Week of September 11, 2017


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reSET 

Pear Therapeutics

INDICATION FOR USE:  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
 increase retention in the outpatient treatment program.

ADDRESSING UNMET NEED:

  • Alcohol, cocaine, marijuana and stimulant SUDs cause clinically and functionally significant impairments
  • Innovative digital technology to provide additional tools during their treatment

REG PATHWAY: De Novo Request

  • Regulation Number: 21 CFR 882.5801
  • Regulation Name: Computerized behavioral therapy device for psychiatric disorders
  • Regulatory Class: Class II
  • Product Code: PWE

GENERIC DEVICE TYPE:  Computerized behavioral therapy device for psychiatric disorders

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.

DEVICE DESCRIPTION: 

  • Mobile medical application system: Patient application + clinician dashboard
  • Delivers cognitive behavioral therapy to teach the user skills that aid in the treatment of SUD
  • Intended to increase abstinence from substance abuse and increase retention in outpatient therapy programs
  • Used in conjunction with outpatient therapy and in addition to a contingency management system (widely-used program for treating SUD)

EFFECTIVENESS AND SAFETY:

  • Multi-site, unblinded 12-week clinical trial, n=399, patients with alcohol, cocaine, marijuana and stimulant SUD, standard treatment + desktop-based version of reSET Vs. standard treatment
  • Statistically significant increase in adherence to abstinence : with reSET (40.3%) vs. who did not (17.6%)
  • Not effective in patients reporting opioids as their substance of abuse
  • No indication of side effects

IDENTIFIED RISKS & MITIGATION MEASURES:

  • Device provides ineffective treatment, leading to worsening condition: Clinical data
    Software verification, validation, and hazard analysis, Labeling
  • Device software failure, leading to delayed access: Software verification, validation, and hazard analysis
  • Use error / improper device use: Labeling

CLASSIFICATION ORDER


Image credit: Pear Therapeutics

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