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.
Recommended Actions
- Prepare comprehensive device description including physical, mechanical specifications and materials
- Conduct biocompatibility testing if using new materials
- Validate sterilization process and demonstrate SAL of 10-6
- Prepare side-by-side comparison with predicate device(s)
- Ensure labeling includes all required statements and meets 21 CFR Part 801
- Provide sample of device if possible
- Include SMDA information (safety and effectiveness summary or statement)
- If including anti-needlestick features, prepare additional documentation demonstrating equivalence and substantiating claims
- Ensure compliance with relevant ISO standards
- 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
- Medical Device Reporting for Needlestick and Other Sharps Injuries
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
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 summary file ID: 6ae84e55a0beddd9d7cc1bebd2dbb559
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