(23 days)
The indications for use for the modified devices described in this submission are the same as those for the Summit OCT Spinal System (K022190). The indications are as follows:
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput -T3), the Summit Occipito-Cervical-Thoracic (OCT) Spinal System is intended for:
- ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- spondylolisthesis
- spinal stenosis
- fracture/dislocation
- atlanto/axial fracture with instability
- occipitocervical dislocation
- revision of previous cervical spine surgery
- tumors
The occipital bone screws are limited to occipital fixation only.
The use of the minipolyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
The Songer Cable System, to be used with the Summit OCT Spinal System, allows for wire/cable attachment to the posterior cervical spine.
The Summit OCT Spinal System can also be linked to the ISOLA, TiMX. MONARCH and MOSS MIAMI Systems using the dual wedding band and axial connectors, and via dual diameter rods.
The Summit OCT Spinal System Minipolyaxial Screws are designed to accept a 3.0mm rod and are available in various sizes and geometries.
The Summit OCT Spinal System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
Manufactured from ASTM F-136 implant grade titanium alloy.
The provided text is a 510(k) summary for a medical device (Summit OCT Spinal System Minipolyaxial Screws) and contains regulatory information, indications for use, and a description of the device. However, it does not contain any information about acceptance criteria, detailed study designs, or performance data beyond a general statement that "Performance data were submitted to characterize the modified Summit OCT Spinal System minipolyaxial screws."
Therefore, I cannot provide the requested information from the given text.
To answer your questions, I would need a document that includes:
- Specific acceptance criteria (e.g., tensile strength, fatigue life, torsional stability thresholds).
- Details of mechanical or other performance studies.
- Results of those studies demonstrating compliance with the acceptance criteria.
- Information on human reader studies or ground truth establishment if this were an AI/image-based device, which it is not.
§ 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.