Intravascular Administration Sets and Accessories - Testing and Documentation Requirements
This guidance document covers intravascular (IV) administration sets and accessories classified under 21 CFR 880.5440 (Class II). This includes extension sets, IV stopcocks and manifolds, in-line filters, flow regulators, fluid delivery tubing, vial adapters, IV transfer sets, subcutaneous administration sets, blood administration sets, and transfusion filters. The guidance also covers IV administration sets with or without needleless access devices or systems.
What You Need to Know? 👇
What are the key requirements for submitting a 510(k) for intravascular administration sets?
You must include device description, risk analysis, bench testing, microbial ingress testing (for needleless devices), sterilization validation, biocompatibility testing, and comprehensive labeling. An Abbreviated 510(k) format is recommended when following FDA guidance documents.
Which product codes and regulations apply to IV administration sets?
IV administration sets fall under 21 CFR 880.5440 (Class II) with product codes including FPA (IV sets), FMG (stopcocks), BRZ (blood transfusion sets), FPB (in-line filters), CAK (transfusion microfilters), FPK (fluid delivery tubing), and LHI (transfer sets).
What biocompatibility testing is required for IV administration sets?
Testing should follow ISO-10993 for prolonged duration, indirect blood path contacting devices. Required tests typically include cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, and hemocompatibility based on contact duration and level.
When is microbial ingress testing necessary for IV administration sets?
Microbial ingress testing is required for needleless devices that facilitate bi-directional fluid flow. Testing must simulate repeated clinical access using minimum 10³ challenge organisms (2 gram-positive, 2 gram-negative) and validate disinfection procedures.
What sterilization requirements must IV administration sets meet?
Devices must achieve sterility assurance level (SAL) of 1 x 10⁻⁶ using validated sterilization cycles per Quality Systems regulations (21 CFR 820.30). Sterilization information should follow FDA guidance K90-1 for sterility review.
What labeling information is essential for IV administration set clearance?
Labeling must include intended use, device description (dimensions, materials, specifications), step-by-step directions for use, precautions for specific solutions, warnings about high-pressure systems, and DEHP identification in PVC tubing where applicable.
What You Need to Do 👇
Recommended Actions
- Conduct comprehensive risk analysis to identify all potential risks
- Develop and execute test protocols for:
- Bench testing under dry and wet conditions
- Microbial ingress testing if applicable
- Simulated clinical use testing for safety features
- Biocompatibility testing
- Prepare detailed device description including:
- Material composition
- Physical specifications
- Mechanical specifications
- Design features
- Validate sterilization process
- Develop comprehensive labeling including:
- Intended use
- Device description
- Directions for use
- Precautions and warnings
- Storage conditions
- Document all testing results and risk mitigation measures in design history file
- Prepare 510(k) submission including all required testing data and documentation
- Ensure compliance with referenced standards where applicable
Key Considerations
Non-clinical testing
- Bench testing under dry and wet conditions comparing to legally marketed devices
- Testing should assess force to attach/detach connections, activate safety features
- Testing of injection port accesses to failure
- Pressure and leak tolerance testing
- Flow characteristics testing
Human Factors
- Simulated clinical use testing for devices with sharps injury prevention features
- Assessment of variables like training, learning curve, user experience
- Protocol should address patient and healthcare professional user populations
Labelling
- Clear statement of intended use and target population
- Device description including specifications
- Step-by-step procedures for use
- Special patient instructions
- Cleaning and disinfection instructions
- Precautions and warnings
- Storage conditions
- DEHP warnings if applicable
Biocompatibility
- Testing as prolonged duration, indirect blood path contacting device
- Selection of appropriate tests for duration and level of contact
- Documentation of pass/fail criteria
Safety
- Risk analysis to identify device-specific risks
- Mitigation measures for identified risks:
- Device malfunction
- Adverse tissue reaction
- Infection
- Improper use
Other considerations
- Sterilization validation with SAL of 1x10-6
- Microbial ingress testing for needleless devices
- Material composition details
- Physical and mechanical specifications
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 8536-4:2004: Infusion Equipment for Medical Use, Part 4
- ANSI/AAMI BF7:R2002: American National Standard for Blood Transfusion Micro Filters
- ISO 1135-4:2004: Transfusion Equipment for Medical Use
- ISO 594: Conical Fittings with a 6% (Luer) Taper
- ANSI/AAMI HE48-1993: Human factors engineering guidelines