| Device |
prognostic assessment software of mild cognitive impairment |
| Definition |
Prognostic assessment software of mild cognitive impairment. Prognostic assessment software of mild cognitive impairment is a prescription-only device that combines information from multiple clinical data sources to produce an output indicative of the likelihood that a patient diagnosed with mild cognitive impairment will progress to more severe forms of cognitive impairment, or will develop dementia, such as Alzheimer’s disease dementia, within a specified period of time. This device is intended for adjunctive use and not intended as a stand-alone diagnostic or prognostic too. |
| Physical State |
Software for analyzing multiple clinical inputs including, but not limited to, medical images, patient demographic information, and clinical test scores. The device may include software for pre-processing and reviewing the algorithmic inputs. |
| Technical Method |
Software analyzes patient-specific clinical and imaging data to aid in prognosis of patients with mild cognitive impairment. May use algorithmic approaches to produce an output indicative of a patient’s likelihood for progression to more severe cognitive impairment, or will develop dementia, such as Alzheimer’s disease dementia. |
| Target Area |
N/A |
| Regulation Medical Specialty |
Neurology |
| Review Panel |
Neurology |
|---|
| Product Code | QWT |
|---|
| Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices
(DHT5A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
882.1454
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
