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.
Recommended Actions
- Prepare detailed device description including all performance specifications and safety features
- Document comparison with predicate devices in tabular format
- Develop comprehensive labeling package including all required instructions
- Validate sterilization processes if applicable
- Conduct biocompatibility testing if device includes patient-contacting components
- Prepare software validation documentation if software is included
- Ensure all safety features are properly documented and tested
- Create detailed maintenance and cleaning instructions
- Prepare complete 510(k) submission package following the suggested format
- 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
- Detailed device description required including schematics and engineering drawings
- Comparative information with predicate devices must be provided in tabular form
- Sterilization validation required for any sterile components
- Reprocessing instructions required for reusable components
Relevant Guidances
- Content of Premarket Submissions for Device Software Functions
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
Related references and norms
- 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
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