We are hoping to use a supplier's component as part of our device, but this component (device) requires a 510(k). The supplier currently has a 510(k) on this component. What makes this situation interesting is that the rest of the device that the component is being attached to is Class 1 and does not require clearance.
1. Would it be possible to utilize the suppliers clearance for the "higher regulatory component" while not having to submit a 510(k) for the rest of the device (Class 1)?
2. Would the labeling need to match the 510(k)? As it is simply a component, our labeling/IFU would not be identical to the component device but the intended use is the same.
3. If a minor change (one that would not meet the requirements of the "when to submit a new 510(k) guidance") was made to the 510(k) component that would not affect its risk profile or performance, would we be required to submit a new 510(k) on the device since it is not our component 510(k) and is now being adulterated?
To give a better idea of a similar circumstance: Gas sampling lines are 510(k). Anesthesia gas masks which are regularly connected to gas sampling lines in practice are Class 1 exempt. If a manufacturer were to connect a gas sampling line to their anesthesia gas mask before placing it into the market, could they rely on their supplier's 510(k) for that component of the mask (the gas sampling line)? Obviously in clinical practice you would not be changing the risk profile of the mask at all, but I haven't seen anything that specifically addresses this scenario.
Thanks in advance for any insight into this!
1. Would it be possible to utilize the suppliers clearance for the "higher regulatory component" while not having to submit a 510(k) for the rest of the device (Class 1)?
2. Would the labeling need to match the 510(k)? As it is simply a component, our labeling/IFU would not be identical to the component device but the intended use is the same.
3. If a minor change (one that would not meet the requirements of the "when to submit a new 510(k) guidance") was made to the 510(k) component that would not affect its risk profile or performance, would we be required to submit a new 510(k) on the device since it is not our component 510(k) and is now being adulterated?
To give a better idea of a similar circumstance: Gas sampling lines are 510(k). Anesthesia gas masks which are regularly connected to gas sampling lines in practice are Class 1 exempt. If a manufacturer were to connect a gas sampling line to their anesthesia gas mask before placing it into the market, could they rely on their supplier's 510(k) for that component of the mask (the gas sampling line)? Obviously in clinical practice you would not be changing the risk profile of the mask at all, but I haven't seen anything that specifically addresses this scenario.
Thanks in advance for any insight into this!
