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Powered Suction Pump 510k Submissions: Information Requirements and Testing Recommendations

This guidance outlines specific information requirements for powered suction pump 510(k) submissions. It covers portable, AC-powered, or compressed air-powered devices intended to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system, used during surgery or at bedside.

  1. Prepare detailed device description including all performance specifications and safety features
  2. Document comparison with predicate devices in tabular format
  3. Develop comprehensive labeling package including all required instructions
  4. Validate sterilization processes if applicable
  5. Conduct biocompatibility testing if device includes patient-contacting components
  6. Prepare software validation documentation if software is included
  7. Ensure all safety features are properly documented and tested
  8. Create detailed maintenance and cleaning instructions
  9. Prepare complete 510(k) submission package following the suggested format
  10. Verify compliance with referenced standards where applicable

Key Considerations

Non-clinical testing

  • Performance specifications must be provided including:
    • Maximum suction flow rate
    • Pressure controls
    • Power operations
    • Safety features (electronic and manual sensors, overflow valve)

Software

  • If software is included, validation documentation must be provided according to the Guidance for Content of Premarket Submissions for Software

Labelling

  • Must include prescription labeling per 21 CFR 801.109(b)(1)
  • Must provide identification labels
  • Must include directions for reprocessing/disinfection/sterilization
  • Must include maintenance intervals
  • Must provide assembly/disassembly instructions
  • Must include detailed cleaning instructions

Biocompatibility

  • Only required if device has patient-contacting parts
  • Must follow ISO 10993-1 if patient contact exists

Safety

  • Must include electronic and manual safety features:
    • Pressure monitoring sensor system
    • Overflow valve system
  • Must include bacterial filter (pore size range of 0.3 microns)

Other considerations

  • ANSI/AAMI HF-18/1993: American National Standard for Electrosurgical Devices
  • IEC 601-2-2: International Electrotechnical Commission Standard for Electrosurgical Devices
  • ISO 10993-1: Biological Evaluation of Medical Devices

Original guidance

  • Powered Suction Pump 510k Submissions: Information Requirements and Testing Recommendations
  • HTML / PDF
  • Issue date: 1998-09-29
  • Last changed date: 2020-03-18
  • Status: FINAL
  • Official FDA topics: Medical Devices
  • ReguVirta summary file ID: 1c61cf12bf86986ff18efb04298b639c
This post is licensed under CC BY 4.0 by the author.