21 CFR 882.2000 — Parkinsonian Syndrome Diagnostic Aid
Neurology (NE) · Part 882 Subpart C · § 882.2000
Identification
The neuropacs™ system is a software application intended to receive and analyze diffusion MRI data from patients aged 40 years and older with either Parkinson's Disease (PD), Multiple System Atrophy Parkinsonian variant (MSAp), or Progressive Supranuclear Palsy (PSP). The system provides a classification report based on degenerative brain patterns of MSAp and PSP to help neuroradiologists and/or neurologists in differentiating these diseases from PD. It is intended for adjunctive use in conjunction with a standard neurological assessment and other clinical tests and is not a stand-alone diagnostic.
Classification Rationale
FDA has determined that the device can be classified in class II with the establishment of special controls for class II. FDA believes that class II (special) controls provide reasonable assurance of the safety and effectiveness of the device type.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| SHO | Parkinsonian Syndrome Diagnostic Aid | 2 | 1 | SaMD |
Special Controls
SHO — Parkinsonian Syndrome Diagnostic Aid
(1) Clinical performance validation testing acquired under anticipated conditions of use must demonstrate that the device performs as intended when used to analyze data from the intended patient population. Testing must demonstrate the diagnostic accuracy and reproducibility for evaluating Parkinsonian syndromes compared to a clinically relevant reference standard. Objective performance measures must be reported. (2) Software verification, validation, and hazard analysis must be provided. Software documentation must include a technical description of the model/algorithm(s), and algorithm inputs and outputs. (3) Labeling must include: (i) A detailed summary of the clinical performance testing methods, including results of the performance testing for tested performance measures/metrics, selection criteria, and the patient demographics; (ii) A description of the patient population that was used in development or training of the device algorithm/model; (iii) Device limitations or subpopulations for which the device may not perform as expected or for whom the device has not been validated, including information about how to incorporate device use into the clinical diagnostic workflow; (iv) A statement that the device is not a stand-alone diagnostic tool and that the device output should only be interpreted in the context of all available clinical information; and (v) Information for interpretation of the device outputs detailing the risks associated with misinterpretation of the device outputs.
De Novo Order DEN240071
