(57 days)
Not Found
No
The document describes a physical spinal implant system and its mechanical testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is a system of titanium implants (cages and screws) indicated for spinal fusion procedures to treat conditions like degenerative disc disease and spondylolisthesis. Its purpose is to facilitate fusion and provide stability in the spine, which directly falls under the definition of a therapeutic intervention to alleviate symptoms and restore function.
No
The device is an interbody fusion system designed for surgical implantation to treat spinal conditions, not to diagnose them. Its purpose is to facilitate fusion by providing structural support and not to identify or characterize medical conditions.
No
The device description explicitly states it is an "interfixated interbody system manufactured from titanium alloy" and consists of "a titanium alloy interbody and three (3) titanium alloy bone screws." This indicates it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the BASE Interfixated Titanium System is an implantable device used for spinal fusion procedures in the lumbar spine. It is a physical implant designed to provide structural support and facilitate bone fusion.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze biological samples or provide diagnostic information. Its function is purely therapeutic and structural.
Therefore, the BASE Interfixated Titanium 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 BASE Interfixated Titanium System is indicated for spinal fusion procedures in skeletally mature patients. The BASE Interfixated Titanium System 10° - 20° lordotic cages may be used as a standalone system. The BASE Interfixated Titanium System 25° - 30° lordotic cages 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. 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 BASE Interfixated Titanium 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 BASE Interfixated Titanium System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis; however, when used in these patients at multiple levels and for patients with degenerative spondylolisthesis, the BASE Interfixated Titanium 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 NuVasive BASE Interfixated Titanium System is an interfixated interbody system manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3. The NuVasive BASE Interfixated Titanium System is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The BASE Interfixated Titanium System consists of a titanium alloy interbody and three (3) titanium alloy bone screws. The BASE Interfixated Titanium System 10° - 20° lordotic cages may be used as a standalone system. The BASE Interfixated Titanium System 25° - 30° lordotic cages 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.
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
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 BASE Interfixated Titanium System is substantially equivalent to other predicate devices. The following testing was performed:
- Static and dynamic compression testing per ASTM F2077
- Static and dynamic torsion testing per ASTM F2077
- Static Push-out Testing per ASTM Work Item Z8423Z
- Subsidence and screw push-out analysis
The results of these studies show that the subject BASE Interfixated Titanium 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): 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.
K161230, K151214, K152943, K073109
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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing design that suggests movement or progress.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 26, 2017
NuVasive, Incorporated Ms. Cynthia Adams Regulatory Affairs Specialist 7475 Lusk Boulevard San Diego, California 92121
Re: K170592
Trade/Device Name: NuVasive® BASE Interfixated Titanium System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: February 27, 2017 Received: February 28, 2017
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 of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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" (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.
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,
Vincent J. Devlin -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: January 31, 2017 See PRA Statement below.
Page 1 of 1
510(k) Number (if known) K170592
Device Name
NuVasive® BASE Interfixated Titanium System
Indications for Use (Describe)
The BASE Interfixated Titanium System is indicated for spinal fusion procedures in sketally mature patients. The BASE Interfixated Titanium System 10° - 20° lordotic cages may be used as a standalone system. The BASE Interfixated Titanium System 25° - 30° lordotic cages 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 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 BASE Interfixated Titanium System is interbody fusions in the lumbar spine from L2 to S1, following discectorny 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 BASE Interfixated Titanium System implants can adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis; however, when used in these patients at multiple levels and for patients with degenerative spondylolisthesis, the BASE Interfixated Titanium 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) | |
|---|---|
| ☑ 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/3/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a stylized leaf-like shape in purple and gray on the left, followed by the word "NUVASIVE" 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. Cynthia Adams Senior Specialist, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 (858) 909-1800
Date Prepared: April 25, 2017
B. Device Name
| Trade or Proprietary Name: | NuVasive® BASE Interfixated Titanium 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 BASE Interfixated Titanium System is substantially equivalent to the following devices:
Primary Predicate
-
K161230 NuVasive Lumbar Interbody Implants ●
Additional Predicates -
K151214 NuVasive ALIF Interfixated System ●
-
K152943 NuVasive Foundation-LL System ●
-
K073109 Surgicraft™ Limited STALIF® TT Intervertebral Body Fusion System ●
D. Device Description
The NuVasive BASE Interfixated Titanium System is an interfixated interbody system manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3. The NuVasive BASE Interfixated Titanium System is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The BASE Interfixated Titanium System consists of a titanium alloy interbody and three (3) titanium alloy bone screws. The BASE Interfixated Titanium System 10° - 20° lordotic cages may be used as a standalone system. The BASE Interfixated Titanium System 25° - 30° lordotic cages 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.
4
Image /page/4/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized purple and gray graphic on the left, followed by the word "NUVASIVE" in gray, sans-serif font. A small registration mark is present to the right of the word.
E. Indications for Use
The BASE Interfixated Titanium System is indicated for spinal fusion procedures in skeletally mature patients. The BASE Interfixated Titanium System 10° - 20° lordotic cages may be used as a standalone system. The BASE Interfixated Titanium System 25° - 30° lordotic cages 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. 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 BASE Interfixated Titanium 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 BASE Interfixated Titanium System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis; however, when used in these patients at multiple levels and for patients with degenerative spondylolisthesis, the BASE Interfixated Titanium 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 BASE Interfixated Titanium 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 BASE Interfixated Titanium System is substantially equivalent to other predicate devices. The following testing was performed:
- Static and dynamic compression testing per ASTM F2077 ●
- Static and dynamic torsion testing per ASTM F2077 ●
- Static Push-out Testing per ASTM Work Item Z8423Z ●
- Subsidence and screw push-out analysis
The results of these studies show that the subject BASE Interfixated Titanium 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.
5
Image /page/5/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a stylized leaf-like shape in purple and gray on the left, followed by the word "NUVASIVE" in gray. The leaf shape is split into two halves, with the top half in purple and the bottom half in gray. The word "NUVASIVE" is in a sans-serif font.
H. Conclusions
Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject BASE Interfixated Titanium System has been shown to be substantially equivalent to legally marketed predicate devices.