K Number
K970285
Manufacturer
Date Cleared
1997-06-25

(152 days)

Product Code
Regulation Number
888.3070
Panel
OR
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The SOCON® Spinal System is intended for patients: a.) having severe spondylolisthesis (Grades 3 and 4) at the Lg-S, vertebral joint; b.) who are receiving fusions using autologous bone grafts only; c.) who are having the device fixed or attached to the lumbar and sacral spine; and d.) who are having the device removed after the development of a solid fusion mass. Levels of pedicle screw fixation for this indication are from L3 to S1.

Device Description

The SOCON® Spinal System is a construct composed of implant-grade 6mm transpedicular bone screws of varying lengths (35mm to 65mm), straight and pre-bent rods, cross bars and specially designed clamps that are tightened by only one locking screw.

AI/ML Overview

The provided text discusses the "Aesculap SOCON® Spinal System," a medical device. While it details the product's intended use, materials, and substantial equivalence to other devices, it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

Instead, the document primarily focuses on regulatory approval (510(k) clearance) based on substantial equivalence. This type of clearance often relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive new performance studies against predefined acceptance criteria for novel claims.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving the device meets them because that data is not present in the provided text.

Specifically, the document does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes used for a test set, data provenance, number of experts for ground truth, or adjudication methods.
  3. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm-only performance study.
  4. The type of ground truth used, sample size for the training set, or how ground truth was established for a training set.

The section "Biomechanical Testing" states: "The implants and construct has undergone a variety of biomechanical testing, including static and dynamic testing for spinal implant assemblies in accordance with a draft ASTM standard. The test results show that the device components and system are able to provide significant stability with comparative realignment forces as other comparative devices." This indicates some testing was performed, but it lacks the specific details and quantitative results necessary to answer your questions thoroughly. It refers to comparing its performance to "other comparative devices" rather than predefined 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.