Non-Automated Sphygmomanometers - Testing and Documentation Requirements
This guidance applies to non-automated sphygmomanometers that use an occluding cuff, either an aneroid or mercury gravity sphygmomanometer to measure pressure, and a stethoscope or other manual system for detecting Korotkoff sounds. It does not apply to automated non-invasive blood pressure monitors or invasive blood pressure monitoring systems.
Recommended Actions
- Determine testing approach: either comparison testing with predicate device or conformance to SP9 standard
- Prepare comprehensive device description with all required elements
- Conduct performance testing according to chosen approach
- Perform intra-device variability testing
- Complete biocompatibility assessment for all patient-contacting materials
- Prepare labeling documentation in accordance with regulations
- Document package integrity testing
- If applicable, address sterilization and shelf life requirements
- Prepare test reports following suggested format (protocol, data/results, analysis)
- Ensure all regulatory requirements are met including required statements and declarations
Key Considerations
Non-clinical testing
- Comparison testing with predicate device or conformance to SP9 standard
- Intra-device variability evaluation among minimum of three devices
- Performance testing according to SP9 standard requirements
- Package integrity testing
Labelling
- Must conform to labeling regulations and policies
- Include SP9 standard labeling requirements or justification for modifications
- Statement of Intended Use
- Indications for Use Statement
- Summary of Safety and Effectiveness or 510(k) Statement
Biocompatibility
- Conform to ISO-10993 for all patient and operator contacting materials
- Documentation of material safety for widely used materials
Safety
- Sterilization requirements if sterile components are present
- Shelf life data if sterile or degradable components are present
Other considerations
- Device description including design, photos, components, materials, and specifications
- Identification of predicate device
- Detailed comparison if modification to existing device
Relevant Guidances
- 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
- Recommended Format and Content for Non-Clinical Bench Performance Testing in Medical Device Premarket Submissions
Related references and norms
- ANSI/AAMI SP9-1994: Non-automated sphygmomanometers
- ISO-10993: Biological Evaluation of Medical Devices Part 1: Evaluation and Testing
Original guidance
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