Premarket Notification Requirements for Cardiac Monitors, Heart Rate Meters, and Alarms
This guidance applies to cardiac monitors regulated under 21 CFR §870.2300 (Class II devices) covered by ANSI/AAMI EC13-1992 standard for Cardiac Monitors, Heart Rate Meters, and Alarms. It excludes fetal heart rate monitors, pulse plethysomographic devices, invasive monitors, ambulatory ECG devices, and Class III devices with real-time arrhythmia detection capabilities.
Recommended Actions
- Prepare comprehensive device description including all required specifications and intended use
- Conduct performance testing either through comparison or standards conformance
- Perform required safety testing (electrical, EMC, environmental)
- Prepare software documentation based on level of concern
- Ensure all patient-contacting materials are properly documented
- Develop compliant labeling including all required elements
- Prepare regulatory documentation (510(k) Statement, Truthful and Accuracy Statement)
- For transport use devices, conduct additional EMC and environmental testing
- Document conformance to applicable standards or justify any deviations
- Prepare test reports following the suggested format (protocol, data/results, analysis)
Key Considerations
Non-clinical testing
- Performance testing through either:
- Comparison testing with predicate device
- Conformance to EC13 standard
- Conformance to equivalent standards
- Environmental testing for expected use conditions
- Electromagnetic compatibility testing (emissions and immunity)
- Electrical safety testing
Software
- Documentation requirements based on level of concern (minor to moderate)
- Refer to “Guidance for Content of Premarket Submissions for Software Contained in Medical Devices”
Labelling
- Must comply with 21 CFR 807.87(e)
- Include EC13 standard labeling requirements if applicable
Biocompatibility
- Material descriptions required for all patient contacting materials
Safety
- Electrical safety testing per appropriate standards (ANSI/AAMI ES-1, IEC 601-1)
- EMC testing for hospital environment (minimum 3 V/m immunity)
- Enhanced EMC testing (20 V/m) for transport environment use
Other considerations
- Device description including intended use, contraindications, specifications
- Comparison to predicate device
- Regulatory requirements including Summary of Safety and Effectiveness or 510(k) Statement
- Truthful and Accuracy Statement
- Indications for Use Statement
Relevant Guidances
- Content of Premarket Submissions for Device Software Functions
- Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
Related references and norms
- ANSI/AAMI EC13-1992: Cardiac monitors, heart rate meters, and alarms
- ANSI/AAMI EC38-1994: Ambulatory electrocardiographs
- ANSI/AAMI ES1-1993: Safe current limits for electromedical apparatus
- IEC 60601-1-2: Medical Electrical Equipment - EMC Requirements and Tests
- IEC 68-2-6: Environmental Testing - Vibration
- IEC 529: Classification of Degrees of Protection Provided by Enclosures
Original guidance
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