(374 days)
reSET, DEN160018
Not Found
No
The summary describes a digital therapeutic delivering pre-programmed cognitive behavioral therapy and skill-building exercises based on the Community Reinforcement Approach. There is no mention of adaptive learning, predictive analytics, or any other features typically associated with AI/ML. The performance study focuses on dropout rates and abstinence based on a fixed intervention, not on the performance of an AI/ML algorithm.
Yes
The device is intended to increase retention of patients with opioid use disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, and is explicitly described as a "digital therapeutic" and an "adjunct to standard of care for patients with OUD."
No.
The device is a digital therapeutic intended to provide cognitive behavioral therapy and increase patient retention, not to diagnose a condition.
Yes
The device description explicitly states it is a "prescription digital therapeutic" and describes its function as delivering behavioral therapy through interactive lessons, text, audio, videos, animations, and graphics. There is no mention of any hardware component being part of the device itself.
Based on the provided information, 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 (like blood, urine, tissue) to detect diseases, conditions, or infections.
- reSET-O's Function: reSET-O is a digital therapeutic that provides cognitive behavioral therapy and skill-building exercises. It interacts directly with the patient through a digital interface and does not involve analyzing biological samples.
- Intended Use: The intended use clearly states it's for increasing retention of patients with opioid use disorder by providing therapy as an adjunct to outpatient treatment. This is a therapeutic intervention, not a diagnostic test.
- Device Description: The description focuses on delivering behavioral therapy through interactive lessons and supporting clinician-patient communication. There is no mention of analyzing biological samples or performing diagnostic tests.
Therefore, reSET-O falls under the category of a digital therapeutic or prescription digital therapeutic, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
reSET-O™ is intended to increase retention of patients with opioid use disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only digital therapeutic.
Product codes
PWE
Device Description
reSET-O™ is a 12-week interval prescription digital therapeutic for Opioid Use Disorder (OUD). reSET-O™ is modeled on the Community Reinforcement Approach (CRA) and engineered to deliver behavioral therapy for patients with OUD. reSET-O™ delivers CRA therapy as a series of interactive therapy lessons. Each therapy lesson is comprised of a cognitive behavioral therapy component and skill building exercises. Therapy lesson content is delivered primarily via text or audio, and may include videos, animations and graphics.
reSET-O™ is intended as an adjunct to standard of care for patients with OUD. It is limited to persons with a valid prescription from their licensed provider. reSET-O™ supports clinician-patient communication between visits, by providing a means for patients to self-report cravings and triggers, and buprenorphine use/non-use. reSET-O™ reinforces the importance of using buprenorphine for treatment of OUD.
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
18 years or older
Intended User / Care Setting
Clinician, outpatient treatment
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)
Clinical data: reSET-O was validated to meet its intended use in a randomized clinical trial (Clinical Trials identifier, NCT00929253). The study enrolled 170 patients seeking treatment for OUD. All study participants met DSM-IV criteria for opioid dependence and qualified for buprenorphine treatment. Patients were randomized to 12-weeks of treatment as usual (TAU) or TAU plus (Therapeutic Educational System) TES. TAU included thrice-weekly in-person administration of buprenorphine treatment, thrice-weekly urine testing, contingency management system, and a face to face visit with a clinician every other week. The primary outcome was abstinence defined as the longest documented period of continuous abstinence from opioids and cocaine for each participant.
The results of the clinical study demonstrates that treatment dropout during the 12-week intervention was reduced in the TES group compared to the TAU group. The dropout rate in the TES group was 17.6% compared to 31.6% in the TAU group, with a p-value of 0.0224. This reduction in treatment dropout was significant.
Abstinence was evaluated for trend over 12 weeks in the three times a week Urine Drug Screen (UDS). The ability of reSET-O to improve abstinence has not been established as clinically significant.
Adverse events were collected and monitored throughout the study, and showed that there was no difference in AE rates between the TES and TAU groups.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Dropout rate in TES group: 17.6%
Dropout rate in TAU group: 31.6%
p-value: 0.0224
Predicate Device(s)
reSET, DEN160018
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
May 23, 2019
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Pear Therapeutics, Inc. Nandini Murthy Regulatory Consultant to Pear Therapeutics, Inc. 745 Atlantic Ave. Boston, Massachusetts 02111
Re: K173681
Trade/Device Name: reSET-O Regulation Number: 21 CFR 882.5801 Regulation Name: Computerized behavioral therapy device for psychiatric disorders Regulatory Class: Class II Product Code: PWE Dated: August 21, 2019 Received: August 22, 2018
Dear Nandini Murthy:
This letter corrects our substantially equivalent letter of December 10, 2018.
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 (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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Carlos Pena, PhD, MS Director OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173681
Device Name reSET-O
Indications for Use (Describe)
reSET-O™ is intended to increase retention of patients with opioid use disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only digital therapeutic.
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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Appendix 2A. 510 (k) Summary [Clean Version]
Pear Therapeutics, Inc.
Traditional 510(k) Premarket Notification Submission - reSET-O
510(k) SUMMARY
| Submitter Name: | Pear Therapeutics, Inc. |
|---|---|
| Submitter Address: | 201 Mission St., San Francisco, CA 94710 |
| Contact Person: | Yuri Maricich |
| Phone Number: | (206) 369-9784 |
| Submission Correspondent: | David Amor |
| Phone Number: | (786) 546-1806 |
| Date Prepared: | November 19, 2018 |
| Device Trade Name: | reSET-O |
| Device Common Name: | Prescription Digital Therapeutic |
| Classification regulation: | 21 CFR 882.5801, Class II Product Code PWE |
| Predicate Device: | reSET, DEN160018 |
| Classification Name: | Computerized Behavioral Therapy Device for Psychiatric Disorders |
Device Description:
reSET-O™ is a 12-week interval prescription digital therapeutic for Opioid Use Disorder (OUD). reSET-O™ is modeled on the Community Reinforcement Approach (CRA) and engineered to deliver behavioral therapy for patients with OUD. reSET-O™ delivers CRA therapy as a series of interactive therapy lessons. Each therapy lesson is comprised of a cognitive behavioral therapy component and skill building exercises. Therapy lesson content is delivered primarily via text or audio, and may include videos, animations and graphics.
reSET-O™ is intended as an adjunct to standard of care for patients with OUD. It is limited to persons with a valid prescription from their licensed provider. reSET-O™ supports clinician-patient communication between visits, by providing a means for patients to self-report cravings and triggers, and buprenorphine use/non-use. reSET-O™ reinforces the importance of using buprenorphine for treatment of OUD.
4
Pear Therapeutics, Inc.
Traditional 510(k) Premarket Notification Submission – reSET-O
Indications for Use:
reSET-O™ is intended to increase retention of patients with opioid use disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only digital therapeutic.
Comparison of reSET-O versus predicate Rationale for Substantial Equivalence:
| Characteristics | reSET-O
K173681 | reSET (Predicate)
DEN160018 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | 21 CFR 882.5801
PWE | 21 CFR 882.5801
PWE |
| Intended Use | Intended to increase retention in
patients with Opioid Use Disorder
(OUD) | Intended to increase abstinence
and retention in patients with
Substance Use Disorder (SUD) |
| Indications for Use | reSET-O™ is intended to
increase retention of patients with
opioid use disorder (OUD) in
outpatient treatment by providing
cognitive behavioral therapy, as
an adjunct to outpatient treatment
with transmucosal buprenorphine
and contingency management, for
patients 18 years or older who are
currently under the supervision of
a clinician. reSET-O is indicated
as a prescription-only digital
therapeutic. | reSET is intended to provide
cognitive behavioral therapy, as an
adjunct to a contingency
management system, for patients 18
years of age and older who are
currently enrolled in outpatient
treatment under the supervision of a
clinician. reSET is indicated as a 12
week (90 days) prescription-only
treatment for patients with
substance use disorder (SUD), who
are not currently on opioid
replacement therapy, who do not
abuse alcohol solely, or who do not
abuse opioids as their primary
substance of abuse. It is intended to:
increase abstinence from a
●
patient's substances of
abuse during treatment, and
increase retention in the
●
outpatient treatment
program. |
5
| Characteristics | reSET-O
K173681 | reSET (Predicate)
DEN160018 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| System
components | Patient facing app, mobile device
platform
Clinician facing app, PC/web
platform | Patient facing app, mobile device
platform
Clinician facing app, PC/web
platform |
| Access | Rx only | Rx only |
| Users | Patients with an opioid use
disorder. | Patients with a substance use
disorder who are not currently on
opioid replacement therapy,
abuse alcohol solely or whose
primary substance of abuse is
opioids. |
| Contingency
Management | Yes | Yes |
| Adjunctive
application | Yes - to Treatment as Usual
(TAU), that includes
transmucosal buprenorphine in
addition to outpatient treatment
and contingency management | Yes - to Treatment as Usual
(TAU), that includes outpatient
treatment and contingency
management |
reSET-O™ and reSET® are both prescription devices, with similar application for use in an outpatient treatment program (standard of care). Retention in the program is a key goal in outpatient treatment for any substance use disorder. Both reSET and reSET-O are adjunctive to standard of care. The only difference with the standard of care for patients with OUD (reSET-O™) is that it includes pharmacotherapy (buprenorphine) along with outpatient treatment.
Performance Data:
Bench data: The results of bench software verification and validation testing supports that reSET-O functions as intended.
Clinical data: reSET-O was validated to meet its intended use in a randomized clinical trial! (Clinical Trials identifier, NCT00929253). The study enrolled 170 patients seeking treatment for OUD. All study participants met DSM-IV criteria for opioid dependence
1 Christensen DR, Landes RD, Jackson L, et al. Adding an Internet-delivered treatment to an efficacious treatment package for opioid dependence. J Consult Clin Psychol. 2014;82(6):964-972. doi:10.1037/a0037496
6
Pear Therapeutics. Inc.
Traditional 510(k) Premarket Notification Submission - reSET-O
and qualified for buprenorphine treatment. Patients were randomized to 12-weeks of treatment as usual (TAU) or TAU plus (Therapeutic Educational System) TES. TAU included thrice-weekly in-person administration of buprenorphine treatment2, thriceweekly urine testing, contingency management system, and a face to face visit with a clinician every other week. The primary outcome was abstinence defined as the longest documented period of continuous abstinence from opioids and cocaine for each participant.
The results of the clinical study demonstrates that treatment dropout during the 12-week intervention was reduced in the TES group compared to the TAU group. The dropout rate in the TES group was 17.6% compared to 31.6% in the TAU group, with a p-yalue of 0.0224. This reduction in treatment dropout was significant.
Abstinence was evaluated for trend over 12 weeks in the three times a week Urine Drug Screen (UDS). The ability of reSET-O to improve abstinence has not been established as clinically significant.
Adverse events were collected and monitored throughout the study, and showed that there was no difference in AE rates between the TES and TAU groups.
Conclusion:
reSET-O has similar indications statements as the predicate device. Both devices are used to provide computerized behavioral therapy to patients suffering from substance use disorder. Both devices are adjunctive to standard of care for patients, intended to provide and reinforce therapy delivered in outpatient treatment. Both devices include self-report features that allow the patient and clinician to recognize patterns related to substance use, triggers and cravings.
Preclinical software testing and pivotal clinical study results validate reSET-O towards its proposed intended use. Further, reSET-O met all of the Special controls per the requirements of the predicate (DEN160018).
Therefore, reSET-O is substantially equivalent to the predicate reSET device.
2 Buprenorphine treatment consisted of buprenorphine/naloxone combination administered sublingually (4:1) ratio during the 12-week study