Premarket Notification Requirements for Penile Rigidity Implants
This guidance outlines the requirements for premarket notifications (510(k)) for penile rigidity implants, which are Class II medical devices consisting of semirigid rods surgically implanted in the corpora cavernosa to provide penile rigidity for patients with erectile dysfunction.
What You Need to Know? 👇
What are the key regulatory requirements for penile rigidity implants under FDA guidance?
Penile rigidity implants are Class II medical devices requiring 510(k) premarket notification. They must comply with special controls including biocompatibility testing, performance testing (fatigue, positioning, buckling), sterilization validation, and comprehensive labeling requirements for both physicians and patients.
What performance testing is required for penile rigidity implant 510(k) submissions?
Required testing includes simulated life/fatigue testing, positioning/concealability testing, buckling strength testing, and tip extender joint strength testing (if applicable). Testing must use final sterilized samples and evaluate both largest and smallest device sizes compared to predicate devices.
When is clinical testing required for penile rigidity implants?
Clinical testing is only recommended for devices significantly different in design, materials, control method, operating principle, or intended use compared to marketed devices. Studies should enroll minimum 50 patients with 6-month follow-up to evaluate safety and effectiveness.
What biocompatibility testing standards apply to penile rigidity implants?
As permanent tissue/bone contacting implants, testing must include cytotoxicity, sensitization, irritation, acute systemic toxicity, genotoxicity, and implantation testing (≥90 days). Materials without prior long-term implant history require additional chronic toxicity and carcinogenicity evaluation per ISO-10993.
What are the essential labeling requirements for penile rigidity implants?
Labeling must include prescription device statement, comprehensive physician instructions covering pre/peri/post-operative procedures, and patient labeling at ≤7th grade reading level. Patient information must describe realistic expectations, risks, complications, alternative therapies, and device care instructions.
How should substantial equivalence be demonstrated for penile rigidity implants?
Substantial equivalence requires detailed comparison of intended use and technological characteristics with legally marketed predicate devices. Comparisons should be presented in tabular format including performance test results, labeling, materials, and design specifications to support equivalence claims.
What You Need to Do 👇
Recommended Actions
- Determine if clinical testing is required based on device novelty
- Conduct comprehensive performance testing program
- Develop detailed physician and patient labeling
- Complete biocompatibility testing per ISO-10993
- Validate sterilization processes
- Prepare substantial equivalence comparison
- Submit complete device description and technical documentation
- Include all required administrative forms
- Develop post-market surveillance plan
- Ensure patient education materials meet readability requirements
Key Considerations
Clinical testing
- Clinical testing only required for devices significantly different in design, materials, control method, operating principle or intended use
- Minimum 50 patients if clinical study needed
- Follow-up examinations at 6 weeks and 6 months post-surgery
- Analysis of outcomes based on multiple variables including etiology, device usage, implant size
- IDE regulations apply for significant risk devices
Non-clinical testing
- Simulated life/fatigue testing to evaluate cyclical forces
- Positioning/concealability testing for bending and positioning
- Buckling testing for column strength
- Tip extender joint strength testing (if applicable)
Human Factors
- Patient questionnaires for sexual function pre and post-treatment
- Patient satisfaction evaluation regarding device qualities
- Patient labeling must be at ≤7th grade reading level
Labelling
- Physician labeling with detailed surgical procedures, risks, warnings
- Patient labeling with benefits, risks, expectations, and care instructions
- Promotional literature must be submitted for review
Biocompatibility
- Testing required for all patient-contacting materials
- Must meet requirements for permanent tissue/bone contacting implants
- Testing includes cytotoxicity, sensitization, irritation, acute systemic toxicity, genotoxicity, and implantation testing
Safety
- Sterilization validation and residual testing required
- Pyrogenicity testing required
- Safety warnings regarding infection risks, mechanical failures
- Post-operative monitoring requirements
Other considerations
- Device description including technical characteristics and all available sizes
- Substantial equivalence comparison to predicate devices
- Administrative requirements including Indications for Use form and Truthful and Accurate Statement
Relevant Guidances 🔗
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
Related references and norms 📂
- ISO-10993: Biological Evaluation of Medical Devices Part-1: Evaluation and Testing