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.
What You Need to Know? 👇
What are the key electrical safety requirements for oxygen conserving devices?
Oxygen conserving devices must include safeguards against electrical spark generation, such as reverse bias diodes or other methods to prevent ignition in enhanced oxygen environments. Power source requirements and battery backup capabilities must be clearly specified.
What pressure specifications are required for oxygen conserving device compatibility?
The device must specify the maximum pressure the oxygen source can deliver for proper functionality. Upper pressure limits should be clearly defined, such as compatibility with oxygen supplies outputting up to 25 psi.
What valve specifications are critical for oxygen conserving device safety?
The valve type used to restrict oxygen flow during expiration must be specified, including whether it’s normally open or closed. Critical safety requirement: the valve must permit oxygen flow to the patient in case of device failure.
What software validation is required for microprocessor-controlled oxygen conserving devices?
Microprocessor-controlled devices must conform to moderate software concern guidance documents. Software-controlled devices require alarm packages for microprocessor failure and must incorporate fail-safe design principles with appropriate alarm systems.
What labeling requirements apply to oxygen conserving devices under FDA regulations?
Oxygen conserving devices are prescription devices requiring labeling per 21 CFR Section 801.109. They must include prescription legends, standard oxygen concentration warnings, and accurate descriptions of device output parameters and compatible oxygen sources.
What inspiratory sensitivity specifications are required for oxygen conserving devices?
The device must demonstrate well-outlined inspiratory effort sensitivity, typically around 1 cm H₂O negative pressure, to provide accurate inspiration detection. This ensures proper timing of oxygen delivery during the respiratory cycle.
What You Need to Do 👇
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