(200 days)
When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Long Lateral Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the spine: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities, (5) fracture, (6) pseudoarthosis, (7) tumor resection, and/or (8) failed previous fusion.
The NuVasive Long Lateral System consists of a variety. of screws, rods, lock screws, and staples. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient.
The provided document is a 510(k) summary for the NuVasive® Long Lateral Spinal System, a medical device for spinal fixation. It details the device description, intended use, and substantial equivalence to predicate devices, but does not describe acceptance criteria or a study proving the device meets those criteria in the context of diagnostic performance or AI/algorithm performance.
Instead, the performance data discussed relates to the mechanical and physical performance of the spinal implant device, demonstrating its structural integrity and comparability to existing devices.
Therefore, I cannot provide the requested information. The document does not contain:
- A table of acceptance criteria and reported device performance related to diagnostic accuracy or AI.
- Sample sizes for test sets or data provenance for AI/diagnostic studies.
- Number or qualifications of experts for ground truth establishment for AI/diagnostic studies.
- Adjudication method for AI/diagnostic studies.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study for AI.
- Information on standalone (algorithm only) performance.
- Type of ground truth used for AI/diagnostic studies.
- Sample size for a training set for AI.
- How ground truth for a training set for AI was established.
The "Performance Data" section (G) in the document refers to nonclinical testing, specifically:
- Static and dynamic compression testing per ASTM F1717
- Static torsion testing per ASTM F1717
- Implantation Cadaver Study
These tests are designed to demonstrate the structural and mechanical equivalence of the new spinal system to predicate devices, not its diagnostic or AI performance. The conclusion is that the device "meets or exceeds the performance of the predicate device" in these mechanical tests, thus establishing substantial equivalence for market clearance.
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Image /page/0/Picture/0 description: The image contains the logo for NuVasive. The logo consists of a stylized graphic to the left of the company name, "NUVASIVE," in bold, sans-serif font. Below the company name is the tagline "Speed of Innovation" in a smaller font size. The graphic element appears to be an abstract design, possibly representing a stylized spine or a medical device.
510(k) Summary
1 2013 FEB
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) 909-1800 Fax: (858) 320-4615
Date Prepared: July 13, 2012
B. Device Name
Trade or Proprietary Name: Common or Usual Name: Classification Name: Device Class: Classification: Product Code:
NuVasive® Long Lateral Spinal System Anterior/ Anterolateral, Noncervical System Spinal Intervertebral Body Fixation orthosis Class II 888.3060 KWQ
C. Predicate Devices
The subject Long Lateral System is substantially equivalent to the following devices:
- · K111410 NuVasive, Inc. Long Lateral Spinal System
- · K000236 Interpore Cross International Synergy VLS Open
D. Device Description
The NuVasive Long Lateral System consists of a variety. of screws, rods, lock screws, and staples. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient.
E. Intended Use
When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Long Lateral System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the spine: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities, (5) fracture, (6) pseudoarthosis, (7) tumor resection, and/or (8) failed previous fusion.
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510(k) Premarket Notification, K122081 Long Lateral Spinal System
Image /page/1/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized, incomplete circle on the left, followed by the word "NUVASIVE" in bold, sans-serif font. Below "NUVASIVE" is the tagline "Speed of Innovation" in a smaller font size.
: ۲۰
Technological Characteristics F.
As was established in this submission, the subject Long Lateral Spinal 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 Long Lateral Spinal 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 • •
- . Implantation Cadaver Study
The results of these studies show that the subject Long Lateral Spinal 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 Long Lateral Spinal 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/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Letter dated: February 1, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
NuVasive, Incorporated % Ms. Sheila Bruschi Associate Manager, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121
Re: K122081
Trade/Device Name: NuVasive® Long Lateral Spinal System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: January 7, 2013 Received: January 9, 2013
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
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Page 2 - Ms. Sheila Bruschi
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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson
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
K122081 510(k) Number (if known):
Device Name:
Indications For Use:
When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Long Lateral Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the spine: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities, (5) fracture, (6) pseudoarthosis, (7) turnor resection, and/or (8) failed previous fusion.
Over-The-Counter Use Prescription Use AND/OR X (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stephanie= 2013.01.311 00,500-88
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K122081
§ 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.