mohanvijay
Registered
Dear All,
I'm writing this post to seek the guidance which help us to get out of this difficult situation.
We are ophthalmic medical device manufacturers located in India. We are manufacturing pediatric contact based retinal camera to capture the fundus and Fluorescence angiography images.
We submitted 510(k) for the above device, which is classified under Product Code: HKI and risk class: II. And recently our submission is rejected by FDA which states that High level disinfection is not provided for probe.
Our explaination:
Subject device have been divided into two parts
1. Lens and outer cone (together called the front cone), which comes in contact with the intended anatomical location of use and,
2. The rest of the device, which includes the probe/cord/control box and does not come into contact with the intended anatomical location of use
Based on this categorisation, only the front cone part may be classified a semi critical component which requires validated cleaning and disinfection instructions to be provided to the user.
Response from FDA:
This statement is incorrect as the front cone is part of the probe, therefore the probe is also a semi critical component and needs to be sterilized or high level disinfected.
In this case how can we do HLD (High level disinfection) of probe which cannot be submerged into the disinfectant (since it is non IP rated containing electrical & electronic components) nor sterilization not also possible.
How can we proceed further? Please awaiting for valuable discussion from here.
Regards,
Mohan Vijay
Engineer - QA&RA
I'm writing this post to seek the guidance which help us to get out of this difficult situation.
We are ophthalmic medical device manufacturers located in India. We are manufacturing pediatric contact based retinal camera to capture the fundus and Fluorescence angiography images.
We submitted 510(k) for the above device, which is classified under Product Code: HKI and risk class: II. And recently our submission is rejected by FDA which states that High level disinfection is not provided for probe.
Our explaination:
Subject device have been divided into two parts
1. Lens and outer cone (together called the front cone), which comes in contact with the intended anatomical location of use and,
2. The rest of the device, which includes the probe/cord/control box and does not come into contact with the intended anatomical location of use
Based on this categorisation, only the front cone part may be classified a semi critical component which requires validated cleaning and disinfection instructions to be provided to the user.
Response from FDA:
This statement is incorrect as the front cone is part of the probe, therefore the probe is also a semi critical component and needs to be sterilized or high level disinfected.
In this case how can we do HLD (High level disinfection) of probe which cannot be submerged into the disinfectant (since it is non IP rated containing electrical & electronic components) nor sterilization not also possible.
How can we proceed further? Please awaiting for valuable discussion from here.
Regards,
Mohan Vijay
Engineer - QA&RA
