Vocal Fold Medialization Devices - Testing and Documentation Requirements
This guidance covers vocal fold medialization devices (procode MIX and KHJ) including injectable materials and materials used in Type I thyroplasty procedures to medialize the vocal fold through external cervical skin incision. The document excludes certain polymers and elastomers regulated under 21 CFR 874.3620.
What You Need to Know? 👇
What are the FDA classification and product codes for vocal fold medialization devices?
Vocal fold medialization devices are Class II medical devices regulated under 21 CFR 874.3620. They are identified by product codes MIX (system, vocal cord medialization) and KHJ (polymer, ENT synthetic-polyamide mesh or foil material).
What biocompatibility testing is required for vocal fold medialization devices?
FDA recommends evaluating biocompatibility according to ISO-10993 Parts 5 and 10 for tissue/bone contacting, long-term implanted devices. For new materials, long-term animal studies (e.g., one-year implantation) are generally recommended to assess tissue interactions.
What are the main risks associated with vocal fold medialization devices?
Key risks include airway compromise, device extrusion/migration, particle migration, improper placement, infection, adverse tissue reactions/granuloma formation, device breakage, poor voice quality, and potential need for revision surgery.
When are clinical studies required for vocal fold medialization device 510(k) submissions?
Clinical studies may be required for devices with material formulations or designs dissimilar from previously cleared devices, new technology different from legally marketed devices, or indications for use dissimilar from existing vocal fold medialization devices.
What sterilization information must be included in a 510(k) submission for sterile devices?
You must provide the sterilization method, validation method description, sterility-maintaining packaging description, sterility assurance level specification, pyrogen testing method (if applicable), ETO residue levels (if applicable), and radiation dose (if applicable).
What particle size considerations apply to injectable vocal fold medialization materials?
Particles less than 65µm may migrate to regional lymph nodes and distant sites. You should provide bench studies on particle size distribution through the delivery system and animal studies demonstrating no material migration when used in the larynx.
What You Need to Do 👇
Recommended Actions
- Conduct comprehensive risk analysis
- Perform required biocompatibility testing
- Complete material characterization and performance testing
- Conduct animal studies for new materials
- Validate sterilization processes if applicable
- Prepare detailed labeling with surgical instructions
- Consider if clinical studies are needed based on device novelty
- Document all testing results in design history file
- Prepare 510(k) submission with all required elements
- Consult with FDA’s ENT Devices Branch for any questions
Key Considerations
Clinical testing
- Clinical studies may be required for:
- Materials/designs dissimilar from previously cleared devices
- New technologies
- Novel indications for use
- Studies must comply with IDE regulations as significant risk devices
Non-clinical testing
- Long-term animal studies (1 year) recommended for new materials
- Animal studies needed to demonstrate:
- Lack of granulomatous inflammation
- No material migration
- Include appropriate controls
Labeling
- Clear surgical technique instructions
- Revision surgery guidance
- Special considerations for injectable materials
- Airway protection/compromise information
- Postoperative complications
- Patient instructions
- Cautions, precautions and warnings
Biocompatibility
- Evaluate according to ISO 10993 Parts 1, 5 and 10
- Long-term implantation studies needed for new materials
- Assess tissue/bone contact compatibility
- Document results in design history file
Safety
- Evaluate risks of:
- Airway compromise
- Device extrusion/migration
- Infection
- Adverse tissue reactions
- Device breakage
- Poor voice quality
Other considerations
- Material characterization required:
- Chemical stability
- Mechanical properties for solid materials
- Physical/chemical analysis for injectables
- Sterilization validation and packaging information needed for sterile devices
Relevant Guidances 🔗
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Biological Evaluation of Medical Devices Standards in the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
- Design Controls for Medical Device Manufacturers
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
Related references and norms 📂
- ISO 10993-1: Biological Evaluation of Medical Devices Part 1: Evaluation and Testing
- ISO 10993-5: Biological Evaluation of Medical Devices Part 5: Tests for In Vitro Cytotoxicity
- ISO 10993-10: Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin Sensitization