(197 days)
Not Found
No
The summary describes a physical interbody fusion device and its materials, intended use, and performance testing. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The device is indicated for spinal fusion procedures to treat degenerative disc disease and is intended for use in the human body to restore function and alleviate a disease condition, which aligns with the definition of a therapeutic device.
No
The device is an interbody system intended for spinal fusion procedures, meaning it is a therapeutic device inserted into the body to treat a condition, not to diagnose one.
No
The device description explicitly states the device is an "interbody system manufactured from PEEK and titanium alloy" and includes "PEEK interbody implant containing radiographic titanium alloy markers, and four (4) titanium alloy bone screws." This indicates it is a physical implant, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for spinal fusion procedures in the lumbar spine. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is an interbody system made of PEEK and titanium alloy, designed to be implanted in the spine.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition. IVDs are used to provide information about a patient's health status through the analysis of these samples.
The Brigade Hyperlordotic System is a surgical implant used for treatment, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Brigade Hyperlordotic System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved level(s). The Brigade Hyperlordotic System is intended for use with autograft. The Brigade Hyperlordotic System must be used with supplemental internal spinal fixation systems (i.e. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Brigade Hyperlordotic System.
Product codes
OVD
Device Description
The NuVasive Brigade Hyperlordotic System is an interbody system manufactured from PEEK and titanium alloy conforming to industry recognized standards. The NuVasive Brigade Hyperlordotic System is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The Brigade Hyperlordotic intervertebral fusion device is a device composed of a PEEK interbody implant containing radiographic titanium alloy markers, and four (4) titanium alloy bone screws. The subject device components are made from Polyetheretherketone (PEEK-OPTIMA LT1) conforming to ASTM F-2026 and titanium alloy (Ti-6AI-4V ELI) conforming to ASTM F136 and ISO 5832-3.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine (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)
Nonclinical testing was performed to demonstrate that the subject Brigade Hyperlordotic System is substantially equivalent to other predicate devices. The following preclinical testing/analysis was performed:
- . Static and dynamic compression, torsion, and compression shear testing per ASTM F2077
- Expulsion testing per ASTM Work Item Z8423Z .
- . Subsidence testing per ASTM F2267
- . Wear debris/mass change analysis during ASTM F2077, per ASTM F1714 and ASTM F1877
- Screw push-out testing .
All test results passed acceptance criteria. The results of these studies, computational modeling, and supporting literature reviews show that the subject Brigade Hyperlordotic System meets or exceeds the performance of the predicate device and does not introduce any new risks; therefore, the system is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Image /page/0/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized, abstract shape on the left, followed by the word "NUVASIVE" in a bold, sans-serif font. Below the word "NUVASIVE" is the tagline "Speed of Innovation" in a smaller font. The logo is black and white.
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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. Cynthia Adams Regulatory Affairs Associate NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 (858) 909-1800
Date Prepared: March 14, 2013
B. Device Name
| Trade or Proprietary Name: | NuVasive® Brigade® Hyperlordotic 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 Hyperlordotic System is substantially equivalent to the following devices:
- K100043 NuVasive, Inc. CoRoent® XLR Standalone System .
- K071309 Surgicraft Limited STALIFTM TT Intervertebral Body Fusion System .
- K071795 NuVasive, Inc. CoRoent System .
D. Device Description
The NuVasive Brigade Hyperlordotic System is an interbody system manufactured from PEEK and titanium alloy conforming to industry recognized standards. The NuVasive Brigade Hyperlordotic System is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The Brigade Hyperlordotic intervertebral fusion device is a device composed of a PEEK interbody implant containing radiographic titanium alloy markers, and four (4) titanium alloy bone screws. The subject device components are made from Polyetheretherketone (PEEK-OPTIMA LT1) conforming to ASTM F-2026 and titanium alloy (Ti-6AI-4V ELI) conforming to ASTM F136 and ISO 5832-3.
E. Intended Use
The Brigade Hyperlordotic System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved
1
Image /page/1/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized graphic to the left of the company name, "NUVASIVE", in all caps. Below the company name is the tagline "...Speed of Innovation."
The Brigade Hyperlordotic System is intended for use with autograft. The level(s). Brigade Hyperlordotic System must be used with supplemental internal spinal fixation systems (i.e. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Brigade Hyperlordotic System.
F. Technological Characteristics
As was established in this submission, the subject Brigade® Hyperlordotic 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
Nonclinical testing was performed to demonstrate that the subject Brigade Hyperlordotic System is substantially equivalent to other predicate devices. The following preclinical testing/analysis was performed:
- . Static and dynamic compression, torsion, and compression shear testing per ASTM F2077
- Expulsion testing per ASTM Work Item Z8423Z .
- . Subsidence testing per ASTM F2267
- . Wear debris/mass change analysis during ASTM F2077, per ASTM F1714 and ASTM F1877
- Screw push-out testing .
All test results passed acceptance criteria. The results of these studies, computational modeling, and supporting literature reviews show that the subject Brigade Hyperlordotic System meets or exceeds the performance of the predicate device and does not introduce any new risks; therefore, the system is substantially equivalent to the predicate device.
H. Conclusions
Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject Brigade Hyperlordotic System has been shown to be substantially equivalent to legally marketed predicate devices, and safe and effective for its intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 16, 2013
NuVasive®, Incorporated % Ms. Cynthia Adams Regulatory Affairs Associate 7475 Lusk Boulevard San Diego, California 92121
Re: K123045
Trade/Device Name: NuVasive® Brigade® Hyperlordotic System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: March 18, 2013 Received: March 19, 2013
Dear Ms. Adams:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Cynthia Adams
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Image /page/3/Picture/6 description: The image shows the name "Erin I. D. Keith" in a stylized font. The letters are bold and black, with some of them having decorative elements. The "I" and "D" have a boxy design, while the "e" in "Keith" has a unique shape.
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): K123045
Device Name: NuVasive® Brigade® Hyperlordotic System
Indications For Use:
The Brigade Hyperlordotic System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved level(s). The Brigade Hyperlordotic System is intended for use with autograft. The Brigade Hyperlordotic System must be used with supplemental internal spinal fixation systems (i.e. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Brigade Hyperlordotic System.
Prescription Use X (Part 21 CFR 801 Subpart D)
:
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedic Devices