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.
What You Need to Know? 👇
What are the key regulatory requirements for submitting a 510(k) for non-automated sphygmomanometers?
Key requirements include a Statement of Intended Use, Indications for Use Statement, predicate device identification, either a Summary of Safety and Effectiveness or 510(k) Statement, Truthful and Accuracy Statement, and appropriate labeling conforming to regulations.
Which testing standards apply to blood pressure cuffs under FDA guidance?
The ANSI/AAMI SP9-1994 standard is the primary standard for non-automated sphygmomanometers. Manufacturers can also use foreign standards that meet or exceed SP9 requirements, or conduct comparison testing with predicate devices.
What devices are excluded from this blood pressure cuff guidance?
This guidance excludes automated non-invasive blood pressure monitors (using oscillometric or other methods) and direct/invasive blood pressure monitoring systems. It only covers non-automated sphygmomanometers with occluding cuffs and manual detection systems.
What biocompatibility testing is required for blood pressure cuff materials?
Manufacturers must identify all patient and operator contacting materials and conform to ISO-10993 “Biological Evaluation of Medical Devices Part 1.” Previously used materials in similar applications may be acceptable with proper documentation.
How many devices should be tested for intra-device variability assessment?
The guidance recommends evaluating intra-device variability among a minimum of three devices. This testing should be conducted in addition to the standard SP9 conformance testing or comparison testing requirements.
What information must be included in device descriptions for 510(k) submissions?
Device descriptions must include overall design, photographs with accessories, component identification, material descriptions for contacting surfaces, product specifications with ranges/accuracies, packaging details, and any operating or functional limitations of the device.
What You Need to Do 👇
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