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.
What You Need to Know? 👇
What are the key performance specifications required for powered suction pump 510(k) submissions?
FDA requires specifications including pump type (AC/DC/microprocessor), maximum suction flow rate, pressure controls, filter details (0.3 micron bacterial filter), power operations, and safety features like electronic sensors and overflow valves.
Do powered suction pumps require biocompatibility testing for FDA clearance?
Typically no, since powered suction pumps don’t contact patients directly. However, if patient-contacting components like suction tips are included, biocompatibility testing following ISO 10993 standards is required.
What predicate device information is needed for substantial equivalence in suction pump 510(k)s?
You must identify legally marketed predicate devices with same intended use and provide side-by-side tabular comparisons of physical descriptions, performance specifications, materials, dimensions, testing parameters, and explain any differences’ safety implications.
Are sterilization requirements mandatory for all powered suction pump components?
No, typically suction pumps have no sterile components. Only if sterile components like suction tips or tubing are included must you provide sterilization method, Sterility Assurance Level, and reprocessing instructions.
What software validation is required for microprocessor-controlled suction pumps?
If your device includes software, you must follow FDA’s “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” and provide appropriate software validation documentation.
What safety features must be documented for powered suction pump 510(k) submissions?
Required safety features include electronic sensors monitoring pressure differentials between unit and suction bottle, and manual overflow valves with floats that block inlet ports when fluid reaches maximum levels.
What You Need to Do 👇
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