(73 days)
The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion 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; 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 pediatric 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 fusion to treat adolescent idiopathic scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. 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 (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/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 turnor.
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 HOR IZON® 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 system also includes various instruments used to assist in the implantation of the system via minimally invasive approaches.
This submission pertains to changes made to existing instruments (SEXTANT®) that are part of the CD HORIZON® Spinal System, rather than a new standalone device or an AI/software-based medical device. Therefore, the typical acceptance criteria and study designs involving performance metrics like accuracy, sensitivity, specificity, MRMC studies, or training/test sets for AI are not applicable here.
The document describes a 510(k) premarket notification for modifications to instruments (SEXTANT®) used with the CD HORIZON® Spinal System. The core of this submission is to demonstrate that these modified instruments are substantially equivalent to previously cleared predicate devices and that the changes do not introduce new issues of safety or effectiveness.
Here's an analysis based on the provided text, addressing the requested points where applicable, and explaining why others are not relevant:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated as numerical performance, but implied) | Reported Device Performance (Summary of findings) |
|---|---|
| Instruments function as intended. | Non-clinical testing (design validation and verification activities, validation lab, and tolerance stacks) demonstrated that the subject SEXTANT® instruments function as intended. |
| No new issues of safety and effectiveness compared to predicate devices. | Non-clinical testing and additional supporting documentation led Medtronic to believe the subject devices demonstrated substantial equivalence to the previously listed predicate devices, implying no new issues of safety and effectiveness. The modifications are described as "minor" and not affecting "form, fit or function." |
| Maintain the same intended use and indications. | The subject instruments still maintain the same intended use and indications as the predicate devices. The 510(k) submission confirms that the CD HORIZON® Spinal System with or without SEXTANT® instrumentation has the same stated Indications for Use as the predicate. |
| Substantially equivalent to predicate devices. | The design features, materials, and indications for use of the subject devices are determined to be substantially equivalent to the predicate CD HORIZON® SEXTANT® instruments cleared in K051674, K063417, and K102807. The device labeling and instrument reprocessing labeling are identical to K122862. |
2. Sample Size Used for the Test Set and the Data Provenance
This is not applicable. The evaluations conducted are non-clinical testing in the form of "design validation and verification activities (validation lab and tolerance stacks)." These are engineering and quality control tests on the physical instruments, not studies involving patient data or clinical "test sets" in the sense of AI/diagnostic device performance. Therefore, there is no "data provenance" (country of origin, retrospective/prospective) for a patient-based test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This is not applicable. The "ground truth" here is the functional performance and safety of the physical instruments, established through engineering tests and regulatory assessment of substantial equivalence. There is no concept of "experts establishing ground truth for a test set" in the context of diagnostic performance for this type of submission. Regulatory bodies and internal engineering teams would assess the test results.
4. Adjudication Method for the Test Set
This is not applicable for the same reasons as points 2 and 3. There is no diagnostic "test set" requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret patient cases. This submission is for modifications to surgical instruments, not a diagnostic tool or an AI system that aids human interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone performance study was not done. This concept applies to AI algorithms. The device in question is a physical surgical instrument.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on engineering specifications, material properties, functional testing results, and established safety and effectiveness profiles of predicate devices. The determination of "substantial equivalence" is the primary regulatory "ground truth." It's not based on expert consensus, pathology, or outcomes data from a clinical trial, but rather on demonstrating that the modified instruments perform equivalently to their predecessors without introducing new risks.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
This is not applicable. There is no "training set."
In summary, the provided document describes a 510(k) submission for minor modifications to existing surgical instruments. The "acceptance criteria" and "study" described are centered around demonstrating that these modifications do not alter the established safety, effectiveness, and functional characteristics of the instruments as compared to their predicate devices, primarily through non-clinical engineering and design validation testing.
§ 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.