Preparing 510k Submissions for Heating and Cooling Therapeutic Devices
This guidance document outlines the requirements for preparing 510(k) premarket notifications for heating and cooling devices, including powered heating units, powered heating pads, infrared lamps, water circulating hot/cold packs, and chemical hot/cold packs.
What You Need to Know? 👇
What are the key regulatory requirements for submitting a 510(k) for heating and cooling medical devices?
A 510(k) submission must include administrative information, device identification, descriptive information with intended use, substantial equivalence comparison to a predicate device, materials specifications, labeling requirements, and a truthful statement. Temperature ranges and safety warnings are mandatory.
Which device classifications fall under the heating and cooling devices guidance?
The guidance covers devices classified under 21 CFR 890.5950 (Powered Heating Unit), 890.5740 (Powered Heating Pad), 890.5500 (Infrared Lamp), 890.5720 (Water Circulating Hot/Cold Pack), and Class I 890.5710 (Chemical Hot/Cold Pack).
What specific safety warnings must be included in labeling for heating and cooling devices?
All devices must include the warning: “WARNING: Use carefully. May cause serious burns. Do not use over sensitive skin areas or in the presence of poor circulation. The unattended use of [device] by children or incapacitated persons may be dangerous.”
How do I identify an appropriate predicate device for substantial equivalence comparison?
You must identify a legally marketed predicate device with the same intended use. Provide evidence of pre-1976 interstate commerce through advertisements, catalogs, or shipping documents, or reference existing 510(k) numbers available through FDA’s Electronic Docket system.
What technical specifications are required for different types of heating and cooling devices?
Requirements vary by device type: infrared lamps need distance specifications, powered devices require leakage current data, water circulating packs need flow rate and pressure specifications, and all devices must specify temperature ranges at skin surface contact.
Can a single 510(k) submission cover multiple heating and cooling devices?
No, each product requires a separate 510(k) submission per 21 CFR 807.90(d). However, one submission can describe multiple components or attachments of a single device, provided each component is compared to the predicate device or noted as absent.
What You Need to Do 👇
Recommended Actions
- Prepare comprehensive device description including all required technical specifications
- Document all materials and their specifications
- Develop required labeling with mandatory warning statement
- Conduct temperature range testing and documentation
- Perform leakage current testing for applicable devices
- Prepare substantial equivalence comparison with predicate device
- Compile engineering drawings and photographs
- Prepare 510(k) summary or statement
- Include truthful and accurate statement
- Ensure all promotional materials are included
- Verify compliance with specific requirements based on device type (e.g., flow rate for water circulating devices, distance specifications for infrared lamps)
Key Considerations
Non-clinical testing
- Temperature range of the device must be specified
- Temperature range at the skin surface where device is applied must be specified
- For water circulating hot/cold packs: flow rate, pressure, and liquid specifications required
- Leakage current must be specified for powered heating pads, infrared lamps, and water circulating hot/cold packs
- For infrared lamps: distance from application area must be specified
Labelling
- Must include draft or sample package labeling and package inserts with complete operator’s instructions
- Must include copies of promotional materials
- Mandatory warning statement required: “WARNING: Use carefully. May cause serious burns. Do not use over sensitive skin areas or in the presence of poor circulation. The unattended use of ……. by children or incapacitated persons may be dangerous.”
Biocompatibility
- Materials for each component must be identified
- Any additional processing affecting material properties must be specified
- For powered heating pads: heating pad cover material must be specified
- For hot/cold packs: chemicals and activators must be described
Safety
- Leakage current specifications required for applicable devices
- Temperature ranges must be specified for safety assessment
Other considerations
- Device description must include engineering drawings and/or photographs
- Complete written descriptions of internal and external features required
- Substantial equivalence comparison with predicate device required
- 510(k) summary or statement required
- Truthful and accurate statement required
Relevant Guidances 🔗
- 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
- Device Labeling Requirements and Content for Premarket Approval Applications
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
Related references and norms 📂
- 21 CFR Part 807: Requirements for premarket notification procedures
- 21 CFR 890.5950: Powered Heating Unit classification
- 21 CFR 890.5740: Powered Heating Pad classification
- 21 CFR 890.5500: Infrared Lamp classification
- 21 CFR 890.5720: Water Circulating Hot or Cold Pack classification
- 21 CFR 890.5710: Chemical Hot/Cold Pack classification