FDA 510k for Nebulizer

FDA 510k for Nebulizer

FDA 510k for Nebulizer – A nebulizer is a device that turns liquid medicine into a mist that is delivered directly to the patient for breathing. As you breathe, the mist of medicine moves into your lungs. The nebulizer is usually connected to a machine that pushes air through the nebulizer. The air helps turn the medicine into a mist. When a nebulizer is used it is called a breathing treatment or nebulizer treatment.

The nebulizer is made up of a main unit, medicine cup, adult mask, kid mask and mouthpiece. The shell of the nebulizer, battery cover and spray nozzle are made of ABS, the button decoration ring is silica gel, the medicine cup and button are made of PC, the mask is made of PVC, the mouthpiece is made of PP and the nebulizer piece is stainless steel.

The nebulizer is powered by an external compressed air or oxygen source, and the aerosol is created by an internal jet located inside the nebulizer jar. The nebulizer is designed to entrain additional room air upon patient inhalation, enhancing aerosol generation and resulting in a faster nebulization rate than traditional jet nebulizers.

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Documents required for Nebulizer 510k

  1. FDA Medical Device User Fee Cover Sheet
  2. FDA Premarket Review Submission Cover Sheet
  3. FDA 510(k) Cover Letter
  4. FDA 510(k) Indications for Use Statement
  5. FDA 510(k) Summary or FDA 510(k) Statement
  6. FDA Truthful and Accuracy Statement
  7. FDA Class III Summary and Certification
  8. Financial Certification or Disclosure Statement
  9. Declarations of FDA Conformity and Summary Reports
  10. FDA 510 (k) Executive Summary
  11. Medical Device Description
  12. FDA 510(k) Substantial Equivalence Discussion
  13. Proposed Labeling
  14. Sterilization and Shelf Life
  15. Biocompatibility
  16. Software
  17. Electromagnetic Compatibility and Electrical Safety
  18. Performance Testing-Bench
  19. Performance Testing-Animal
  20. Performance Testing-Clinical

In both Traditional and Abbreviated 510(k) submissions, the FDA advises including the listed section headings in the recommended sequence. Although certain sections may not apply to your device, maintaining the specified order of headings is suggested by the FDA to facilitate expedited reviews.

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FDA Classification for Nebulizer

S.No. Regulation Number Product Code Device class Device Name/Regulation Name
1 868.5270 BZE 2 Heater, Breathing System W/Wo Controller (Not Humidifier or Nebulizer
2 868.5630 CAF 2 Nebulizer (Direct Patient Interface)
3 NVO 2 Spacer, Direct Patient Interface
4 NVP 2 Holding Chambers, Direct Patient Interface
5 868.5450 OGG 2 Humidifier Nebulizer Kit
6 868.5640 CCQ 1 [510 (k) Exempt] Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
7 874.5220 EPN 1 [510 (k) Exempt] Pump, Nebulizer, Manual
8 874.5220 JPW 1 [510 (k) Exempt] Pump, Nebulizer, Electrically Powered

FDA 510k test requirements for Nebulizer

Performance test:

To guarantee the safety and effectiveness of the device through verification of its resilience and reliability during clinical usage, as well as to establish substantial equivalence with the predicate device, a range of non-clinical performance assessments are carried out. These assessments include several fundamental tests.

  • Hose diameter.
  • Test for emissions of particulate matter (PM) according to ISO 18562-2
  • Test for emission of VOC with additional humidity according to ISO 18562-3
  • Test for leachable in condensate according to ISO 18562-4

Mechanical Testing

  • Environmental testing
  • Flow Performance
  • Life cycle Testing
  • Drop Testing
  • Resistivity Verification

Electrical Safety and Electromagnetic Compatibility (EMC): according to

  • AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment – Part 1,
  • IEC 60601-1-2:2014 Medical electrical equipment – Part 1-2
  • IEC 60601-1-11:2015 Medical electrical equipment – Part 1-11
  • Gas pathway evaluation and testing according to ISO 18562-1.


Biocompatibility test:

We recommend that you conduct biocompatibility testing for your device as described in the guidance entitled, Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.

  • Material characterization according to ISO 10993-18 (2009-08) (organic and inorganic extractable/ leachable)
  • Cytotoxicity according to ISO 10993-5
  • Sensitization according to ISO 10993-10
  • Irritation and Intracutaneous reactivity according to ISO 10993-10
  • Implantation test according to ISO 10993-6
  • Genotoxicity test according to ISO 10993-3
  • Acute Systemic Toxicity Test (polar and non-polar) according to ISO10993-11
  • Material-mediated pyrogens Test according to ISO10993-11
  • Ames Test (polar and DMSO Extract) according to ISO10993-3
  • In Vitro Mammalian Chromosomal Aberration test according to ISO10993-3
  • Bacterial Reverse Mutation Study and Mouse Lymphoma Assay according to ISO10993-3
  • Subchronic systemic toxicity Test (polar and non-polar) according to ISO10993-11
  • Subacute systemic Toxicity Test (polar and non-polar) according to ISO10993-11
  • Toxicological risk assessment study according to ISO10993-17
  • Extractable/leachable according to ISO10993-17

Shelf life:

Shelf-life testing is necessary to verify that the device retains its integrity and performance over its intended shelf life. The FDA mandates real-time ageing tests to validate the outcomes of accelerated ageing.

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Tags FDA 510k for Nebulizer- Page developed by Hinal Shah 07.06 2024