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510k Requirements for Hypodermic Single Lumen Needles

This guidance establishes the 510(k) review requirements for hypodermic single lumen needles, which are devices intended to inject fluids into or withdraw fluids from parts of the body below the surface of the skin. The guidance aims to assist manufacturers in organizing premarket notifications and achieve consistency in meeting requirements.

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By ReguVirta
3 min read

What You Need to Know? 👇

What are the key requirements for a 510(k) submission for hypodermic single lumen needles?

A 510(k) submission must include a signed cover letter, device description with specifications, labeling, substantial equivalence comparison to a predicate device, performance data including biocompatibility testing, sterilization information, and SMDA safety/effectiveness summary or statement.

Which biocompatibility standards apply to hypodermic single lumen needles?

Hypodermic needles are categorized as “Externally Communicating, Circulating Blood, Limited Exposure” devices under ISO 194. Testing must follow the 1987 Tripartite Biocompatibility Guidance and 1992 draft ISO 194 standard for biological testing of medical devices.

What sterilization information is required for sterile hypodermic needles in 510(k) submissions?

You must provide the sterilization method, validation method description, sterility assurance level (SAL of 10⁻⁶ required), packaging description, EtO residual levels if applicable, pyrogen-free determination method, and radiation dose for radiation sterilization.

How do I demonstrate substantial equivalence for a new hypodermic needle design?

Identify a legally marketed predicate device with similar intended use and technology. Provide side-by-side comparisons of materials, physical/mechanical specifications, intended use, and labeling. Explain how any differences may affect safety and effectiveness.

What additional requirements apply to hypodermic needles with anti-needlestick features?

You must completely describe the anti-needlestick mechanism, demonstrate equivalence of the mechanism to existing devices, and substantiate all labeling claims associated with the safety feature. Additional performance data may be required.

What ISO standards are relevant for hypodermic single lumen needle 510(k) submissions?

Key standards include ISO 7864 (sterile hypodermic needles), ISO 594 (Luer taper fittings), ISO 9626 (stainless steel needle tubing), ISO 6009 (color coding), and ASTM standards for stainless steel tubing testing.

What You Need to Do 👇

  1. Prepare comprehensive device description including physical, mechanical specifications and materials
  2. Conduct biocompatibility testing if using new materials
  3. Validate sterilization process and demonstrate SAL of 10-6
  4. Prepare side-by-side comparison with predicate device(s)
  5. Ensure labeling includes all required statements and meets 21 CFR Part 801
  6. Provide sample of device if possible
  7. Include SMDA information (safety and effectiveness summary or statement)
  8. If including anti-needlestick features, prepare additional documentation demonstrating equivalence and substantiating claims
  9. Ensure compliance with relevant ISO standards
  10. Maintain complete documentation of all testing and validation data

Key Considerations

Non-clinical testing

  • Physical specifications including needle length, gauge, and tip configuration must be provided
  • Mechanical specifications including cover strength and hub/needle bond strength must be demonstrated
  • Performance data supporting substantial equivalence claims must be provided

Labelling

  • Must include device identity (gauge and length) and quantity
  • Required statements: “sterile, single use only, nonpyrogenic, nontoxic”
  • Must include prescription statement under 801.109(b)(1)
  • Labels must meet requirements of 21 CFR Part 801

Biocompatibility

  • Devices are categorized as Externally Communicating, Circulating Blood, Limited Exposure
  • Must certify materials have been used in other legally marketed devices or provide biocompatibility data
  • Testing according to Tripartite Biocompatibility Guidance required if new materials are used

Safety

  • Sterilization validation with SAL of 10-6 required
  • Maximum residue levels must be specified if EtO sterilization is used
  • Pyrogen-free status must be demonstrated

Other considerations

  • Complete description of all materials used in fabrication required
  • Side-by-side comparison with predicate device(s) needed
  • Additional requirements if anti-needlestick features are included

Relevant Guidances 🔗

Related references and norms 📂

  • 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 194: Biocompatibility Standard

Original guidance

  • 510k Requirements for Hypodermic Single Lumen Needles
  • HTML
  • Issue date: 1993-03-31
  • Last changed date: 2020-03-17
  • Status: FINAL
  • Official FDA topics: Medical Devices, 510(k), Premarket
  • ReguVirta ID: 6ae84e55a0beddd9d7cc1bebd2dbb559
FDA guidance, Final
Medical Devices 510(k) Premarket
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