Special Controls for Implanted Blood Access Devices for Hemodialysis

What You Need to Know? 👇

What are the key special controls for implanted blood access devices for hemodialysis under FDA regulations?

The special controls include material identification requirements, biocompatibility testing, performance data demonstrating intended function, sterility validation, shelf-life support data, specific labeling requirements including pressure/flow rates and recirculation data, and additional requirements for subcutaneous ports, coatings, and A-V shunt cannulae.

What biocompatibility testing is required for hemodialysis catheters according to FDA guidance?

Required biocompatibility evaluations include cytotoxicity, sensitization, irritation/intracutaneous reactivity, systemic toxicity, sub-chronic toxicity, implantation testing, hemocompatibility, and genotoxicity testing. These tests must be performed on finished, sterilized devices for “permanent contact duration” classification.

What performance testing must be conducted for hemodialysis catheter 510(k) submissions?

Performance testing includes pressure versus flow rates, recirculation rates, priming volumes, tensile testing of joints/materials, air and liquid leakage testing, repeated clamping simulation, mechanical hemolysis testing for new designs, and chemical tolerance testing to commonly used disinfection agents.

When is clinical testing required for implanted blood access devices for hemodialysis?

Clinical testing is generally not required except for subcutaneous catheters, A-V shunt cannulae, devices with dissimilar indications from legally marketed devices, different technology that doesn’t raise safety/effectiveness questions, or when engineering/animal testing raises issues warranting clinical evaluation.

What specific labeling requirements apply to hemodialysis catheters with antimicrobial coatings?

Labeling must include coating description and characterization, identification of coatings with performance testing summary, warning statements for potential allergic reactions including anaphylaxis if containing known allergens, and performance data demonstrating coating efficacy and duration of effectiveness.

What are the minimum acceptance criteria for tensile testing of hemodialysis catheter materials?

The minimum force at break should be at least 10 pounds for polyurethane joints and materials comprising main catheter lumens (excluding catheter tip). Testing should follow FDA-recognized ISO 10555-1 standards, with criteria at least equal to predicate devices.

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What You Need to Do 👇

Recommended Actions

1. Determine device category and applicable special controls
2. Conduct required performance testing based on device type
3. Perform biocompatibility testing according to ISO 10993
4. Validate sterility and establish shelf-life
5. Prepare comprehensive labeling including all required elements
6. Consider need for clinical testing based on device novelty
7. Document material specifications and compatibility with disinfectants
8. Prepare patient implant card and instructions
9. For coated devices, provide additional coating characterization and performance data
10. Consider pre-submission consultation for novel features or materials

Key Considerations

Clinical testing

• Clinical testing generally not required except for:
  • Subcutaneous catheters
  • A-V shunt cannulae
  • New coatings/materials requiring clinical validation
• Must demonstrate safe and effective use and capture adverse events when required

Non-clinical testing

• Pressure vs flow rates testing for arterial and venous lumens
• Recirculation rates testing in forward and reverse flow
• Priming volumes determination
• Tensile testing of joints and materials
• Air and liquid leakage testing
• Repeated clamping simulation testing
• Mechanical hemolysis testing for new designs
• Chemical tolerance testing to disinfection agents

Labelling

• Must include arterial and venous pressure vs flow rates
• Must specify forward and reverse recirculation rates
• Must provide priming volumes
• Must specify expiration date
• Must identify incompatible disinfecting agents
• Must include patient implant card
• Must include comprehensive instructions for preparation, care, maintenance and removal

Biocompatibility

• Components in human contact must be demonstrated biocompatible
• Testing should follow ISO 10993 for:
  • Cytotoxicity
  • Sensitization
  • Irritation
  • Systemic toxicity
  • Sub-chronic toxicity
  • Implantation
  • Hemocompatibility
  • Genotoxicity

Safety

• Must demonstrate device performs as intended under anticipated conditions
• Must include sterility validation
• Must support shelf-life claims
• Special safety considerations for subcutaneous catheters and A-V shunt cannulae

Other considerations

• Special requirements for coatings and additives including:
  • Material characterization
  • Duration of effectiveness
  • Performance data
  • Appropriate warnings for allergens

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Relevant Guidances 🔗

• Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
• Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
• Submission Requirements for Terminally Sterilized Medical Devices

Related references and norms 📂

• ISO 10993: Biological Evaluation of Medical Devices
• ISO 10555-1: Sterile, single-use intravascular catheters – General requirements
• ISO 80369: Small-bore connectors for liquids and gases in healthcare applications
• ASTM F1830-97: Standard practice for selection of blood for in vitro evaluation of blood pumps
• ASTM F1841-97: Standard practice for assessment of hemolysis in continuous flow blood pumps
• ASTM F1980-7: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

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Original guidance

• Special Controls for Implanted Blood Access Devices for Hemodialysis
• HTML / PDF
• Issue date: 2016-01-21
• Last changed date: 2019-02-09
• Status: FINAL
• Official FDA topics: Medical Devices
• ReguVirta ID: e7c69ae09d4d7b94d2c06c1b3eeb35d6