Clinical Investigation Requirements for Prostate Tissue Ablation Systems
This guidance document focuses on clinical investigations required to support marketing authorization for general indications of prostate tissue ablation systems (product code PLP). It specifically excludes devices intended to treat specific prostatic diseases and does not address non-clinical testing, training, or labeling requirements.
What You Need to Know? 👇
What are the minimum sample size requirements for clinical studies of prostate tissue ablation devices?
FDA recommends a minimum of 100 patients treated with the subject device and clinically followed for safety endpoints. This sample size ensures adequate estimation of adverse event profiles with clinically meaningful precision, including infrequent device-related complications.
How long should patients be followed after prostate tissue ablation procedures in clinical studies?
The minimum recommended follow-up duration is one year. This timeframe accounts for delayed onset of known adverse events like urethral stricture and rectal fistula, and allows time for potential resolution of complications such as erectile dysfunction.
What are the key safety endpoints that must be evaluated in prostate ablation device studies?
Key safety endpoints include erectile dysfunction, urinary incontinence, voiding symptoms, urethral stricture, rectal fistula, and osteomyelitis pubis. These endpoints reflect potential damage to surrounding non-target tissues and must be prospectively collected using standardized criteria.
Can real-world data be used to support changes to prostate ablation devices?
Yes, real-world data may support changes to ablation energy output characteristics for already-cleared devices. If a cleared device is used in normal medical practice, an IDE may not be required, depending on specific circumstances.
What effectiveness endpoints are acceptable for demonstrating prostate tissue ablation?
FDA accepts either direct measurements (histopathology from “treat and resect” studies) or indirect measurements using a composite of prostate biopsies, imaging-based volume assessments, and PSA levels. Both approaches are considered equally valid for demonstrating tissue ablation.
Are prostate tissue ablation devices considered significant risk devices requiring IDE approval?
Generally, yes. FDA believes prostate tissue ablation devices are significant risk devices subject to all IDE regulation requirements (21 CFR 812) for US studies, including institutional review board approval and informed consent requirements.
What You Need to Do 👇
Recommended Actions
- Submit Pre-Submission to FDA for detailed feedback before initiating clinical investigation
- Design clinical study with minimum 100 patients and 1-year follow-up
- Establish clear inclusion/exclusion criteria and uniform treatment protocols
- Implement robust adverse event collection and monitoring system
- Select appropriate effectiveness endpoints (direct or indirect measurements)
- Develop comprehensive data collection plan for patient demographics and treatment parameters
- Set up independent clinical events committee for adverse event adjudication
- Plan statistical analysis using intent-to-treat approach
- Prepare complete test report with all required elements
- Compare results with existing prostate ablation device to demonstrate equivalent or better benefit-risk profile
Key Considerations
Clinical testing
- Minimum of 100 patients treated with the device and followed for safety
- Minimum follow-up duration of 1 year
- Either internally or externally controlled trial
- Collection of adverse events at regular intervals
- Uniform patient and treatment characteristics regarding underlying conditions, treatment history, and ablation extent
Safety
- Must demonstrate device does not ablate or damage tissue outside targeted volume
- Monitor key safety issues including erectile dysfunction, urinary incontinence, voiding symptoms, urethral stricture, rectal fistula, and osteomyelitis pubis
- Adverse events must be prospectively collected, graded for severity, and adjudicated by independent committee
Other considerations
- Effectiveness must demonstrate device ablates tissue within targeted volume
- Can use either direct measurements (histopathology) or indirect measurements (biopsy, imaging, PSA levels)
- Statistical analysis using intent-to-treat approach
- Patient demographics and treatment parameters must be thoroughly documented
- Results must be compared to existing prostate ablation device
Relevant Guidances 🔗
- Clinical Decision Support Software Functions: Device vs Non-Device Classification
- Clinical Study Design for Surgical Ablation Devices Used in Treatment of Atrial Fibrillation Under Direct Visualization
- Design Considerations for Medical Device Pivotal Clinical Studies
- Early Feasibility Medical Device Clinical Studies Including First in Human (FIH) Studies
- Statistical Guidance for Reporting Diagnostic Test Results with Qualitative Outcomes
Related references and norms 📂
- 21 CFR 876.4340: Code of Federal Regulations for high intensity ultrasound systems for prostate tissue ablation
- 21 CFR 812: Investigational Device Exemptions regulation
- 21 CFR 56: Institutional review boards
- 21 CFR 50: Informed consent
Original guidance
- Clinical Investigation Requirements for Prostate Tissue Ablation Systems
- HTML / PDF
- Issue date: 2020-07-15
- Last changed date: 2020-07-14
- Status: FINAL
- Official FDA topics: Medical Devices, Gastroenterology-Urology, Good Clinical Practice (GCP), 510(k), Premarket, Investigational Device Exemption (IDE)
- ReguVirta ID: 30215abfc5ed8cd895f1039636761fa1