(267 days)
Not Found
No
The summary describes a digital therapeutic delivering CBT techniques and presents results from a clinical trial comparing it to psychoeducation. There is no mention of AI, ML, or any related technologies in the device description, performance studies, or key metrics.
Yes
The device is intended to treat generalized anxiety disorder by improving a patient's GAD symptoms, indicating a therapeutic purpose.
No
Explanation: The device is described as a "digital therapeutic intended to treat generalized anxiety disorder (GAD) by improving a patient's GAD symptoms," not to diagnose GAD.
Yes
The device description explicitly states that the program is delivered digitally through iOS/Android apps, indicating it is software-based. There is no mention of any accompanying hardware components required for its function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Daylight's Function: Daylight is a digital therapeutic that delivers Cognitive Behavioral Therapy (CBT) directly to the patient through a mobile application. It does not involve the analysis of any biological samples.
- Intended Use: The intended use clearly states that Daylight is a "prescription device delivering Cognitive Behavioral Therapy" and is "intended to treat generalized anxiety disorder (GAD) by improving a patient's GAD symptoms." This is a therapeutic intervention, not a diagnostic test.
- Device Description: The description reinforces that it's a "digital therapeutic designed to address the symptoms of adults with generalized anxiety disorder (GAD) through the use of Cognitive Behavioral Therapy (CBT) techniques."
- Lack of Biological Sample Analysis: There is no mention of collecting or analyzing any biological samples.
Therefore, based on the provided information, Daylight falls under the category of a digital therapeutic or a software as a medical device (SaMD) for treatment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Daylight is a prescription device delivering Cognitive Behavioral Therapy and can be made available on the order of a licensed healthcare provider. Daylight is a digital therapeutic intended to treat generalized anxiety disorder (GAD) by improving a patient's GAD symptoms as an adjunct to usual care in patients aged 22 years and older.
Product codes
SCP
Device Description
Daylight is a digital therapeutic designed to address the symptoms of adults with generalized anxiety disorder (GAD) through the use of Cognitive Behavioral Therapy (CBT) techniques. The Daylight program is has been demonstrated to help improve symptoms of GAD, if followed correctly, and is supported by evidence from peer-reviewed studies and clinical trials. The program is delivered digitally through the Daylight iOS/Android apps, giving users easy access to effective techniques.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
patients aged 22 years and older
Intended User / Care Setting
Patients, licensed healthcare providers (physicians, practitioners, psychologists, and registered nurses)
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
Daylight was evaluated in the Generalized Anxiety Therapy Effectiveness (GATE) trial which was a two-arm, parallel group, randomized controlled trial (RCT) comparing digital CBT (Daylight) with online anxiety psychoeducation in 351 adults aged 22+ with generalized anxiety disorder (GAD). Participants were recruited from across the United States via social media. Participants with a diagnosis of GAD according to DSM-5 were allocated to receive Daylight (n=175) or online anxiety psychoeducation (n=176), using a blind-tohypothesis approach.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Randomized controlled trial (RCT)
Sample Size: 351 adults (175 in Daylight arm, 176 in psychoeducation arm)
Key Results:
- Co-primary outcome measures: remission based on the Clinical Global Impression - Improvement scale (CGI-I) scores of 1 or 2 and patientreported generalized anxiety symptom severity, assessed using the generalized anxiety disorder 7-item questionnaire (GAD-7).
- The primary endpoint was 10 weeks post-randomization and a follow-up assessment occurred at 24 weeks post-randomization.
- GAD-7 scores:
- Week 6: Adjusted difference of 3.42 (2.50, 4.34) with Cohen's d of 1.04, p
§ 882.5801 Computerized behavioral therapy device for psychiatric disorders.
(a)
Identification. A computerized behavioral therapy device for psychiatric disorders is a prescription only device intended to provide a computerized version of condition-specific behavioral therapy as an adjunct to clinician supervised outpatient treatment to patients with psychiatric conditions. The digital therapy is intended to provide patients access to therapy tools used during treatment sessions to improve recognized treatment outcomes.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical data must be provided to fulfill the following:
(i) Describe a validated model of behavioral therapy for the psychiatric disorder; and
(ii) Validate the model of behavioral therapy as implemented by the device.
(2) Software must be described in detail in the software requirements specification (SRS) and software design specification (SDS). Software verification, validation, and hazard analysis must be performed. Software documentation must demonstrate that the device effectively implements the behavioral therapy model.
(3) The following labeling must be provided:
(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 compatible devices.
(iii) Patient and physician labeling must include a warning that the device is not intended for use as a standalone therapy.
(iv) Patient and physician labeling must include a warning that the device does not represent a substitution for the patient's medication.
(v) Physician labeling must include a summary of the clinical testing with the device.
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August 30, 2024
Big Health, Inc. Reuben Lawson Vice President, Regulatory Affairs & Quality Systems 461 Bush St. Suite 200 San Francisco, California 94108
Re: K233872
Trade/Device Name: Daylight Regulation Number: 21 CFR 882.5801 Regulation Name: Computerized Behavioral Therapy Device For Psychiatric Disorders Regulatory Class: Class II Product Code: SCP Dated: August 1, 2024 Received: August 1, 2024
Dear Reuben Lawson:
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.
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).
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Your device is also subject to, among other requirements, the Quality System (OS) 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).
Sincerely,
Pamela D. Scott -S
Pamela D. Scott 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
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Indications for Use
510(k) Number (if known) K233872
Device Name Daylight
Indications for Use (Describe)
Daylight is a prescription device delivering Cognitive Behavioral Therapy and can be made available on the order of a licensed healthcare provider. Daylight is a digital therapeutic intended to treat generalized anxiety disorder (GAD) by improving a patient's GAD symptoms as an adjunct to usual care in patients aged 22 years and older.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary - K233872
1. Submitter
| Submitted by: | Big Health Inc. |
|---|---|
| Contact Name: | Reuben Lawson, |
| Vice President, Quality Systems & Regulatory Affairs | |
| Contact Phone: | (949) 439 3629 |
| Additional Contact: | Dr. Tali M. Ball, Senior Manager, Clinical Research |
| Device | |
| Device name: | Daylight |
| Classification name: | Computerized Behavioral Therapy for |
| Psychiatry Disorders (21 CFR 882.5801) | |
| Regulatory class: | Class II (Special Controls) |
| Product code: | SCP |
| Predicate device | |
| Device name: | Somryst |
| Manufacturer: | Pear Therapeutics |
| Classification name: | Computerized Behavioral Therapy for |
| Psychiatry Disorders (21 CFR 882.5801) | |
| Regulatory class: | Class II (Special Controls) |
| 510(k) Number: | K191716 |
4. Device Description
Product code:
Daylight is a digital therapeutic designed to address the symptoms of adults with generalized anxiety disorder (GAD) through the use of Cognitive Behavioral Therapy (CBT) techniques. The Daylight program is has been demonstrated to help improve symptoms of GAD, if followed correctly, and is supported by evidence from peer-reviewed studies and clinical trials. The program is delivered digitally through the Daylight iOS/Android apps, giving users easy access to effective techniques.
QVO
5. Intended use / Indications for use
Daylight is a prescription device delivering Cognitive Behavioral Therapy and can be made available on the order of a licensed healthcare provider. Daylight is a digital therapeutic intended to treat generalized anxiety disorder (GAD) by improving a patient's GAD symptoms as an adjunct to usual care in patients aged 22 years and older.
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6. Substantial equivalence
Daylight has an identical intended use and nearly identical technological characteristics compared to the predicate device, Somryst. Like Somryst, Daylight delivers cognitive behavioral therapy for treatment of psychiatric disorders by way of an app provided as an adjunct to usual care by the patient's healthcare provider. The specific indication differs, in that Daylight is indicated for use in treatment of generalized anxiety disorder (GAD), not insomnia disorder. Patients can only access the product on the order of a licensed healthcare provider, who will themselves have access to patient progress through an online portal where salient patient information is provided. The software and clinical validation data demonstrate that Daylight doesn't raise different types of questions of safety or effectiveness. Thus, considering available performance testing, Daylight is considered substantially equivalent to Somryst.
| Category | Daylight (this submission) | Somryst (predicate) |
|---|---|---|
| 510(k) number | K233872 | K191716 |
| Classification regulation | 21 CFR 882.5801 | |
| Computerized behavioral | ||
| therapy device for psychiatric | ||
| disorders | 21 CFR 882.5801 | |
| Computerized behavioral | ||
| therapy device for psychiatric | ||
| disorders | ||
| Intended use | SaMD intended to be | |
| computerized behavioral | ||
| therapy device to treat patients | ||
| with generalized anxiety | ||
| disorder (GAD) | SaMD intended to be | |
| computerized behavioral | ||
| therapy device to treat patients | ||
| with chronic insomnia | ||
| Indications for use | Daylight is a digital therapeutic | |
| intended for the treatment of | ||
| generalized anxiety disorder | ||
| as an adjunct to usual care in | ||
| patients aged 22 years and | ||
| older. Daylight is a prescription | ||
| device delivering Cognitive | ||
| Behavioral Therapy and can | ||
| be made available on the | ||
| order of a licensed healthcare | ||
| provider. | Somryst is a prescription-only | |
| digital therapeutic intended to | ||
| provide a neurobehavioral | ||
| intervention (Cognitive | ||
| Behavioral Therapy for | ||
| Insomnia - CBT-I) in patients | ||
| 22 years of age and older with | ||
| chronic insomnia. Somryst | ||
| treats chronic insomnia by | ||
| improving a patient's insomnia | ||
| symptoms | ||
| Intended User population | Patients, licensed healthcare | |
| providers (physicians, | ||
| practitioners, psychologists, | ||
| and registered nurses) | Patients, licensed healthcare | |
| providers (physicians, | ||
| practitioners, psychologists, | ||
| and registered nurses) | ||
| Medical Device Type | Software as a Medical Device | |
| (SaMD) | Software as a Medical Device | |
| (SaMD) | ||
| Access | Prescription only | Prescription only |
| Adjunct use | Adjunct to supervised | |
| outpatient treatment | Adjunct to supervised | |
| outpatient treatment |
Table 1: Substantial Equivalence Assessment
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| Mobile platform | Mobile application
(Smartphones, tablets [iOS
and Android]) | Mobile application
(Smartphones, tablets [iOS
and Android]) |
|-----------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Software architecture | Patient facing mobile
application, clinician facing
dashboard, backend services | Patient facing mobile
application, clinician facing
dashboard, backend services |
| Software safety
classification | Class B | Class B |
7. Performance data
7.1. Summary of nonclinical performance data
Software verification and validation testing was completed and documentation was provided as recommended by Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005), for a Moderate level of concern device.
7.2. Summary of clinical performance data
Daylight was evaluated in the Generalized Anxiety Therapy Effectiveness (GATE) trial which was a two-arm, parallel group, randomized controlled trial (RCT) comparing digital CBT (Daylight) with online anxiety psychoeducation in 351 adults aged 22+ with generalized anxiety disorder (GAD). Participants were recruited from across the United States via social media. Participants with a diagnosis of GAD according to DSM-5 were allocated to receive Daylight (n=175) or online anxiety psychoeducation (n=176), using a blind-tohypothesis approach.
Although psychoeducation and Daylight have some differences in format and interactivity, the psychoeducation control used in the GATE trial matched Daylight on key characteristics including human contact, self-pacing, and retention. Although Daylight included more content separated into modules and required more time to complete, both groups were able to access all of the content immediately and neither treatment was time-locked. In prior research1 on the Daylight device and the same psychoeducation treatment, psychoeducation has also been shown to match Daylight on patient perceptions of credibility and expectation of benefit (Table 2).
| Psychoeducation | Daylight | |
|---|---|---|
| Credibility | 22.0 (SD = 3.8) | 19.5 (SD = 4.0) |
| Expectancy | ||
| (average expected | ||
| symptom reduction) | 32% | 39% |
Table 2. Patient credibility and expectancy of Psychoeducation and Daylight
Carl et al (2020). Efficacy of digital cognitive behave symptoms of generalized anxiety disorder: A randomized ontrolled trial. Depression and Anxiety, 37(12), 1168–1178. https://doi.org/10.1002/da.23079; and additional unpublished internal data
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Note: SD = standard deviation.
The co-primary outcome measures were remission based on the Clinical Global Impression - Improvement scale (CGI-I) scores of 1 or 2 and patientreported generalized anxiety symptom severity, assessed using the generalized anxiety disorder 7-item questionnaire (GAD-7). The primary endpoint was 10 weeks post-randomization and a follow-up assessment occurred at 24 weeks post-randomization. Secondary outcomes included depression symptoms assessed by the Patient Health Questionnaire (PHQ-8), insomnia symptoms assessed by the Sleep Condition Indicator (SCI-8), and anxiety severity assessed by the Clinical Global Impression - Severity (CGI-S) scale and the patient-reported Overall Anxiety Severity and Impairment Scale (OASIS).
Across the total sample, 24% of participants (23% Daylight and 25% Control) were taking concomitant prescription anxiety medications at baseline, and 18% of participants (19% Daylight, 18% Control) were taking non-prescription substances to target anxiety. In addition, 4% of participants reported having seen a treatment provider for anxiety in the 3 weeks prior to their baseline assessment (4% Daylight, 4.5% Control), and 41% of participants reported previous therapy experience (38% Daylight, 43% Control).
A summary of the results of the GATE trial for Daylight vs psychoeducation is provided in Tables 3 and 4 and Figure 1 below.
| Unadjusted mean (SD) | Adjusted difference | Cohen's d | p-value | ||
|---|---|---|---|---|---|
| Daylight | Psychoeducation | ||||
| Control | (95% CI) | ||||
| Baseline | 15.58 (3.50) | ||||
| n = 175 | 16.14 (3.07) | ||||
| n = 176 | N/A | N/A | N/A | ||
| Week 6 | 8.82 (4.50) | ||||
| n = 159 | 12.45 (4.35) | ||||
| n = 170 | 3.42 (2.50, 4.34) | 1.04 | p 1 indicates greater odds of remission in Daylight than Psychoeducation Control; OR = Odds Ratio; Cl=Confidence Interval. |
One adverse event was rated "probably" related to Daylight use during the treatment period: worsening panic attack severity. Adverse events that were rated "possibly" related to Daylight use were: panic attacks (n=4 [2.3%]), depression symptoms (n=5 [2.9%]), premenstrual/post-partum/seasonal mood symptoms (n=3 [1.7%]), thoughts of death or suicide (n=3 [1.7%]), PTSD symptoms (n=1 [0.6%]), musculoskeletal pain (n=6 [3.4%]), and headache (n=3 [1.7%]).Two serious adverse events were reported by study participants in the Daylight arm; neither of these were related to use of Daylight or participation in the trial. There were no unanticipated adverse device effects.
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8. Conclusion
Daylight and the predicate Somryst have the same Intended Use as computerized behavioral therapy devices for psychiatric disorders. There are slight differences in indications for use in that Daylight is indicated for treatment of symptoms of generalized anxiety disorder, but this does not constitute a new intended use. Daylight has similar technological characteristics to Somryst, including software architecture and delivery of digital cognitive behavioral therapy through a mobile application. Software testing and pivotal clinical study results validate Daylight towards its proposed Indications for Use. This validation reasonably assures that Daylight is substantially equivalent to the predicate device. Further, Daylight met all of the Special Controls per the requirements of the regulation (21 CFR 882.5801). Thus, Daylight is substantially equivalent to Somryst.