(91 days)
Not Found
No
The 510(k) summary describes a physical interbody fusion device made of PEEK and titanium, with no mention of software, algorithms, or any AI/ML related terms or functionalities. The performance studies are based on Finite Elemental Analysis, not data-driven AI/ML models.
Yes
The device is indicated for spinal fusion procedures to treat conditions like degenerative disc disease and spondylolisthesis, which are medical treatments.
No
The device is an interbody fusion system designed for spinal fusion procedures, specifically in the lumbar spine. Its purpose is to facilitate fusion and provide stability, not to diagnose medical conditions or diseases.
No
The device description explicitly states the device is an interbody system manufactured from PEEK and titanium alloy, including physical implants and screws. This indicates it is a hardware device, 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 for spinal fusion procedures. This involves physically interacting with the patient's body to treat a condition.
- Device Description: The device is described as an interbody system made of PEEK and titanium alloy, designed to be implanted in the spine. This is a physical medical device, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Brigade® Lateral System is indicated for spinal fusion procedures in skeletally mature patients. The Brigade® Lateral System must be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The System is designed for use with autogenous and/or allogenic bone graft comprised of cancellous 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® Lateral System is interbody fusions in the lumbar spine from L2 to S1, following discectomy in the treatment of symptomatic degenerative disc disease (DDD) or degenerative 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® Lateral System implants can also 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)
OVD
Device Description
The NuVasive® Brigade® Lateral System is an interfixated interbody system manufactured from PEEK and titanium alloy conforming to industry recognized standards. The NuVasive Brigade Lateral System is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The Brigade Lateral System intervertebral fusion device is composed of a PEEK interbody implant containing radiographic titanium alloy markers, and two (2) titanium alloy bone screws. The subject device components are made from Polyetheretherketone (PEEK-OPTIMAL LT1) conforming to ASTM F2026 and titanium alloy (Ti-6A-4V ELI) conforming to ASTM F136 and ISO 5832-3 or (Ti-6A-4V) conforming to ASTM F1472. The purpose of this Premarket Notification in to implement design changes to the Brigade System previously cleared in K161230 (NuVasive® Lumbar Interbody Implant).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine from L2 to S1
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
No non-clinical or clinical studies were conducted.
Description of the test set, sample size, data source, and annotation protocol
No non-clinical or clinical studies were conducted.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Finite Elemental Analysis (FEA) and engineering rationale were provided as evidence that the modified design of the Brigade® Lateral System construct did not create a new worst case for performance testing. The results of testing and Finite Elemental Analysis demonstrate that the subject Brigade Lateral System is substantially equivalent to predicate devices. No non-clinical or clinical studies were conducted.
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.
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' in bold blue letters, and the word 'ADMINISTRATION' in smaller blue letters below.
August 24, 2018
NuVasive, Incorporated Jessica Silverman Regulatory Affairs Specialist 7475 Lusk Blvd. San Diego, California 92121
Re: K181386
Trade/Device Name: NuVasive® Brigade® Lateral System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: July 31, 2018 Received: August 1, 2018
Dear Ms. Silverman:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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,
Melissa Hall -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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K181386
Device Name NuVasive® Brigade® Lateral System
Indications for Use (Describe)
The Brigade® Lateral System is indicated for spinal fusion procedures in skeletally mature patients. The Brigade® Lateral System must be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The System is designed for use with autogenous and/or allogenic bone graft comprised of cancellous 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® Lateral System is interbody fusions in the lumbar spine from L2 to S1, following discectomy in the treatment of symptomatic degenerative disc disease (DDD) or degenerative 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® Lateral System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
| 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) | X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a stylized leaf shape in purple and gray, followed by the word "NUVASIVE" in gray sans-serif font. The leaf shape is split into two parts, with the top part in purple and the bottom part in gray. The logo is simple and modern, and the colors are muted and professional.
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:
Ms. Jessica Silverman Regulatory Affairs Specialist NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 (858) 909-3302
Date Prepared: May 24, 2018
B. Device Name
| Trade or Proprietary Name: | NuVasive® Brigade® Lateral 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 Brigade Lateral System is substantially equivalent to the following devices:
Primary Predicate
- K161230 NuVasive Lumbar Interbody Implants ●
Additional Predicates
Device Description D.
The NuVasive® Brigade® Lateral System is an interfixated interbody system manufactured from PEEK and titanium alloy conforming to industry recognized standards. The NuVasive Brigade Lateral System is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The Brigade Lateral System intervertebral fusion device is composed of a PEEK interbody implant containing radiographic titanium alloy markers, and two (2) titanium alloy bone screws. The subject device components are made from Polyetheretherketone (PEEK-OPTIMAL LT1) conforming to ASTM F2026 and titanium alloy (Ti-6A-4V ELI) conforming to ASTM F136 and ISO 5832-3 or (Ti-6A-4V) conforming to ASTM F1472. The purpose of this Premarket Notification in to implement design changes to the Brigade System previously cleared in K161230 (NuVasive® Lumbar Interbody Implant).
4
Image /page/4/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf-like shape in purple and gray, followed by the company name "NUVASIVE" in gray sans-serif font. The logo is simple and modern.
Indications for Use E.
The Brigade® Lateral System is indicated for spinal fusion procedures in skeletally mature patients. The Brigade® Lateral System must be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous 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® Lateral 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) or degenerative 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® Lateral System implants can also 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 Brigade® Lateral 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, function, and range of sizes.
G. Performance Data
Finite Elemental Analysis (FEA) and engineering rationale were provided as evidence that the modified design of the Brigade® Lateral System construct did not create a new worst case for performance testing. The results of testing and Finite Elemental Analysis demonstrate that the subject Brigade Lateral System is substantially equivalent to predicate devices. No non-clinical or clinical studies were conducted.
H. Conclusions
Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject Brigade® Lateral System has been shown to be substantially equivalent to legally marketed predicate devices.