Tests Required for Syringe 510k Submission

Submitting a syringe notification for 510(k) clearance requires the submission of various tests and information to the FDA. Some of the tests that may be required for a syringe 510 k submission include:

Syringe 510K – Test Requirements.

  1. Biocompatibility Testing:
    • Primary Skin Irritation ISO - 10993
    • Dermal Sensitization ISO - 10993
    • In vitro cytotoxicity ISO - 10993
    • Acute systemic toxicity - ISO10993
    • Material-Mediated Pyrogenicity
    • Hemolysis
    • Bacterial Endotoxin Testing and Validation
  2. Sterilization Testing
    • ISO 11135 - Sterilization of Health Care Products
  3. Transportation
    • ASTM D4169-16 – Transportation
  4. Packaging
    • ASTM F1886 - Visual Inspection
    • ASTM F2096 - Bubble Emission
    • ASTM F88/F88M - Seal Peel Strength
  5. Performance Testing
    • ISO 7886-1- Leakage during aspiration
    • ISO 7886-1 - Determination of Dead Space
    • ISO 7886-1 - Leakage during compression
    • ISO 7886-1 - Piston operating force
    • ISO 7886-1 - Silicone quantity (lubricant)
    • ISO 7886-1 - Limits for Extractable Metals
    • ISO 7864 - Needle fragmentation
    • ISO 7864 - Needle flow rate
    • ISO 7864 - Needle penetration and drag force
    • ISO 7864 - Needle bonding strength
    • ISO 23908 - Needle Safety Mechanism
    • ISO 9626 - Needle Stiffness
    • ISO 9626 - Needle Resistance to breakage
    • ISO 9626 - Needle Resistance to corrosion
    • ISO 7886-4 - Re-use prevention feature
    • ISO 7886-1 - Limits for Alkalinity/Acidity
    • ISO 7864 - Limits for Extractable Metals
    • ISO 7864-1 - Limits for Alkalinity/Acidity
    • ISO 7864 - Needle Silicone quantity (lubricant)
    • ISO 7886-1 - Graduated Tolerance Testing

It's essential to note that the required tests can vary depending on the specific product's characteristics and intended use, so it is crucial to consult with the FDA Consultant to ensure that all necessary testing is conducted and submitted for 510(k) clearance.

LMG Provides assistance to syringe manufacturers in FDA registration, 510k clearance, device listing, and US FDA Agent requirements. Our experienced consultants can help you to comply with FDA requirements. Our expertise includes

  • Prepare 510k notification
  • Submission of 510k notification
  • FDA Agent service for 510k submission
  • Guidance in test requirements
  • Register your establishment with FDA
  • List your syringe with FDA.

Syringe US FDA 510K Submission

US FDA 510K Submission Requirements

FDA 510K Consultant