Inferior Vena Cava Filters - Testing and Labeling Requirements
This guidance addresses cardiovascular intravascular filters that are permanently implanted in the inferior vena cava to prevent thromboemboli from lower limbs reaching the heart and pulmonary circulation. It specifically covers filters with hooks/struts design converging at an apex, indicated for prevention of recurrent pulmonary embolism in specific clinical situations.
What You Need to Know? 👇
What are the specific indications for cardiovascular intravascular filters according to FDA guidance?
Cardiovascular intravascular filters are indicated for preventing recurrent pulmonary embolism when anticoagulants are contraindicated, anticoagulant therapy fails, emergency treatment following massive pulmonary embolism, or chronic recurrent pulmonary embolism where anticoagulation has failed or is contraindicated.
What biocompatibility testing is required for cardiovascular intravascular filters?
Biocompatibility testing must follow FDA guidance “Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1.” Cardiovascular intravascular filters are classified as permanent implant, blood-contacting devices requiring comprehensive biocompatibility evaluation.
What are the key preclinical performance tests for vena cava filters?
Key tests include simulated deployment assessment, introducer/sheath suitability, clot trapping ability, filter fracture resistance, caval perforation/migration evaluation, thrombogenicity testing, and MRI compatibility assessment. All tests should simulate clinical conditions with statistically meaningful results.
When are clinical investigations required for cardiovascular intravascular filter 510(k) submissions?
Clinical investigations may be necessary for “new” vena cava filters or modified designs to establish substantial equivalence to marketed filters. The need should be discussed with FDA prior to IDE application submission, considering study design and clinically relevant endpoints.
What are the critical complications that must be monitored in cardiovascular filter clinical studies?
Critical complications include insertion complications, recurrent pulmonary embolism, death, filter migration (≥5mm), caval penetration, filter tilting/angulation, caval occlusion, filter embolization, and puncture site complications. All must be prospectively defined with clear analysis methods.
What MRI compatibility labeling requirements apply to cardiovascular intravascular filters?
Labeling must specify MRI-Safe (no additional patient risk), MRI-Compatible (safe and no interference), or Non-Compatible (should not be used with MRI). Supporting data for the chosen classification must be included in the 510(k) submission.
What You Need to Do 👇
Recommended Actions
- Develop comprehensive pre-clinical testing plan addressing all performance aspects
- Conduct biocompatibility testing per ISO 10993-1
- Consider need for clinical investigation - discuss with FDA
- Prepare detailed test protocols with clear acceptance criteria
- Ensure statistical significance in test sample sizes
- Document all test results comprehensively
- Develop labeling with required indications, contraindications and MRI information
- Validate manufacturing processes
- Consider consulting FDA before initiating animal studies
- Prepare comprehensive risk analysis considering all potential complications
Key Considerations
Clinical testing
- Clinical investigations may be necessary for new or modified filter designs
- Study should demonstrate comparable complication rates to marketed filters
- Key complications to monitor:
- Insertion complications (sheath/introducer issues, deployment problems)
- Recurrent pulmonary embolism
- Filter migration (>5mm movement)
- Caval penetration
- Filter tilting and angulation
- Caval occlusion
- Filter embolization
- Death related to device
Non-clinical testing
- Simulated deployment testing
- Introducer/sheath suitability assessment
- Clot trapping ability evaluation
- Filter fracture resistance testing
- Caval perforation/migration testing
- Thrombogenicity assessment
Labelling
- Must include specific indications for use
- Must include contraindications (e.g., septic embolism)
- Must include MRI safety information (Safe, Compatible, or Non-Compatible)
Biocompatibility
- Testing according to ISO 10993-1 for permanent implant, blood-contacting devices
Safety
- Device fixation and endothelialization assessment
- Fatigue resistance evaluation
- Corrosion resistance testing
- Weld strength assessment
Other considerations
- MRI compatibility testing required
- Statistical analysis of all test results required
- Manufacturing process validation
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
Related references and norms 📂
- ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Original guidance
- Inferior Vena Cava Filters - Testing and Labeling Requirements
- HTML
- Issue date: 1999-11-25
- Last changed date: 2020-03-18
- Status: FINAL
- Official FDA topics: Medical Devices, Cardiovascular, Premarket
- ReguVirta ID: 0d2c50739f48e139eda3ad3ba930a118