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Testing of Tissue Containment Systems Used During Power Morcellation Procedures

This guidance provides recommendations for non-clinical performance testing of tissue containment systems used during power morcellation procedures for gynecologic and general laparoscopic surgeries. These devices are intended to isolate and contain tissue that is considered benign during morcellation to prevent potential spread of cancerous tissue in cases of occult cancer.

  1. Develop comprehensive test plan covering:
    • Final finished device integrity testing
    • Material characterization testing
    • Clinical simulation studies
    • Mechanical strength testing
    • Biocompatibility evaluation
  2. Ensure test protocols include:
    • Worst-case scenarios
    • Statistically significant sample sizes
    • End-of-shelf-life conditions
    • Appropriate controls and acceptance criteria
  3. Document detailed test reports with:
    • Complete methodology
    • Raw data
    • Statistical analyses
    • Acceptance criteria rationale
    • Protocol deviations and impact assessment
  4. Prepare 510(k) submission including:
    • Device description and predicate comparison
    • Complete test reports
    • Risk analysis
    • Labeling with required warnings
    • Training program details
  5. Consider seeking FDA feedback through Q-Submission process before conducting major testing

Key Considerations

Non-clinical testing

  • Final finished tissue containment system integrity testing to demonstrate impermeability to tissue, cells, and fluids
  • Insufflation pressure control testing to verify maintenance of pneumoperitoneum
  • Clinical simulation study to evaluate device performance under simulated use conditions
  • Pull force testing to assess tensile strength during insertion/removal
  • Burst strength testing to evaluate structural integrity
  • Material thickness and composition testing
  • Material permeability testing
  • Mechanical strength characterization including tensile, puncture, and partial puncture testing

Human Factors

  • Clinical simulation study must demonstrate that intended users can adequately:
    • Deploy the device
    • Morcellate specimen without compromising integrity
    • Remove device without spillage of contents

Labeling

  • Must include boxed warning
  • Must include training requirements

Biocompatibility

  • Must demonstrate biocompatibility of materials

Safety

  • Must demonstrate device maintains integrity during use
  • Must demonstrate impermeability to tissue, cells and fluids
  • Must demonstrate adequate visualization during procedure

Other considerations

  • ASTM F1671/F1671M-13: Standard Test Method For Resistance of Materials Used in Protective Clothing To Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System

Original guidance

  • Testing of Tissue Containment Systems Used During Power Morcellation Procedures
  • HTML / PDF
  • Issue date: 2023-05-26
  • Last changed date: 2023-05-25
  • Status: FINAL
  • Official FDA topics: Medical Devices, Obstetrical & Gynecological, General & Plastic Surgery, Premarket, Clinical - Medical
  • ReguVirta summary file ID: 3e64676645a7015538c88a4ac93e2089
This post is licensed under CC BY 4.0 by the author.