Case Study: Spinal Disc Replacement

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Case Study Spinal Disc Replacement
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Substantial Equivalence?

• A spinal disc replacement is not substantially
  equivalent to products on the market.
• Safety and bench work must be performed before
  applying to the FDA.

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Safety Issues

• Failure modes
• How will the device fail?
• If a new material is used
• Biocompatibility studies with bulk material and
  wear debris performed in animals

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Tests Failure Modes

• Static fatigue tests to determine strength and
  durability
• Compression
• Shear
• Torsion
• Wear
• Integrity of porous/osseointegration coating

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Mechanical Testing
Uniaxial Fatigue testing machine www.instron.com
Axial-torsional testing machine www.mts.com
12-Station Hip Wear Simulator www.mts.com

• Determine what tools are needed to perform the
  required tests
• At this point, you still cant perform human
  trials!

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Investigational Device Exemption

• Investigational Device Exemption (IDE) is filed
  with the FDA after all bench work is complete
• IDE allows you to perform human clinical trials
• 2-year study
• New Device vs. Control Group
• New device must be at least as good or better
  than the Control Group
• The clinical data is used to file for marketing
  approval from the FDA

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Premarket Approval
Animal Data
Biocompatibility
Clinical
Statistical
Software
Engineering
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Post Approval Responsibilities

• High risk devices require additional
  responsibilities to the FDA
• Post-market surveillance
• Annual Report
• FDA must be notified if the design, material, or
  manufacturing process is modified

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Flowchart for Spinal Disc
Spinal disc device
Similar?
PMA
Human clinical trials
No
Bench Work
IDE
Mechanical tests animal studies todetermine
failure modes
Yes
FDA
No
PMAsupplement
510(k) Substantially Equivalent(not applicable
for most Class III devices)
Yes
Spinal disc device goes to market
High Risk Devices -post-market surveillance -Annua
l Report
Design, material, or manufacturing modifications