Cleared Traditional

K233496 - EndeavorOTC (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence.

K233496 · Akili Interactive Labs, Inc. · Neurology device
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Jun 2024
Decision
228d
Days
Class 2
Risk

K233496 is an FDA 510(k) clearance for the EndeavorOTC. Classified as Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder (product code QFT), Class II - Special Controls.

Submitted by Akili Interactive Labs, Inc. (Boston,, US). The FDA issued a Cleared decision on June 14, 2024 after a review of 228 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5803 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Akili Interactive Labs, Inc. devices

Submission Details

510(k) Number K233496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2023
Decision Date June 14, 2024
Days to Decision 228 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 148d · This submission: 228d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QFT Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5803
Definition A Digital Therapy Device For Attention Deficit Hyperactivity Disorder (adhd) Is A Software Intended To Provide Therapy For Adhd Or Any Of Its Individual Symptoms As An Adjunct To Clinician Supervised Treatment.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Neurology devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
Bhupinder Singh

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT05183919 Completed Interventional Industry-sponsored

Software Treatment for Actively Reducing Severity of ADHD in Adults (STARS ADHD Adult)

A Single Arm, Adaptive Design, Pivotal Trial to Assess the Efficacy of AKL-T01, a Novel Digital Intervention Designed to Improve Attention, in Adults Diagnosed With Attention Deficit Hyperactive Disorder

223
Patients (actual)
14
Sites
Treatment
Purpose
Open label
Masking
Condition studied Attention Deficit Hyperactivity Disorder
Study design Single group
Eligibility All sexes · 18 Years+
Sponsor Akili Interactive Labs, Inc. (industry)
Started 2021-11-29 → Primary completion 2023-01-13
Primary outcome
To evaluate the efficacy of AKL-T01 as determined by the change in a digitally assessed measure, Test of Variables of Attention (TOVA®) Attention Comparison Score (ACS), of sustained and selective attention, after 6 weeks of treatment with AKL-T01
Secondary outcome
To evaluate the change in ADHD symptoms, as determined by change in the ADHD Rating Scale-IV with adult prompts inattention sub-scale and total scale scores, after 6 weeks of treatment with AKL-T01
Study completed - no results published. This trial concluded in 2023 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov