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Premarket Notification Requirements for Esophageal and Tracheal Prostheses Including Metal Self-Expandable Stents

This guidance outlines the requirements for premarket notifications (510(k)) submissions for esophageal and tracheal prostheses, including metal self-expandable stents. It covers devices intended to restore the structure and/or function of the esophagus and trachea or trachealbronchial tree, along with their accessories and delivery systems.

  1. Prepare detailed device description and specifications
  2. Conduct comprehensive bench testing program
  3. Complete biocompatibility testing according to ISO-10993
  4. Validate sterilization process
  5. Develop complete labeling package
  6. Document comparison with predicate device
  7. Prepare materials and manufacturing information
  8. Consider need for animal/clinical testing based on device novelty
  9. Include certification statements and 510(k) summary/statement
  10. Ensure all test results are presented in clear tabular or graphical form
  11. Contact FDA before submission if significant differences from predicate device exist

Key Considerations

Clinical testing

  • Clinical data may be required if technology/materials significantly differ from predicate device
  • Contact FDA before submission if clinical testing might be needed

Non-clinical testing

  • Deployment testing for largest diameter device
  • Expansion force testing for representative device diameters
  • Compression force testing for representative device diameters
  • Dimensional testing for all diameter devices
  • Corrosion testing with simulated gastric contents
  • Tensile strength tests for bonded/welded components
  • Animal testing required if technology/materials significantly differ from predicate device

Labelling

  • Device name
  • Indications for use
  • U.S. point of contact
  • Corporation details
  • Sterility information
  • Expiration date if applicable
  • Single/multiple use statement
  • Clear deployment and positioning instructions
  • Warnings, precautions, contraindications

Biocompatibility

  • Testing according to ISO-10993
  • Cytotoxicity
  • Sensitization
  • Implantation
  • Sub-chronic toxicity
  • Chronic toxicity (for prostheses)
  • Additional tests for delivery system: irritation/intracutaneous reactivity

Safety

  • Sterility assurance level (SAL) of 10-6 required
  • Sterilization validation method
  • Packaging method description
  • Residuals levels for sterilization agents if applicable

Other considerations

  • ISO-10993: Biological Evaluation of Medical Devices Part 1: Evaluation and Testing

Original guidance

  • Premarket Notification Requirements for Esophageal and Tracheal Prostheses Including Metal Self-Expandable Stents
  • HTML / PDF
  • Issue date: 1998-04-27
  • Last changed date: 2020-03-18
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: f89a6d726c71d45f421ea1f5c08b1a40
This post is licensed under CC BY 4.0 by the author.