(75 days)
When intended to promote fusion of the cervical spine and occipito-thoracic junction (Occiput-T3), the NuVasive OCT System is indicated for: (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) Degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) Fracture/Dislocation, (4) Spinal Stenosis, (5) Atlantoaxial fracture with instability, (6) Occipitocervical dislocation, (7) Spinal turnor and/or (8) Revision of previous cervical spine surgery.
The occipital bone screws are limited to occipital fixation only.
The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
The NuVasive OCT System can also be linked to the NuVasive SpheRx Spinal System via the rod to rod connectors.
The NuVasive OCT System is a posterior system, which consists of a variety of shapes and sizes of screws, rods, hooks, offset connectors, set screws, and cross connectors which can be rigidly locked in a variety of configurations to accommodate patient anatomy.
This document describes the NuVasive OCT System, a spinal fixation system, and its FDA 510(k) premarket notification. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria related to an AI/ML or diagnostic device.
The document is a 510(k) summary for a traditional medical device (spinal fixation system), not a software or AI-based diagnostic tool. Therefore, the questions related to device performance in terms of AI/ML metrics (like AUC, sensitivity, specificity), sample sizes for test/training sets, expert adjudication, or MRMC studies are not applicable to the information provided.
Specifically, the document states in section G and H:
- "Summary of Non-Clinical Tests: Mechanical testing was presented." This indicates that the device's physical properties and structural integrity were evaluated.
- "Summary of Clinical Tests: (Not Applicable)." This explicitly states that clinical tests (which would typically involve human subjects or data to assess diagnostic or prognostic performance) were not required or applicable for this submission. The device is a hardware implant, and its substantial equivalence was demonstrated through comparison to predicate devices and mechanical testing, not by evaluating its performance in interpreting medical data or providing diagnostic insights.
Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study findings, sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided text for this type of device.
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AUG - 6 -
510(k) Premarket Notification OCT System
5. 510(K) SUMMARY
In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title of the Code of Federal Regulations Part 807 (21 CFR §807), and in particular §807.92, the following summary of safety and effectiveness information is provided:
A. Submitted by
Laetitia Cousin Dircctor of Regulatory Affairs and Quality Assurance NuVasive, Incorporated 4545 Towne Centre Court San Diego, CA 92121 Telephone: (858) 909-1868 Date Prepared: May 22, 2007.
B. Device Name
Trade or Proprietary Name: Common or Usual Name: Classification Name:
NuVasive OCT System Spinal Fixation Appliances Appliance, Fixation, Spinal Interlaminal and Spinal Pedicle Fixation Orthosis
C. Predicate Devices
The subject device is substantially equivalent to similar previously cleared devices.
D. Device Description
The NuVasive OCT System is a posterior system, which consists of a variety of shapes and sizes of screws, rods, hooks, offset connectors, set screws, and cross connectors which can be rigidly locked in a variety of configurations to accommodate patient anatomy.
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E. Intended Use
When intended to promote fusion of the cervical spine and occipito-thoracic junction (Occiput-T3), the NuVasive OCT System is indicated for: (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) Degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) Fracture/Dislocation, (4) Spinal Stenosis, (5) Atlantoaxial fracture with instability, (6) Occipitocervical dislocation, (7) Spinal tumor and/or (8) Revision of previous cervical spine surgery.
The occipital bone screws are limited to occipital fixation only.
The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
The NuVasive OCT System can also be linked to the NuVasive SpheRx Spinal System via the rod to rod connectors.
F. Comparison to Predicate Devices
As was established in this submission, the subject device is substantially equivalent to other devices cleared by the agency for commercial distribution in the United States.
Engineering drawings, labeling, and mechanical testing have demonstrated that the subject device is substantially equivalent, if not identical, to its predicate devices in terms of design, materials of composition, indications for use, and such other characteristics as may be associated with the manufacture of any medical device.
G. Summary of Non-Clinical Tests
Mechanical testing was presented.
H. Summary of Clinical Tests
(Not Applicable).
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 6 2007
NuVasive, Incorporated % Ms. Laetitia Cousin Director of Regulatory Affairs and Quality Assurance 4545 Towne Centre Court San Diego, CA 92121
Re: K071435
Trade/Device Name: NuVasive OCT System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: MNI Dated: May 22, 2007 Received: May 23, 2007
Dear Ms. Laetitia Cousin:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
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Page 2 - Ms. Laetitia Cousin
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Milliken
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. INDICATIONS FOR USE
510(k) Number (if known):
Device Name: NuVasive OCT System
Indications for Use:
When intended to promote fusion of the cervical spine and occipito-thoracic junction (Occiput-T3), the NuVasive OCT System is indicated for: (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) Degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) Fracture/Dislocation, (4) Spinal Stenosis, (5) Atlantoaxial fracture with instability, (6) Occipitocervical dislocation, (7) Spinal turnor and/or (8) Revision of previous cervical spine surgery.
The occipital bone screws are limited to occipital fixation only.
The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
The NuVasive OCT System can also be linked to the NuVasive SpheRx Spinal System via the rod to rod connectors.
Mark M. Milburn
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
071435
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)
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when 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 thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.