Testing of Tissue Containment Systems Used During Power Morcellation Procedures

What You Need to Know? 👇

What are the key special controls for tissue containment systems used in power morcellation procedures?

The special controls require non-clinical performance data demonstrating device impermeability to tissue/cells/fluids, maintenance of pneumoperitoneum during instrument insertion/withdrawal, adequate space and visualization for morcellation, compatibility with laparoscopic instruments without compromising integrity, and proper deployment/removal without spillage.

How should manufacturers conduct integrity testing for tissue containment systems after clinical simulation?

Manufacturers should perform microbial leakage testing using samples post-clinical simulation with quantitative methods sensitive enough to detect single cancer cells. Testing must include worst-case pressure conditions, proper bag distension, validation of detection limits, and positive/negative controls for assay verification.

What are the recommended test methods for demonstrating burst strength of tissue containment systems?

Conduct burst strength testing on final finished devices at end of shelf life, testing specimens to failure. Results should include pressure-time curves, burst pressure measurements, factor of safety analysis comparing to clinical forces, and documentation of failure locations based on device design.

How should clinical simulation studies be designed for tissue containment system validation?

Studies should include users with varying surgical experience, test setups mimicking clinical conditions with appropriate abdominal wall properties, tissue surrogates matching human tissue characteristics, blood/analog fluids for visibility, and comprehensive documentation of user ability to deploy, operate, and remove the device safely.

What material permeability testing is recommended for tissue containment system materials?

Use viral or bacteriophage markers following ASTM F1671 methodology with markers smaller than cancer cells. Testing should include clinically relevant pressures with safety factors, validation of detection limits for single cancer cell passage, and evaluation of critical device sections like straps and bonded areas.

What mechanical strength testing should be performed on tissue containment system materials?

Conduct tensile strength testing providing stress-strain curves, ultimate tensile strength comparisons to clinical forces, elongation at break, and toughness measurements. Include puncture testing with surgical instruments and partial puncture followed by permeability testing to evaluate composite material layer damage scenarios.

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What You Need to Do 👇

Recommended Actions

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

• Must demonstrate shelf life
• Must demonstrate sterility

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Relevant Guidances 🔗

• Applying Human Factors Engineering and Usability Engineering to Medical Devices
• Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
• Recommended Format and Content for Non-Clinical Bench Performance Testing in Medical Device Premarket Submissions
• Q-Submission Program: Strategic Framework for FDA Interactions in Medical Device Development

Related references and norms 📂

• 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

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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 ID: 3e64676645a7015538c88a4ac93e2089