(27 days)
The CD HORIZON® Spinal System with or without SEXTENT® instrumentation is intended for posterior, non-cervical fixation for the 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, kyphosis and/or lordosis); tumor; pseudarthritis; 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.
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.
The CD HORIZON® SPIRE Plate is a posterior, non-pedicle supplemental fixation device intended for use in the non-cervical spine (TI-SI). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc discase (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 rods, hooks, screws, CROSSLINK® plates, staples, and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.
The CD HORIZON® Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The CD HORIZON® Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. If necessary, the CD HORIZON® Spinal System can be connected to the VERTEX™ Reconstruction System through a rod connector.
Certain implant components from other Medtronic Sofamor Danek spinal systems can be used with the CD HORIZON® Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples and washers; GDLH® rods, hooks, connectors and CROSSLINK® bar and connectors; LIBERTY® rods and screws; DYNALOK PLUS® bolts; and Medtronic Sofamor Danek Multi-Axial rods and screws.
CD HORIZON® hooks are intended for posterior use only. CD HORIZON® staples and CD HORIZON® ECLIPSE® rods and screws are intended for anterior use only. However, for patients of smaller stature, CD HORIZON® 4.5mm rods and associated components may be used posteriorly.
The purpose of this 510(k) submission is to include slightly modified staples and screws to the CD HORIZON® Spinal System,
This 510(k) submission (K063083) is for a medical device, the CD HORIZON® Spinal System, and therefore the acceptance criteria and study described will pertain to demonstrating substantial equivalence to a predicate device, rather than explicit performance metrics against a pre-defined acceptance criteria for a new AI/software device.
The provided document describes a spinal implant system, not an AI or software-driven device. Therefore, a table of acceptance criteria and reported device performance related to AI/software, as well as information about sample sizes for test/training sets, experts, adjudication methods, MRMC studies, or standalone performance, are not applicable in this context.
Instead, the "acceptance criteria" for this type of medical device generally revolve around demonstrating substantial equivalence to existing, legally marketed predicate devices in terms of intended use, technological characteristics, and safety and effectiveness.
Here's an interpretation of the relevant information provided in the document:
Acceptance Criteria (for Substantial Equivalence of a Spinal Implant System):
For a spinal implant system like the CD HORIZON® Spinal System, the primary "acceptance criteria" for 510(k) clearance by the FDA are focused on demonstrating that the new or modified device is substantially equivalent to a predicate device. This typically involves showing that the device:
- Has the same intended use as a predicate device.
- Has the same technological characteristics as a predicate device; OR
- Has different technological characteristics than a predicate device but can demonstrate that the device is as safe and effective as a legally marketed device, and does not raise different questions of safety and effectiveness.
The Study that Proves the Device Meets the Acceptance Criteria (Substantial Equivalence):
The document explicitly states the mechanism used to demonstrate that the modified components of the CD HORIZON® Spinal System meet the acceptance criteria for 510(k) clearance:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Demonstrating Substantial Equivalence) | Reported Device Performance/Evidence from Study |
|---|---|
| Intended Use: Same as predicate device(s). | The CD HORIZON® Spinal System's indications for use (V. Indications) are clearly defined and align with typical uses for pedicle screw spinal systems. The submission asserts substantial equivalence to predicate devices (K010249, K052747, K042025, K981676) which implies similar intended uses. |
| Technological Characteristics: Similar to predicate device(s) OR differences do not raise new questions of safety/effectiveness. | The purpose of the 510(k) submission is to include "slightly modified staples and screws" to the existing CD HORIZON® Spinal System. This indicates minor technological adjustments. The document states: "Documentation, including a Risk Analysis, was provided which demonstrated the subject staples and screws are substantially equivalent to similar CD HORIZON® Spinal System components cleared previously in K010249, K052747 and K042025... as well as TSRH® Spinal System components cleared for use in the CD HORIZON® Spinal System in K981676." |
| Safety and Effectiveness: As safe and effective as predicate device(s). | The provision of a "Risk Analysis" (VI. Substantial Equivalence) is a key part of demonstrating safety. By asserting substantial equivalence to previously cleared devices, the submission implicitly argues that the modified components are as safe and effective as those predicates. The FDA's clearance letter (K063083, dated Nov 6, 2006) confirms their agreement that the device is substantially equivalent for the stated indications. |
Information Not Applicable or Not Provided for a Non-AI/Software Device:
As this is a traditional medical device (spinal implant hardware), the following points are not applicable and are not found in the provided documentation:
- Sample sizes used for the test set and the data provenance: Not applicable to a hardware substantial equivalence submission in the context of AI/software.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a hardware device is established through engineering testing, material science, and clinical judgment often based on historical device performance.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this device does not involve human readers interpreting output from an AI.
- Standalone (i.e., algorithm only without human-in-the-loop performance) study: Not applicable, as there is no algorithm or software being assessed.
- Type of ground truth used: For a hardware implant, "ground truth" would relate to its physical properties, biocompatibility, mechanical strength, and clinical outcomes, not expert consensus on image interpretation or pathology.
- Sample size for the training set: Not applicable, as there is no machine learning model involved.
- 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.