(153 days)
Not Found
No
The summary describes a mechanical spine plate system and its components. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are focused on mechanical testing.
No
The device is an anterior/anterolateral plate system used for spinal instability, functioning as an implant to stabilize the spine, not to treat a disease or condition itself.
No
Explanation: The provided text describes a surgical plate system used for spine instability, not a device designed to diagnose medical conditions.
No
The device description explicitly states it includes plates, bolts, and surgical instruments made of titanium alloy, which are physical hardware components.
Based on the provided information, 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 like fractures, tumors, and degenerative disc disease. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is described as an anterior/anterolateral plate system made of titanium alloy, along with associated surgical instruments. This is consistent with a surgical implant and not a diagnostic device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the NuVasive Decade Lateral Plate System is a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NuVasive Decade 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 (TI-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
KWQ
Device Description
The NuVasive Decade Lateral Plate System is an anterior/anterolateral plate system that may be used in the thoracic, lumbar, and sacral spine (T1-S1). The Decade Lateral Plate System includes plates, large bolts, threaded small bolts, and impactable small bolts manufactured from titanium alloy (Ti-6A1-4V 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. The subject of this 510(k) premarket notification is for the addition of the impactable small bolt.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine (T1-S1)
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical testing was performed to demonstrate that the subject Decade Lateral Plate System is substantially equivalent to other predicate devices. The following testing and analysis was performed:
- Static and dynamic compression testing per ASTM F1717 .
- . Static torsion testing per ASTM F1717
- . Cadaveric dynamic torsional physiological testing with analysis of micro-CT scans
- Static tension testing per ASTM F1717 .
- Static separation testing .
- Nominal and angled screw push-out testing .
- . CAD dimensional analysis
The results demonstrate that the subject Decade Lateral Plate System presents no new worst-case for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate devices.
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
§ 888.3060 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.
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Image /page/0/Picture/0 description: The image contains the logo for Nuvasive. The logo consists of a stylized, abstract shape on the left, followed by the word "NUVASIVE" in capital letters. Below the company name is the tagline "Speed of Innovation" in a smaller font size.
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:
Cynthia Adams Regulatory Affairs Associate NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 320-4549 Fax: (858) 320-4649
AUG 2 9 2013
Date Prepared: August 28, 2013
B. Device Name
| Trade or Proprietary Name: | Decade 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 Decade Lateral Plate System is substantially equivalent to the predicate device, NuVasive® Sage Lateral Plate System (K121815) and NuVasive® Halo II Anterior Lumbar Plate System (K111866).
D. Device Description
The NuVasive Decade Lateral Plate System is an anterior/anterolateral plate system that may be used in the thoracic, lumbar, and sacral spine (T1-S1). The Decade Lateral Plate System includes plates, large bolts, threaded small bolts, and impactable small bolts manufactured from titanium alloy (Ti-6A1-4V 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. The subject of this 510(k) premarket notification is for the addition of the impactable small bolt.
1
Image /page/1/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized black and white graphic to the left of the company name, "NUVASIVE". Below the company name is the tagline "Speed of Innovation" in a smaller font.
E. Intended Use
The NuVasive Decade 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 (TI-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.
F. Technological Characteristics
As was established in this submission, the subject Decade 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 equivalent technological characteristics to its predicate device through comparison in areas including design, intended use, material composition, and function.
G. Performance Data
Nonclinical testing was performed to demonstrate that the subject Decade Lateral Plate System is substantially equivalent to other predicate devices. The following testing and analysis was performed:
- Static and dynamic compression testing per ASTM F1717 .
- . Static torsion testing per ASTM F1717
- . Cadaveric dynamic torsional physiological testing with analysis of micro-CT scans
- Static tension testing per ASTM F1717 .
- Static separation testing .
- Nominal and angled screw push-out testing .
- . CAD dimensional analysis
The results demonstrate that the subject Decade Lateral Plate System presents no new worst-case for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate devices.
H. Conclusions
Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject Decade Lateral Plate 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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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. 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 Center - W(066-G60 Silver Spring, MD 20993-0002
August 29, 2013
NuVasive. Incorporated Ms. Cynthia Adams Regulatory Affairs Associate 7475 Lusk Boulevard San Diego. California 92121
Re: K130868
Trade/Device Name: NuVasive® Decade Lateral Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 2. 2013 Received: August 5, 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. Iisting 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 four of alley 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. 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Image /page/3/Picture/6 description: The image shows the name "Erin I. Keith" in a bold, sans-serif font. The name is arranged horizontally, with "Erin" appearing first, followed by "I." and then "Keith". The letters are black against a white background, and the text appears to be clear and legible.
For
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):_ K130868
Device Name: _ NuVasive® Decade Lateral Plate System
Indications For Use:
The NuVasive Decade 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.
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 Center for Devices and Radiological Health (CDRH)
Anton E. Dmitriev, PhD Division of Orthopedic Devices