(125 days)
Not Found
No
The summary describes a mechanical implant system (plates, screws, spikes) and associated manual instruments. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are mechanical tests, not algorithmic performance evaluations.
Yes
The device is indicated for treating various spinal conditions such as fractures, tumors, degenerative disc disease, scoliosis, and kyphosis, which are therapeutic interventions.
No
This device is an anterior/anterolateral plate system, including plates, screws, and spikes, used for spine instability treatment. It is an implantable medical device for stabilization, not for diagnosis.
No
The device description explicitly states that the system includes plates, screws, spikes, and associated manual surgical instruments, all of which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system used to stabilize the spine in the treatment of various conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details plates, screws, and spikes made of titanium alloy, which are physical implants used in surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on mechanical testing (compression, torsion) to demonstrate the structural integrity of the implant, not the accuracy of a diagnostic test.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used for treatment.
N/A
Intended Use / Indications for Use
The NuVasive Sage Lateral 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, lordosis, spinal stenosis, or a failed previous spine surgery.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The NuVasive Sage Lateral Plate System is an anterior/anterolateral plate system that may be used in the thoracic, lumbar, and sacral spine (T1-S1). The Sage Lateral Plate System includes plates, screws, and spikes manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or ISO 5832-3, as well as associated manual general surgical instruments. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.
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
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 Sage Lateral 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 demonstrate that the subject Sage Lateral Plate System presents no new worstcase for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate.
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.
NuVasive® Lateral Plate System (K061789), NuVasive Anterior Lumbar Plate (K072339), Synthes Antegra-T System (K081568)
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
§ 888.3060 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
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:
Submitted by: A.
Sheila Bruschi Associate Manager, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 320-4515 Fax: (858) 320-4615
Date Prepared: August 24, 2012
B. Device Name
| Trade or Proprietary Name: | Sage® Lateral Plate System |
|---|---|
| Common or Usual Name: | Spinal Implants |
| Classification Name: | Spinal Intervertebral Body Fixation orthosis |
| Device Class: | Class II |
|---|---|
| Classification: | 21 CFR § 888.3060 |
| Product Code: | KWQ |
C. Predicate Devices
The subject Sage Lateral Plate System is substantially equivalent to the following predicate devices: NuVasive® Lateral Plate System (K061789), NuVasive Anterior Lumbar Plate (K072339) and Synthes Antegra-T System (K081568).
D. Device Description
The NuVasive Sage Lateral Plate System is an anterior/anterolateral plate system that may be used in the thoracic, lumbar, and sacral spine (T1-S1). The Sage Lateral Plate System includes plates, screws, and spikes manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or ISO 5832-3, as well as associated manual general surgical instruments. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.
Page 1 of 2
OCT 2 3 2012
1
NUVASIVE
Speed of Innovation
K121815/S01 -- NuVasive® Sage® Lateral Plate System August 24, 2012
E. Intended Use
The NuVasive Sage Lateral 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 (LJ-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, lordosis, spinal stenosis, or a failed previous spine surgery.
F. Technological Characteristics
As was established in this submission, the subject Sage Lateral 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, and function.
G. Performance Data
Nonclinical testing was performed to demonstrate that the subject Sage Lateral 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 demonstrate that the subject Sage Lateral Plate System presents no new worstcase for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate.
H. Conclusions
Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject Sage Lateral 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 & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The eagle is depicted in black and white, and the text is also in black.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NuVasive, Incorporated % Ms. Sheila Bruschi Associate Manager, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121
OCT
23 2012
Re: K121815
Trade/Device Name: NuVasive® Sage® Lateral Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: October 16, 2012 Received: October 17, 2012
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 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
3
Page 2 - Ms. Sheila Bruschi
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 yours,
Daniel Keane
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
121815
Indications for Use
510(k) Number (if known): K121815
Device Name:
Indications For Use:
The NuVasive Sage Lateral Plate System is indicated for use via a lateral or anterolateral surgical 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, deqenerative 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 (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)
Calisti
(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number k/2/8/5