Performance Testing and Safety Requirements for Single-Use Cutaneous Recording Electrodes
This guidance covers non-invasive, single-use cutaneous electrodes intended for recording purposes on normal, healthy, clean, intact skin. These Class II devices are regulated under 21 CFR 882.1320 (GXY). The guidance excludes electrodes for stimulation, MR use, reuse, dry electrodes, and those regulated under different regulations.
What You Need to Know? 👇
What are the key electrical performance criteria for cutaneous electrodes under FDA’s Safety and Performance Based Pathway?
Cutaneous electrodes must meet AC impedance limits (2 kOhms maximum average, 3 kOhms individual), offset voltage ≤100 mV, combined offset instability/noise ≤150 µV, and bias current tolerance ≤100 mV per ANSI/AAMI EC12 standards.
Which cutaneous electrodes are excluded from the Safety and Performance Based Pathway guidance?
Excluded devices include stimulation electrodes, MR-compatible electrodes, reusable electrodes, dry electrodes without electroconductive media, and devices regulated under different CFR sections like cardiac or surgical applications.
What biocompatibility testing is required for cutaneous recording electrodes?
Surface devices with intact skin contact require cytotoxicity, sensitization, and irritation/intracutaneous reactivity testing per ISO 10993-1. Testing may be waived if identical materials and manufacturing processes are used.
How does the Safety and Performance Based Pathway differ from traditional 510(k) submissions for electrodes?
This pathway allows manufacturers to demonstrate substantial equivalence using predetermined performance criteria rather than direct comparison testing against predicate devices, streamlining the regulatory process while maintaining safety standards.
What adhesive performance requirements must cutaneous electrodes meet?
Electrodes must pass pull tests (≤5% adhesive separation in 90% of tests), conformability tests (≤10% separation after 1 hour), and fluid tolerance tests (≤10% separation within 15 minutes) per IEC 60601-2-2.
Are there specific requirements for electrode lead wires in this guidance?
Yes, if included, lead wires must comply with ES 60601-1 standards for conductive connections to patients, ensuring protection from electrical shock hazards through proper connector construction and safety measures.
What You Need to Do 👇
Recommended Actions
- Verify device design characteristics match intended use and patient population
- Conduct electrical performance testing (AC Impedance, Offset Voltage, etc.)
- Perform adhesive performance testing
- Complete shelf life validation
- Conduct biocompatibility evaluation
- If applicable, ensure lead wire compliance with safety standards
- Prepare Declaration of Conformity (DoC) documentation for all required tests
- Consider Pre-Submission if additional testing beyond guidance scope is needed
- Prepare test results summary for all evaluations
- Ensure all manufacturing materials and processes are documented if using biocompatibility rationale
Key Considerations
Non-clinical testing
- AC Impedance: Maximum 2 kOhms (average), 3 kOhms (individual pair)
- Offset Voltage: Maximum 100 mV
- Combined offset instability and internal noise: Maximum 150 µV
- Bias Current Tolerance: Maximum 100 mV
- Adhesive Performance:
- Pull Test: ≤5% separation in 90% of tests
- Conformability: ≤10% separation after 1 hour
- Fluid Tolerance: ≤10% separation within 15 minutes after saline exposure
Biocompatibility
- Required testing for surface devices with intact skin contact:
- Cytotoxicity
- Sensitization
- Irritation or Intracutaneous Reactivity
Safety
- For electrode lead wires: Must comply with conductive connection requirements as per ES 60601-1
Other considerations
- Shelf Life testing required
- Device design (size, shape, type) must be appropriate for application site and intended use
- Size and spacing must be suitable for indicated patient population
Relevant Guidances 🔗
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Basic Safety and Essential Performance Standards for Medical Electrical Equipment Under the ASCA Pilot Program
- Recommended Format and Content for Non-Clinical Bench Performance Testing in Medical Device Premarket Submissions
- Safety and Performance Based Pathway for 510k Substantial Equivalence Demonstration
Related references and norms 📂
- ANSI/AAMI EC12: Disposable ECG Electrodes
- IEC 60601-2-2: Medical electrical equipment – Part 2-2: Particular requirements for basic safety and essential performance of high frequency surgical equipment
- ES 60601-1: Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance
- ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process