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-DR analyzes the patient’s fundus photographs. It is a reusable, non-invasive, non-implantable, non-contact device.
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.
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.