(61 days)
The CD HORIZON® Spinal System without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion.
With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific indications noted below.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® Spinal System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD HORIZON® SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (TI-SI) as an adjunct to fusion in skeletally mature patients. It is intended for plate fration/ attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: degenerative disc disease (as previously defined), spondylolisthesis, trauma, and/or tumor.
In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.
The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, staples, and connecting components, as well as implant components from other Medtronic spinal systems which can be rigidly locked into a variety of configurations with each construct being tailor-made for the individual case.
A subset of CD HORIZON® Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameter from 3.5mm to 6.35mm), hooks, screws, CROSSLINK® Plates and connecting components. Similarly to the CD HORIZON® implants used in adult cases, these components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
The purpose of this submission is to modify Medtronic's CD HORIZON Spinal System to add additional components to the system, specifically, modified multi-axial screws.
This document describes a 510(k) premarket notification for the CD HORIZON® Spinal System. It does not contain information about a study with acceptance criteria and reported device performance in the way a typical diagnostic or AI/ML device submission would. This submission is for a medical implant (pedicle screw spinal system), and the evaluation focuses on substantial equivalence to a predicate device rather than performance metrics like sensitivity or specificity.
Therefore, many of the requested elements (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance) are not applicable or provided in this type of submission.
However, I can extract information related to the demonstration of equivalence:
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) for a spinal implant, the "acceptance criteria" are typically related to demonstrating substantial equivalence to a legally marketed predicate device, rather than specific performance metrics (like accuracy) for a diagnostic AI. The "reported device performance" in this context refers to the demonstration that the modified device does not raise new questions of safety or effectiveness.
| Acceptance Criteria (Implied for 510(k) Substantial Equivalence) | Reported Device Performance (as per submission) |
|---|---|
| Identical indications for use | The subject CD HORIZON® Spinal System has identical indications for use as the previously FDA cleared predicate, CD HORIZON® Spinal System K091974 (S.E. 09/02/2009). The indications for use are also identical to those cleared most recently in K140276 (S.E. 03/13/2014). |
| Identical intended use | The subject CD HORIZON® Spinal System has identical intended use as the predicate. |
| Identical fundamental scientific technology | The subject CD HORIZON® Spinal System has identical fundamental scientific technology as the predicate. |
| Identical materials | The subject screws are manufactured from medical grade titanium alloy and cobalt chrome, which are the same materials as the predicate CD HORIZON® Spinal System multi-axial screws. |
| Similar design features | The subject device has similar design features to the predicate. Both the predicate and subject devices attach to a 4.75mm diameter rod. The screw diameters of the subject device fall within the range of previously cleared diameters of the predicate device. The submission emphasizes that the modification is to add additional components (modified multi-axial screws) to an existing system. |
| No new issues of safety or effectiveness introduced | A risk analysis was completed and, along with an engineering rationale, demonstrated that the subject CD HORIZON® Spinal System does not introduce new issues of safety or effectiveness. (This is the primary "performance" demonstration for this type of submission – showing that the modification doesn't negatively impact safety or effectiveness relative to the predicate.) |
| Biocompatibility and other regulatory requirements met | (Implied general requirements for medical devices, not specifically detailed as acceptance criteria here, but assumed to be addressed in the broader submission for the predicate and modifications). |
2. Sample sized used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. This submission relies on demonstrating substantial equivalence through comparison of technological characteristics and a risk analysis, not through a "test set" of performance data like a software algorithm.
- Data Provenance: Not applicable for performance testing directly. The "data" here refers to design specifications, material properties, and risk assessments related to the device components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not a study requiring expert-established ground truth for a diagnostic outcome. The evaluation is based on engineering and materials comparison.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a spinal implant, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a spinal implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable. The basis for approval is substantial equivalence to a predicate, not performance against a "ground truth" derived from patient data in this context. The "truth" considered is the safety and effectiveness profile of the predicate device.
8. The sample size for the training set:
- Not applicable. This is not a machine learning device.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.