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510(k) Data Aggregation
K Number
K243729Device Name
Prismira
Manufacturer
Date Cleared
2025-06-13
(192 days)
Product Code
Regulation Number
882.5803Why did this record match?
Applicant Name (Manufacturer) :
Lumos Labs, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Prismira is a digital therapeutic indicated to improve attention function in adults ages 22-55 years old with primarily inattentive or combined-type Attention Deficit and Hyperactivity Disorder (ADHD). Patients who engage with Prismira demonstrate improvements in a digitally assessed measure of sustained and selective attention, Test of Variables of Attention (TOVA), and may not display benefits in typical behavioral symptoms, such as hyperactivity.
Prismira should be considered for use as part of a therapeutic program that may include clinician directed therapy, medication, and/or educational programs, which further address symptoms of the disorder.
Device Description
Prismira is software-as-a-medical device (SaMD) that resides on the user's mobile device and can be executed at home.
Prismira is a prescription digital therapeutic indicated to improve attention function in patients 22 and older with primarily inattentive or combined type ADHD. Patients who engage with Prismira demonstrate improvements in attention functioning and may not display benefits in other behavioral symptoms such as hyperactivity. Prismira is intended to be used as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder.
The Prismira App also includes an Engagement System to promote compliance with the treatment. The Engagement System gives the patient encouragement and feedback on progress at multiple timescales: performance on the most recent gameplay and historical game performance, completion of the daily assignment, progress toward the weekly target in the current week, and historical assignment completion.
Each game includes visual and optional auditory stimulus presentation. The basic input from the patient includes physical interaction with a touch screen accomplished by using the mobile device. The device's feedback within each game includes visual and optional auditory responses to the inputs. Output from each game includes a score earned by playing the game. Each gameplay is brief, typically between 1 and 5 minutes in duration, depending on the game. The treatment program guides patients through an ordered list of games (the "script") that enables subjects to engage in the recommended daily regimen (approximately 15 minutes per day).
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