(119 days)
The Baxano Surgical MIS Pedicle Screw System is intended for posterior, non-cervical pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion for the following indications: (1) Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) Spondylolisthesis, (3) Trauma (i.e. fracture or dislocation), (4) Spinal stenosis, (5) Curvatures (i.e. scoliosis, and/or lordosis), (6) Tumor, (7) Pseudoarthrosis and (8) Failed previous fusion.
The Baxano Surgical MIS Pedicle Screw System is a multiple component system comprised of non-sterile, single-use implantable components fabricated from titanium alloy and cobalt chrome. When assembled, the components are implanted via a percutaneous, mini-open or open delivery to create a rigid structure to provide stabilization and promote spinal fusion. The system consists of an assortment of polyaxial cannulated pedicle screws, rods, cross connectors and locking caps, and associated instruments.
This document describes the premarket notification (510(k)) for the Baxano Surgical MIS Pedicle Screw System, a medical device. The information provided focuses on the mechanical testing of the device to demonstrate its substantial equivalence to a predicate device, rather than a clinical study involving human readers or algorithm performance for image analysis.
Therefore, many of the requested categories related to clinical studies, human reader performance, ground truth establishment for images, and training sets for algorithms are not applicable to this submission.
Here is an analysis based on the provided document:
Acceptance Criteria and Device Performance (Mechanical Testing)
The acceptance criteria for the Baxano Surgical MIS Pedicle Screw System were established by applicable ASTM standards for spinal implant testing. The reported device performance demonstrated that it met or exceeded these requirements.
| Test | Standard | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Static Compression | ASTM F1717-13 | Met or exceeded requirements of ASTM F1717-13 | Met or exceeded requirements as established by test protocol and ASTM standards |
| Static Torsion | ASTM F1717-13 | Met or exceeded requirements of ASTM F1717-13 | Met or exceeded requirements as established by test protocol and ASTM standards |
| Dynamic Compression | ASTM F1717-13 | Met or exceeded requirements of ASTM F1717-13 | Met or exceeded requirements as established by test protocol and ASTM standards |
| Axial Pullout | ASTM F543-07 | Met or exceeded requirements of ASTM F543-07 | Met or exceeded requirements as established by test protocol and ASTM standards |
| Torque to Failure | ASTM F543-07 | Met or exceeded requirements of ASTM F543-07 | Met or exceeded requirements as established by test protocol and ASTM standards |
| Axial Grip | ASTM F1798-97 | Met or exceeded requirements of ASTM F1798-97 | Met or exceeded requirements as established by test protocol and ASTM standards |
| Torsional Grip | ASTM F1798-97 | Met or exceeded requirements of ASTM F1798-97 | Met or exceeded requirements as established by test protocol and ASTM standards |
| Flexural Grip | ASTM F1798-97 | Met or exceeded requirements of ASTM F1798-97 | Met or exceeded requirements as established by test protocol and ASTM standards |
Study Information (Mechanical Testing)
This submission relies on non-clinical mechanical testing rather than a clinical study.
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document states that testing was performed on the "worst case subject device" and "components of the Baxano Surgical MIS Pedicle Screw System." It does not specify an exact numerical sample size for the mechanical tests, but implied that multiple components or configurations were tested to represent the worst-case scenario.
- Data Provenance: The testing was conducted internally or by a contracted lab, as it refers to "test protocol." It is non-clinical, controlled laboratory testing.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. The "ground truth" for mechanical testing is defined by the performance standards (ASTM) and the physical properties of the materials and design, not by expert interpretation.
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Adjudication Method for the Test Set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert disagreement in image interpretation or clinical diagnosis. Mechanical testing results are objective measurements against defined standards.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This is a mechanical device submission, not an AI or image analysis device subject to MRMC studies.
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Standalone (Algorithm Only) Performance Study:
- No. This is not an algorithm-based device.
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Type of Ground Truth Used:
- The "ground truth" for this device's performance is the mechanical performance standards set by ASTM (e.g., F1717-13, F543-07, F1798-97).
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Sample Size for the Training Set:
- Not applicable. There is no AI model or algorithm being trained for this medical device.
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How the Ground Truth for the Training Set was Established:
- Not applicable. As there is no training set for an algorithm, there is no ground truth to establish for it.
§ 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.