Powered Muscle Stimulator Premarket Notification 510k Submissions
This guidance document provides updated and consolidated guidance for powered muscle stimulators classified under 21 CFR 890.5850 and reviewed under the 510(k) process. It outlines administrative, descriptive, and technical information requirements for 510(k) submissions.
What You Need to Know? 👇
What are the standard indications for use for Powered Muscle Stimulators under FDA regulations?
The FDA recognizes six standard indications: relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, and maintaining or increasing range of motion.
What key technical information must be included in a 510(k) submission for powered muscle stimulators?
Submissions must include output waveform tracings under different loads (500Ω, 2kΩ, 10kΩ), basic unit characteristics, output specifications, accessory descriptions, and software/firmware documentation. Patient leakage current measurements and compliance with safety standards are also required.
Are powered muscle stimulators considered prescription devices by the FDA?
Yes, powered muscle stimulators regulated under 21 CFR 890.5850 are prescription devices. They must display the federal prescription statement prominently on labels and labeling materials, restricting sale to licensed practitioners only.
What are the main contraindications and warnings for powered muscle stimulators?
The primary contraindication is use on patients with cardiac demand pacemakers. Key warnings include avoiding stimulation over carotid sinus, neck/mouth, transthoracically, transcerebrally, and over infected/inflamed areas or cancerous lesions.
What safety standards apply to electrode lead wires used with powered muscle stimulators?
Electrode lead wires and patient cables must comply with the mandatory performance standard in 21 CFR Part 898. For powered muscle stimulators, compliance became required on May 9, 2000, ensuring electrical safety and proper isolation.
What documentation is required for software-controlled powered muscle stimulators in 510(k) submissions?
Software documentation must include level of concern determination, description of software-controlled functions, hazard analysis, functional requirements, system-level test protocols with pass/fail criteria, and summary of test results following FDA software guidance.
What You Need to Do 👇
Recommended Actions
- Prepare comprehensive device description including all technological characteristics
- Document output waveforms with oscilloscope tracings for each mode
- Provide detailed comparison to predicate device
- Develop complete labeling package with all required safety information
- Conduct necessary testing for patient leakage current and power density
- Ensure compliance with 21 CFR 898 for lead wires and cables
- Prepare software documentation if applicable
- Document biocompatibility data for any new materials
- Create user manual with all required safety information and instructions
- 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