(108 days)
The EVEREST Spinal System may be used in conjunction with the RANGE® (MESA® and DENALI®) Spinal Systems, all of which are cleared for the following indications: 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 EVEREST Spinal System may also be used for the same indications as an adjunct to fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients the EVEREST Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Range (Mesa and Denali) and ARI are cleared for the following indications: 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 Range Spinal System may also be used for the same indications as an adjunct to fusion. Except for the ARI staples, the Range Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The Caspian OCT/MESA Mini/DENALI Mini Spinal System is intended to provide immobilization and stabilization of spinal seqments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Caspian OCT/MESA Mini/DENALI Mini Spinal System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the Caspian OCT/MESA Mini/DENALI Mini Spinal System may be connected to Range/MESA/DENALI Spinal System and Everest Spinal System components via the rod to rod connectors or transition rods.
The YUKON OCT Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations: instability or deformity: failed previous fusions (e.q., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The YUKON OCT Spinal System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the YUKON OCT Spinal System may be connected to Everest Spinal System components via the rod to rod connectors or transition rods.
The previously cleared K2M EVEREST, RANGE (MESA and DENALI), CASPIAN OCT (MESA Mini and DENALI mini) and YUKON OCT Spinal Systems are top-loading, multiple component posterior spinal fixation implants consisting of pedicle screws, hooks, rods and connectors, intended to provide support during spinal fusion procedures. The primary purpose of this submission is to establish an MR Conditional labeling claim for these implants. In addition, CASPIAN components that were previously provided non-sterile are now being optionally offered as sterile packaged devices.
Here's an analysis of the provided text regarding the acceptance criteria and study for the EVEREST, RANGE, CASPIAN OCT, and YUKON OCT Spinal Systems:
Based on the provided FDA 510(k) summary, the primary purpose of this submission is not to introduce a new device with novel performance criteria, but rather to:
- Establish an MR Conditional labeling claim for existing, previously cleared spinal systems.
- Optionally offer previously non-sterile CASPIAN components as sterile packaged devices.
Therefore, the "acceptance criteria" and "device performance" in this context refer to demonstrating the safety and compatibility of the devices in an MRI environment, and that their core technological characteristics remain equivalent to their predicates.
It is important to note that this document is a 510(k) summary for modifications to existing devices (primarily MR compatibility and sterilization options), not for the initial clearance of the spinal systems themselves. The original studies for the biomechanical and clinical performance of the spinal systems would have been part of their initial 510(k) submissions. This document focuses on the new testing related to the modifications.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for MR Conditional Labeling and Sterilization) | Reported Device Performance |
|---|---|
| MR Conditional Labeling: Devices must meet relevant ASTM standards for MRI safety. | MR Compatibility testing per ASTM F2503 was performed. The test results demonstrate that the listed spinal systems' performance is substantially equivalent to the predicate devices. |
| Sterilization: Sterile packaged devices must meet appropriate sterilization standards. | CASPIAN components previously provided non-sterile are now being optionally offered as sterile packaged devices. (Implies that sterilization validation was performed, though specific standards or results are not detailed in this summary.) |
| Technological Characteristics: No changes to the fundamental scientific technology or performance of the spinal systems. | The systems possess the same technological characteristics as their predicate devices; no changes have been made to any of the devices. The fundamental scientific technology is the same as previously cleared devices. |
| Intended Use: The intended use of the systems remains the same as their predicate devices. | The systems possess the same intended use as the predicate devices. |
Study Details (Relevant to this 510(k) submission)
The primary study mentioned in this document is related to MR Compatibility testing.
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Sample size used for the test set and the data provenance:
- The document does not specify a "sample size" in terms of number of patients or cases for this particular testing. MR compatibility testing (per ASTM F2503) typically involves testing the physical devices themselves (e.g., assessing heating, artifact generation, and displacement forces), not patient data.
- Data provenance: Not applicable in the context of device testing for MR compatibility. The tests would be conducted in a controlled laboratory environment.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a device performance test, not an AI or diagnostic expert review study. MR compatibility testing is conducted by engineers and technicians following established ASTM protocols.
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Adjudication method for the test set:
- Not applicable for device performance testing. Results are typically determined by measurements against predefined ASTM standards.
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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 document pertains to spinal implants (physical medical devices), not AI software or diagnostic imaging analysis. Therefore, no MRMC study, AI integration, or human reader improvement assessment was performed or is relevant to this submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm or software device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable as this concerns the physical properties of the device for MR compatibility. The "ground truth" would be the measured physical interactions (e.g., temperature rise, deflection) of the implant components in an MRI electromagnetic field compared to acceptable limits defined by ASTM F2503.
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The sample size for the training set:
- Not applicable. There is no software or AI model involved that would require a training set.
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How the ground truth for the training set was established:
- Not applicable. There is no software or AI model involved.
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.