Metal Expandable Biliary Stents and Associated Delivery Systems - Content and Testing Requirements for 510k Submissions

What You Need to Know? 👇

What are the key biocompatibility requirements for metal expandable biliary stents?

Biliary stents require evaluation for cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity, subacute/subchronic toxicity, chronic toxicity, and implantation testing per ISO 10993-1 standards.

Do biliary stents require clinical studies for 510(k) clearance?

Clinical evidence is generally unnecessary for biliary stents. However, studies may be required for polymer-covered designs, removable stents, or devices with significantly different technology from legally marketed predicates.

What MRI safety testing is required for biliary stents?

MRI compatibility testing must address magnetically induced deflection force, torque, RF-induced heating, and image artifacts. Testing should follow FDA guidance for passive implants in MR environments.

Why do biliary stents have vascular use limitations in their labeling?

FDA requires warnings stating “safety and effectiveness for vascular use has not been established” due to lack of clinical data for vascular applications and different safety concerns like restenosis and fatigue.

What corrosion testing is mandatory for metal biliary stents?

Pitting corrosion potential testing per ASTM F2129 is required after simulated use conditioning. Galvanic corrosion testing per ASTM F3044 is needed for multi-metal designs or overlapping stent scenarios.

What are the essential performance tests for stent delivery systems?

Key tests include delivery/deployment/withdrawal forces, crossing profile measurement, bond strength testing, balloon burst pressure (if applicable), and stent securement evaluation for unsheathed designs.

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What You Need to Do 👇

Recommended Actions

1. Conduct comprehensive non-clinical testing program including corrosion, mechanical, and functional testing
2. Validate biocompatibility through testing or leveraging existing data
3. Perform MR compatibility testing and develop appropriate labeling
4. Develop and validate sterilization process and packaging
5. Create compliant labeling with required warnings and limitations
6. Prepare detailed device description and predicate comparison
7. Consider if clinical data is needed based on device novelty
8. Document all testing in format recommended in guidance appendix
9. Ensure prominent display of “biliary” designation in labeling
10. Validate shelf life through accelerated and real-time aging studies

Key Considerations

Clinical testing

• Generally not required unless for:
  • Polymer covered designs
  • Novel indications dissimilar from legally marketed devices
  • Novel designs/sizes
  • Different technology
  • Removable stents

Non-clinical testing

• Stent corrosion resistance testing
• Dimensional verification
• Foreshortening evaluation
• Radial compression force testing
• Radial outward force testing (self-expanding stents)
• Delivery, deployment and withdrawal testing
• Balloon rated burst pressure (balloon expandable stents)
• Balloon fatigue testing (balloon expandable stents)
• Stent securement testing for unsheathed stents

Labeling

• Must prominently display “biliary” near trade name
• Device description with specifications
• Contraindications
• Warnings including vascular use limitation
• Precautions
• MRI safety information
• Clinical studies overview if applicable
• Potential adverse events
• Directions for use
• Patient labeling

Biocompatibility

• Testing required for:
  • Cytotoxicity
  • Sensitization
  • Irritation
  • Acute systemic toxicity
  • Material-mediated pyrogenicity
  • Subacute/subchronic toxicity
  • Chronic toxicity
  • Implantation

Safety

• MR compatibility testing required
• Sterility validation
• Shelf life testing
• Package integrity testing

Other considerations

• Predicate comparison required
• Manufacturing process information needed for surface treatments

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Relevant Guidances 🔗

• Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
• Testing and Labeling of Medical Devices for Magnetic Resonance (MR) Environment Safety and Compatibility
• Recommended Format and Content for Non-Clinical Bench Performance Testing in Medical Device Premarket Submissions
• Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
• Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence

Related references and norms 📂

• ASTM F2129: Standard test method for conducting cyclic potentiodynamic polarization measurements
• ASTM G5: Standard reference test method for making potentiodynamic anodic polarization measurements
• ASTM F3044: Standard test method for evaluating the potential for galvanic corrosion for medical implants
• ASTM F2503: Standard Practice for Marking Medical Devices for Safety in the Magnetic Resonance Environment
• ISO 11607-1: Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging
• ISO 11607-2: Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes
• ASTM F1980: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

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Original guidance

• Metal Expandable Biliary Stents and Associated Delivery Systems - Content and Testing Requirements for 510k Submissions
• HTML / PDF
• Issue date: 2019-07-26
• Last changed date: 2024-08-09
• Status: FINAL
• Official FDA topics: Medical Devices, Gastroenterology-Urology, 510(k), Premarket
• ReguVirta ID: 47513762fcf18d7e96a1ed6feb636863