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Clinical Investigation Requirements for Prostate Tissue Ablation Systems

This guidance document focuses on clinical investigations required to support marketing authorization for general indications of prostate tissue ablation systems (product code PLP). It specifically excludes devices intended to treat specific prostatic diseases and does not address non-clinical testing, training, or labeling requirements.

  1. Submit Pre-Submission to FDA for detailed feedback before initiating clinical investigation
  2. Design clinical study with minimum 100 patients and 1-year follow-up
  3. Establish clear inclusion/exclusion criteria and uniform treatment protocols
  4. Implement robust adverse event collection and monitoring system
  5. Select appropriate effectiveness endpoints (direct or indirect measurements)
  6. Develop comprehensive data collection plan for patient demographics and treatment parameters
  7. Set up independent clinical events committee for adverse event adjudication
  8. Plan statistical analysis using intent-to-treat approach
  9. Prepare complete test report with all required elements
  10. Compare results with existing prostate ablation device to demonstrate equivalent or better benefit-risk profile

Key Considerations

Clinical testing

  • Minimum of 100 patients treated with the device and followed for safety
  • Minimum follow-up duration of 1 year
  • Either internally or externally controlled trial
  • Collection of adverse events at regular intervals
  • Uniform patient and treatment characteristics regarding underlying conditions, treatment history, and ablation extent

Safety

  • Must demonstrate device does not ablate or damage tissue outside targeted volume
  • Monitor key safety issues including erectile dysfunction, urinary incontinence, voiding symptoms, urethral stricture, rectal fistula, and osteomyelitis pubis
  • Adverse events must be prospectively collected, graded for severity, and adjudicated by independent committee

Other considerations

  • 21 CFR 876.4340: Code of Federal Regulations for high intensity ultrasound systems for prostate tissue ablation
  • 21 CFR 812: Investigational Device Exemptions regulation
  • 21 CFR 56: Institutional review boards
  • 21 CFR 50: Informed consent

Original guidance

  • Clinical Investigation Requirements for Prostate Tissue Ablation Systems
  • HTML / PDF
  • Issue date: 2020-07-15
  • Last changed date: 2020-07-14
  • Status: FINAL
  • Official FDA topics: Medical Devices, Gastroenterology-Urology, Good Clinical Practice (GCP), 510(k), Premarket, Investigational Device Exemption (IDE)
  • ReguVirta summary file ID: 30215abfc5ed8cd895f1039636761fa1
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