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Piston Syringes and Accessories - Review Requirements and Testing Specifications for 510k Submissions

This guidance establishes the 510(k) review requirements for piston syringes, including insulin syringes, syringes with anti-needlestick features, control syringes, and cartridge or pen syringes (excluding the cartridge). It also covers accessory devices like dispensing pens and syringe holders. Pre-filled syringes, fluid injectors, and irrigating syringes are excluded from this guidance.

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By ReguVirta
2 min read
  1. Prepare comprehensive device description including all models and variations
  2. Conduct required performance testing based on device type and claims
  3. Perform biocompatibility testing unless using previously cleared materials
  4. Develop complete labeling package meeting all requirements
  5. Prepare side-by-side comparison with predicate device(s)
  6. Submit sterilization validation information if sold sterile
  7. Include SMDA safety and effectiveness information
  8. Provide drug/biologic compatibility data if applicable
  9. Submit sample if possible
  10. Include additional documentation for anti-needlestick features if applicable
  11. Prepare special documentation for kits if applicable

Key Considerations

Non-clinical testing

  • Performance testing for delivery accuracy
  • Reuse durability testing for reusable syringes
  • Needle cover strength testing (if applicable)
  • Hub/needle bond strength testing (if applicable)
  • Drug/biologic compatibility testing if specific drugs mentioned in labeling
  • Stability testing if drug storage in syringe is indicated

Human Factors

  • Legibility criteria for markings and graduations
  • Color contrast requirements for insulin syringes
  • Needle cover color coding (orange) for insulin syringes for visually impaired users

Labelling

  • Device identity (type, size, needle gauge/length)
  • Sterility and single-use statements
  • Prescription statement (except insulin syringes)
  • Special requirements for insulin syringes
  • Instructions for specialized syringes
  • Specific drug/biologic use information
  • Cleaning/sterilization instructions for reusable components

Biocompatibility

  • Testing according to ISO 194 standard for:
    • Externally Communicating Devices, Blood Path Indirect, Limited Exposure (syringes)
    • Externally Communicating, Circulating Blood, Limited Exposure (needles)

Safety

  • Sterility assurance level (SAL) of 10^-6 required
  • Pyrogen testing requirements
  • EtO residuals testing if applicable

Other considerations

  • ISO 7886: Sterile Hypodermic Syringes for Single Use
  • ISO 7864: Sterile Hypodermic Needles for Single Use
  • ISO 594: Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, and Certain Other Medical Equipment
  • ISO 9626: Stainless Steel Needle Tubing for Manufacture of Medical Devices
  • ISO 6009: Hypodermic Needles for Single Use - Colour Coding for Identification
  • ISO 8537: Sterile, Single-Use Syringes, with or without Needle, for Insulin
  • ANSI/HIMA MD70: Luer Taper Fittings for Medical Material

Original guidance

  • Piston Syringes and Accessories - Review Requirements and Testing Specifications for 510k Submissions
  • HTML
  • Issue date: 1993-03-31
  • Last changed date: 2020-03-17
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: c146d2f04a13a3442d3d3e3cdc7164a1
FDA guidance, Final
Medical Devices Premarket
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