Requirements for 510k Submissions for Oxygen Conserving Devices
This guidance outlines the requirements for 510(k) review of Oxygen Conserving Devices, classified as Class II non-continuous ventilators. These devices are used with oxygen sources for patients requiring supplemental oxygen, particularly those with conditions like COPD or Emphysema, and are specifically designed for use with nasal oxygen cannulas.
Recommended Actions
- Develop comprehensive device specifications documentation addressing all power, pressure, and flow requirements
- Implement and validate all required safety features and alarms
- Ensure proper spark prevention mechanisms are in place
- Develop complete labeling package including all required warnings and prescriptive elements
- Conduct verification testing for pressure limits and flow rates
- If software-controlled, ensure compliance with moderate software concern guidance
- Establish fail-safe mechanisms and alarm systems
- Create detailed documentation of valve characteristics and failure modes
- Validate inspiratory effort sensitivity
- Prepare comprehensive 510(k) submission package addressing all specified requirements
Key Considerations
Non-clinical testing
- Verification of maximum pressure limits for oxygen source compatibility
- Testing of valve functionality and failure modes
- Verification of flow rates compatibility (0.5 to 10 lpm)
- Testing of inspiratory effort sensitivity (approximately 1 cm H₂O negative pressure)
Software
- Compliance with moderate software concern guidance document for microprocessor-controlled devices
- Implementation of microprocessor failure alarms if software-controlled
Labelling
- Must comply with 21 CFR Section 801.109 for prescription devices
- Include prescription legend on device and labeling
- Specify compatible oxygen sources
- Include standard warning labels for elevated oxygen concentration environments
- Provide accurate description of device and output parameters
Safety
- Implementation of safeguards against electrical spark generation
- Protection against ignition in oxygen-enhanced environments
- Safeguards for moving metal parts
- Power failure or low battery alarms
- Flow failure alarms
- Fail-safe design considerations
Other considerations
- Specification of electrical power source requirements
- Battery backup availability
- Valve type and failure mode characteristics
- Impact on normal oxygen flow rate
Relevant Guidances
- Content of Premarket Submissions for Device Software Functions
- Off-The-Shelf Software in Medical Devices: Documentation Requirements for Premarket Submissions
- 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
Related references and norms
- 21 CFR 801.109: Prescription devices
Original guidance
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