Preparation of IDE Applications for Spinal Systems: Pedicle Screws, Intervertebral Body Fusion, Vertebral Body Replacement, and Disc Replacement Devices

What You Need to Know? 👇

What are the key requirements for mechanical testing of spinal systems in IDE applications?

All spinal systems require mechanical testing including fatigue and static testing with minimum six samples for fatigue (reaching 5 million cycles) and five samples for static testing. For non-fusion devices maintaining disc mobility, fatigue testing should reach 10 million cycles to support long-term implantation.

How long should clinical follow-up be for spinal system IDE studies?

A minimum of 2 years follow-up is required to properly assess safety and primary effectiveness outcomes. Each patient should be followed annually until the last enrolled patient completes their 2-year evaluation, with suggested evaluation intervals at 6 weeks, 3 months, 6 months, 12 months, and 24 months.

What are the primary effectiveness evaluation parameters for lumbar spinal studies?

Primary evaluation parameters include radiographic success (fusion status), back and leg pain assessment, and functional evaluation. Secondary parameters include donor site pain, disc height assessment, and health-related quality of life measures using validated instruments like the Oswestry Disability Questionnaire.

What constitutes successful fusion for spinal systems intended for fusion?

Successful fusion requires evidence of bridging trabecular bone between involved motion segments, translational motion less than 3mm, and angular motion less than 5 degrees. All radiographs must be read by at least two radiologists, with one being independent and masked when possible.

When is a feasibility/pilot study recommended versus a pivotal study for spinal devices?

Feasibility/pilot studies are recommended for novel device designs with no available data or similar devices. They collect preliminary safety/effectiveness information in limited trials. Pivotal studies should be proposed when adequate preliminary information exists from feasibility studies, animal studies, or other preclinical data.

What are the requirements for concurrent controls in spinal IDE studies?

Concurrent controls should involve PMA-approved or 510(k)-cleared systems labeled for the indication, or medically acceptable treatments. Control and investigational groups must share the same clinical endpoints. Randomized concurrent controls are preferred to address inherent biases in study design and data interpretation.

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What You Need to Do 👇

Recommended Actions

1. Develop comprehensive preclinical testing plan including mechanical testing and animal studies if needed
2. Design clinical study protocol with:
   • Clear inclusion/exclusion criteria
   • Appropriate control group
   • Minimum 2-year follow-up
   • Validated assessment tools
   • Defined success criteria
3. Prepare complete device description documentation including:
   • Component descriptions and drawings
   • Materials information
   • Manufacturing processes
   • Sterilization validation
4. Develop risk management documentation:
   • Comprehensive risk analysis
   • Risk mitigation strategies
   • Adverse event monitoring plan
5. Create labeling package:
   • Package labels
   • Package insert
   • Surgical technique manual
6. Establish monitoring procedures and investigator requirements
7. Consider early consultation with FDA, especially regarding:
   • Mechanical testing requirements
   • Animal study design
   • Clinical protocol design
   • Success criteria
8. Prepare statistical analysis plan including sample size justification
9. Develop retrieval study protocol for removed devices
10. Ensure compliance with biocompatibility requirements based on materials used

Key Considerations

Clinical testing

• Minimum 2 years follow-up data required
• Primary evaluation parameters: radiographic success, pain assessment, functional assessment
• Secondary parameters: donor site pain, disc/vertebral height assessment, quality of life
• Clear success criteria needed for both patient and study level
• Comprehensive neurological evaluation required
• Detailed tracking of complications and subsequent surgical interventions

Non-clinical testing

• Complete mechanical testing reports required (static and fatigue testing)
• Animal studies may be needed for:
  • Biologic response evaluation
  • Dosing studies
  • Functional studies
  • Novel designs validation
• Rationale needed if testing is not performed

Human Factors

• Surgical technique manual required
• Post-operative regimen must be detailed
• Training requirements for investigators must be specified

Labeling

• Package labels must include:
  • Device name and quantity
  • Material information
  • Sterility status
  • Manufacturer details
  • Investigational device caution statement
• Package insert required with:
  • Device description
  • Inclusion criteria
  • Contraindications/warnings
  • Potential adverse events
• Surgical technique manual required

Biocompatibility

• Testing required based on materials used
• Must comply with AAMI/ANSI 10993-1
• Additional requirements for biological/drug components

Safety

• Comprehensive risk analysis required
• All adverse events must be recorded and reported
• Subsequent surgical interventions must be tracked
• Neurological status must be monitored
• Retrieval study recommended for removed devices

Other considerations

• Sample size justification required
• Statistical analysis plan needed
• Clear inclusion/exclusion criteria
• IRB and investigator information
• Monitoring procedures
• Environmental impact assessment

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Relevant Guidances 🔗

• Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
• Design Considerations for Medical Device Pivotal Clinical Studies
• Benefit-Risk Factors in IDE Applications for Medical Device Clinical Investigations
• IDE Clinical Investigation Decision Process and Requirements

Related references and norms 📂

• ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
• AAMI/ANSI 10993-1: Biological evaluation of medical devices

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Original guidance

• Preparation of IDE Applications for Spinal Systems: Pedicle Screws, Intervertebral Body Fusion, Vertebral Body Replacement, and Disc Replacement Devices
• HTML / PDF
• Issue date: 2000-01-12
• Last changed date: 2024-04-11
• Status: FINAL
• Official FDA topics: Medical Devices, Labeling, Pediatric Product Development
• ReguVirta ID: 8b05e9a963e655a3de019c6450376e84