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    K Number
    K211372
    Device Name
    Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS)
    Date Cleared
    2021-06-02

    (29 days)

    Product Code
    Regulation Number
    876.5960
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mahana Therapeutics Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Parallel™ is a prescription-only digital therapeutic intended to provide cognitive behavioral therapy for adults aged 22 years of age and older who have been diagnosed with Irritable Bowel Syndrome (IBS). Parallel is indicated as a 3 month treatment for patients with IBS. Parallel treats IBS by reducing the severity of symptoms and is intended to be used together with other IBS treatments.
    Device Description
    Parallel is a Prescription Digital Therapeutic (PDT) mobile application designed to deliver Cognitive Behavioral Therapy (CBT) to patients with Irritable Bowel Syndrome (IBS). PDTs are a new class of treatment using software to treat medical diseases. The Parallel CBT program has been tailored for patients with IBS. The rationale for applying CBT to treat IBS is grounded in the biopsychosocial model. This model states that one's biology, thoughts, and behaviors influence IBS symptom expression in a bidirectional way. The biological substrate of these interactions that affect IBS outcomes is the "brain-gut axis". The brain-gut axis underlies the pathways (e.g., psychological, behavioral functioning, and physiological interactions) that contribute to IBS symptom manifestation. CBT allows patients to influence brain-gut communication in order to reduce the severity of IBS. Parallel is available by prescription only and is intended to provide 3 months of cognitive behavioral therapy for adult patients, aged 22 years and older, with IBS. Parallel is intended to provide CBT, as an adjunct to any other IBS treatments. The Parallel mobile application uses the patient's mobile phone or tablet to deliver therapy on demand as a complement to the provider's care. Typical length of the therapy period is 3 months and is composed of ten (10) sessions. The first session explains IBS symptoms, the key features of the brain-gut axis, and the personalization of the rationale for CBT. The next nine (9) sessions provide personalized treatment for IBS by asking patients and getting them to complete interactive tasks. Each session contains several pages of content which may be text, audio files, video files, or interactive components. During the program, patients are provided short tasks to complete during the week. Patients are also asked to complete questionnaires from time to rate the severity of their IBS symptoms and the impact symptoms are having on their life and mood.
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