Indications for Use - European Union

IDx-DR is intended for use by health care providers to automatically detect more than mild diabetic retinopathy (mtmDR) in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy.  

Short Description of IDx-DR

IDx-DR is a software device, consisting of a server connected to the internet and a software client  that can automatically determine whether patients with diabetes have referable retinopathy.  The output helps decide whether  that patient  needs referral  to  an  eye  care  provider.  In  cases  where  the  IDx-DR  test provides  no  result the patient  should  always  be  referred.  To  make  this determination, IDx- It is a reusable,  non-invasive,  non-implantable,  non-contact device. 

Intended Use

Screen patients who  are  at  risk  for  diabetic  retinopathy and  have  no visual complaints  and  no  history  of  retinal disease.   IDx-DR can autonomously detect diabetic retinopathy  in adult  people with  diabetes.  The  output  helps  the  health care  provider  to  decide  which  patients  need immediate  referral to  an  eye-care provider  for  further  screening and treatment.   It  provides  a  quantitative  aid  for the diagnosis and  management  of diabetic  retinopathy.  If  IDx-DR  is not  able  to generate  a  screening  result  following the  IDx-DR imaging  protocol  and troubleshooting,  the patient should  be  referred  to  an  eye  care  provider.  Images have  to  be  retinal images  of  at least  reasonable  quality as  set  forward in  the operating  manual.   IDx-DR  is intended  for  use  on  retinal color  images  from digital fundus cameras.  

Reasonably foreseeable medical conditions for which the device is not to be used

The  devices  should  only  be used  for  detection of  retinopathy  in  people  with diabetes  with  no  visual  complaints, and  is  not suitable for  detection  of  other  eye diseases or  detection of  retinopathy  in  patients  with  visual  complaints. 

Indications for Use

IDx-DR is intended for use by health care providers to detect diabetic retinopathy in adult people with diabetes by analyzing color images of the retina.  

Contraindications

IDx-DR exclusion criteria:   

  • Persistent vision loss, blurred vision, or floaters. 
  • Diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or central or branch retinal vein occlusion (CRVO or BRVO). 
  • History of laser treatment of the retina or injections into either eye, or any history of retinal surgery.  
  • Patient is contraindicated for imaging by the fundus imaging system used to obtain retinal images.