Peripheral Vascular Atherectomy Devices - Content and Testing Requirements for 510k Submissions
This guidance document provides recommendations for 510(k) submissions for peripheral vascular atherectomy devices used to remove atherosclerotic plaque from diseased arteries. It covers devices regulated under 21 CFR 870.4875 with product code MCW (Intraluminal Artery Stripper). The guidance excludes atherectomy devices used in coronary vasculature which require PMA approval.
What You Need to Know? 👇
What Documentation Level is required for peripheral vascular atherectomy devices under the new FDA software guidance?
Peripheral vascular atherectomy devices should generally address recommendations for a Basic Documentation Level under the 2023 “Content of Premarket Submissions for Device Software Functions” guidance. However, devices with novel indications or software controlling cutting/lasing functions may warrant Enhanced Documentation Level.
What are the four main categories of atherectomy devices regulated by FDA?
The four main categories are: 1) Directional - cuts plaque in longitudinal plane, 2) Rotational - uses high-speed rotating burr with abrasive material, 3) Orbital - employs 360° rotational coil that “sands” plaque, and 4) Laser - uses high-energy light beam to vaporize plaque.
What biocompatibility endpoints must be addressed for atherectomy devices?
Required endpoints include cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity, and hemocompatibility (hemolysis, complement activation, thrombogenicity). Genotoxicity assessment may be requested for novel patient-contacting materials.
When is clinical data typically required for peripheral vascular atherectomy devices?
Clinical data is expected for new devices, devices with modified design/functionality, new indications for use, devices intended as primary treatment versus PTA, devices for specific lesion types (below-the-knee, ISR), and devices with novel design characteristics requiring substantial equivalence demonstration.
What animal testing is recommended for atherectomy devices?
FDA recommends porcine or ovine large animal models with both acute (Day 0) and chronic (28+ days) testing elements. Studies should evaluate usability, vascular safety, hemolysis, emboli, thrombogenicity acutely, and long-term endpoints including histopathology and histomorphometric evaluation.
What modifications to atherectomy devices require a new 510(k) submission?
Modifications requiring new 510(k) include: significant dimensional changes, debulking component changes, critical material/supplier changes, laser component specification changes, sterilization technique changes, altered user techniques (manual to automatic), power source changes, and indications for use modifications.
What You Need to Do 👇
Recommended Actions
- Conduct comprehensive risk analysis following ISO 14971
- Develop test plan covering all required testing categories:
- Engineering bench testing
- Biocompatibility
- Sterilization validation
- Animal studies if needed
- Clinical studies if needed
- Prepare documentation for software and cybersecurity if applicable
- Validate device performance through simulated use testing
- Conduct particulate and coating evaluations if applicable
- Prepare comprehensive labeling with all required information
- Consider early engagement with FDA through Q-Submission program
- Validate shelf life and packaging
- Prepare complete test reports following FDA guidance format
- Consider need for clinical data based on device novelty and indications
Key Considerations
Clinical testing
- Multi-center prospective study recommended for new devices and modifications
- Sample size based on sound clinical and statistical principles
- Safety assessment through Major Adverse Events (MAEs) at 30 days
- Performance assessment through acute technical success and clinical success at 6 months
- Real-world data may be acceptable for expanded indications
Non-clinical testing
- Simulated use testing in anatomical models
- Engineering testing for dimensional verification, kink resistance, corrosion resistance, heat generation
- Torsional and tensile strength testing
- Rotational speed verification
- Plaque removal efficiency testing
- Life cycle/fatigue testing
- Additional testing for in-stent restenosis applications
Software
- Documentation level should be Basic for most peripheral atherectomy devices
- Higher documentation level may be needed for novel applications
- Software verification and validation required
- Off-the-shelf software requires additional documentation
Cybersecurity
- Cybersecurity documentation required if device includes software
- Follow FDA guidance on cybersecurity for medical devices
Labelling
- Must include adequate information for practitioner use
- Include device specifications and performance characteristics
- Describe operational parameters like rotational speed
- Include orbit performance data if applicable
- Specify duration of treatment and aspiration characteristics
Biocompatibility
- Testing required for all patient-contacting materials
- Cytotoxicity, sensitization, irritation testing needed
- Acute systemic toxicity testing required
- Hemocompatibility testing required
- Additional testing may be needed for novel materials
Safety
- Sterility validation required
- Pyrogenicity testing needed
- Shelf life validation required
- Electrical safety testing per standards
- Battery safety testing if applicable
Other considerations
- Animal testing recommended for new designs/modifications
- Particulate evaluation required
- Coating integrity assessment if applicable
- Risk management documentation required
Relevant Guidances đź”—
- Content of Premarket Submissions for Device Software Functions
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Cybersecurity in Medical Devices: Design, Implementation, and Premarket Submissions
- Recommended Format and Content for Non-Clinical Bench Performance Testing in Medical Device Premarket Submissions
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
Related references and norms đź“‚
- ANSI/AAMI/ES 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- AAMI/ANSI/ISO 11607-1: Packaging for terminally sterilized medical devices
- ISO 10993-1: Biological evaluation of medical devices
- ISO 14971: Medical devices - Application of risk management to medical devices
- ASTM F1980: Standard guide for accelerated aging of sterile barrier systems for medical devices