Clinical and Non-Clinical Testing for Medical Devices to Treat Benign Prostatic Hyperplasia (BPH)

What You Need to Know? 👇

What are the key non-clinical testing requirements for BPH treatment devices before human studies?

Comprehensive testing includes material safety biocompatibility, electrical safety/EMC compliance, mechanical testing, corrosion/degradation assessment, sterilization validation, and for thermal devices, in vitro thermal mapping in tissue-equivalent phantoms plus animal studies to evaluate tissue effects and safety.

How should the primary effectiveness endpoint be defined in BPH device clinical trials?

The primary effectiveness endpoint should be based on improvement in AUA-SI (or IPSS) compared to baseline. FDA recommends a minimum clinical improvement of ≥30% over baseline AUA-SI score, with 12-month analysis for active control trials and shorter timepoints for sham-controlled studies.

What study design does FDA recommend for pivotal BPH device clinical trials?

FDA recommends randomized, controlled trials to address placebo effects, spontaneous remissions, and subjective symptom variability. Controls may include TURP, legally marketed similar devices, or sham treatment. Alternative designs require scientific justification addressing bias minimization and placebo effects.

What are the essential inclusion and exclusion criteria for BPH device studies?

Include men >50 with symptomatic BPH, appropriate prostate size, AUA-SI scores consistent with symptom severity, and reduced peak flow rates (<12 ml/sec). Exclude confounding conditions, prostate cancer (PSA screening required), relevant surgical history, and medications affecting BPH symptoms unless stable dosing.

When are animal studies required for BPH treatment devices?

Animal studies are recommended for most new BPH devices, particularly thermal field-producing devices requiring complete thermal mapping and histological assessment. For stents, studies should evaluate migration, encrustation, erosion, and tissue response. Studies must follow 21 CFR part 58 requirements.

What safety monitoring and adverse event reporting is required during BPH device trials?

Comprehensive monitoring includes all genitourinary events, infections, erectile/ejaculatory dysfunction, secondary interventions, and deaths. Events should be categorized by device-relatedness and severity using standardized classifications. One-year follow-up is recommended to monitor adverse events and treatment stability.

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What You Need to Do 👇

Recommended Actions

1. Develop comprehensive non-clinical testing plan with predefined specifications
2. Consider need for animal studies based on device novelty and risk
3. Design pilot study if device is novel or represents significant technology shift
4. Plan randomized, controlled pivotal study with appropriate control group
5. Define clear inclusion/exclusion criteria and evaluation schedule
6. Select appropriate primary endpoints (effectiveness and safety)
7. Develop statistical analysis plan and sample size calculation
8. Create detailed monitoring plan and case report forms
9. Establish procedures to minimize missing data
10. Consider need for post-approval studies for Class III devices
11. Contact FDA early to discuss study design through Pre-Submission process

Key Considerations

Clinical testing

• Pilot study recommended for novel devices to assess short-term safety, treatment technique, and optimal patient population
• Pivotal study should be randomized, controlled, multi-center trial
• 1-year minimum follow-up recommended
• Primary effectiveness endpoint based on AUA-SI/IPSS improvement (≥30% over baseline)
• Primary safety endpoint based on adverse events
• Clear inclusion/exclusion criteria needed
• Detailed pre and post-treatment evaluation schedule required

Non-clinical testing

• Comprehensive testing with predefined performance limits required
• Testing should simulate mechanical stresses during use
• Evaluate device function and safety under controlled conditions
• Provides foundation for assessing future device changes

Software

• Provide information based on “Level of Concern”
• Follow FDA guidance for software in medical devices

Biocompatibility

• Testing required for all patient-contacting components
• Testing on finished devices in final form
• Evaluate impact of device storage on material safety
• Follow ISO 10993-1 standard

Safety

• Electrical safety testing per ES60601-1
• EMC testing per 60601-1-2
• MR compatibility assessment for implants
• Sterilization validation if provided sterile
• Reprocessing validation if reusable

Other considerations

• Animal studies may be needed based on device design and risk
• Statistical analysis plan must be pre-specified
• Study monitoring procedures required
• Case report forms needed to document all study data

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Relevant Guidances 🔗

• Content of Premarket Submissions for Device Software Functions
• Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
• Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
• Q-Submission Program: Strategic Framework for FDA Interactions in Medical Device Development

Related references and norms 📂

• ANSI/AAMI ES60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• ANSI/AAMI/IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances
• ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

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Original guidance

• Clinical and Non-Clinical Testing for Medical Devices to Treat Benign Prostatic Hyperplasia (BPH)
• HTML / PDF
• Issue date: 2021-12-27
• Last changed date: 2021-12-23
• Status: FINAL
• Official FDA topics: Medical Devices, Gastroenterology-Urology, Premarket, Good Clinical Practice (GCP)
• ReguVirta ID: d612e682f9fdbabc049e1ad6acef21e8