(65 days)
The ENNOVATE Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograff or allograft. The ENNOVATE System can be used in both an Open and Minimally Invasive Surgery (MIS). The device is indicated for treatment of the following acute and chronic instabilities or deformities.
- Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).
- Spondylolisthesis,
- Trauma (i.e., fracture or dislocation)
- Spinal Stenosis.
- Deformities or Curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- Tumor.
- Pseudoarthrosis, and
- Failed previous fusion
The ENNOVATE Spinal System is an implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar and sacral areas of the spine. This submission includes modified polyaxial screws, additional multiaxial-cross-connectors, offset connectors and additional components in sterile version. All implant components are top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6Al-4V), conforming to ISO 5832-3.
The ENNOVATE Spinal System is a spinal rod and screw system. This system's polyaxial screws can be locked into a wide range of configurations, therefore allowing each construct to be formed to the needs of an individual patient. Rods of this system are shaped intraoperatively to correct or maintain proper spinal curvature.
This document is a 510(k) premarket notification for a medical device (ENNOVATE® Spinal System) and as such, it describes the equivalence of the device to existing predicate devices, rather than establishing acceptance criteria and proving the device meets them through a performance study against a defined ground truth.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, expert consensus, adjudication methods, MRMC studies, and standalone algorithm performance, is not present in this document.
The document focuses on demonstrating substantial equivalence through:
- Indications for Use: Listing the conditions the device is intended to treat, which are the same as the predicate devices.
- Technological Characteristics: Stating that the components, materials (titanium alloy, medical grade silicone, stainless steel, titanium alloy, PEEK), and configurations are similar to predicate and reference devices.
- Performance Data: Citing various ASTM standards (F1717-15, F2193-14, F1798-13, F543-13/17) for mechanical testing (dynamic/static compression, torsion, flexion bending, pull-out strength, driving torque). These tests confirm the physical properties and mechanical performance are comparable to the predicate, not that the device meets clinical acceptance criteria.
In summary, this document does not contain the information required to populate the requested table or answer the specific questions about clinical performance studies, AI algorithms, or human-in-the-loop improvements, because it is a 510(k) submission focused on substantial equivalence, not a clinical trial report proving a device meets specific clinical performance acceptance criteria.
§ 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.