(219 days)
Not Found
Yes
The device description explicitly mentions "adaptive algorithms (also known as Selective Stimulus Management Engine, SSME™)" and states that these algorithms "automatically adjust the difficulty level for a personalized treatment experience." While not explicitly using the terms "AI" or "ML," adaptive algorithms that personalize treatment based on user performance are a common application of machine learning techniques. The description of a "closed-loop system" where the algorithms "constantly pushes patients precisely at predefined performance bounds relative to each individual" further supports the use of adaptive, likely ML-driven, technology.
Yes
The "Intended Use / Indications for Use" section explicitly states that EndeavorRx is a "digital therapeutic indicated to improve attention" and is "part of a therapeutic program." Additionally, the "Device Description" labels it as a "prescription-only digital therapeutic software indicated for use in the treatment of attention impairment."
No
EndeavorRx is described as a "digital therapeutic indicated to improve attention" and a "therapeutically active treatment for attention," not a diagnostic tool. While it uses a digitally assessed measure (TOVA) to track improvement, this is a measure of effect, not a diagnostic measure for ADHD itself.
Yes
The device description explicitly states "EndeavorRx is a software-as-a-medical device (SaMD) that resides on the user's mobile device". It also describes the inputs and outputs as utilizing the mobile device's internal components (accelerometer, touch screen, display, speaker) and does not mention any external hardware components included with the device.
Based on the provided text, EndeavorRx is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples from the human body. The definition of an IVD involves examining specimens derived from the human body (like blood, urine, tissue, etc.) to provide information about a person's health.
- EndeavorRx is a digital therapeutic. It is a software-as-a-medical device (SaMD) that the patient interacts with directly through a mobile device. It does not analyze any biological samples.
- Its purpose is treatment, not diagnosis. The intended use is to "improve attention as measured by computer-based testing" and is used "as part of a therapeutic program." While it uses a computer-based test (TOVA) to measure attention, this is a measure of the effect of the therapy, not a diagnostic test performed on a biological sample.
Therefore, EndeavorRx falls under the category of a therapeutic device, specifically a digital therapeutic, rather than an In Vitro Diagnostic.
No
The letter does not mention any FDA review or approval of a Predetermined Change Control Plan (PCCP) for this device.
Intended Use / Indications for Use
EndeavorRx is a digital therapeutic indicated to improve attention as measured by computer-based testing in children ages 8-17 years old with primarily inattentive or combined-type ADHD, who have demonstrated attention issue. Patients who engage with EndeavorRx demonstrate improvements in a digitally assessed measure Tests of Variables of Attention (TOVA) of sustained and selective attention and may not display benefits in typical behavioral symptoms, such as hyperactivity. EndeavorRx 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.
Product codes (comma separated list FDA assigned to the subject device)
OFT
Device Description
EndeavorRx is a modification to the previously granted EndeavorRx (DEN200026) with the primary difference being the expansion of the indicated patient population from 8-12 years old to 8-17 years old. In addition, minor software changes were made to improve app accessibility and user engagement. The core therapeutic software technology was not changed.
EndeavorRx is a prescription-only digital therapeutic software indicated for use in the treatment of attention impairment in pediatric patients (8-17 years of age) with primarily inattentive or combinedtype ADHD. EndeavorRx is a software-as-a-medical device (SaMD) that resides on the user's mobile device and can be executed at home.
EndeavorRx is engineered as a therapeutically active treatment for attention in pediatric patients affected by ADHD. EndeavorRx is built on Akili's proprietary, patented, technology platform and uses adaptive algorithms (also known as Selective Stimulus Management Engine, SSME™) to deliver stimuli that are designed to engage the patient in a manner that improves their attention function. In a closedloop system, the adaptive SSME™ algorithms automatically adjust the difficulty level for a personalized treatment experience that is tailored to the needs of each individual patient.
EndeavorRx is delivered through a video game experience which leverages art, music, storytelling, and reward cycles to keep patients engaged. The adaptive algorithm constantly pushes patients precisely at predefined performance bounds relative to each individual, such that they are continuously encouraged to exceed their historic performance. The science behind EndeavorRx was developed at the University of California, San Francisco by Adam Gazzaley, M.D., Ph.D., Founding Director of the University of California San Francisco's Neuroscape and Akili's Chief Science Advisor.
The basic program inputs are steering, which is accomplished by using the mobile device's internal accelerometer to measure the degree to which it is tilted, and tapping, which is accomplished using the touch screen to measure correct and incorrect targeting. The basic outputs are the visual display of the game progression along with audio, which is accomplished by using the internal high resolution display and internal speaker. The program includes features to ensure it is used per the prescribed regimen (approximately 25 minutes per day, 5 days per week, for 4 weeks or as recommended by the health care provider).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
EndeavorRx is built on Akili's proprietary, patented, technology platform and uses adaptive algorithms (also known as Selective Stimulus Management Engine, SSME™) to deliver stimuli that are designed to engage the patient in a manner that improves their attention function. In a closedloop system, the adaptive SSME™ algorithms automatically adjust the difficulty level for a personalized treatment experience that is tailored to the needs of each individual patient.
The adaptive algorithm constantly pushes patients precisely at predefined performance bounds relative to each individual, such that they are continuously encouraged to exceed their historic performance.
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
8-17 years old
Intended User / Care Setting
Used in the treatment of attention impairment in pediatric patients by prescription only. It can be executed at home.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Performance Data: Bench software testing has been performed on the EndeavorRx and demonstrates compliance with the following international and FDA-recognized consensus standards and FDA guidance documents:
- ISO 14971:2019 Medical devices - Application of risk management to medical devices
- IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION ● Medical device software - Software life cycle processes
- IEC 82304-1 Edition 1.0 2016-10 Health software - Part 1: General requirements for product safety
- FDA Guidance Document for Industry and FDA Staff -Guidance for the content of Premarket Submissions for Software Contained in Medical Devices, issued May 11, 2005
- . FDA Guidance Document for Industry and FDA Staff -Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, issued October 2, 2015
The results of bench software verification and validation testing supports that EndeavorRx functions as intended.
Summary of Clinical Performance Data: Efficacy and safety of EndeavorRx in adolescents 13 to 17 years of age.
- Study Type: Multi-center open-label, single-arm study.
- Sample Size: 162 adolescents subjects with inattentive or combined-type ADHD were enrolled. 146 subjects in the Efficacy Population.
- Key Results:
- Primary efficacy endpoint (TOVA): significant positive mean change from baseline to study day 28 of 2.639 (SD 3.7986 [95% Cl: 2.018, 3.261]; P 0:** 24.7% for subject device, 11% for predicate device.
- % Responders with > 1.4 point change on TOVA-ACS: N/A (66.4% for ≥ 1.0 point improvement from Baseline to Day 28) for subject device, 46.7% for predicate device.
- % Responders with >30% change in ADHD-RS Total Score: 27% for subject device, 24% for predicate device.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5803 Digital therapy device for Attention Deficit Hyperactivity Disorder.
(a)
Identification. 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.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must demonstrate and document the following under the labeled conditions for use, which include considerations for the ability of the device to:
(i) Use a validated measure to evaluate effectiveness of device to provide therapy for ADHD or any of its individual symptoms; and
(ii) Capture all adverse events.
(2) Software must be described and provided in a clear and detailed manner to include all features and functions of the software implementing the digital therapy. Software verification, validation, and hazard analysis must also be provided.
(3) The labeling must include the following items:
(i) Patient and physician labeling must include instructions for use, including images that demonstrate how to interact with the device;
(ii) Patient and physician labeling must list the minimum operating system (OS) requirements that support the software of the device;
(iii) Patient and physician labeling must include a warning that the digital therapy device is not intended for use as a standalone therapeutic device;
(iv) Patient and physician labeling must include a warning that the digital therapy device does not represent a substitution for the patient's medication; and
(v) Physician labeling must include a summary of the clinical performance testing conducted with the device.
0
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December 13, 2023
Akili Interactive Labs, Inc. Bhupinder Singh Head of Quality and Regulatory Affairs 22 Boston Wharf Road 7th Floor Boston, MA 02210
Re: K231337
Trade/Device Name: EndeavorRx Regulation Number: 21 CFR 882.5803 Regulation Name: Digital therapy device for attention deficit hyperactivity disorder Regulatory Class: Class II Product Code: OFT Dated: November 13, 2023 Received: November 13, 2023
Dear Bhupinder Singh:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Robert Kang -S
for Pamela Scott, MS Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K231337
Device Name EndeavorRx
Indications for Use (Describe)
EndeavorRx is a digital therapeutic indicated to improve attention as measured by computer-based testing in children ages 8-17 years old with primarily inattentive or combined-type ADHD, who have demonstrated attention issue. Patients who engage with EndeavorRx demonstrate improvements in a digitally assessed measure Tests of Variables of Attention (TOVA) of sustained and selective attention and may not display benefits in typical behavioral symptoms, such as hyperactivity. EndeavorRx should be considered for use as part of a therapeutic program that may include: cliniciandirected therapy, medication, and/ or educational programs, which further address symptoms of the disorder.
Type of Use (Select one or both, as applicable)
| Reproduction Use (Part 21 CFR 201 Subpart D) | Sample, Test, or Control Use (21 CFR 201.25) |
|---|---|
| -------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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8. 510(k) Summary
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR § 807.92.
| Date Prepared: | May 5, 2023 |
|---|---|
| Legal Manufacturer: | Akili Interactive Labs, Inc. |
| 125 Broad Street, 5th Floor | |
| Boston, MA 02110 | |
| Primary Contact Person: | Bhupinder Singh |
| Head of Quality and Regulatory Affairs | |
| Phone: +1 (408) 832-7124 | |
| E-mail: bsingh@akiliinteractive.com |
Regulatory Information
| Device Trade Name: | EndeavorRx |
|---|---|
| Device Classification Name: | Digital Therapeutic Software for Attention Deficit |
| Hyperactivity Disorder | |
| Regulation Number: | 21 CFR § 882.5803 |
| Classification Product Code: | QFT |
| Review Advisory Committee: | Neurology |
| Device Classification: | Class II |
Predicate Device Information
| Device Manufacturer: | Akili Interactive Labs, Inc. |
|---|---|
| ---------------------- | ------------------------------ |
- Submission Number: DEN200026
- Device Name: EndeavorRx
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Image /page/5/Picture/0 description: The image shows the word ".KILI" in white font against a blue background. The font is stylized with rounded edges and a slightly futuristic look. The dot before "KILI" is small and round, and the letters themselves are bold and sans-serif.
Device Description: EndeavorRx is a modification to the previously granted EndeavorRx (DEN200026) with the primary difference being the expansion of the indicated patient population from 8-12 years old to 8-17 years old. In addition, minor software changes were made to improve app accessibility and user engagement. The core therapeutic software technology was not changed.
EndeavorRx is a prescription-only digital therapeutic software indicated for use in the treatment of attention impairment in pediatric patients (8-17 years of age) with primarily inattentive or combinedtype ADHD. EndeavorRx is a software-as-a-medical device (SaMD) that resides on the user's mobile device and can be executed at home.
EndeavorRx is engineered as a therapeutically active treatment for attention in pediatric patients affected by ADHD. EndeavorRx is built on Akili's proprietary, patented, technology platform and uses adaptive algorithms (also known as Selective Stimulus Management Engine, SSME™) to deliver stimuli that are designed to engage the patient in a manner that improves their attention function. In a closedloop system, the adaptive SSME™ algorithms automatically adjust the difficulty level for a personalized treatment experience that is tailored to the needs of each individual patient.
EndeavorRx is delivered through a video game experience which leverages art, music, storytelling, and reward cycles to keep patients engaged. The adaptive algorithm constantly pushes patients precisely at predefined performance bounds relative to each individual, such that they are continuously encouraged to exceed their historic performance. The science behind EndeavorRx was developed at the University of California, San Francisco by Adam Gazzaley, M.D., Ph.D., Founding Director of the University of California San Francisco's Neuroscape and Akili's Chief Science Advisor.
The basic program inputs are steering, which is accomplished by using the mobile device's internal accelerometer to measure the degree to which it is tilted, and tapping, which is accomplished using the touch screen to measure correct and incorrect targeting. The basic outputs are the visual display of the game progression along with audio, which is accomplished by using the internal high resolution display and internal speaker. The program includes features to ensure it is used per the prescribed regimen (approximately 25 minutes per day, 5 days per week, for 4 weeks or as recommended by the health care provider).
Indications for Use:
EndeavorRx is a digital therapeutic indicated to improve attention
AKILI CONFIDENTIAL
Akili Interactive Labs, Inc. Premarket Notification [510(k) Submission] EndeavorRx
6
Image /page/6/Picture/0 description: The image shows the word ".KILI" in white font against a blue background. The font is stylized with rounded edges and a modern look. The dot before "KILI" is small and round, and the letters are spaced closely together.
| function as measured by computer-based testing in children ages 8-17 years old with primarily inattentive or combined-type ADHD, who have demonstrated attention issue. Patients who engage with EndeavorRx demonstrate improvements in a digitally assessed measure Tests of Variables of Attention (TOVA) of sustained and selective attention and may not display benefits in typical behavioral symptoms, such as hyperactivity. EndeavorRx 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. | |
|---|---|
| Limitations | Prescription-only medical device restricted to sale by or on the order of a licensed health care provider. |
| EndeavorRx may not be appropriate for patients with photo-sensitive epilepsy, color blindness, or physical limitations that restrict use of a mobile device; parents should consult with their child's health care provider. | |
| This single arm study did not include a sham control group and it is therefore possible that a placebo effect may have impacted the study results by inflating the effect of the EndeavorRx device. The study had sufficient statistical power to detect a significant effect of treatment compared to a similarly sized control group with placebo response of up to a 1.7-point improvement in TOVA-ACS. Patients and health care providers should consider the totality of the clinical evidence in light of this before using this product. |
| Attribute | Subject Device:
EndeavorRx v3.0 | Predicate Device:
EndeavorRx (DEN200026) | Comparison |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Akili Interactive Labs, Inc. | Akili Interactive Labs, Inc. | Same |
| Device
Classification Name | Digital Therapeutic Software
for Attention Deficit
Hyperactivity Disorder | Digital Therapeutic Software
for Attention Deficit
Hyperactivity Disorder | Same |
| Product Code | QFT | QFT | Same |
| Regulation Number | 21 CFR § 882.5803 | 21 CFR § 882.5803 | Same |
| Intended Use | Digital therapeutic adaptive
stimulus software for the
closed-loop treatment of | Digital therapeutic adaptive
stimulus software for the
closed-loop treatment of | Same |
| | psychiatric disorders and
cognitive dysfunction
associated with medical
conditions. | psychiatric disorders and
cognitive dysfunction
associated with medical
conditions. | |
| Indications for Use | EndeavorRx is a digital
therapeutic indicated to
improve attention function as
measured by computer based
testing in children ages 8-17
years old with primarily
inattentive or combined-type
ADHD, who have a
demonstrated attention issue.
Patients who engage with
EndeavorRx demonstrate
improvements in a digitally
assessed measure Tests of
Variables of Attention (TOVA)
of sustained and selective
attention and may not display
benefits in typical behavioral
symptoms, such as
hyperactivity. EndeavorRx
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. | EndeavorRx is a digital
therapeutic indicated to
improve attention function as
measured by computer based
testing in children ages 8-12
years old with primarily
inattentive or combined-type
ADHD, who have a
demonstrated attention issue.
Patients who engage with
EndeavorRx demonstrate
improvements in a digitally
assessed measure Tests of
Variables of Attention (TOVA)
of sustained and selective
attention and may not display
benefits in typical behavioral
symptoms, such as
hyperactivity. EndeavorRx
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. | Substantially
equivalent.
EndeavorRx v3.0
is indicated for a
larger range of
pediatric
patients (8-17
years of age)
compared to the
predicate device
(8-12 years of
age). This does
not change the
intended use of
the device, and
clinical testing
demonstrates
the subject
device is safe and
effective in the
expanded
population. |
| System
Components | Patient facing video game
application
Mobile device platform | Patient facing video game
application
Mobile device platform | Same |
| Proprietary
Algorithm | Selective Stimulus
Management Engine
(SSMETM) | Selective Stimulus
Management Engine
(SSMETM) | Same |
| Basic Operations | Steering, Tapping, Multi-
tasking | Steering, Tapping, Multi-
tasking | Same |
| Presentation | Structured manner across | Structured manner across | Same |
| | game "Challenges" and
"Worlds" | game "Challenges" and
"Worlds" | |
| Mobile Platform
Compatibility | iOS and Android | iOS | Substantially
equivalent.
Addition of
Android
compatibility
does not present
different
questions. |
| Access | Prescription use only.
Authorized and overseen by a
licensed health care provider. | Prescription use only.
Authorized and overseen by a
licensed health care provider. | Same |
Summary Comparison of technological Characteristics
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.KILI
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Image /page/8/Picture/0 description: The image shows the word ".AKILI" in white font against a blue background. The font is stylized with rounded edges and unique shapes for each letter. The dot before "AKILI" is a small circle, and the "A" is shaped like a triangle with a rounded top.
Summary of Non-Clinical Performance Data: Bench software testing has been performed on the EndeavorRx and demonstrates compliance with the following international and FDA-recognized consensus standards and FDA guidance documents:
- ISO 14971:2019 Medical devices - Application of risk management to medical devices
- IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION ● Medical device software - Software life cycle processes
- IEC 82304-1 Edition 1.0 2016-10 Health software - Part 1: General requirements for product safety
- FDA Guidance Document for Industry and FDA Staff -Guidance for the content of Premarket Submissions for Software Contained in Medical Devices, issued May 11, 2005
- . FDA Guidance Document for Industry and FDA Staff -Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, issued October 2, 2015
The results of bench software verification and validation testing supports that EndeavorRx functions as intended.
Summary of Clinical performance testing was conducted to evaluate the efficacy and safety Clinical Data: of EndeavorRx in adolescents 13 to 17 years of age. Efficacy was determined primarily by the change from baseline in a digitally assessed measure of sustained and selective attention, the Test of Variables of Attention (TOVA®), after 4 weeks of treatment. The multi-center open-label study enrolled 162 adolescents subjects with inattentive or combined-type ADHD. The results of the clinical performance study support the performance and safety of
AKILI CONFIDENTIAL
Akili Interactive Labs, Inc. Premarket Notification [510(k) Submission] EndeavorRx
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Image /page/9/Picture/0 description: The image shows the word ".KILI" in white font against a blue background. The font is stylized with rounded edges and a modern look. The dot before "KILI" is small and round, and the letters are evenly spaced.
EndeavorRx in the expanded pediatric age range. Analysis of the primary efficacy endpoint in the Efficacy Population (N=146) showed a significant positive mean change from baseline to study day 28 in the TOVA of 2.639 (SD 3.7986 [95% Cl: 2.018, 3.261]; P 0 | 24.7% | 11% | The percentage of
responders with final
TOVA score ≥0 is more
than doubled in
adolescents as compared
to STARS |
| 5. % Responders with >
1.4 point change on
TOVA-ACS | N/A (66.4% for ≥ 1.0
point improvement
from Baseline to Day
28) | 46.7% | Adolescents show a
similarly positive rate |
| 6. % Responders with
30% change in ADHD-
RS Total Score | 27% | 24% | Higher percentage of
responders in
adolescents than STARS.
Clinically meaningful
improvement based on
literature for the ADHD-
RS is estimated at 10
point difference3 or a
30% change in Total |
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Comparison of Inclusion/Exclusion Criteria for Subject and Predicate Studies
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Image /page/20/Picture/0 description: The image shows the word ".AKILI" in white font against a blue background. The font is stylized with rounded edges and unique letterforms. The dot before "AKILI" is a small circle, and the "A" is designed with a slanted line and a curved shape.
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Clinical Study Outcome Comparison Table
4 Nasser A, Kosheleff AR, Hull JT, et al. Translating Attention-Deficit/Hyperactivity Disorder Rating Scale-5 and Weiss Functional Impairment Rating Scale-Parent Effectiveness Scores into Clinical Global Impressions Clinical AKILI CONFIDENTIAL
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Significance Levels in Four Randomized Clinical Trials of SPN-812 (Viloxazine Extended-Release) in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2021;31(3):214-226. doi:10.1089/cap.2020.0148
Akili Interactive Labs, Inc. Premarket Notification [510(k) Submission] EndeavorRx
2 Zhang, S., Faries, D. E., Vowles, M., & Michelson, D. (2005). ADHD rating scale IV: psychometric properties from a multinational study as clinician-administered instrument. International journal of methods in psychiatric research, 14(4), 186-201.
3 Nasser A, Kosheleff AR, Hull JT, et al. Translating Attention-Deficit/Hyperactivity Disorder Rating Scale-5 and Weiss Functional Impairment Rating Scale-Parent Effectiveness Scores into Clinical Global Impressions Clinical Significance Levels in Four Randomized Clinical Trials of SPN-812 (Viloxazine Extended-Release) in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2021;31(3):214-226. doi:10.1089/cap.2020.0148
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| Outcome Measure | Clinical Study for
Subject Device
EndeavorRx v3.0
(K231337) | Clinical Study for
Predicate Device
(DEN200026) | Comparison |
|-----------------|----------------------------------------------------------------------|-------------------------------------------------------|------------|
| | Adolescents
(ages 13-17)(Efficacy
Population; n=146) | STARS
(ages 8-12)(IIT;
n=180) | |
| | | | Score.4 |
Clinical Safety Outcome Comparison Table
| Safety Outcomes | Clinical Study for
Subject Device
EndeavorRx v3.0
(K231337) | Clinical Study for
Predicate Device
(DEN200026) | Comparison |
|--------------------------------------------------------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------------|------------------------------------------------|
| | Adolescents
(ages 13-17)(Efficacy
Population; n=162) | STARS
(ages 8-12)(IIT;
n=180) | |
| 1. Any TE-ADE | 4 (2.5%) | 12 (6.7%) | Adolescents show better
(lower) TE-ADE rate |
| 2. TE-ADE related to
study treatment
(possibly, probably, and
definitely-related) | 4 (2.5%) | 12 (6.7%) | Adolescents show better
(lower) TE-ADE rate |
| 3. Serious TE-ADE | 0 (0%) | 0 (0%) | No difference |
| 4. TE-ADE leading to
study discontinuation | 0 (0%) | 0 (0%) | No difference |
| 5. Unanticipated TE-ADE | 0 (0%) | 0 (0%) | No difference |
4 Zhang, S., Faries, D. E., Vowles, M., & Michelson, D. (2005). ADHD rating scale IV: psychometric properties from a multinational study as clinician-administered instrument. International journal of methods in psychiatric research, 14(4), 186-201.
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Substantial Equivalence Discussion:
EndeavorRx has the same intended use and similar indications, technological characteristics, and principles of operation as the predicate device, EndeavorRx (DEN200026). Moreover, EndeavorRx complies with the same special controls as the predicate Endeavor Rx (DEN200026) set forth in 21 CFR § 882.5803. The expanded age range and minor software changes do not raise different questions of safety or efficacy.
Substantial equivalence was supported by clinical and non-clinical performance (verification and validation) tests, which complied with the requirements specified in the international and FDA-recognized consensus standards, ISO 14971, IEC 62304, and IEC 82304. The non-clinical testing included software testing, which verified the minor software changes in EndeavorRx. Clinical testing validated the safety and effectiveness of EndeavorRx for its intended use in the indicated patient age range of 8-17 years old. The prior clinical trial results that supported the original clearance of EndeavorRx for 8-12 vear old patients under DEN200026 support the use of EndeavorRx in the younger cohort. A new clinical study was executed to demonstrate the performance and safety of EndeavorRx in the older cohort of adolescents 13 to 17 years of age. The clinical trial results showed a significant improvement in the primary effectiveness measure, TOVA, a digitally assessed measure of sustained and selective attention. Results also showed improvements in ADHD symptoms as assessed in key secondary measures, the ADHD-RS inattention scale and ADHD-RS total score. These results were similar to the findings of the prior clinical trial that supported the original clearance of EndeavorRx for 8-12 year-old patients under DEN200026. The clinical testing also showed no new or increased safety risks in the expanded patient population compared to the predicate device.
The results of these tests demonstrate that EndeavorRx is as safe and effective as its predicate device. Therefore, EndeavorRx is substantially equivalent.
No serious adverse events were reported. Of 342 participants who Benefit-Risk Profile: received AKL-T01 in the two clinical trials supporting EndeavorRx authorization for age ranges 8-17, 16 participants (9.88%) experienced treatment-related adverse events (TE-ADE) (possible, probable, likely). TE-ADEs reported at greater than 1% across the studies include: frustration tolerance decreased (2.34%) and headache (1.17%). Other adverse events occurred less than 1% and included dizziness, emotional disorder, nausea, and aggression. All adverse events were transient and no events led to device discontinuation. All adverse events resolved by the end of treatment.
EndeavorRx showed a general improvement in attention as well as areas
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of improvement in other symptoms associated with ADHD. The totality of the evidence demonstrated clinical benefit in attention, as measured by the TOVA, as well as other assessments of symptoms and functioning in children with ADHD with a demonstrated attention issue. Improvements in ADHD symptoms and impairment favored EndeavorRx over control, including rates of participants exhibiting clinically meaningful symptom reductions. As noted, the risks associated with EndeavorRx are minimal
For EndeavorRx the AE rates were extremely low, in mild-moderate severity range. There were no SAEs, and all AE's were resolved. Given the favorable safety profile, even small benefit would justify use of the product.