System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation systems (e.g., pedicle or facet screws) cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The devices are to be used in patients who have had at least six months of non-operative treatment.
The CoRoent XL-F System is intended for use in interbody fusions in the lumbar spine from L2 to L5, following discectomy in the treatment of symptomatic degenerative disc disease (DDD) with up to Grade I spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The CoRoent XL-F System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
Brigade System
The Brigade System is indicated for spinal fusion procedures in skeletally mature patients. The Brigade Standalone System (lordotic angles of 8° and 12°) is a standalone system. The Brigade Hyperlordotic System (lordotic angels of 15° to 30°) must be used with supplemental internal spinal fixation systems (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The System is designed for use with autogenous bone graft to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment.
The Brigade System is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectorny in the treatment of symptomatic degenerative disc disease (DDD) with up to Grade I spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Brigade System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis, and when used in these patients at multiple levels, the Brigade Standalone System must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/3/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a purple and gray abstract shape resembling a stylized leaf or eye, followed by the company name "NUVASIVE" in gray capital letters. Below the name, there is a tagline that says "Speed of Innovation" in a smaller font.
510(k) Summary
A.
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: Michelle Cheung, Esq. Associate, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-3360
Date Prepared: January 8, 2016
B. Device Name
| Trade or Proprietary Name: | NuVasive® Interfixated 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: | OVD |
C. Predicate Devices
The subject NuVasive Interfixated Interbody System is substantially equivalent to primary predicate NuVasive CoRoent XL-F System (K140479), and additional predicates NuVasive CoRoent Single Tab System (K131723), CoRoent XLR Standalone System (K100043), Brigade Hyperlordotic System (K123045), and CoRoent Thoracolumbar System (K153419).
D. Device Description
The subject NuVasive Interfixated Interbody System are interbodies manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026 PEEK-Optima® LT-1, with radiographic markers manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136. The devices all contain integrated screws made of titanium alloy, and include a hollow core or graft aperture which allows for packing of autograft to help promote a solid fusion. The subject implants contain small spikes or teeth on each end of the device which serve to grip the adjacent vertebrae to resist migration and expulsion.
The implants are available in a variety sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. In addition to the integrated screws, the CoRoent XL-F System and Brigade Hyperlordotic System devices are intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.
4
Image /page/4/Picture/0 description: The image shows the Nuvasive logo. 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, with the word "Speed" in purple and the rest of the phrase in gray. The logo is clean and modern, with a focus on innovation and technology.
E. Intended Use
The NuVasive® Interfixated Interbody System is indicated for the following:
CoRoent XL-F System:
The NuVasive CoRoent XL-F System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation systems (e.g., pedicle or facet screws) cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The devices are to be used in patients who have had at least six months of non-operative treatment.
The CoRoent XL-F System is intended for use in interbody fusions in the lumbar spine from L2 to L5, following discectomy in the treatment of symptomatic degenerative disc disease (DDD) with up to Grade I spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The CoRoent XL-F System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
Brigade System:
The Brigade System is indicated for spinal fusion procedures in skeletally mature patients. The Brigade Standalone System (lordotic angles of 8° and 12°) is a standalone system. The Brigade Hyperlordotic System (lordotic angles of 15° to 30°) must be used with supplemental internal spinal fixation systems (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The System is designed for use with autogenous bone graft to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment.
The Brigade System is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectomy in the treatment of symptomatic degenerative disc disease (DDD) with up to Grade I spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Brigade System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis, and when used in these patients at multiple levels, the Brigade Standalone System must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.
F. Technological Characteristics
As was established in this submission, the subject Interfixated Interbody System is substantially equivalent to predicate device systems already 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. This device does not contain software or electrical equipment.
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Image /page/5/Picture/0 description: The image is a logo for Nuvasive. The logo features a stylized purple and gray leaf-like shape on the left, followed by the word "NUVASIVE" in gray, block letters. Below the word "NUVASIVE" is the tagline "Speed of Innovation" in a smaller, italicized font.
G. Performance Data
No new device designs for the CoRoent XL-F System and no new worst case sizes for the Brigade System are being introduced to the subject Interfixated Interbody System. Therefore, no performance testing was performed for this 510(k) submission.
A retrospective clinical analysis was performed to support the use of the subject device as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
H. Conclusions
Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject Interfixated Interbody System has been shown to be substantially equivalent to legally marketed predicate devices, and as effective for its intended use.