# DEN220066: BrainSee

- Pathway: De Novo (Direct)
- Applicant: Darmiyan, Inc.
- Decided: Jan 11, 2024 after 469 days
- Product code: QWT (Prognostic Assessment Software Of Mild Cognitive Impairment)
- Device class: 2
- Regulation: 21 CFR 882.1454
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
BrainSee is a software application indicated as a prognostic tool to aid in the clinical assessment of how likely patients aged between 55 and 95 years old who are diagnosed with amnestic mild cognitive impairment (aMCI) are to progress to clinical Alzheimer’s disease (AD)-dementia within 5 years of assessment. BrainSee analyzes inputs of brain magnetic resonance imaging (MRI), patient demographic information, and cognitive assessment scores to produce a similarity score between 0 and 100 reflecting the degree of similarity between the patient and two reference populations of aMCI patients who either did not progress to clinical AD-dementia within 5 years (non-converters) or progressed to clinical AD-dementia within 5 years (converters). Clinical AD-dementia is defined as probable Alzheimer’s disease established according to the National Institute of Neurological and Communicative Disorders and Stroke – Alzheimer’s Disease and Related Disorders Association (NINCDS-ADRDA) Alzheimer’s Criteria. • Similarity scores less than 50 indicate that a patient’s inputs are more similar to those of the non-converter population. • Similarity scores greater than 50 indicate that a patient’s inputs are more similar to those of the converter population. • Patients with a similarity score close to 50 have inputs that are similar to both the converter and non-converter aMCI patient populations used to develop and train the BrainSee device. The similarity score output is provided along with information to assist in the interpretation of the output to aid in evaluating the prognosis of patients diagnosed with aMCI to progress to clinical AD-dementia within 5 years. The BrainSee analysis is intended to provide supplemental information for interpretation in conjunction with a standard neurological assessment. Patient management decisions should not be made solely on the results of the BrainSee analysis. BrainSee is not indicated as a stand-alone diagnostic or prognostic tool. BrainSee should not be used to diagnose aMCI.

Source page: https://510kreport.com/device/DEN220066
Methodology: https://510kreport.com/methodology