(22 days)
Not Found
No
The summary describes a mechanical implant system (plates and screws) and mentions only nonclinical mechanical testing. There is no mention of AI, ML, image processing, or any software-driven functionality that would suggest the use of AI/ML.
Yes
The device is indicated for treating various spine instabilities, including fractures, tumors, and degenerative disc disease, which are conditions that require therapeutic intervention to manage or alleviate.
No
The device is a system of plates and screws used for surgical stabilization of the spine, not for diagnosing medical conditions.
No
The device description explicitly states that the system consists of physical components (plates and screws) made from specific materials (Ti-6Al-4V and Nitinol alloy). This indicates it is a hardware medical 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 (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The NuVasive Halo II Anterior Lumbar Plate System is a surgical implant designed to stabilize the spine. It is used in vivo (within the body) during surgery, not for testing samples in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, performing diagnostic tests, or providing diagnostic information based on laboratory analysis.
Therefore, the NuVasive Halo II Anterior Lumbar Plate System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NuVasive Halo II Anterior Lumbar Plate System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, spinal stenosis, or a failed previous spine surgery.
Product codes
KWQ
Device Description
The NuVasive Halo II Anterior Lumbar Plate System consists of a series of plates and screws manufactured from Ti-6Al-4V per ASTM F-136 and ISO 5832-3. The plates also include components manufactured from Nitinol alloy SE508 per ASTM F2063.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and thoracolumbar (T1-L5) spine, lumbar and lumbosacral (L1-S1) spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 Halo II Anterior Lumbar Plate System is substantially equivalent to other predicate devices. The following testing was performed:
- . Static and dynamic compression testing per ASTM F1717
- . Static torsion testing per ASTM F1717
The results of these studies show that the subject Halo II Anterior Lumbar Plate System meets or exceeds the performance of the predicate device, and the device was therefore found to be substantially equivalent.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the Nuvasive logo. The logo consists of a stylized eye-like shape on the left and the word "NUVASIVE" on the right. Below the word "NUVASIVE" is the phrase "speed of innovation" in a smaller font.
510(k) Premarket Notification Halo II Anterior Lumbar Plate System
510(k) Summary
2 2 2011 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:
Sheila Bruschi Associate Manager, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 (858) 320-4515
Date Prepared: July 20, 2011
B. Device Name
| Trade or Proprietary Name: | NuVasive Halo II Anterior Lumbar Plate System |
|---|---|
| Common or Usual Name: | Anterior, Noncervical Spinal Implant |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis |
| Device Class: | Class II |
|---|---|
| Classification: | 21 CRF §888.3060 |
| Product Code: | KWQ |
C. Predicate Devices
The subject NuVasive Halo II Anterior Lumbar Plute System is substantially equivalent to the following devices:
- · K072339 NuVasive, Inc. Anterior Lumbar Plate System
- · K052546 Depuy Spine AEGIS Anterior Lumbar Plate System
D. Device Description
The NuVasive Halo II Anterior Lumbar Plate System consists of a series of plates and screws manufactured from Ti-6Al-4V per ASTM F-136 and ISO 5832-3. The plates also include components manufactured from Nitinol alloy SE508 per ASTM F2063.
E. Intended Use
The NuVasive Halo II Anterior Lumbar Plate System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (TI-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L) .-SI) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.
1
K11866
Image /page/1/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized letter "N" on the left, followed by the word "NUVASIVE" in all caps. Below the word "NUVASIVE" is the tagline "Speed of Innovation" in a smaller font. The logo is simple and modern, and the tagline emphasizes the company's focus on innovation.
510(k) Premarket Notification Halo II Anterior Lumbar Plate System
Technological Characteristics F.
As was established in this submission, the subject Halo II Anterior Lumbar Plate 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 Halo II Anterior Lumbar Plate System is substantially equivalent to other predicate devices. The following testing was performed:
- . Static and dynamic compression testing per ASTM F1717
- . Static torsion testing per ASTM F1717
The results of these studies show that the subject Halo II Anterior Lumbar Plate System meets or exceeds the performance of the predicate device, and the device was therefore found to be substantially equivalent.
H. Conclusions
Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject Halo II Anterior Lumbar Plate System has been shown to be substantially equivalent to legally marketed predicate devices, and safe and effective for its intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NuVasive, Inc. % Ms. Sheila Bruschi Associate Manager, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121
JULL 2 22 22 2013
Re: K111866
Trade/Device Name: NuVasive Halo II Anterior Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: June 28, 2011 Received: June 30, 2011
Dear Ms. Bruschi:
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
3
Page 2 - Ms. Sheila Bruschi
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 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/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 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 vours.
Kru Dothin Lirir
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): KI | | 866
Device Name:
Indications For Use:
The NuVasive Halo II Anterior Lumbar Plate System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, spinal stenosis, or a failed previous spine surgery.
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)
(Division/Sign-O :)
Division of Surgi - 1. Orthopedic, and Restorative Levices
KIII866 510(k) Number_