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Premarket Notification Requirements for Penile Rigidity Implants

This guidance outlines the requirements for premarket notifications (510(k)) for penile rigidity implants, which are Class II medical devices consisting of semirigid rods surgically implanted in the corpora cavernosa to provide penile rigidity for patients with erectile dysfunction.

  1. Determine if clinical testing is required based on device novelty
  2. Conduct comprehensive performance testing program
  3. Develop detailed physician and patient labeling
  4. Complete biocompatibility testing per ISO-10993
  5. Validate sterilization processes
  6. Prepare substantial equivalence comparison
  7. Submit complete device description and technical documentation
  8. Include all required administrative forms
  9. Develop post-market surveillance plan
  10. Ensure patient education materials meet readability requirements

Key Considerations

Clinical testing

  • Clinical testing only required for devices significantly different in design, materials, control method, operating principle or intended use
  • Minimum 50 patients if clinical study needed
  • Follow-up examinations at 6 weeks and 6 months post-surgery
  • Analysis of outcomes based on multiple variables including etiology, device usage, implant size
  • IDE regulations apply for significant risk devices

Non-clinical testing

  • Simulated life/fatigue testing to evaluate cyclical forces
  • Positioning/concealability testing for bending and positioning
  • Buckling testing for column strength
  • Tip extender joint strength testing (if applicable)

Human Factors

  • Patient questionnaires for sexual function pre and post-treatment
  • Patient satisfaction evaluation regarding device qualities
  • Patient labeling must be at ≤7th grade reading level

Labelling

  • Physician labeling with detailed surgical procedures, risks, warnings
  • Patient labeling with benefits, risks, expectations, and care instructions
  • Promotional literature must be submitted for review

Biocompatibility

  • Testing required for all patient-contacting materials
  • Must meet requirements for permanent tissue/bone contacting implants
  • Testing includes cytotoxicity, sensitization, irritation, acute systemic toxicity, genotoxicity, and implantation testing

Safety

  • Sterilization validation and residual testing required
  • Pyrogenicity testing required
  • Safety warnings regarding infection risks, mechanical failures
  • Post-operative monitoring requirements

Other considerations

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

Original guidance

  • Premarket Notification Requirements for Penile Rigidity Implants
  • HTML / PDF
  • Issue date: 2000-01-15
  • Last changed date: 2020-03-18
  • Status: FINAL
  • Official FDA topics: Medical Devices, 510(k), Premarket
  • ReguVirta summary file ID: 1ebde572e4e3a2d0719f4bb2cc54394a
This post is licensed under CC BY 4.0 by the author.