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K Number
K020426
Device Name
MSD WIRE SYSTEM
Manufacturer
MEDTRONIC SOFAMOR DANEK, INC.
Date Cleared
2002-02-26

(18 days)

Product Code
KWP
Regulation Number
888.3050
Type
Special
Panel
OR
Reference & Predicate Devices
K934007
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. This system is intended for use only in the thoracic, lumbar and sacral levels of the spine. This system is not for use in the cervical spine. Specific indications include:

  1. Degenerative Disc Disease (DDD as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
  2. Pseudoarthrosis.
  3. Stenosis
  4. Spondylolisthesis.
  5. Spinal deformities such as scoliosis and lordosis.
  6. Fracture.
  7. Unsuccessful previous fusion surgery.
  8. Tumor resection.
Device Description

The MSD WIRE System construct consists of rods and segmental sublaminal wiring, being pre-formed and put in place by simple, commonly used, instrumentation. The purpose of this submission is to change the name of the system to the MSD WIRE System and to add previously cleared rods to the MSD WIRE System. The implant components are made of stainless steel as described by ASTM Standard F138 or ISO 5832-1. Stainless steel and titanium implant components must not be used together in a construct.

AI/ML Overview

The provided text describes the 510(k) summary for the Medtronic Sofamor Danek MSD WIRE System. It is focused on regulatory clearance based on substantial equivalence to a predicate device and does not contain information about the performance of a device based on specific acceptance criteria from a study.

Therefore, I cannot provide the requested information in the format of acceptance criteria and device performance based on a study, as the document does not contain this type of data.

Here's why the prompt cannot be fully answered with the given text:

  • No acceptance criteria or study details: The 510(k) summary is a regulatory document to demonstrate equivalence, not a clinical study report that would outline acceptance criteria, reported device performance, sample sizes, expert qualifications, or ground truth establishment.
  • Focus on substantial equivalence: The core conclusion of this document is that the MSD WIRE System is "substantially equivalent to the original ORFIL Spine Fixation System (K934007)." This indicates a comparison to a previously cleared device, not a de novo study with performance metrics against pre-defined criteria.
  • Functionality & Safety Testing: The document mentions "A Risk Analysis was performed on the MSD WIRE System and was included in this submission." While this is a safety activity, it's not a performance study with quantitative acceptance criteria as would be expected for a diagnostic or AI-driven device.

In summary, the provided document is a regulatory submission for device clearance and does not contain the specific type of performance study data requested.

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.