Powered Muscle Stimulator Premarket Notification 510k Submissions

Recommended Actions

1. Prepare comprehensive device description including all technological characteristics
2. Document output waveforms with oscilloscope tracings for each mode
3. Provide detailed comparison to predicate device
4. Develop complete labeling package with all required safety information
5. Conduct necessary testing for patient leakage current and power density
6. Ensure compliance with 21 CFR 898 for lead wires and cables
7. Prepare software documentation if applicable
8. Document biocompatibility data for any new materials
9. Create user manual with all required safety information and instructions
10. Compile administrative documentation including 510(k) summary/statement

Key Considerations

Non-clinical testing

• Patient leakage current should be measured under normal and single fault conditions (<100μA and <500μA respectively)
• Maximum power density should be less than 0.25 Watts/cm2 to reduce thermal burn risks
• For devices with multiple output modes, testing documentation required for each mode

Human Factors

• Device should have patient override control
• For portable devices, warning against use while driving or operating machinery
• Clear user controls, displays and functions description required

Software

• Determination of level of concern
• Description of device functions controlled by software
• Hazard analysis
• Software functional requirements
• System-level test protocol with pass/fail criteria
• Summary of test results

Labeling

• Must include prescription statement per 21 CFR 801.109
• Complete user manual with device description, illustrations, controls, specifications
• Clear indications, contraindications, warnings, precautions and adverse reactions
• Cleaning/maintenance instructions if applicable
• Electrode placement and stimulation settings guidance

Biocompatibility

• For new electrode materials: sensitization and irritation data required
• Chemical composition of adhesive materials must be identified

Safety

• Automatic overload trip
• Automatic no-load trip
• Automatic shut off
• Method of line current isolation for AC-powered devices
• Compliance with 21 CFR 898 for electrode lead wires and patient cables

Other considerations

• Detailed comparison to predicate device required
• Output waveform documentation with oscilloscope tracings
• Basic unit characteristics documentation
• Output specifications for each mode
• Description of all accessories

  Relevant Guidances

• Content of Premarket Submissions for Device Software Functions
• Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
• Applying Human Factors Engineering and Usability Engineering to Medical Devices
• Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence

Related references and norms

• IEC 601-1: Medical electrical equipment safety standard

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Original guidance

• Powered Muscle Stimulator Premarket Notification 510k Submissions
• HTML / PDF
• Issue date: 1999-06-08
• Last changed date: 2023-02-15
• Status: FINAL
• Official FDA topics: Medical Devices, Premarket
• ReguVirta summary file ID: dfeadce47e3736c709800a9d98774fbc